Drugs / Relatlimab
Relatlimab
also known as
BMS-986016 · BMS-986213 · Relatlimab-rmbw · rela · Relatlimab component of bms-986213 · Relatlimab component of opdualag -rmbw · Relatlimab: BMS-986016
Monoclonal antibody targets LAG3
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed melanomatosis 2 milestones | |||||
| Filed | EU (EMA) | — | melanomatosis | 2021-10-01 | “today announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for the LAG-3-blocking antibody relatlimab and nivolumab...” bms.com ↗ |
| Filed | US (FDA) | — | melanomatosis | 2021-09-20 | “FDA has accepted for priority review the Biologics License Application (BLA) for the LAG-3-blocking antibody relatlimab and nivolumab fixed-dose combination” bms.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Opdualag | — | 2022-09-15 | europa.eu ↗ |
Trials 85 · started per year
today
EU approved 2022
1
2
2
4
6
7
11
5
12
7
6
10
6
5
1
201420152016201720182019202020212022202320242025202620272028
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05704933 | Jun 2023 → Jun 2024 | metastatic malignant neoplasm in the brain, metastatic melanoma | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 111 trials · 3 met primary | ||||||
| Phase 1 | NCT05498480 | Jul 2022 → Jan 2024 | cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT05176483 | Dec 2021 → Jan 2027 expected | castration-resistant prostate carcinoma, clear cell renal carcinoma, colorectal cancer, head and neck squamous cell carcinoma +3 | Exelixis | Recruiting | No outcome recorded |
| Phase 1 | NCT03978611 | Dec 2021 → Jul 2023 | melanoma | Bristol-Myers Squibb | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04935229 | Aug 2021 → Jul 2024 | uveal melanoma | TriSalus Life Sciences, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04658147 | May 2021 → Sep 2025 overdue | hepatocellular carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04112498 | Oct 2019 → Feb 2023 | cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03493932 | Sep 2018 → Apr 2023 | glioblastoma | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 1 | NCT03335540 | May 2018 → Mar 2021 | cancer of unknown primary site | Bristol-Myers Squibb | Completed | Met primary |
| Phase 1 | NCT03044613 | Jul 2017 → Mar 2027 expected | esophageal cancer, gastric cancer, gastroesophageal cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active not recruiting | Met primary |
| Phase 1 | NCT02966548 | Jan 2017 → Jul 2024 | cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02658981 | Aug 2016 → Apr 2022 | gliosarcoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | Met primary |
| Phase 1/215 trials | ||||||
| Phase 1/2 | NCT07281924 | Oct 2026 → Dec 2030 expected | metastatic melanoma | University of Wisconsin, Madison | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06683755 | May 2025 → Aug 2030 expected | melanoma | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06697197 | Feb 2025 → Jan 2029 expected | cancer | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06208657 | Jul 2024 → Dec 2030 expected | brain cancer, childhood malignant neoplasm, refractory malignant neoplasm | Australian & New Zealand Children's Haematology/Oncology Group | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05255601 | Sep 2022 → Dec 2025 | Hodgkins lymphoma, non-Hodgkin lymphoma | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 1/2 | NCT05337137 | May 2022 → Jul 2025 | hepatocellular carcinoma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT05134948 | Nov 2021 → Sep 2025 | cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT04611126 | Apr 2021 → Mar 2024 | fallopian tube cancer, ovarian cancer, peritoneal carcinoma | Inge Marie Svane | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT04150965 | Jul 2020 → Aug 2024 | plasma cell myeloma, refractory plasma cell neoplasm | Multiple Myeloma Research Consortium | Terminated | No outcome recorded |
