Drugs / Cemiplimab
Cemiplimab
also known as
REGN2810 · Cemiplimab-Rwlc · LIBTAYO · cemi · Cemiplemab · LIBTAYO (cemiplimab) · REGN2810/ipi · SAR439684
Monoclonal antibody targets PDCD1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 16 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed non-small cell lung carcinoma 3 milestones | |||||
| Filed | Japan (PMDA) | Libtayo | non-small cell lung carcinoma | 2024-10-31 | “The Company submitted a regulatory application in Japan for Libtayo for first-line advanced NSCLC” regeneron.com ↗ |
| Filed | US (FDA) | Libtayo | non-small cell lung carcinoma | 2022-02-04 | “The FDA accepted the sBLA for Libtayo® (cemiplimab), in combination with chemotherapy to treat patients with advanced non-small cell lung cancer” regeneron.com ↗ |
| Filed | EU (EMA) | Libtayo | non-small cell lung carcinoma | — | “The European Medicines Agency is assessing regulatory submissions for Libtayo monotherapy in advanced NSCLC with ≥50% PD-L1 expression” regeneron.com ↗ “A regulatory application for Libtayo as monotherapy in first-line NSCLC was also submitted in the EU.” regeneron.com ↗ |
| Filed sebaceous basal cell carcinoma 1 milestone | |||||
| Filed | EU (EMA) | Libtayo | sebaceous basal cell carcinoma | — | “A regulatory application for Libtayo in advanced BCC was also submitted in the EU.” regeneron.com ↗ |
| Filed skin squamous cell carcinoma 4 milestones | |||||
| Filed | US (FDA) | Libtayo | skin squamous cell carcinoma | 2025-04-29 | “Regulatory applications have been submitted for Libtayo in the treatment of adjuvant CSCC in the United States and European Union.” regeneron.com ↗ “The Company submitted an sBLA to the FDA and a regulatory application in the EU for Libtayo (cemiplimab) in adjuvant CSCC” regeneron.com ↗ |
| Filed | EU (EMA) | Libtayo | skin squamous cell carcinoma | 2025-04-29 | “In April 2018, the European Medicines Agency (EMA) also accepted for review the MAA for cemiplimab in patients with metastatic CSCC” regeneron.com ↗ “Regulatory applications have been submitted for Libtayo in the treatment of adjuvant CSCC in the United States and European Union.” regeneron.com ↗ “The Company submitted an sBLA to the FDA and a regulatory application in the EU for Libtayo (cemiplimab) in adjuvant CSCC” regeneron.com ↗ “A regulatory application for Libtayo has also been submitted in the EU.” regeneron.com ↗ |
| Filed | US (FDA) | — | skin squamous cell carcinoma | 2018-04-30 | “FDA has accepted for priority review the Biologics License Application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma” regeneron.com ↗ “In April 2018, the FDA accepted for priority review the BLA for cemiplimab for the treatment of patients with metastatic CSCC” regeneron.com ↗ |
| Filed | EU (EMA) | — | skin squamous cell carcinoma | 2018-04-03 | “has accepted for review the Marketing Authorization Application (MAA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma.” regeneron.com ↗ “the European Medicines Agency accepted for review in April 2018 the Marketing Authorization Application for cemiplimab in patients with metastatic CSCC” regeneron.com ↗ “In April 2018, the EMA also accepted for review the Marketing Authorization Application (MAA) for cemiplimab in patients with metastatic CSCC” regeneron.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (6) | US (FDA) | LIBTAYO | — | 2020-06-25 – 2025-10-08 | fda.gov ↗ |
| Approved | EU (EMA) | Libtayo | — | 2019-06-28 | europa.eu ↗ |
| Approved | US (FDA) | LIBTAYO | — | 2018-09-28 | fda.gov ↗ |
Trials 193 · started per year
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 138 trials | ||||||
| Phase 1 | NCT07422363 | Dec 2026 → Feb 2027 expected | IDH-wildtype glioblastoma, gliosarcoma | National Cancer Institute (NCI) | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07365839 | Oct 2026 → May 2035 | hepatocellular carcinoma | Virginia Commonwealth University | Withdrawn | No outcome recorded |
| Phase 1 | NCT07650266 | Jul 2026 → Jul 2030 expected | nasopharyngeal carcinoma | Memorial Sloan Kettering Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06826768 | Jul 2025 → May 2027 expected | prostate cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06902376 | Jun 2025 → Mar 2028 expected | thyroid gland undifferentiated (anaplastic) carcinoma | UNC Lineberger Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06874335 | Mar 2025 → Mar 2029 expected | cancer | Biohaven Therapeutics Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT06469281 | Aug 2024 → May 2030 expected | fallopian tube cancer, malignant epithelial tumor of ovary, primary peritoneal carcinoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT06171750 | Jan 2024 → Apr 2027 expected | metastatic neoplasm, non-small cell lung carcinoma, skin squamous cell carcinoma, soft tissue neoplasm | Ankyra Therapeutics, Inc | Recruiting | No outcome recorded |
| Phase 1 | NCT06508463 | Jan 2024 → Dec 2028 expected | anaplastic large cell lymphoma, mycosis fungoides, peripheral T-cell lymphoma, not otherwise specified | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 1 | NCT06022029 | Oct 2023 → Apr 2026 overdue | cervical cancer, diffuse large B-cell lymphoma, follicular lymphoma, head and neck squamous cell carcinoma +7 | OncoNano Medicine, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06052852 | Oct 2023 → Aug 2025 | clear cell renal carcinoma, colorectal cancer, head and neck cancer, melanoma +3 | Bolt Biotherapeutics, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT05704634 | Aug 2023 → Jan 2028 expected | lung cancer | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05259709 | Feb 2023 → May 2027 expected | metastatic neoplasm, neoplasm | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT05137054 | Aug 2022 → Mar 2028 expected | plasma cell myeloma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT05376553 | Jul 2022 → Oct 2025 overdue | head and neck squamous cell carcinoma | Krzysztof Misiukiewicz | Enrolling by invitation | No outcome recorded |
| Phase 1 | NCT05142189 | Jun 2022 → Feb 2030 expected | non-small cell lung carcinoma | BioNTech SE | Recruiting | No outcome recorded |
| Phase 1 | NCT04826393 | Mar → Oct 2022 | glioblastoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT04982224 | Nov 2021 → Oct 2025 | non-small cell lung carcinoma | Regeneron Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04975152 | Oct 2021 → Mar 2028 expected | cutaneous neuroendocrine carcinoma, skin squamous cell carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 1 | NCT05064085 | Oct 2021 → Sep 2024 | hormone receptor-positive breast cancer | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT05054348 | Sep 2021 → Apr 2024 | cancer | Immune-Onc Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04729725 | Feb 2021 → Dec 2022 | high grade malignant neoplasm, metastatic malignant neoplasm | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1 | NCT04722523 | Jan 2021 → Jun 2026 overdue | head and neck squamous cell carcinoma, malignant tumor of neck | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT04465487 | Oct 2020 → Feb 2025 | head and neck squamous cell carcinoma | Regeneron Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04428671 | May 2020 → Oct 2030 expected | skin squamous cell carcinoma | Emory University | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03889912 | Apr 2019 → Nov 2025 | basal cell carcinoma, skin squamous cell carcinoma | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT03871348 | Jan 2019 → Jul 2022 | metastatic neoplasm | Sanofi | Terminated | No outcome recorded |
| Phase 1 | NCT03477864 | Dec 2018 → Nov 2019 | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03580694 | Jun 2018 → Dec 2019 | non-small cell lung carcinoma | Regeneron Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT03198130 | Jul 2017 → Jun 2019 | head and neck squamous cell carcinoma | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT03233139 | Jun 2017 → Sep 2027 expected | cancer | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03192345 | Jun 2017 → Dec 2021 | cancer | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT03002376 | Apr 2017 → Mar 2019 | melanoma | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT03017820 | Apr 2017 → Dec 2028 expected | B-cell non-Hodgkin lymphoma, acute myeloid leukemia, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma +5 | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 1 | NCT03005782 | Nov 2016 → Apr 2024 | cancer | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02651662 | Jan 2016 → Apr 2026 | aggressive B-cell non-Hodgkin lymphoma | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02520245 | Aug 2015 → Nov 2023 | cancer | Regeneron Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 1 | NCT02383212 | Feb 2015 → Nov 2019 | cancer | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/233 trials · 2 missed | ||||||
