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 · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (8) | US (FDA) | LIBTAYO | — | 2020-06-25 – 2025-10-29 | fda.gov ↗ |
| Approved | EU (EMA) | Libtayo | — | 2019-06-28 | europa.eu ↗ |
| Approved | US (FDA) | LIBTAYO | — | 2018-09-28 | fda.gov ↗ |
Trials 191 · started per year
today
US approved 2018
EU approved 2019
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Also used as a comparator or background therapy in 24 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| 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 15 trials | ||||||
| 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Phase 1 | NCT05729139 Background | Jul 2023 → Jul 2026 | skin squamous cell carcinoma | Baptist Health South Florida | Withdrawn | No outcome recorded |
| Phase 1 | NCT04387084 Background | Aug 2020 → Aug 2026 overdue | 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 1/26 trials | ||||||
| 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 27 trials | ||||||
| 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 2/31 trial | ||||||
| Phase 2/3 | NCT05800015 Background | Aug 2023 → Jan 2030 expected | non-small cell lung carcinoma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| 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 |
| Phase not stated1 trial | ||||||
| — | NCT06132191 Background | — | non-small cell lung carcinoma, skin basal cell carcinoma, skin squamous cell carcinoma | Regeneron Pharmaceuticals | Approved for marketing | No outcome recorded |
Press releases naming this drug 79 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-11-19 | Regeneron Pharmaceuticals | 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 ↗ |
| 2025-10-17 | Regeneron Pharmaceuticals | 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 | 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 | 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 ↗ |
| 2025-05-31 | Regeneron Pharmaceuticals | 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 ↗ |
| 2025-05-01 | Regeneron Pharmaceuticals | Regeneron to Highlight Advances at ASCO with Phase 3 Adjuvant Libtayo® (cemiplimab) CSCC Updates and Promising Early Blood Cancer Data with Linvoseltamab Combination regeneron.com ↗ |
| 2025-01-13 | Regeneron Pharmaceuticals | 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 ↗ |
| 2024-09-09 | Regeneron Pharmaceuticals | Libtayo® (cemiplimab) Demonstrates Durable Survival Benefit at Five Years in Advanced Non-small Cell Lung Cancer regeneron.com ↗ |
| 2024-05-23 | Regeneron Pharmaceuticals | Promising Anti-tumor Activity of Novel Costimulatory Bispecific Antibody REGN7075 (EGFRxCD28) in Combination with Libtayo® (cemiplimab) to be Reported at ASCO regeneron.com ↗ |
| 2023-10-21 | Regeneron Pharmaceuticals | Libtayo® (cemiplimab) Neoadjuvant Treatment Demonstrates Encouraging Event-Free Survival in Patients with Resectable Cutaneous Squamous Cell Carcinoma (CSCC) regeneron.com ↗ |
| 2023-05-25 | Regeneron Pharmaceuticals | Fianlimab (LAG-3 inhibitor) Combined with Libtayo® (cemiplimab) Shows Clinically Meaningful and Durable Tumor Responses Across Key Advanced Melanoma Patient Populations regeneron.com ↗ |
| 2023-03-29 | Regeneron Pharmaceuticals | 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 ↗ |
| 2023-02-24 | Regeneron Pharmaceuticals | 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 ↗ |
| 2022-12-23 | Regeneron Pharmaceuticals | Libtayo® (cemiplimab) Approved in Japan for Advanced or Recurrent Cervical Cancer regeneron.com ↗ |