| Phase 1/2 | NCT03610711 | Mar 2019 → Dec 2026 expected | gastroesophageal cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03459222 | May 2018 → Feb 2025 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT03310619 | Dec 2017 → Feb 2023 | diffuse large B-cell lymphoma, follicular lymphoma | Celgene Corporation | Completed | No outcome recorded |
| Phase 1/2 | NCT02488759 | Oct 2015 → Mar 2021 | cancer of unknown primary site | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT02061761 | Mar 2014 → Feb 2022 | hematopoietic and lymphoid cell neoplasm | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT01968109 | Nov 2013 → May 2024 | neoplasm | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 251 trials · 2 met primary · 3 missed | ||||||
| Phase 2 | NCT07644312 | Mar 2027 → Mar 2033 expected | DNA repair disease, diffuse intrinsic pontine glioma, grade III glioma | Nationwide Children's Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07369791 | Dec 2026 → Dec 2035 | biliary tract cancer | National Health Research Institutes, Taiwan | Withdrawn | No outcome recorded |
| Phase 2 | NCT06999980 | Feb 2026 → Mar 2028 expected | cutaneous melanoma, mucosal melanoma | Melanoma Institute Australia | Recruiting | No outcome recorded |
| Phase 2 | NCT06816927 | Nov 2025 → Jun 2029 expected | glioblastoma | Duke University | Recruiting | No outcome recorded |
| Phase 2 | NCT06624475 | Aug 2025 → May 2028 expected | basal cell carcinoma | University of California, San Diego | Recruiting | No outcome recorded |
| Phase 2 | NCT06712927 | Aug 2025 → Nov 2026 expected | melanoma, metastatic malignant neoplasm in the brain | Stanford University | Recruiting | No outcome recorded |
| Phase 2 | NCT06708949 | Mar 2025 → Dec 2028 expected | clear cell renal carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06715241 | Dec 2024 → Dec 2030 expected | cervical carcinoma | ARCAGY/ GINECO GROUP | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06325683 | Nov 2024 → Jul 2028 | glioblastoma | National Cancer Institute (NCI) | Suspended | No outcome recorded |
| Phase 2 | NCT06029270 | Jul 2024 → Apr 2029 expected | nasopharyngeal carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT06288191 | Jun 2024 → Sep 2026 overdue | skin squamous cell carcinoma | Melanoma Institute Australia | Recruiting | No outcome recorded |
| Phase 2 | NCT06295159 | May 2024 → Nov 2028 expected | melanoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06151236 | Mar 2024 → Dec 2026 expected | cutaneous neuroendocrine carcinoma | Melanoma Institute Australia | Recruiting | No outcome recorded |
| Phase 2 | NCT06237920 | Feb 2024 → Dec 2026 expected | poisoning, urinary bladder carcinoma, urothelial carcinoma | The Netherlands Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06101134 | Nov 2023 → Apr 2025 overdue | melanoma | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05418972 | Aug 2023 → Dec 2025 overdue | melanoma | Melanoma Institute Australia | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05912244 | Jun 2023 → Jun 2027 expected | melanoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05704647 | Feb 2023 → Jul 2028 expected | cutaneous melanoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05347212 | Sep 2022 → Jul 2027 expected | kidney medullary carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05148546 | Apr 2022 → Apr 2025 overdue | renal cell carcinoma | The Netherlands Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06400264 | Feb 2022 → Jan 2023 | adult lymphoma, plasma cell myeloma, refractory malignant neoplasm | National Cancer Institute (NCI) | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05034536 | Feb 2022 → Jun 2026 overdue | metastatic melanoma | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04953104 | Sep 2021 → Dec 2026 expected | bladder transitional cell carcinoma, renal pelvis urothelial carcinoma, ureter transitional cell carcinoma, urethra transitional cell carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05077280 | Sep 2021 → Mar 2024 | uveal melanoma | California Pacific Medical Center Research Institute | Unknown | No outcome recorded |