| Phase 1/2 | NCT07567469 | Aug 2026 → Aug 2032 expected | pediatric high-grade glioma, posterior fossa group A ependymoma | Regeneron Pharmaceuticals | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07147231 | Aug 2026 → Sep 2027 expected | colorectal adenocarcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07594106 | Jul 2026 → Oct 2030 expected | castration-resistant prostate carcinoma, clear cell renal carcinoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07251413 | Oct 2025 → Dec 2028 expected | skin basal cell carcinoma | Instituto Oncológico Dr Rosell | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05538988 | Dec 2024 → Feb 2025 | mycosis fungoides | AHS Cancer Control Alberta | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT06413680 | Sep 2024 → Feb 2030 expected | clear cell renal carcinoma, melanoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06412198 | Aug 2024 → Mar 2029 expected | colorectal cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06162572 | Aug 2024 → Apr 2027 expected | non-small cell lung carcinoma | Servier Bio-Innovation LLC | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06384807 | Apr 2024 → Feb 2028 expected | neoplasm | Biohaven Therapeutics Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06088771 | Mar 2024 → Apr 2026 overdue | non-small cell lung carcinoma | Icahn School of Medicine at Mount Sinai | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04046107 | Jan 2024 → Sep 2027 | hepatitis B virus infection | National Institute of Allergy and Infectious Diseases (NIAID) | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT05882734 | Sep 2023 → Jul 2026 | non-small cell lung carcinoma | EMD Serono Research & Development Institute, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT05864144 | May 2023 → Jun 2026 | breast cancer, cervical cancer, colon carcinoma, cutaneous neuroendocrine carcinoma +13 | Sensei Biotherapeutics, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT05501665 | May 2023 → Feb 2026 overdue | non-small cell lung carcinoma | Vanderbilt-Ingram Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05259696 | Feb 2022 → Oct 2024 | breast cancer, colon carcinoma, gastric cancer, gastroesophageal cancer +7 | Palleon Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT04989946 | Dec 2021 → Dec 2026 expected | prostate cancer | University of Wisconsin, Madison | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05094804 | Sep 2021 → Apr 2024 | head and neck squamous cell carcinoma, leiomyosarcoma, liposarcoma, melanoma +2 | OncoResponse, Inc. | Unknown | No outcome recorded |
| Phase 1/2 | NCT04913220 | Jul 2021 → Aug 2023 | melanoma, skin squamous cell carcinoma | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04305795 | Dec 2020 → Jun 2026 overdue | head and neck squamous cell carcinoma, skin squamous cell carcinoma | Rakuten Medical, Inc. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04590326 | Dec 2020 → Nov 2028 expected | endometrial cancer, fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04339062 | Nov 2020 → Jun 2023 | skin squamous cell carcinoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT04382898 | Dec 2019 → Jan 2024 | prostate cancer | BioNTech SE | Terminated | Missed primary Stop: Business |
| Phase 1/2 | NCT03787095 | Aug 2019 → Aug 2020 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 1/2 | NCT03972657 | Aug 2019 → Nov 2027 expected | castration-resistant prostate carcinoma, clear cell renal carcinoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03684785 | Dec 2018 → Mar 2022 | cutaneous neuroendocrine carcinoma, head and neck squamous cell carcinoma, melanoma, skin squamous cell carcinoma | Exicure, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT03769181 | Dec 2018 → Nov 2022 | lymphoma | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03721679 | Sep 2018 → Jan 2021 | — | Oncovir, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03690869 | Sep 2018 → May 2023 | diffuse intrinsic pontine glioma, refractory malignant neoplasm | Regeneron Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03294083 | Jun 2018 → Feb 2023 | renal cell carcinoma | SillaJen, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT03491683 | May 2018 → Dec 2026 expected | glioblastoma | Inovio Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03564340 | May 2018 → May 2027 expected | endometrial cancer, fallopian tube cancer, malignant ovarian serous tumor, primary peritoneal carcinoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03194867 | Feb 2018 → Apr 2023 | plasma cell myeloma | Sanofi | Completed | No outcome recorded |
| Phase 1/2 | NCT03367819 | Jan 2018 → Mar 2021 | non-small cell lung carcinoma, prostate cancer | Sanofi | Terminated | Missed primary |
| Phase 2106 trials · 2 met primary | ||||||
| Phase 2 | NCT07346196 | Feb 2027 → Aug 2031 expected | squamous cell carcinoma | University of Chicago | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07450183 | Jan → Dec 2027 expected | non-small cell lung carcinoma | Henry Ford Health System | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07603856 | Dec 2026 → Jun 2030 expected | non-small cell lung carcinoma | University of Chicago | Recruiting | No outcome recorded |
| Phase 2 | NCT07527325 | Dec 2026 → Feb 2029 expected | cutaneous melanoma | University of California, Irvine | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06449313 | Nov 2026 → Dec 2027 expected | non-small cell lung carcinoma | Georgetown University | Recruiting | No outcome recorded |
| Phase 2 | NCT06418724 | Oct 2026 → Jul 2030 expected | skin squamous cell carcinoma | Melanoma and Skin Cancer Trials Limited | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07808515 | Oct 2026 → Nov 2030 expected | skin basal cell carcinoma | Regeneron Pharmaceuticals | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07470489 | Sep 2026 → Sep 2030 expected | thyroid gland undifferentiated (anaplastic) carcinoma | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07715734 | Sep 2026 → Mar 2031 expected | skin squamous cell carcinoma | Washington University School of Medicine | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07511036 | Sep 2026 → May 2028 expected | melanoma | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07281417 | Sep 2026 → Dec 2030 expected | nasal cavity and paranasal sinus squamous cell carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT07414992 | Sep 2026 → Mar 2028 | urothelial carcinoma | Memorial Sloan Kettering Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT07620548 | Aug 2026 → Feb 2031 expected | IDH-wildtype glioblastoma | Washington University School of Medicine | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07360743 | Aug 2026 → Dec 2028 expected | non-small cell lung carcinoma | UNICANCER | Recruiting | No outcome recorded |
| Phase 2 | NCT06943664 | Aug 2026 → May 2027 | non-small cell lung carcinoma | Roswell Park Cancer Institute | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT07433673 | Aug 2026 → Jan 2028 expected | colorectal cancer | Columbia University | Recruiting | No outcome recorded |
| Phase 2 | NCT07224022 | Jul 2026 → Aug 2028 expected | colon carcinoma | John Strickler, M.D. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07281768 | Jul 2026 → Jul 2030 expected | colorectal cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT07179315 | Jun 2026 → Nov 2029 expected | head and neck cancer | University of Chicago | Recruiting | No outcome recorded |
| Phase 2 | NCT07387198 | May 2026 → Dec 2029 expected | — | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting | No outcome recorded |
| Phase 2 | NCT06980038 | May 2026 → Nov 2027 expected | hypopharynx squamous cell carcinoma, laryngeal squamous cell carcinoma, nasal cavity squamous cell carcinoma, nasopharyngeal carcinoma +2 | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT06790602 | May 2026 → Jul 2028 expected | pancreatic ductal adenocarcinoma | University of California, San Diego | Recruiting | No outcome recorded |
| Phase 2 | NCT07418931 | May 2026 → May 2028 expected | squamous cell lung carcinoma | Italian Oncology Group for Clinical Research | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07188896 | Apr 2026 → Nov 2029 expected | clear cell renal carcinoma | Brian Rini | Recruiting | No outcome recorded |
| Phase 2 | NCT07195734 | Apr 2026 → Feb 2033 expected | hypopharynx squamous cell carcinoma, laryngeal squamous cell carcinoma, oral cavity squamous cell carcinoma, oropharynx squamous cell carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT07058012 | Apr 2026 → Apr 2029 expected | colorectal cancer | NSABP Foundation Inc | Recruiting | No outcome recorded |
| Phase 2 | NCT06769698 | Apr 2026 → Jun 2028 expected | head and neck squamous cell carcinoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT07020065 | Apr 2026 → Sep 2028 expected | non-small cell lung carcinoma | Swiss Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06900595 | Feb 2026 → Jun 2029 expected | adrenal cortex carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT06860815 | Jan 2026 → Jan 2027 expected | female breast carcinoma, invasive breast carcinoma, metastatic carcinoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07223541 | Jan 2026 → Aug 2029 expected | clear cell renal carcinoma | University of Oklahoma | Recruiting | No outcome recorded |