| 2022-12-01 | Regeneron Pharmaceuticals | Regeneron ESMO IO Presentations Highlight Potential of Fianlimab and Libtayo® (cemiplimab) in Multiple Solid Tumor Types regeneron.com ↗ |
| 2022-11-22 | Regeneron Pharmaceuticals | 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 ↗ |
| 2022-11-08 | Regeneron Pharmaceuticals | 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 | Libtayo® (cemiplimab) Receives Positive CHMP Opinion Recommending Approval to Treat Advanced Cervical Cancer regeneron.com ↗ |
| 2022-09-12 | Regeneron Pharmaceuticals | Positive Neoadjuvant Libtayo® (cemiplimab) Monotherapy Data in Resectable Cutaneous Squamous Cell Carcinoma Presented at ESMO and Published in NEJM regeneron.com ↗ |
| 2022-09-12 | Regeneron Pharmaceuticals | 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 ↗ |
| 2022-09-04 | Regeneron Pharmaceuticals | ESMO Presentations of Libtayo® (cemiplimab), Fianlimab and Novel Bispecific Antibodies Showcase Expanding Potential of Regeneron's Oncology Pipeline in Multiple Cancers regeneron.com ↗ |
| 2022-08-03 | Regeneron Pharmaceuticals | 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 ↗ |
| 2022-07-01 | Regeneron Pharmaceuticals | Regeneron Completes Purchase of Sanofi's Stake in Libtayo® (cemiplimab) regeneron.com ↗ |
| 2022-06-02 | Sanofi | Press Release: Sanofi grants Regeneron worldwide exclusive license rights to Libtayo® (cemiplimab) sanofi.com ↗ |
| 2022-06-02 | Regeneron Pharmaceuticals | Regeneron Strengthens Commitment to Oncology through Purchase of Sanofi's Stake in the Regeneron and Sanofi Collaboration on Libtayo® (cemiplimab), a PD-1 Inhibitor Approved for Multiple Forms of Cancer regeneron.com ↗ |
| 2022-03-08 | BioNTech SE | BioNTech and Regeneron Expand Strategic Collaboration to Advance Clinical Development of FixVac and Libtayo® (cemiplimab) Combination in NSCLC biontech.com ↗ |
| 2022-01-28 | Sanofi | Sanofi and Regeneron provide regulatory update on Libtayo® (cemiplimab-rwlc) in advanced cervical cancer sanofi.com ↗ |
| 2022-01-28 | Regeneron Pharmaceuticals | Regeneron and Sanofi Provide Regulatory Update on Libtayo® (cemiplimab-rwlc) in Advanced Cervical Cancer regeneron.com ↗ |
| 2022-01-19 | Regeneron Pharmaceuticals | FDA Accepts for Review Libtayo® (cemiplimab-rwlc) in Combination with Chemotherapy for First-line Treatment of Advanced NSCLC regeneron.com ↗ |
| 2021-09-28 | Regeneron Pharmaceuticals | FDA Accepts Libtayo® (cemiplimab-rwlc) for Priority Review for Advanced Cervical Cancer regeneron.com ↗ |
| 2021-09-19 | Sanofi | 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 | ESMO Late-breaking Data Show Libtayo® (cemiplimab) and Chemotherapy First-line Treatment Combination Significantly Improved Overall Survival in Patients with Advanced NSCLC regeneron.com ↗ |
| 2021-08-05 | Sanofi | 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 ↗ |
| 2021-08-05 | Regeneron Pharmaceuticals | 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 ↗ |
| 2021-06-25 | Sanofi | Press Release: Libtayo® (cemiplimab) approved by the European Commission as the first immunotherapy indicated for patients with advanced basal cell carcinoma sanofi.com ↗ |
| 2021-06-25 | Sanofi | 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 ↗ |
| 2021-06-25 | Regeneron Pharmaceuticals | Libtayo® (cemiplimab) Approved by the European Commission as the First Immunotherapy Indicated for Patients with Advanced Basal Cell Carcinoma regeneron.com ↗ |
| 2021-06-25 | Regeneron Pharmaceuticals | 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 ↗ |