| Phase 2 | NCT04913922 | May 2021 → Mar 2025 | acute myeloid leukemia | Ludwig-Maximilians - University of Munich | Unknown | No outcome recorded |
| Phase 2 | NCT04623775 | Feb 2021 → Jan 2024 | non-small cell lung carcinoma | Bristol-Myers Squibb | Completed | Missed primary |
| Phase 2 | NCT04567615 | Feb 2021 → Aug 2023 | adult hepatocellular carcinoma | Bristol-Myers Squibb | Completed | Missed primary |
| Phase 2 | NCT04552223 | Nov 2020 → Jan 2024 | uveal melanoma | Jose Lutzky, MD | Completed | No outcome recorded |
| Phase 2 | NCT04326257 | May 2020 → Aug 2023 | head and neck squamous cell carcinoma | Dan Zandberg | Completed | No outcome recorded |
| Phase 2 | NCT04205552 | Mar 2020 → Nov 2025 | non-small cell lung carcinoma | University Hospital, Essen | Completed | Met primary |
| Phase 2 | NCT04095208 | Feb 2020 → Sep 2024 | soft tissue sarcoma | Institut Bergonié | Completed | No outcome recorded |
| Phase 2 | NCT04080804 | Dec 2019 → Apr 2026 overdue | head and neck squamous cell carcinoma | Dan Zandberg | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03704077 | Oct 2019 → Feb 2022 | gastric carcinoma, gastroesophageal junction adenocarcinoma | Bristol-Myers Squibb | Withdrawn | No outcome recorded |
| Phase 2 | NCT04062656 | Sep 2019 → Mar 2024 | gastric cancer, gastroesophageal junction adenocarcinoma | University Hospital, Essen | Unknown | No outcome recorded |
| Phase 2 | NCT03899155 | Aug 2019 → Aug 2029 expected | cancer | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 2 | NCT03623854 | Apr 2019 → Sep 2023 | chordoma | Jonsson Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT03743766 | Mar 2019 → Jul 2024 | melanoma | John Kirkwood | Completed | No outcome recorded |
| Phase 2 | NCT03867799 | Mar 2019 → Oct 2022 | colorectal cancer | Royal Marsden NHS Foundation Trust | Unknown | No outcome recorded |
| Phase 2 | NCT03642067 | Feb 2019 → Feb 2024 | colorectal adenocarcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2 | NCT03724968 | Jan 2019 → May 2020 | metastatic melanoma | Elizabeth Davis | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03521830 | Nov 2018 → Jul 2027 expected | basal cell carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT03607890 | Nov 2018 → Oct 2027 expected | refractory malignant neoplasm | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03662659 | Oct 2018 → Aug 2020 | gastric cancer, gastroesophageal junction adenocarcinoma | Bristol-Myers Squibb | Completed | Missed primary |
| Phase 2 | NCT03026140 | Mar 2017 → Mar 2032 expected | colon carcinoma | The Netherlands Cancer Institute | Recruiting | Met primary |
| Phase 2 | NCT04204837 | Mar 2017 → Dec 2026 expected | skin squamous cell carcinoma | Salzburger Landeskliniken | Recruiting | No outcome recorded |
| Phase 2 | NCT02996110 | Feb 2017 → Nov 2021 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT02935634 | Nov 2016 → May 2022 | gastric cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT02750514 | May 2016 → Jan 2020 | cancer of unknown primary site | Bristol-Myers Squibb | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02519322 | Feb 2016 → Jan 2023 | acral lentiginous melanoma, mucosal melanoma, uveal melanoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02465060 | Aug 2015 → Dec 2027 expected | breast carcinoma, carcinoma of esophagus, cervical carcinoma, colon carcinoma +17 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02060188 | Mar 2014 → Oct 2024 | colorectal cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2/32 trials · 1 met primary | ||||||
| Phase 2/3 | NCT05987241 | Feb 2024 → Sep 2030 expected | infiltrating bladder urothelial carcinoma, infiltrating renal pelvis/ureter urothelial carcinoma, urethra transitional cell carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2/3 | NCT03470922 | Apr 2018 → Jan 2021 overdue | melanoma | Bristol-Myers Squibb | Active not recruiting | Met primary |