| Phase 2 | NCT07224971 | Dec 2025 → May 2027 expected | non-small cell lung carcinoma | Liza Villaruz, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT07101822 | Dec 2025 → Dec 2028 expected | squamous cell carcinoma of penis | Hospital Israelita Albert Einstein | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07001618 | Nov 2025 → Sep 2030 expected | non-small cell lung carcinoma | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 2 | NCT06656598 | Nov 2025 → Sep 2028 expected | non-small cell lung carcinoma | French Cooperative Thoracic Intergroup | Recruiting | No outcome recorded |
| Phase 2 | NCT07101848 | Nov 2025 → Dec 2028 expected | vulvar squamous cell carcinoma | Hospital Israelita Albert Einstein | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07085572 | Sep 2025 → Jul 2028 expected | adrenal cortex carcinoma | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia | Recruiting | No outcome recorded |
| Phase 2 | NCT06528769 | Sep 2025 → Dec 2027 expected | leiomyosarcoma | Gabriel Tinoco | Recruiting | No outcome recorded |
| Phase 2 | NCT07050186 | Aug 2025 → Nov 2030 expected | nut midline carcinoma | Northwestern University | Recruiting | No outcome recorded |
| Phase 2 | NCT06571708 | Aug 2025 → Dec 2028 expected | infiltrating bladder urothelial carcinoma | Columbia University | Recruiting | No outcome recorded |
| Phase 2 | NCT06981325 | Aug 2025 → Oct 2028 expected | skin basal cell carcinoma | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting | No outcome recorded |
| Phase 2 | NCT06865339 | Aug 2025 → Aug 2027 expected | non-small cell lung carcinoma | Montefiore Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06917573 | Jul 2025 → Dec 2031 expected | non-small cell lung carcinoma | Fundación GECP | Recruiting | No outcome recorded |
| Phase 2 | NCT06651593 | Jul 2025 → Sep 2028 expected | cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06887088 | May 2025 → Jan 2028 expected | melanoma | Spanish Melanoma Group | Recruiting | No outcome recorded |
| Phase 2 | NCT06787612 | May 2025 → Jun 2028 expected | fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT06918132 | May 2025 → Dec 2030 expected | non-small cell lung carcinoma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT05840770 | Apr 2025 → Oct 2029 | metastatic malignant neoplasm in the brain, non-small cell lung carcinoma | City of Hope Medical Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06385262 | Mar 2025 → Oct 2028 | non-small cell lung carcinoma | Duke University | Suspended | No outcome recorded |
| Phase 2 | NCT06855212 | Feb 2025 → Mar 2028 expected | head and neck squamous cell carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06623656 | Feb 2025 → Dec 2026 expected | non-small cell lung carcinoma | Weill Medical College of Cornell University | Recruiting | No outcome recorded |
| Phase 2 | NCT06699602 | Feb 2025 → Feb 2028 expected | renal cell carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06219317 | Jan 2025 → Jan 2030 expected | non-small cell lung carcinoma | European Organisation for Research and Treatment of Cancer - EORTC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06448026 | Nov 2024 → May 2027 expected | oral cavity squamous cell carcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06465329 | Nov 2024 → May 2027 expected | non-small cell lung carcinoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT06384820 | Nov 2024 → Jun 2026 | skin squamous cell carcinoma | Regeneron Pharmaceuticals | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT06121180 | Nov 2024 → Oct 2030 expected | uveal melanoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06444880 | Oct 2024 → Jul 2028 expected | epithelioid sarcoma, kidney medullary carcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06463665 | Sep 2024 → Feb 2027 expected | non-small cell squamous lung carcinoma | Genelux GmbH | Recruiting | No outcome recorded |
| Phase 2 | NCT06594991 | Sep 2024 → Sep 2027 expected | melanoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06161441 | Jul 2024 → Apr 2026 overdue | non-small cell lung carcinoma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06205836 | Jun 2024 → May 2030 expected | colorectal cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT05961709 | May 2024 → Apr 2027 expected | colon carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05967884 | Aug 2023 → Aug 2024 | breast cancer | Ottawa Hospital Research Institute | Unknown | No outcome recorded |
| Phase 2 | NCT05929664 | Jul 2023 → Jul 2031 | skin basal cell carcinoma | Thomas Jefferson University | Suspended | No outcome recorded |
| Phase 2 | NCT05694871 | Jun 2023 → May 2027 expected | dedifferentiated liposarcoma | Alliance for Clinical Trials in Oncology | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05878288 | May 2023 → May 2029 expected | head and neck squamous cell carcinoma, skin squamous cell carcinoma | Peter MacCallum Cancer Centre, Australia | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05553834 | May 2023 → Sep 2025 overdue | non-small cell lung carcinoma | Duke University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05557591 | Apr 2023 → Jan 2028 expected | non-small cell lung carcinoma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05401786 | Jan 2023 → Nov 2024 overdue | non-small cell lung carcinoma | The Netherlands Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05574101 | Oct 2022 → Oct 2026 expected | skin squamous cell carcinoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05429866 | Sep 2022 → Jun 2024 | breast cancer, colorectal cancer, cutaneous neuroendocrine carcinoma, head and neck cancer +7 | Jules Bordet Institute | Unknown | No outcome recorded |
| Phase 2 | NCT05535023 | Aug 2022 → Jul 2023 | oropharynx cancer, squamous cell carcinoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT05344209 | Aug 2022 → Jul 2025 overdue | non-small cell lung carcinoma | Vestre Viken Hospital Trust | Recruiting | No outcome recorded |
| Phase 2 | NCT04831450 | Jul 2022 | hypopharynx squamous cell carcinoma, laryngeal squamous cell carcinoma, oral cavity squamous cell carcinoma | University of Miami | Withdrawn | No outcome recorded |
| Phase 2 | NCT05208944 | Jun 2022 → Sep 2027 expected | non-small cell lung carcinoma | Maia Biotechnology | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04873375 | Jan 2022 → Oct 2024 | angiosarcoma, metastatic neoplasm | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT04988074 | Dec 2021 → Jun 2027 expected | human papillomavirus-related squamous cell carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT04862650 | Nov 2021 → Jun 2026 overdue | cancer of unknown primary site, hypopharynx squamous cell carcinoma, laryngeal squamous cell carcinoma, oral cavity squamous cell carcinoma +1 | Marcelo Bonomi | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04916002 | Nov 2021 → Oct 2024 | cutaneous neuroendocrine carcinoma, non-small cell lung carcinoma, oropharynx squamous cell carcinoma, skin basal cell carcinoma +2 | Regeneron Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04398524 | Jul 2021 → Jun 2024 | oropharynx squamous cell carcinoma | ISA Pharmaceuticals | Unknown | No outcome recorded |
| Phase 2 | NCT04646005 | Jun 2021 → May 2023 | cervical cancer | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT04763616 | Jun 2021 → Apr 2023 | mature T-cell and NK-cell non-Hodgkin lymphoma | Won Seog Kim | Completed | Met primary |
| Phase 2 | NCT04526899 | May 2021 → Jan 2024 | melanoma | BioNTech SE | Completed | Met primary |
| Phase 2 | NCT04679480 | Feb 2021 → Dec 2024 overdue | basal cell carcinoma | Reinhard Dummer | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04632433 | Feb 2021 → Feb 2023 overdue | skin squamous cell carcinoma | Fondazione Melanoma Onlus | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04177810 | Nov 2020 → Mar 2023 | malignant pancreatic neoplasm | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2 | NCT04373083 | Nov 2020 → Dec 2022 | classic Hodgkin lymphoma | Regeneron Pharmaceuticals | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04543071 | Nov 2020 → Jun 2028 expected | pancreatic adenocarcinoma | Columbia University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04253964 | Jul 2020 → Sep 2027 expected | non-small cell lung carcinoma | Wake Forest University Health Sciences | Recruiting | No outcome recorded |
| Phase 2 | NCT04242173 | Jun 2020 → May 2022 | head and neck squamous cell carcinoma, skin squamous cell carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Terminated | No outcome recorded |