| 2021-05-24 | Sanofi | Libtayo® (cemiplimab) receives positive CHMP opinion for the treatment in Europe of two advanced cancers sanofi.com ↗ |
| 2021-05-24 | Regeneron Pharmaceuticals | Libtayo® (cemiplimab) Receives Positive CHMP Opinion for the Treatment in Europe of Two Advanced Cancers regeneron.com ↗ |
| 2021-05-19 | Regeneron Pharmaceuticals | Libtayo® (cemiplimab-rwlc) Presentations at ASCO Highlight Expanding Clinical Data in Diverse Cancers regeneron.com ↗ |
| 2021-05-12 | Sanofi | Positive Phase 3 Libtayo® (cemiplimab) results in advanced cervical cancer presented at ESMO Virtual Plenary sanofi.com ↗ |
| 2021-05-12 | Regeneron Pharmaceuticals | Positive Phase 3 Libtayo® (cemiplimab) Results in Advanced Cervical Cancer Presented at ESMO Virtual Plenary regeneron.com ↗ |
| 2021-03-15 | Sanofi | Phase 3 trial of Libtayo® (cemiplimab) monotherapy in advanced cervical cancer stopped early for positive result on overall survival sanofi.com ↗ |
| 2021-03-15 | Regeneron Pharmaceuticals | Phase 3 Trial of Libtayo® (cemiplimab) Monotherapy in Advanced Cervical Cancer Stopped Early for Positive Result on Overall Survival regeneron.com ↗ |
| 2021-02-22 | Sanofi | 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 ↗ |
| 2021-02-22 | Regeneron Pharmaceuticals | 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 ↗ |
| 2021-02-12 | Sanofi | 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 ↗ |
| 2021-02-12 | Regeneron Pharmaceuticals | 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 ↗ |
| 2021-02-09 | Sanofi | FDA approves Libtayo® (Cemiplimab-rwlc) as first immunotherapy indicated for patients with advanced basal cell carcinoma sanofi.com ↗ |
| 2021-02-09 | Regeneron Pharmaceuticals | FDA Approves Libtayo® (cemiplimab-rwlc) as First Immunotherapy Indicated for Patients with Advanced Basal Cell Carcinoma regeneron.com ↗ |
| 2020-10-29 | Regeneron Pharmaceuticals | FDA Accepts for Priority Review Libtayo® (cemiplimab-rwlc) for Advanced Non-small Cell Lung Cancer with PD-L1 Expression of ≥50% regeneron.com ↗ |
| 2020-09-21 | Sanofi | 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 ↗ |
| 2020-09-21 | Regeneron Pharmaceuticals | 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 ↗ |
| 2020-09-18 | Sanofi | Positive pivotal data for Libtayo® (cemiplimab) monotherapy in locally advanced basal cell carcinoma featured as a late-breaking presentation at ESMO sanofi.com ↗ |
| 2020-09-18 | Regeneron Pharmaceuticals | Positive Pivotal Data for Libtayo® (cemiplimab) Monotherapy in Locally Advanced Basal Cell Carcinoma Featured as a Late-breaking Presentation at ESMO regeneron.com ↗ |
| 2020-09-03 | Regeneron Pharmaceuticals | Late-breaking Libtayo® (cemiplimab) Pivotal Data in Advanced Non-small Cell Lung Cancer and Basal Cell Carcinoma to Be Presented at ESMO regeneron.com ↗ |
| 2020-07-31 | BioNTech SE | BioNTech Announces Strategic Collaboration with Regeneron to Advance FixVac and Libtayo® (cemiplimab) Combination in Melanoma biontech.com ↗ |
| 2020-06-24 | Regeneron Pharmaceuticals | New Publication Highlights Preclinical Research Showing Potential to Enhance Cancer Treatment by Combining Novel Costimulatory Bispecific Antibodies with Libtayo® (cemiplimab) regeneron.com ↗ |
| 2020-05-29 | Sanofi | 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 ↗ |
| 2020-05-29 | Regeneron Pharmaceuticals | 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 ↗ |
| 2020-05-05 | Sanofi | Libtayo® (cemiplimab) shows clinically meaningful and durable responses in second-line advanced basal cell carcinoma sanofi.com ↗ |