| Phase 33 trials · 1 missed | ||||||
| Phase 3 | NCT06561386 | Oct 2024 → Jul 2030 expected | non-small cell lung carcinoma | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 3 | NCT05625399 | Mar 2023 → Aug 2025 overdue | melanoma | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05002569 | Oct 2021 → Dec 2024 | melanoma | Bristol-Myers Squibb | Terminated | Missed primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT07459543 | Nov 2026 → May 2029 expected | metastatic melanoma | Bristol-Myers Squibb | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07574047 | Sep 2026 → Jun 2030 expected | melanoma | Swiss Cancer Institute | Not yet recruiting | No outcome recorded |
| Comparator or background therapy11 trials | ||||||
| Phase 1 | NCT04697576 Background | Oct 2021 → Sep 2027 expected | cutaneous melanoma, metastatic melanoma | Carlo Contreras | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06963905 Comparator | Dec 2025 → Dec 2030 expected | triple-negative breast carcinoma | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT05428007 Background | Feb 2023 → Aug 2026 overdue | melanoma | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2/3 | NCT06624644 Comparator | Aug 2025 → Feb 2029 expected | cutaneous melanoma | Linnaeus Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06743126 Comparator | Jan 2025 → Jan 2028 expected | cutaneous melanoma | Immatics US, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06246916 Comparator | Sep 2024 → Mar 2027 expected | melanoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06264180 Comparator | Jul 2024 → Sep 2030 expected | melanoma | Replimune, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06112314 Comparator | Jun 2024 → Oct 2027 expected | melanoma | Immunocore Ltd | Recruiting | No outcome recorded |
| Phase 4 | NCT07504796 Background | Apr 2026 → May 2029 expected | metastatic melanoma | NYU Langone Health | Recruiting | No outcome recorded |
| — | NCT05170659 Background | — | — | Bristol-Myers Squibb | No longer available | No outcome recorded |
| — | NCT05170685 Background | — | — | Bristol-Myers Squibb | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2025-05-22 | Exelixis | Results Exelixis Announces Encouraging Results from Phase 1b/2 STELLAR-002 Trial Evaluating Zanzalintinib in Combination with Immune Checkpoint Inhibitors in Advanced Kidney Cancer at ASCO 2025 exelixis.com ↗
Exelixis, Inc. (Nasdaq: EXEL) today announced results from an expansion cohort of the phase 1b/2 STELLAR-002 trial evaluating zanzalintinib in combination with either nivolumab (Opdivo®) or a fixed-dose combination of nivolumab and relatlimab (Opdualag™) in patients with previously untreated advanced clear cell renal cell carcinoma (RCC). |
| 2025-02-13 | Bristol-Myers Squibb | Results Bristol Myers Squibb Provides Update on Phase 3 RELATIVITY-098 Trial bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 RELATIVITY-098 trial evaluating Opdualag™ (nivolumab and relatlimab-rmbw) for the adjuvant treatment of patients with completely resected stage III-IV melanoma did not meet its primary endpoint of recurrence-free survival (RFS). |
| 2024-05-23 | Bristol-Myers Squibb | Results Bristol Myers Squibb to Present Data at ASCO & EHA from More Than 130 Studies Across 25 Diseases Supporting Expansion into New Indications, Demonstrating Long-Term Survival, and Highlighting Novel Modalities and Research Platforms bms.com ↗
Three-year follow-up data from the Phase 3 RELATIVITY-047 study demonstrating sustained responses with Opdualag™ (nivolumab and relatlimab-rmbw) in previously untreated metastatic or unresectable melanoma. |
| 2024-04-25 | Bristol-Myers Squibb | Results Bristol Myers Squibb Reports First Quarter Financial Results for 2024 bms.com ↗
Initial data from a randomized Phase 2 study evaluating Opdualag in NSCLC support the initiation of a Phase 3 trial in 2024 evaluating Opdualag plus chemotherapy versus PD-1/PD-L1 plus chemotherapy in an important segment of the disease. |