| Phase 2 | NCT04315701 | Jun 2020 → Dec 2026 expected | skin squamous cell carcinoma | University of Southern California | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04291105 | Apr 2020 → Oct 2026 expected | colorectal cancer, head and neck squamous cell carcinoma, melanoma | Vyriad, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04154943 | Mar 2020 → Dec 2021 | skin squamous cell carcinoma | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT04243616 | Mar 2020 → Aug 2025 overdue | invasive breast carcinoma | Medical College of Wisconsin | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04050436 | Oct 2019 → Sep 2025 overdue | skin squamous cell carcinoma | Replimune, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04006119 | Aug 2019 → Aug 2021 | glioblastoma | Alaunos Therapeutics | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03916627 | Jul 2019 → Mar 2025 overdue | head and neck squamous cell carcinoma, hepatocellular carcinoma, non-small cell lung carcinoma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03951831 | May 2019 → Nov 2026 expected | metastatic prostate carcinoma | Mark Stein | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03669718 | Nov 2018 → Sep 2024 | human papillomavirus-related squamous cell carcinoma, oropharynx squamous cell carcinoma | ISA Pharmaceuticals | Unknown | No outcome recorded |
| Phase 2 | NCT03565783 | Jul 2018 → Dec 2027 expected | head and neck squamous cell carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03430063 | May 2018 → Oct 2021 | non-small cell lung carcinoma | Regeneron Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03132636 | Jun 2017 → May 2021 | basal cell carcinoma | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02760498 | Apr 2016 → Oct 2023 | skin squamous cell carcinoma | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02423863 | Mar 2015 → Aug 2020 | head and neck cancer, melanoma, sarcoma, skin cancer | Oncovir, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01042379 | Mar 2010 → Dec 2030 expected | HER2 positive breast carcinoma, angiosarcoma, female breast carcinoma, hormone receptor-positive breast cancer +1 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06616584 | May 2025 → Dec 2027 expected | non-small cell lung carcinoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05785767 | Jun 2023 → Sep 2027 expected | non-small cell lung carcinoma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 312 trials · 3 met primary · 1 missed | ||||||
| Phase 3 | NCT06931717 | Jan 2026 → Mar 2029 expected | non-small cell lung carcinoma | ETOP IBCSG Partners Foundation | Recruiting | No outcome recorded |
| Phase 3 | NCT06908304 | Dec 2025 → Jul 2027 expected | non-small cell lung carcinoma | Maia Biotechnology | Recruiting | No outcome recorded |
| Phase 3 | NCT06568172 | Feb 2025 → Aug 2031 | acantholytic squamous cell skin carcinoma, clear cell squamous cell skin carcinoma, eyelid carcinoma, head and neck squamous cell carcinoma +2 | National Cancer Institute (NCI) | Suspended | No outcome recorded |
| Phase 3 | NCT06585410 | Jan 2025 → May 2030 expected | skin squamous cell carcinoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06246916 | Sep 2024 → Mar 2027 expected | melanoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT05608291 | Jan 2023 → Jul 2026 overdue | melanoma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05352672 | Jul 2022 → Mar 2026 overdue | melanoma | Regeneron Pharmaceuticals | Active not recruiting | Missed primary |
| Phase 3 | NCT03969004 | Jun 2019 → Jan 2028 expected | skin squamous cell carcinoma | Regeneron Pharmaceuticals | Active not recruiting | Met primary |
| Phase 3 | NCT03515629 | Jul 2018 → Jul 2021 | non-small cell lung carcinoma | Regeneron Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03409614 | Mar 2018 → Feb 2025 | non-small cell lung carcinoma | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03257267 | Sep 2017 → Mar 2021 | squamous cell carcinoma | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT03088540 | May 2017 → Apr 2025 | non-small cell lung carcinoma | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT06743581 | Feb 2025 → Feb 2027 expected | non-small cell lung carcinoma | University of Montreal Hospital Centre (CHUM) | Not yet recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03492489 | — | skin squamous cell carcinoma | Regeneron Pharmaceuticals | No longer available | No outcome recorded |
| Comparator or background therapy25 trials | ||||||
| Phase 0 | NCT05358938 Background | Jun 2022 → Oct 2024 overdue | cutaneous melanoma, cutaneous neuroendocrine carcinoma, skin squamous cell carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT07404332 Background | Feb 2026 → Feb 2028 expected | cancer, metastatic neoplasm | Mohammed Milhem | Recruiting | No outcome recorded |
| Phase 1 | NCT06302426 Background | Jul 2024 → Oct 2026 expected | neoplasm | Inimmune Corporation | Recruiting | No outcome recorded |
| Phase 1 | NCT05729139 Background | Jul 2023 → Jul 2026 | skin squamous cell carcinoma | Baptist Health South Florida | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04387084 Background | Aug 2020 → Mar 2027 expected | skin cancer | University of Southern California | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04460456 Background | Jul 2020 → Dec 2022 | HER2 positive breast carcinoma | Silverback Therapeutics | Unknown | No outcome recorded |
| Phase 1/2 | NCT06090266 Background | Oct 2023 → Aug 2026 overdue | cutaneous melanoma, metastatic malignant neoplasm, non-small cell lung carcinoma | OncoResponse, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04954599 Background | May 2023 → Feb 2027 expected | cancer of unknown primary site | Maastricht University Medical Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06923761 Background | May 2023 → Apr 2027 expected | cancer | Grey Wolf Therapeutics | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05662397 Background | Mar 2023 → Dec 2025 overdue | cancer | HotSpot Therapeutics, Inc | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04706715 Background | Jan 2022 → Nov 2025 overdue | metastatic neoplasm | University Medical Center Groningen | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04626635 Background | Dec 2020 → Nov 2026 expected | cancer | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07808138 Comparator | Nov 2026 → Dec 2029 expected | non-small cell lung carcinoma | The Netherlands Cancer Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07234058 Background | Feb 2026 → May 2028 expected | malignant pleural mesothelioma | French Cooperative Thoracic Intergroup | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07274384 Comparator | Jan 2026 → Dec 2029 expected | non-small cell lung carcinoma | Vita-Salute San Raffaele University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07264673 Comparator | Apr 2025 → Oct 2027 expected | non-small cell lung carcinoma | Fondazione Ricerca Traslazionale | Recruiting | No outcome recorded |
| Phase 2 | NCT06848088 Background | Apr 2025 → Oct 2029 expected | melanoma | Regeneron Pharmaceuticals | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT06731270 Background | Apr 2025 → Jan 2027 expected | non-small cell lung carcinoma | Emory University | Recruiting | No outcome recorded |
| Phase 2 | NCT06190951 Comparator | Sep 2024 → Nov 2026 expected | melanoma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05669989 Background | Apr 2023 → Nov 2026 expected | plasma cell myeloma | Sanofi | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT05800015 Background | Aug 2023 → Jan 2030 expected | non-small cell lung carcinoma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06840782 Background | Sep 2025 → Feb 2030 expected | non-small cell lung carcinoma | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT05317858 Background | Aug 2022 → Jun 2027 expected | brain neoplasm, non-small cell lung carcinoma | InSightec | Recruiting | No outcome recorded |
| Phase 3 | NCT04157985 Comparator | Nov 2019 → Oct 2025 | anal carcinoma, cervical cancer, cholangiocarcinoma, cutaneous neuroendocrine carcinoma +7 | Dan Zandberg | Completed | No outcome recorded |
| — | NCT06132191 Background | — | non-small cell lung carcinoma, skin basal cell carcinoma, skin squamous cell carcinoma | Regeneron Pharmaceuticals | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 93
| Date | Issuer | Release |
|---|---|---|
| 2026-10-06 | Regeneron Pharmaceuticals | Results Regeneron Showcases Advances in Care Across Several Cancers and Cancer-associated Complications at ESMO 2026 regeneron.com ↗
Late-breaking Phase 3 C-POST data provide longer-term survival outcomes for adjuvant Libtayo® (cemiplimab) in high-risk cutaneous squamous cell carcinoma (CSCC) after surgery and radiation |
| 2026-06-02 | Grey Wolf Therapeutics | Results Greywolf Therapeutics reports durable clinical responses with first-in-class oral ERAP1 inhibitor GRWD5769 across six solid tumor types greywolftherapeutics.com ↗
First-in-class oral ERAP1 inhibitor demonstrates objective response rates (ORR) of 13–36% across patients with secondary anti-PD-1 resistance or microsatellite stable colorectal cancer without liver metastases in combination with cemiplimab (anti-PD-1) |
| 2026-05-15 | Regeneron Pharmaceuticals | Results Regeneron Provides Update on Phase 3 Trial of Fianlimab (LAG-3 Inhibitor) Combination in First-Line Unresectable or Metastatic Melanoma regeneron.com ↗