| 2020-05-05 | Regeneron Pharmaceuticals | Libtayo® (cemiplimab) Shows Clinically-Meaningful and Durable Responses in Second-line Advanced Basal Cell Carcinoma regeneron.com ↗ |
| 2020-04-27 | Sanofi | 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 ↗ |
| 2020-04-27 | Regeneron Pharmaceuticals | 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 ↗ |
| 2019-11-05 | Regeneron Pharmaceuticals | Regeneron Provides Updates on Phase 3 Libtayo® (cemiplimab) Development Program in Advanced Non-small Cell Lung Cancer regeneron.com ↗ |
| 2019-07-01 | Regeneron Pharmaceuticals | Libtayo® (cemiplimab) Approved for Advanced Cutaneous Squamous Cell Carcinoma in the European Union regeneron.com ↗ |
| 2019-05-16 | Regeneron Pharmaceuticals | Updated Libtayo® (cemiplimab-rwlc) Results Reinforce Durable and Substantial Response Rates in Advanced Cutaneous Squamous Cell Carcinoma regeneron.com ↗ |
| 2019-04-26 | Regeneron Pharmaceuticals | CHMP Issues Positive Opinion for Libtayo® (cemiplimab) in Advanced Cutaneous Squamous Cell Carcinoma regeneron.com ↗ |
| 2018-10-08 | Regeneron Pharmaceuticals | Libtayo® (cemiplimab-rwlc) Data at ESMO 2018 Congress Provide New Insights in Six Tumor Types Under Investigation regeneron.com ↗ |
| 2018-09-28 | Regeneron Pharmaceuticals | FDA Approves Libtayo® (cemiplimab-rwlc) as First and Only Treatment for Advanced Cutaneous Squamous Cell Carcinoma regeneron.com ↗ |
| 2018-06-04 | Regeneron Pharmaceuticals | New England Journal of Medicine Publishes Pivotal Cemiplimab Trials Showing Positive Results in Advanced Cutaneous Squamous Cell Carcinoma regeneron.com ↗ |
| 2018-05-16 | Regeneron Pharmaceuticals | Regeneron and Sanofi Share First Positive Clinical Data for Cemiplimab in Advanced Non-small Cell Lung Cancer at ASCO regeneron.com ↗ |
| 2018-04-30 | Regeneron Pharmaceuticals | FDA to Conduct Priority Review of Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma regeneron.com ↗ |
| 2018-04-03 | Regeneron Pharmaceuticals | EMA to Review Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma regeneron.com ↗ |
| 2018-01-08 | Regeneron Pharmaceuticals | Regeneron and Sanofi To Accelerate and Expand Investment for Cemiplimab and Dupilumab Development Programs regeneron.com ↗ |
| 2017-12-13 | Regeneron Pharmaceuticals | Regeneron and Sanofi Announce Positive Topline Pivotal Results for PD-1 Antibody Cemiplimab in Advanced Cutaneous Squamous Cell Carcinoma regeneron.com ↗ |
| 2017-11-01 | Regeneron Pharmaceuticals | Regeneron to Share Clinical Progress of REGN1979 and Cemiplimab (REGN2810) in B-Cell Lymphomas at the 2017 ASH Annual Meeting regeneron.com ↗ |
| 2017-09-08 | Regeneron Pharmaceuticals | Regeneron and Sanofi Announce Cemiplimab (REGN2810) Has Received FDA Breakthrough Therapy Designation for Advanced Cutaneous Squamous Cell Carcinoma regeneron.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 217 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 ↗204“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 ↗ “LIBTAYO (cemiplimab)” NCT04157985 ↗ “Cemiplimab (Libtayo)” NCT03721679 ↗ “cemiplimab” NCT03409614 ↗ “Cemiplimab” NCT04954599 ↗ “Cemiplimab” NCT05429866 ↗ |
| 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 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05729139 ↗ |
| 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 ↗10“Drug: Cemiplimab REGN2810” NCT03192345 ↗ “Drug: cemiplimab REGN2810” NCT03769181 ↗ “Cemiplimab REGN2810” NCT03194867 ↗ “Cemiplimab REGN2810” NCT03871348 ↗ |
| 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 |