Drugs / Fianlimab
Trials 38
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT07365839 | Oct 2026 → May 2035 | hepatocellular carcinoma | Virginia Commonwealth University | Withdrawn | No outcome recorded |
| Phase 1 | NCT05137054 | Aug 2022 → Mar 2028 expected | plasma cell myeloma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT03233139 | Jun 2017 → Sep 2027 expected | cancer | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03005782 | Nov 2016 → Apr 2024 | cancer | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| 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 | NCT04989946 | Dec 2021 → Dec 2026 expected | prostate cancer | University of Wisconsin, Madison | 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 226 trials | ||||||
| Phase 2 | NCT07346196 | Feb 2027 → Aug 2031 expected | squamous cell carcinoma | University of Chicago | Not yet 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 | NCT07808515 | Oct 2026 → Nov 2030 expected | skin basal cell carcinoma | Regeneron Pharmaceuticals | 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| Phase 2 | NCT07414992 | Sep 2026 → Mar 2028 | urothelial carcinoma | Memorial Sloan Kettering Cancer Center | Withdrawn | No outcome recorded |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 | NCT07188896 | Apr 2026 → Nov 2029 expected | clear cell renal carcinoma | Brian Rini | 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 | NCT07234058 | Feb 2026 → May 2028 expected | malignant pleural mesothelioma | French Cooperative Thoracic Intergroup | Not yet 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 | NCT06571708 | Aug 2025 → Dec 2028 expected | infiltrating bladder urothelial carcinoma | Columbia University | 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 | 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 | NCT06699602 | Feb 2025 → Feb 2028 expected | renal cell carcinoma | Memorial Sloan Kettering Cancer Center | 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 | NCT06190951 | Sep 2024 → Nov 2026 expected | melanoma | Regeneron Pharmaceuticals | Active not 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 | NCT05929664 | Jul 2023 → Jul 2031 | skin basal cell carcinoma | Thomas Jefferson University | Suspended | No outcome recorded |
| 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 | 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 | NCT05800015 | Aug 2023 → Jan 2030 expected | non-small cell lung carcinoma | Regeneron Pharmaceuticals | Active not 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 33 trials · 1 missed | ||||||
| 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 |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT07650266 Comparator | Jul 2026 → Jul 2030 expected | nasopharyngeal carcinoma | Memorial Sloan Kettering Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07058012 Comparator | Apr 2026 → Apr 2029 expected | colorectal cancer | NSABP Foundation Inc | Recruiting | No outcome recorded |
| Phase 2 | NCT06848088 Background | Apr 2025 → Oct 2029 expected | melanoma | Regeneron Pharmaceuticals | Enrolling by invitation | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 2022-09-12 | 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. |
| 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. |
All press releases naming this drug 7 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fianlimab | “This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called...” NCT06246916 ↗38“Fianlimab (REGN3767) administered intravenously in combination with Cemiplimab.” NCT05929664 ↗ “Cemiplimab 350mg + Fianlimab 1600mg intravenously” NCT07058012 ↗ |
| Known as | R3767 | “This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called REGN2810, also known as cemiplimab” NCT05352672 ↗2“This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab” NCT05608291 ↗ “This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767)” NCT06190951 ↗ |
| Known as | REGN3767 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01042379 ↗ |
| Action | Inhibit | “Fianlimab is a drug that blocks the action of a protein called lymphocyte activation gene (LAG)-33 (LAG-3)” NCT03916627 ↗ |
| Modality | Monoclonal antibody | “Cemiplimab (also known as REGN2810) and fianlimab (also known as REGN3767) are both a type of drug called a monoclonal antibody.” NCT03916627 ↗ |
| Route | Intravenous | “REGN 3767: 1600 mg q3W X 12 weeks IV” NCT01042379 ↗ |
| Target | LAG3 | “Fianlimab is a human IgG4 antibody to lymphocyte activation gene-3 (LAG-3)” NCT04989946 ↗ |