The trial did not reach statistical significance for the primary endpoint of improvement in progression-free survival (PFS) compared to pembrolizumab (PD-1 inhibitor) monotherapy. |
| 2025-11-19 | Regeneron Pharmaceuticals | Regulatory Libtayo® (cemiplimab) Approved in the European Union as First and Only Immunotherapy for Adjuvant Treatment of Cutaneous Squamous Cell Carcinoma (CSCC) with High Risk of Recurrence after Surgery and Radiation regeneron.com ↗
This expands the existing European Union (EU) indication for Libtayo in advanced CSCC to include patients at high risk of disease recurrence. |
| 2025-10-22 | Grey Wolf Therapeutics | Results We won Best Poster at ESMO 2025 greywolftherapeutics.com ↗
GRWD5769, both as monotherapy and in combination with cemiplimab, was well tolerated with no new safety signals. |
| 2025-10-17 | Regeneron Pharmaceuticals | Regulatory Libtayo® (cemiplimab) Recommended for EU Approval by the CHMP for Adjuvant Treatment of Cutaneous Squamous Cell Carcinoma (CSCC) with a High Risk of Recurrence After Surgery and Radiation regeneron.com ↗ |
| 2025-10-08 | Regeneron Pharmaceuticals | Regulatory Libtayo® (cemiplimab-rwlc) Approved in the U.S. as First and Only Immunotherapy for Adjuvant Treatment of Cutaneous Squamous Cell Carcinoma (CSCC) with a High Risk of Recurrence After Surgery and Radiation regeneron.com ↗ |
| 2025-09-09 | Regeneron Pharmaceuticals | Results Libtayo® (cemiplimab) Plus Chemotherapy Results at Five Years Reinforce Significant and Durable Improvements in Survival Outcomes for Advanced Non-small Cell Lung Cancer regeneron.com ↗
Late-breaking data from exploratory analyses at WCLC show Libtayo plus chemotherapy demonstrates a more than double five-year overall survival rate of 19.4%, compared to 8.8% with chemotherapy alone |
| 2025-05-31 | Regeneron Pharmaceuticals | Results Libtayo® (cemiplimab) Phase 3 Data in the Adjuvant Treatment of Post-Surgical High-Risk Cutaneous Squamous Cell Carcinoma (CSCC) Have Potential to Be Practice-Changing regeneron.com ↗
Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death, the primary endpoint of the trial (p<0.0001) |
| 2025-05-30 | BioLineRx, Ltd. | Results BioLineRx Announces New Pilot Phase Data from Phase 2 Combination Trial of Motixafortide in First-Line Pancreatic Cancer (PDAC) to be Presented at ASCO 2025 Annual Meeting biolinerx.com ↗
Updated results from the pilot phase indicate that four of eleven patients remained progression free after more than one year. |
| 2025-04-24 | BioNTech SE | Results BioNTech to Present Clinical and Preclinical Data Across mRNA and Next-Generation Immuno-Oncology Priority Programs at AACR 2025 biontech.com ↗
The preliminary data showed anti-tumor activity, consistent immune response induction, and a manageable safety profile. |
| 2025-01-13 | Regeneron Pharmaceuticals | Results Regeneron Provides Business Updates and Highlights from Broad Clinical Pipeline at the 43rd Annual J.P. Morgan Healthcare Conference regeneron.com ↗
As announced this morning, a Phase 3 study demonstrated that Libtayo is the only immunotherapy to show a statistically significant and clinically meaningful benefit in high-risk cutaneous squamous cell carcinoma (CSCC) in the adjuvant setting; |
| 2025-01-13 | Regeneron Pharmaceuticals | Results Adjuvant Libtayo® (cemiplimab) Significantly Improves Disease-Free Survival (DFS) After Surgery in High-Risk Cutaneous Squamous Cell Carcinoma (CSCC) in Phase 3 Trial regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive results from the Phase 3 C-POST trial, which demonstrated that adjuvant treatment with PD-1 inhibitor Libtayo® (cemiplimab) led to a statistically significant and clinically meaningful improvement in the primary endpoint of disease-free survival (DFS) in patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery. |
| 2024-11-08 | Palleon Pharmaceuticals, Inc. | Results Palleon Pharmaceuticals Presents Results from the Phase 1/2 GLIMMER-01 Trial of E-602 in Combination with Cemiplimab in Patients with Solid Tumors at the Society for Immunotherapy of Cancer (SITC) Annual Meeting palleonpharma.com ↗
Patients with tumor hypersialylation trended toward better clinical outcomes compared to those lacking hypersialylation, including a confirmed partial response achieved in one anti-PD-1 resistant melanoma patient, and disease stabilization achieved in another six patients. |
| 2024-09-09 | Regeneron Pharmaceuticals | Results Regeneron to Highlight Progress Across Its Differentiated Oncology Portfolio and Pipeline at WCLC and ESMO regeneron.com ↗
At ESMO, the latest two-year data for our LAG-3 inhibitor fianlimab combined with Libtayo show persistent and high clinical activity in advanced melanoma patients. |
| 2024-09-09 | Regeneron Pharmaceuticals | Results Libtayo® (cemiplimab) Demonstrates Durable Survival Benefit at Five Years in Advanced Non-small Cell Lung Cancer regeneron.com ↗
Late-breaking data at WCLC show Libtayo monotherapy nearly doubled median overall survival and reduced the risks of death and disease progression by 41% and 50%, respectively, compared to chemotherapy |
| 2024-07-30 | BioNTech SE | Results BioNTech Announces Positive Topline Phase 2 Results for mRNA Immunotherapy Candidate BNT111 in Patients with Advanced Melanoma biontech.com ↗
The trial met its primary efficacy outcome measure, demonstrating a statistically significant improvement in ORR in patients treated with BNT111 in combination with cemiplimab as compared to historical control in this indication and treatment setting. |
| 2024-05-24 | BioLineRx, Ltd. | Results BioLineRx Announces Abstract on Pilot Study Data from Phase 2 Combination Clinical Trial Evaluating Motixafortide in First-Line Pancreatic Cancer (PDAC) at American Society of Clinical Oncology (ASCO) 2024 Annual Meeting biolinerx.com ↗
7 of 11 patients in the pilot phase experienced a partial response, with 6 confirmed; 10 of 11 patients experienced disease control |
| 2024-05-23 | Regeneron Pharmaceuticals | Results Promising Anti-tumor Activity of Novel Costimulatory Bispecific Antibody REGN7075 (EGFRxCD28) in Combination with Libtayo® (cemiplimab) to be Reported at ASCO regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive new results from an ongoing Phase 1/2 trial evaluating its first-in-class costimulatory bispecific antibody, REGN7075 (EGFRxCD28), in combination with Libtayo® (cemiplimab) in patients with advanced solid tumors. |
| 2023-12-07 | Regeneron Pharmaceuticals | Results Regeneron to Share Progress of Novel Combination Therapies in Oncology at ESMO IO regeneron.com ↗
Per initial results to be shared at ESMO IO, a combination of REGN5668 with Libtayo showed early clinical activity in patients with recurrent ovarian cancer. |
| 2023-12-05 | Replimune, Inc. | Results Replimune Shares Initial Primary Analysis Results from CERPASS Clinical Trial in Advanced Cutaneous Squamous Cell Carcinoma and Presents New Data from IGNYTE Clinical Trial of RP1 in Anti-PD1 Failed Melanoma and Non-Melanoma Skin Cancers replimune.com ↗
RP1 in combination with cemiplimab demonstrated clinically meaningful improvements in complete response rate and duration of response compared to cemiplimab in the CERPASS clinical trial, but did not meet either of the two primary endpoints |
| 2023-10-31 | BioNTech SE | Results BioNTech to Present Clinical and Preclinical Data Updates Across Multiple Immuno-Oncology Programs at 2023 SITC Annual Meeting biontech.com ↗
The data show encouraging initial clinical activity in heavily pre-treated patients with advanced NSCLC and a tolerable safety profile. |
| 2023-10-21 | Regeneron Pharmaceuticals | Results Libtayo® (cemiplimab) Neoadjuvant Treatment Demonstrates Encouraging Event-Free Survival in Patients with Resectable Cutaneous Squamous Cell Carcinoma (CSCC) regeneron.com ↗
These robust responses were durable, translating into event-free survival for the vast majority of patients at one and two years. |
| 2023-09-28 | BioLineRx, Ltd. | Results BioLineRx Announces Encouraging Data from Pilot Phase of Phase 2 Combination Clinical Trial with Motixafortide in First-Line Pancreatic Cancer (PDAC) biolinerx.com ↗
As of May 2023, 6 patients (55%) experienced a partial response (PR) of which 4 (36%) were confirmed PRs with one patient experiencing resolution of the hepatic (liver) metastatic lesion. |
| 2023-05-25 | Regeneron Pharmaceuticals | Results Fianlimab (LAG-3 inhibitor) Combined with Libtayo® (cemiplimab) Shows Clinically Meaningful and Durable Tumor Responses Across Key Advanced Melanoma Patient Populations regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive data from three independent cohorts evaluating an investigational combination of LAG-3 inhibitor fianlimab and PD-1 inhibitor Libtayo® (cemiplimab) in adults with advanced melanoma. |
| 2023-03-29 | Regeneron Pharmaceuticals | Regulatory Libtayo® (cemiplimab) in Combination with Chemotherapy Approved by European Commission for the First-line Treatment of Advanced PD-L1 Positive Non-small Cell Lung Cancer (NSCLC) regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Commission (EC) approved Libtayo® (cemiplimab) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression. |