| 2023-12-15 | Bristol-Myers Squibb | Results Bristol Myers Squibb Provides Update on RELATIVITY-123 Trial Evaluating the Fixed-Dose Combination of Nivolumab and Relatlimab in Patients with Previously Treated Metastatic Microsatellite Stable (MSS) Colorectal Cancer bms.com ↗
It was determined that the trial was unlikely to meet its primary endpoints upon completion. |
| 2023-10-12 | Bristol-Myers Squibb | Results Bristol Myers Squibb to Showcase Data Demonstrating Improved Outcomes in Earlier Stages of Cancer, Durable Long-Term Benefits with Opdivo-Based Regimens, and Addressing High Unmet Needs in Multiple Tumor Types at ESMO 2023 bms.com ↗ |
| 2023-05-11 | Bristol-Myers Squibb | Results Bristol Myers Squibb to Highlight Diversified Approaches and Commitment to Improving Outcomes for Patients with Cancer and Serious Blood Disorders at ASCO, EHA and ICML 2023 bms.com ↗
Two-year data from the Phase 2/3 RELATIVITY-047 trial showed consistent benefit with the company’s third distinct checkpoint inhibitor Opdualag (nivolumab and relatlimab-rmbw) in patients with previously untreated metastatic or unresectable melanoma. |
| 2022-09-16 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives European Commission Approval for LAG-3-Blocking Antibody Combination, Opdualag (nivolumab and relatlimab), for the Treatment of Unresectable or Metastatic Melanoma with Tumor Cell PD-L1 Expression < 1% bms.com ↗
Opdualag is now the first approved LAG-3-blocking antibody combination for advanced melanoma in the European Union. |
| 2022-07-22 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval for LAG-3-Blocking Antibody Combination Opdualag (nivolumab and relatlimab) for Treatment of Patients with Unresectable or Metastatic Melanoma bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of the fixed-dose combination of nivolumab and relatlimab for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumor cell PD-L1 expression < 1%. |
| 2022-05-19 | Bristol-Myers Squibb | Results Bristol Myers Squibb Data at ASCO and EHA 2022 Highlight Progress in Transforming Treatment for Patients with Cancer and Blood Disorders bms.com ↗
Data from pivotal RELATIVITY -047 trial studying Opdualag reinforce efficacy of LAG-3 mechanism in advanced melanoma |
| 2022-03-18 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves First LAG-3-Blocking Antibody Combination, Opdualag™ (nivolumab and relatlimab-rmbw), as Treatment for Patients with Unresectable or Metastatic Melanoma bms.com ↗ |
| 2021-10-01 | Bristol-Myers Squibb | Regulatory European Medicines Agency Validates Bristol Myers Squibb’s Application for LAG-3-Blocking Antibody Relatlimab and Nivolumab Fixed-Dose Combination as First-Line Treatment for Patients with Unresectable or Metastatic Melanoma bms.com ↗
This validation confirms completion of the submission and begins the EMA’s centralized review process. |
| 2021-09-20 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for LAG-3-Blocking Antibody Relatlimab and Nivolumab Fixed-Dose Combination as Treatment for Patients with Unresectable or Metastatic Melanoma bms.com ↗ |
| 2021-09-08 | Bristol-Myers Squibb | Results Bristol Myers Squibb Research at ESMO 2021 Demonstrates Clinical Benefits of Immunotherapies in Multiple Hard-to-Treat Advanced or Metastatic Cancers and Reinforces the Benefit of Opdivo in Earlier-Stage Cancers bms.com ↗
Phase 3 data from RELATIVITY-047 demonstrate prolonged benefit beyond initial treatment of the LAG-3 blocking antibody relatlimab and PD-1 inhibitor nivolumab fixed-dose combination for patients with previously untreated unresectable or metastatic melanoma |
| 2021-05-19 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces LAG-3-Blocking Antibody Relatlimab and Nivolumab Fixed-Dose Combination Significantly Improves Progression-Free Survival vs. Opdivo (nivolumab) in Patients with Previously Untreated Metastatic or Unresectable Melanoma bms.com ↗