| 2023-02-24 | Regeneron Pharmaceuticals | Regulatory Libtayo® (cemiplimab) in Combination with Chemotherapy Receives Positive CHMP Opinion for the Treatment of Advanced PD-L1 Positive Non-small Cell Lung Cancer (NSCLC) regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Libtayo® (cemiplimab) in combination with platinum-based chemotherapy. |
| 2022-12-23 | Regeneron Pharmaceuticals | Regulatory Libtayo® (cemiplimab) Approved in Japan for Advanced or Recurrent Cervical Cancer regeneron.com ↗
Regeneron Pharmaceuticals (NASDAQ: REGN) today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Libtayo® (cemiplimab) as monotherapy to treat patients with advanced or recurrent cervical cancer whose disease progressed after chemotherapy. |
| 2022-12-01 | Regeneron Pharmaceuticals | Results Regeneron ESMO IO Presentations Highlight Potential of Fianlimab and Libtayo® (cemiplimab) in Multiple Solid Tumor Types regeneron.com ↗
Fianlimab combined with Libtayo has generated early-but-promising clinical activity in advanced melanoma and non-small cell lung cancer, demonstrating the potential of Regeneron's oncology pipeline to potentially advance the standard-of-care in various cancers. |
| 2022-11-22 | Regeneron Pharmaceuticals | Regulatory Libtayo® (cemiplimab) Approved by the European Commission as the First Immunotherapy in Second Line Recurrent or Metastatic Cervical Cancer Irrespective of PD-L1 Expression Level or Tumor Histology regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Commission (EC) approved Libtayo® (cemiplimab) as monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy. |
| 2022-11-08 | Regeneron Pharmaceuticals | Regulatory Libtayo® (cemiplimab-rwlc) in Combination with Chemotherapy Approved by the FDA as First-line Treatment for Advanced Non-small Cell Lung Cancer (NSCLC) regeneron.com ↗ |
| 2022-10-14 | Regeneron Pharmaceuticals | Regulatory Libtayo® (cemiplimab) Receives Positive CHMP Opinion Recommending Approval to Treat Advanced Cervical Cancer regeneron.com ↗ |
| 2022-09-12 | Regeneron Pharmaceuticals | Results Positive Neoadjuvant Libtayo® (cemiplimab) Monotherapy Data in Resectable Cutaneous Squamous Cell Carcinoma Presented at ESMO and Published in NEJM regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive clinical data for an investigational regimen of PD-1 inhibitor Libtayo® (cemiplimab) as neoadjuvant monotherapy in stage II to IV resectable cutaneous squamous cell carcinoma (CSCC). |
| 2022-09-12 | Regeneron Pharmaceuticals | Results Fianlimab (LAG-3 Inhibitor) Combined with Libtayo® (cemiplimab) Demonstrates Greater than 60% Response Rates in Two Independent Cohorts of Patients with Advanced Melanoma Naïve to PD-1 or PD-L1 Inhibitors regeneron.com ↗
In two independent dose expansion cohorts from a Phase 1 clinical trial of patients naïve to PD-1 or PD-L1 inhibitors, our LAG-3 inhibitor fianlimab combined with Libtayo demonstrated greater than 60% response rates. |
| 2022-08-03 | Regeneron Pharmaceuticals | Results Novel Costimulatory Bispecific Antibody Shows Encouraging Anti-tumor Activity When Combined with PD-1 Inhibitor Libtayo® (cemiplimab) in Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC) regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2 trial investigating REGN5678, a novel PSMAxCD28 costimulatory bispecific antibody, in combination with the company's PD-1 inhibitor Libtayo® (cemiplimab) in advanced metastatic castration-resistant prostate cancer (mCRPC). |
| 2022-05-27 | Inovio Pharmaceuticals | Results INOVIO Announces Survival Results for INO-5401 + INO-9012 in Combination with Libtayo® (cemiplimab) in Patients with Newly Diagnosed GBM at ASCO Annual Meeting 2022 inovio.com ↗
Overall, INO-5401 + INO-9012 is demonstrated to be tolerable and immunogenic when administered with Libtayo and RT/TMZ (radiation and temozolomide) to newly diagnosed GBM patients. |
| 2022-01-28 | Sanofi | Regulatory Sanofi and Regeneron provide regulatory update on Libtayo® (cemiplimab-rwlc) in advanced cervical cancer sanofi.com ↗
Sanofi and Regeneron today announced the voluntary withdrawal of the supplemental Biologics License Application (sBLA) for Libtayo ® (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer. |
| 2022-01-28 | Regeneron Pharmaceuticals | Regulatory Regeneron and Sanofi Provide Regulatory Update on Libtayo® (cemiplimab-rwlc) in Advanced Cervical Cancer regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the voluntary withdrawal of the supplemental Biologics License Application (sBLA) for Libtayo® (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer. |
| 2022-01-19 | Regeneron Pharmaceuticals | Regulatory FDA Accepts for Review Libtayo® (cemiplimab-rwlc) in Combination with Chemotherapy for First-line Treatment of Advanced NSCLC regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo® (cemiplimab-rwlc) in combination with chemotherapy as first-line treatment in advanced non-small cell lung cancer (NSCLC). |
| 2021-09-28 | Regeneron Pharmaceuticals | Regulatory FDA Accepts Libtayo® (cemiplimab-rwlc) for Priority Review for Advanced Cervical Cancer regeneron.com ↗ |
| 2021-09-19 | Sanofi | Results ESMO late-breaking data show Libtayo® (cemiplimab) and chemotherapy first-line treatment combination significantly improved overall survival in patients with advanced NSCLC sanofi.com ↗ |
| 2021-09-19 | Regeneron Pharmaceuticals | Results ESMO Late-breaking Data Show Libtayo® (cemiplimab) and Chemotherapy First-line Treatment Combination Significantly Improved Overall Survival in Patients with Advanced NSCLC regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced positive Phase 3 results for a Libtayo® (cemiplimab) combination treatment were presented today during a late-breaking session at the European Society for Medical Oncology Virtual Congress 2021. |
| 2021-08-05 | Sanofi | Results Press Release: Phase 3 trial of Libtayo® (cemiplimab) combined with chemotherapy stopped early due to significant improvement in overall survival in patients with first-line advanced non- small cell lung cancer sanofi.com ↗
Adding Libtayo to chemotherapy significantly improved OS, compared to chemotherapy alone, in the trial that enrolled patients with metastatic or locally advanced disease and tumors with either squamous or non-squamous histology and across all PD-L1 expression levels. |
| 2021-08-05 | Regeneron Pharmaceuticals | Results Regeneron Reports Second Quarter 2021 Financial and Operating Results regeneron.com ↗
In August 2021, the Company and Sanofi announced that the Phase 3 trial of Libtayo in combination with platinum-doublet chemotherapy was stopped early after meeting its overall survival primary endpoint in patients with advanced NSCLC. |
| 2021-08-05 | Regeneron Pharmaceuticals | Results Phase 3 Trial of Libtayo® (cemiplimab-rwlc) Combined with Chemotherapy Stopped Early Due to Significant Improvement in Overall Survival in Patients with First-line Advanced Non-small Cell Lung Cancer regeneron.com ↗
Adding Libtayo to chemotherapy significantly improved OS, compared to chemotherapy alone, in the trial that enrolled patients with metastatic or locally advanced disease and tumors with either squamous or non-squamous histology and across all PD-L1 expression levels. |
| 2021-06-25 | Sanofi | Regulatory Press Release: Libtayo® (cemiplimab) approved by the European Commission as the first immunotherapy indicated for patients with advanced basal cell carcinoma sanofi.com ↗
The European Commission (EC) has approved Sanofi and Regeneron’s PD-1 inhibitor Libtayo ® (cemiplimab) to treat adults with locally advanced or metastatic basal cell carcinoma (BCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI). |
| 2021-06-25 | Sanofi | Regulatory Sanofi: Libtayo® (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with ≥50% PD-L1 expression sanofi.com ↗
The European Commission (EC) has approved Sanofi and Regeneron’s PD-1 inhibitor Libtayo ® (cemiplimab) for the first-line treatment of adults with non-small cell lung cancer (NSCLC) whose tumor cells have ≥50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations. |
| 2021-06-25 | Regeneron Pharmaceuticals | Regulatory Libtayo® (cemiplimab) Approved by the European Commission as the First Immunotherapy Indicated for Patients with Advanced Basal Cell Carcinoma regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has approved the PD-1 inhibitor Libtayo® (cemiplimab) to treat adults with locally advanced or metastatic basal cell carcinoma (BCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI). |
| 2021-06-25 | Regeneron Pharmaceuticals | Regulatory Libtayo® (cemiplimab) Approved by the European Commission for First-Line Treatment of Patients with Advanced Non-small Cell Lung Cancer with ≥50% PD-L1 Expression regeneron.com ↗
Libtayo is now approved for three advanced cancers in the European Union. |
| 2021-05-24 | Sanofi | Regulatory Libtayo® (cemiplimab) receives positive CHMP opinion for the treatment in Europe of two advanced cancers sanofi.com ↗