This is the first regimen to demonstrate a statistical benefit over anti-PD-1 monotherapy in metastatic melanoma. |
| 2021-05-12 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents New Research at ASCO and EHA 2021 Featuring Novel Approaches and Demonstrating Significant Progress to Improve Survival in Cancer and Blood Disorders bms.com ↗
First Phase 3 data from the RELATIVITY-047 trial highlight clinical benefit of LAG-3 blocking antibody relatlimab – the company’s third distinct checkpoint inhibitor – in combination with nivolumab for patients with previously untreated unresectable or metastatic melanoma |
| 2021-03-25 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces RELATIVITY-047, a Trial Evaluating Anti-LAG-3 Antibody Relatlimab and Opdivo (nivolumab) in Patients with Previously Untreated Metastatic or Unresectable Melanoma, Meets Primary Endpoint of Progression-Free Survival bms.com ↗
The trial met its primary endpoint of progression-free survival (PFS). |
| 2017-06-03 | Bristol-Myers Squibb | Results Anti-LAG-3 (BMS-986016) in Combination with Opdivo (nivolumab) Showed Activity in Patients with Melanoma Who Were Relapsed or Refractory to Anti-PD-1/PD-L1 Therapy bms.com ↗
In the ongoing expansion study of heavily pretreated patients who were refractory to or relapsed on anti-PD1/PDL1 therapy, the objective response rate (ORR) was 12.5 percent in evaluable patients (n=48). |
All press releases naming this drug 27 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 98 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Relatlimab | “Opdualag, a fixed-dose combination of Nivolumab 480mg and Relatlimab 160mg, intravenous, on day 1, 28 day cycle, 26 cycles” NCT06208657 ↗88“Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years” NCT05077280 ↗ “Nivolumab 480mg and Relatlimab 160mg will be administered intravenously every 4 weeks” NCT03867799 ↗ “Nivolumab 480 mg and relatlimab 160 mg administered intravenously every 4 weeks (Q4W)” NCT07574047 ↗ “Fixed dose combination of relatlimab and nivolumab (Opdualag)” NCT07644312 ↗ “Nivolumab + Relatlimab Fixed-Dose Combination (FDC)” NCT07459543 ↗ “Relatlimab (Anti-LAG-3 Monoclonal Antibody)” NCT05134948 ↗ |
| Known as | BMS-986016 | “Nivolumab and BMS-986016 (Relatlimab) as Potentially Targeting Treatment” NCT06400264 ↗9“Biological: Anti-LAG-3 Monoclonal Antibody BMS 986016” NCT02658981 ↗ “Relatlimab (BMS-986016) With Nivolumab (BMS-936558)” NCT04913922 ↗ “anti-LAG-3 monoclonal antibody BMS-986016” NCT02658981 ↗ “Relatlimab (BMS-986016)” NCT03026140 ↗ “Anti-LAG-3 (BMS-986016)” NCT04150965 ↗ “BMS986016” NCT06029270 ↗ |
| Known as | BMS-986213 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03662659 ↗ |
| Known as | rela | “This is a multicenter, phase II trial of relatlimab (rela), nivolumab (nivo), and ipilimumab (ipi) in patients with asymptomatic and symptomatic melanoma brain metastases.” NCT06712927 ↗ |
| Known as | Relatlimab component of bms-986213 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3990044 ↗ |
| Known as | Relatlimab component of opdualag -rmbw | ChEMBL registry synonym — accepted as the source's own label CHEMBL3990044 ↗ |
| Known as | Relatlimab-rmbw | “Opdualag (Nivolumab and Relatlimab-rmbw) is a combination formulation composed of nivolumab, a human immunoglobulin (Ig) G4 monoclonal antibody directed against the negative...” NCT06295159 ↗1“Opdualag (Nivolumab and Relatlimab-rmbw) is a human monoclonal antibody to LAG-3, currently under investigation.” NCT05704933 ↗ |
| Known as | Relatlimab: BMS-986016 | “Relatlimab: BMS-986016” NCT04326257 ↗ |
| Action | Inhibit | “relatlimab (anti-lymphocyte-activation gene 3 (LAG-3))” PMID 40010775 ↗ Feb 2025 |
| Modality | Monoclonal antibody | “Anti-LAG-3 Monoclonal Antibody (Relatlimab, BMS-986016)” NCT02061761 ↗ |
| Route | Intravenous | “relatlimab IV over 30 minutes” NCT02465060 ↗ |
| Target | LAG3 | “relatlimab (anti-lymphocyte-activation gene 3 (LAG-3))” PMID 40010775 ↗ Feb 2025 |