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for Sanofi and Regeneron’s PD-1 inhibitor Libtayo ® (cemiplimab) as monotherapy in two advanced cancers. |
| 2021-05-24 | Regeneron Pharmaceuticals | Regulatory Libtayo® (cemiplimab) Receives Positive CHMP Opinion for the Treatment in Europe of Two Advanced Cancers regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for Libtayo® (cemiplimab) as monotherapy in two advanced cancers. |
| 2021-05-19 | Sanofi | Results Sanofi to showcase data from its transformative oncology pipeline at 2021 ASCO Meeting sanofi.com ↗
Data that reinforce Libtayo ® (cemiplimab-rwlc) as a standard of care in advanced non-melanoma skin cancer and advanced non-small cell lung cancer, including new data in historically underrepresented patients with brain metastases |
| 2021-05-19 | Regeneron Pharmaceuticals | Results Libtayo® (cemiplimab-rwlc) Presentations at ASCO Highlight Expanding Clinical Data in Diverse Cancers regeneron.com ↗
Efficacy was greatest in PD-1 inhibitor naïve patients, who experienced a 64% objective response rate (21 of 33 patients; 3 complete responses, 18 partial responses), and the median progression-free survival and median duration of response had not yet been reached. |
| 2021-05-12 | Sanofi | Results Positive Phase 3 Libtayo® (cemiplimab) results in advanced cervical cancer presented at ESMO Virtual Plenary sanofi.com ↗
Libtayo is the first immunotherapy to demonstrate an improvement in overall survival in advanced cervical cancer, as well as progression-free survival and objective response rate, compared to chemotherapy |
| 2021-05-12 | Regeneron Pharmaceuticals | Results Positive Phase 3 Libtayo® (cemiplimab) Results in Advanced Cervical Cancer Presented at ESMO Virtual Plenary regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the presentation of positive results from the Phase 3 trial investigating the PD-1 inhibitor Libtayo® (cemiplimab) in patients with recurrent or metastatic cervical cancer who had previously progressed on chemotherapy. |
| 2021-03-15 | Sanofi | Results Phase 3 trial of Libtayo® (cemiplimab) monotherapy in advanced cervical cancer stopped early for positive result on overall survival sanofi.com ↗
Positive results demonstrating an overall survival (OS) benefit from the Phase 3 trial investigating Sanofi and Regeneron’s PD-1 inhibitor Libtayo ® (cemiplimab) monotherapy compared to chemotherapy in patients previously treated with chemotherapy whose cervical cancer is recurrent or metastatic, were announced today. |
| 2021-03-15 | Regeneron Pharmaceuticals | Results Phase 3 Trial of Libtayo® (cemiplimab) Monotherapy in Advanced Cervical Cancer Stopped Early for Positive Result on Overall Survival regeneron.com ↗
Libtayo is the first immunotherapy to demonstrate improved overall survival in patients with cervical cancer, reducing the risk of death by 31% compared to chemotherapy |
| 2021-02-22 | Sanofi | Regulatory FDA approves Libtayo® (cemiplimab-rwlc) monotherapy for patients with first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50% sanofi.com ↗
This is the third approval for Libtayo in the U.S. |
| 2021-02-22 | Regeneron Pharmaceuticals | Regulatory FDA Approves Libtayo® (cemiplimab-rwlc) Monotherapy for Patients with First-line Advanced Non-small Cell Lung Cancer with PD-L1 Expression of ≥50% regeneron.com ↗
This is the third approval for Libtayo in the U.S. |
| 2021-02-12 | Sanofi | Results The Lancet publishes Libtayo® (cemiplimab) data showing extended overall survival in patients with first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50% sanofi.com ↗
Libtayo was superior in extending overall survival compared to chemotherapy, even with 74% of patients crossing over to the Libtayo arm following progression on chemotherapy. |
| 2021-02-12 | Regeneron Pharmaceuticals | Results The Lancet Publishes Libtayo® (cemiplimab) Data Showing Extended Overall Survival in Patients with First-line Advanced Non-small Cell Lung Cancer with PD-L1 Expression of ≥50% regeneron.com ↗
Libtayo was superior in extending overall survival compared to chemotherapy, even with 74% of patients crossing over to the Libtayo arm following progression on chemotherapy. |
| 2021-02-09 | Sanofi | Regulatory FDA approves Libtayo® (Cemiplimab-rwlc) as first immunotherapy indicated for patients with advanced basal cell carcinoma sanofi.com ↗ |
| 2021-02-09 | Regeneron Pharmaceuticals | Regulatory FDA Approves Libtayo® (cemiplimab-rwlc) as First Immunotherapy Indicated for Patients with Advanced Basal Cell Carcinoma regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) as the first immunotherapy treatment indicated for patients with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. |
| 2020-11-20 | Inovio Pharmaceuticals | Results INOVIO Presents Clinical Results of its DNA Medicines INO-5401 + INO-9012 in Novel Combination with PD-1 Inhibitor Libtayo® (cemiplimab) in the Treatment of Newly Diagnosed Glioblastoma Multiforme at Society for Neuro-Oncology 2020 Annual Meeting inovio.com ↗
The study demonstrated that INO-5401 + INO-9012 with Libtayo, radiation (RT) and temozolomide (TMZ) are tolerable, immunogenic, and may improve median survival for patients with newly diagnosed GBM. |
| 2020-11-19 | Alaunos Therapeutics | Results Ziopharm Oncology Presents Encouraging Clinical Data for Controlled IL-12 for the Treatment of Glioblastoma and DIPG at the 2020 Society for Neuro-Oncology Annual Meeting alaunos.com ↗
Controlled IL-12 with cemiplimab was well tolerated |
| 2020-10-29 | Regeneron Pharmaceuticals | Regulatory FDA Accepts for Priority Review Libtayo® (cemiplimab-rwlc) for Advanced Non-small Cell Lung Cancer with PD-L1 Expression of ≥50% regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo® (cemiplimab-rwlc) to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression. |
| 2020-09-21 | Sanofi | Results Late-breaking ESMO presentation shows Libtayo® (cemiplimab) monotherapy increases overall survival in first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50% sanofi.com ↗
In new analyses presented at ESMO, Libtayo reduced the risk of death by 43% in patients whose cancer had confirmed PD-L1 expression of 50% or greater. |
| 2020-09-21 | Regeneron Pharmaceuticals | Results Late-breaking ESMO Presentation Shows Libtayo® (cemiplimab) Monotherapy Increases Overall Survival in First-line Advanced Non-small Cell Lung Cancer with PD-L1 Expression of ≥50% regeneron.com ↗
In new analyses presented at ESMO, Libtayo reduced the risk of death by 43% in patients whose cancer had confirmed PD-L1 expression of 50% or greater. |
| 2020-09-18 | Sanofi | Results Positive pivotal data for Libtayo® (cemiplimab) monotherapy in locally advanced basal cell carcinoma featured as a late-breaking presentation at ESMO sanofi.com ↗
Positive results from the pivotal Phase 2 trial for the PD-1 inhibitor Libtayo® (cemiplimab) in patients with locally advanced basal cell carcinoma (BCC) who had progressed on or were intolerant to hedgehog inhibitor (HHI) therapy were shared in a late-breaking presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. |
| 2020-09-18 | Regeneron Pharmaceuticals | Results Positive Pivotal Data for Libtayo® (cemiplimab) Monotherapy in Locally Advanced Basal Cell Carcinoma Featured as a Late-breaking Presentation at ESMO regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the presentation of positive results from the pivotal Phase 2 trial for the PD-1 inhibitor Libtayo® (cemiplimab) in patients with locally advanced basal cell carcinoma (BCC) who had progressed on or were intolerant to hedgehog inhibitor (HHI) therapy. |
| 2020-06-24 | Regeneron Pharmaceuticals | Results New Publication Highlights Preclinical Research Showing Potential to Enhance Cancer Treatment by Combining Novel Costimulatory Bispecific Antibodies with Libtayo® (cemiplimab) regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced new scientific findings have been highlighted today in a Science Translational Medicine cover publication. |
| 2020-05-29 | Sanofi | Results Libtayo® (cemiplimab-rwlc) longer-term results in advanced cutaneous squamous cell carcinoma presented at ASCO 2020 show durable responses that deepen over time sanofi.com ↗
These results demonstrate both longer durability and higher complete response (CR) rates than previously reported. |
| 2020-05-29 | Regeneron Pharmaceuticals | Results Libtayo® (cemiplimab-rwlc) Longer-term Results in Advanced Cutaneous Squamous Cell Carcinoma Presented at ASCO 2020 Show Durable Responses that Deepen Over Time regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced new, longer-term data for PD-1 inhibitor Libtayo® (cemiplimab-rwlc) from a pivotal Phase 2 trial in advanced cutaneous squamous cell carcinoma (CSCC), the deadliest non-melanoma skin cancer. |
| 2020-05-26 | Inovio Pharmaceuticals | Results INOVIO to Host Webinar "DNA Medicines: From COVID-19 to Cancer" inovio.com ↗ |
| 2020-05-14 | Inovio Pharmaceuticals | Results INOVIO's INO-5401 in Combination with PD-1 Inhibitor Libtayo® (cemiplimab) Demonstrates 85% of Newly Diagnosed Glioblastoma Patients Are Alive 12 Months Following Treatment inovio.com ↗
The Phase 1/2 clinical trial demonstrated that 84.4% percent (27 of 32) of patients with MGMT promoter unmethylated tumors, and 85% (17 of 20) of patients with MGMT promoter methylated tumors were alive at 12 months. |
| 2020-05-13 | Regeneron Pharmaceuticals | Results Regeneron Presentations at ASCO 2020 Showcase Diverse Clinical Oncology Portfolio regeneron.com ↗ |
| 2020-05-05 | Sanofi | Results Libtayo® (cemiplimab) shows clinically meaningful and durable responses in second-line advanced basal cell carcinoma sanofi.com ↗
Libtayo demonstrated clinically meaningful and durable responses in this group of patients for whom there are no approved treatments. |
| 2020-05-05 | Regeneron Pharmaceuticals | Results Libtayo® (cemiplimab) Shows Clinically-Meaningful and Durable Responses in Second-line Advanced Basal Cell Carcinoma regeneron.com ↗
Libtayo demonstrated clinically meaningful and durable responses in this group of patients for whom there are currently no approved treatments. |
| 2020-04-27 | Sanofi | Results Sanofi: Phase 3 trial of Libtayo® (cemiplimab) as monotherapy for first-line advanced non-small cell lung cancer stopped early due to highly significant improvement in overall survival sanofi.com ↗
A protocol-specified interim analysis conducted by the Independent Data Monitoring Committee demonstrated that patients treated with Libtayo monotherapy had a significant increase in OS. |
| 2020-04-27 | Regeneron Pharmaceuticals | Results Phase 3 Trial of Libtayo® (cemiplimab) as Monotherapy for First-Line Advanced Non-small Cell Lung Cancer Stopped Early Due to Highly Significant Improvement in Overall Survival regeneron.com ↗
A protocol-specified interim analysis conducted by the Independent Data Monitoring Committee demonstrated that patients treated with Libtayo monotherapy had a significant increase in OS. |
| 2019-11-23 | Alaunos Therapeutics | Results Ziopharm Oncology Presents Encouraging Clinical Data for Controlled IL-12 for the Treatment of Recurrent Glioblastoma at the 2019 Society for Neuro-Oncology Annual Meeting alaunos.com ↗ |
| 2019-11-05 | Inovio Pharmaceuticals | Results Inovio Demonstrates 80% 6-Month Progression-Free Survival In Phase 2 Glioblastoma Multiforme (GBM) Study with INO-5401 In Combination with PD-1 Inhibitor Libtayo® (cemiplimab) inovio.com ↗
80% of Methylated Patients and 75% of Unmethylated Patients Were Disease Progression-Free at 6 Months |
| 2019-11-05 | Regeneron Pharmaceuticals | Results Regeneron Provides Updates on Phase 3 Libtayo® (cemiplimab) Development Program in Advanced Non-small Cell Lung Cancer regeneron.com ↗
In the first 361 randomized patients (minimum 6 months of follow-up), the confirmed objective response rate (ORR), as determined by investigators, is currently 42% for Libtayo patients and 22% for patients treated with chemotherapy. |
| 2019-07-01 | Regeneron Pharmaceuticals | Regulatory Libtayo® (cemiplimab) Approved for Advanced Cutaneous Squamous Cell Carcinoma in the European Union regeneron.com ↗
Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and is the only treatment approved in advanced CSCC in the European Union (EU). |
| 2019-05-16 | Regeneron Pharmaceuticals | Results Updated Libtayo® (cemiplimab-rwlc) Results Reinforce Durable and Substantial Response Rates in Advanced Cutaneous Squamous Cell Carcinoma regeneron.com ↗ |
| 2019-04-26 | Regeneron Pharmaceuticals | Regulatory CHMP Issues Positive Opinion for Libtayo® (cemiplimab) in Advanced Cutaneous Squamous Cell Carcinoma regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of Libtayo® (cemiplimab). |
| 2018-09-28 | Regeneron Pharmaceuticals | Regulatory FDA Approves Libtayo® (cemiplimab-rwlc) as First and Only Treatment for Advanced Cutaneous Squamous Cell Carcinoma regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Libtayo® (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. |
| 2018-06-04 | Regeneron Pharmaceuticals | Results New England Journal of Medicine Publishes Pivotal Cemiplimab Trials Showing Positive Results in Advanced Cutaneous Squamous Cell Carcinoma regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that pivotal data from two trials evaluating cemiplimab in advanced cutaneous squamous cell carcinoma (CSCC) were published today in the New England Journal of Medicine (NEJM) and presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting. |
| 2018-05-16 | Regeneron Pharmaceuticals | Results Regeneron and Sanofi Share First Positive Clinical Data for Cemiplimab in Advanced Non-small Cell Lung Cancer at ASCO regeneron.com ↗
The duration of response exceeded eight months in five of six patients. |
| 2018-04-30 | Regeneron Pharmaceuticals | Regulatory FDA to Conduct Priority Review of Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery. |
| 2018-04-03 | Regeneron Pharmaceuticals | Regulatory EMA to Review Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery. |
| 2017-12-13 | Regeneron Pharmaceuticals | Results Regeneron and Sanofi Announce Positive Topline Pivotal Results for PD-1 Antibody Cemiplimab in Advanced Cutaneous Squamous Cell Carcinoma regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced positive topline results from a pivotal Phase 2 clinical study of cemiplimab in 82 patients with advanced cutaneous squamous cell carcinoma (CSCC), the second deadliest skin cancer after melanoma. |
| 2017-09-08 | Regeneron Pharmaceuticals | Regulatory Regeneron and Sanofi Announce Cemiplimab (REGN2810) Has Received FDA Breakthrough Therapy Designation for Advanced Cutaneous Squamous Cell Carcinoma regeneron.com ↗
TARRYTOWN, N.Y. and PARIS, Sept. 8, 2017 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation status to cemiplimab (REGN2810) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC, the second deadliest skin cancer after melanoma. |
All press releases naming this drug 109 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 109 releases opens the full record — a long page | ||
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 220 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | cemiplimab | “Standard of Care Drugs (at investigator's discretion) may include: pembrolizumab, nivolumab, cemiplimab, durvalumab, dostarlimab, avelumab, and atezolizumab, or other immune...” NCT07224971 ↗207“Cemiplimab (REGN 2810) is administered starting at week 4 at a dose of 350mg IV every 3 weeks (flat dose) for up to 55 weeks or intolerable side effect or progression of disease.” NCT03951831 ↗ “therapy with avelumab, cemiplimab, ipilimumab, nivolumab, pembrolizumab or relatlimab, or currently approved standard of care treatment, either alone or in combination” NCT05358938 ↗ “Anti PD-1 monotherapy if PD-L1 ≥ 50% is a possible alternative (pembrolizumab or atezolizumab or cemiplimab).” NCT06840782 ↗ “Cemiplimab-rwlc (called Cemiplimab in this document)” NCT04975152 ↗ “either pembrolizumab, atezolizumab or cemiplimab” NCT05344209 ↗ “Cemiplimab, an Anti-PD-1 Monoclonal Antibody” NCT04398524 ↗ “high dose cemiplimab (HDREGN2810)” NCT03430063 ↗ “Cemiplimab (Libtayo) OR” NCT02423863 ↗ “Cemiplimab (Libtayo)” NCT03721679 ↗ “LIBTAYO (cemiplimab)” NCT04157985 ↗ |
| Known as | cemi | “with cemiplimab (cemi) versus cemiplimab monotherapy” NCT07020065 ↗ |
| Known as | Cemiplemab | “This clinical trial is a study that uses two antibodies called 'Isatuximab' and 'Cemiplemab' as a rescue anticancer therapy for patients with relapsed or refractory'NK/T cell lymphoma'.” NCT04763616 ↗ |
| Known as | Cemiplimab-Rwlc | “Drug: Cemiplimab-Rwlc” NCT06449313 ↗ |
| Known as | LIBTAYO | “This proposal is for a Window of Opportunity (WOO) clinical trial using a novel combination of two Health Canada approved agents, cemiplimab (Libtayo) and dupilumab (Dupixent),...” NCT05967884 ↗5“Neoadjuvant treatment with Cemiplimab (Libtayo®) 350 mg D1-D21 (3 cycles of 4 weeks).” NCT06656598 ↗ “another anticancer drug called Libtayo® (cemiplimab)” NCT06923761 ↗ “Cemiplimab (LIBTAYO) is a PD-1 blocking antibody” NCT07650266 ↗ “Cemiplimab (Libtayo) OR” NCT02423863 ↗ “Cemiplimab (Libtayo)” NCT03721679 ↗ |
| Known as | LIBTAYO (cemiplimab) | “LIBTAYO (cemiplimab)” NCT04157985 ↗ |
| Known as | REGN2810 | “Cemiplimab, also known as REGN2810, is in late stage trials and appears to have similar activity to approved anti PD-1 antibodies in a number of malignancies .” NCT03669718 ↗11“combined with cemiplimab (also known as REGN2810)” NCT04590326 ↗ “Drug: cemiplimab REGN2810” NCT03769181 ↗ “Drug: Cemiplimab REGN2810” NCT03192345 ↗ “Cemiplimab REGN2810” NCT03871348 ↗ “Cemiplimab REGN2810” NCT03194867 ↗ |
| Known as | REGN2810/ipi | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03515629 ↗ |
| Known as | SAR439684 | “Cemiplimab (SAR439684)” NCT05669989 ↗ |
| Action | Inhibit | “anti-PD-1 (Nivolumab, Pembrolizumab or Cemiplimab)” NCT02423863 ↗ |
| Modality | Monoclonal antibody | “Cemiplimab is a human anti-PD-1 monoclonal antibody.” PMID 33942954 ↗ May 2021 |
| Route | Intravenous | “Cemiplimab: 350 mg q3w X 12 weeks IV” NCT01042379 ↗ |
| Target | PDCD1 | “Fianlimab and cemiplimab are high-affinity, human, hinge-stabilized IgG4 monoclonal antibodies, targeting LAG-3 and PD-1, respectively.” PMID 38900987 ↗ Jun 2024 |