Relatlimab
- Generic Name
- Relatlimab
- Brand Names
- Opdualag
- Drug Type
- Biotech
- CAS Number
- 1673516-98-7
- Unique Ingredient Identifier
- AF75XOF6W3
- Background
Relatlimab is a human IgG4 monoclonal antibody and novel immune checkpoint inhibitor that targets lymphocyte activation gene-3 (LAG-3). It was the first commercially developed anti-LAG-3 antibody, entering clinical trials in 2013, and has garnered interest in the treatment of a variety of cancers, including leukemia and melanoma. As immune checkpoint inhibitors have limited efficacy when used alone, drugs like relatlimab have been trialed in combination with other checkpoint inhibitors - for example, PD-1 inhibitors like nivolumab or CTLA-4 inhibitors like ipilimumab - to enhance their efficacy.
Relatlimab received FDA approval in March 2022, alongside the PD-1 inhibitor nivolumab in the combination product Opdualag (Bristol-Myers Squibb), for the treatment of unresectable or metastatic melanoma. It was the first anti-LAG-3 antibody demonstrate benefit in a Phase 3 study, as well as the first to receive FDA approval.
- Indication
Relatlimab is indicated in combination with nivolumab, in the combination product Opdualag, for the treatment of adult and pediatric patients ≥12 years old with unresectable or metastatic melanoma.
- Associated Conditions
- Metastatic Melanoma, Unresectable Melanoma
First U.S. Patient Dosed in Moderna's Phase 1 Trial of Novel mRNA-4106 Pan-Tumor Therapy
• The START Center for Cancer Research has administered the first U.S. dose of Moderna's mRNA-4106, a novel pan-tumor antigen therapy candidate, to a patient with advanced solid tumors.
• The Phase 1 trial (NCT06880549) will evaluate mRNA-4106 alone and in combination with checkpoint inhibitors, assessing safety, pharmacodynamics, immunogenicity, and preliminary efficacy.
• Moderna's mRNA-4106 employs a multivalent approach targeting antigens shared across multiple tumor types, potentially expanding treatment options beyond single-targeted immunotherapies.
SystImmune to Present Promising Data on Iza-bren for HER2-Negative Breast Cancer at ESMO Breast 2025
• SystImmune will present updated safety and efficacy data for izalontamab brengitecan (iza-bren), an EGFRxHER3 bispecific antibody-drug conjugate, in locally advanced or metastatic breast cancer at ESMO Breast 2025 on May 16.
• Early clinical results show encouraging efficacy across all HER2 levels in HER2-negative breast cancer patients, including HER2 0 patients, suggesting potential therapeutic benefits for patients with limited treatment options.
• Iza-bren, being jointly developed by SystImmune and Bristol Myers Squibb, works by blocking EGFR and HER3 signals to cancer cells while delivering a therapeutic payload that induces cancer cell death.
BMS's Opdualag Shows Strong Early Performance as First LAG-3 Checkpoint Inhibitor for Melanoma
• Bristol-Myers Squibb's Opdualag, the first FDA-approved LAG-3 inhibitor combination, generated $58 million in second-quarter sales following its March approval for metastatic melanoma.
• Clinical data shows Opdualag more than doubles progression-free survival compared to PD-1 monotherapy, positioning it as a potential new standard of care with anticipated EU approval in coming weeks.
• BMS expects Opdualag to reach $4 billion in peak sales across multiple cancer indications, strengthening its immuno-oncology portfolio as competitors including Merck develop rival LAG-3 inhibitors.
Over 220 Pipeline Therapies in Development for Non-Hodgkin's Lymphoma, Reports DelveInsight
• DelveInsight's 2025 pipeline report reveals more than 200 companies developing 220+ therapies for Non-Hodgkin's Lymphoma, demonstrating robust research activity in this therapeutic area.
• Key investigational therapies include Mosunetuzumab (Roche), Tisagenlecleucel (Novartis), Capivasertib (AstraZeneca), BI-1206 (BioInvent), and HMPL-760 (Hutchmed), each employing distinct mechanisms of action.
• Novel approaches include T-cell bispecific antibodies, CAR-T cell therapies, AKT inhibitors, and next-generation BTK inhibitors, addressing treatment resistance and improving outcomes for relapsed/refractory patients.
Aulos Bioscience to Present Promising Phase 2 Data for Novel IL-2 Therapeutic in Melanoma Treatment
• Aulos Bioscience will present new Phase 2 data for AU-007, an AI-designed monoclonal antibody targeting IL-2, showing promising results in second-line melanoma treatment at the upcoming AACR Annual Meeting.
• AU-007's unique mechanism prevents IL-2 from binding to regulatory T cells while allowing it to activate effector T cells and NK cells, potentially overcoming limitations of traditional IL-2 therapies.
• The novel therapeutic may significantly reduce serious side effects associated with high-dose IL-2 therapy, including vascular leak syndrome and pulmonary edema, by preventing IL-2 binding to CD25-containing receptors.
Pipeline Progress: Over 25 New Therapies in Development for Metastatic Liver Cancer
• DelveInsight's latest report reveals a robust pipeline with over 20 companies developing 25+ therapies for metastatic liver cancer, offering new hope for patients with limited treatment options.
• Several promising clinical trials are underway in 2025, including studies evaluating novel combinations such as AK104 plus lenvatinib, tislelizumab with lenvatinib, and triplet therapy of nivolumab, relatlimab and bevacizumab.
• Key emerging therapies include exoASO-STAT6 targeting tumor-associated macrophages, STP705 dual TGF-ß1/COX-2 inhibitor, and ONCR-177, an oncolytic viral immunotherapy expressing five transgenes to fight tumors through multiple mechanisms.
Agilent's PD-L1 IHC 28-8 pharmDx Receives EU Certification for Lung Cancer and Melanoma Diagnostics
• Agilent Technologies' PD-L1 IHC 28-8 pharmDx test has received EU IVDR certification for two new companion diagnostic indications in non-small cell lung cancer and advanced melanoma, bringing its total European indications to nine.
• The diagnostic test helps identify eligible patients for Bristol Myers Squibb's OPDIVO (nivolumab) in resectable NSCLC patients and Opdualag (nivolumab and relatlimab) in previously untreated advanced melanoma patients.
• As the only clinically validated test for these specific treatments, the expanded indications will provide critical information to European physicians for treatment decisions in cancers that account for over 2 million new cases and 1.77 million deaths annually.
Novel Chemo-Immunotherapy Approach Shows Promise for Advanced HPV-Negative Head and Neck Cancer
• A Phase 2 clinical trial at UChicago Medicine demonstrated that combining nivolumab immunotherapy with chemotherapy led to tumor shrinkage in 53% of advanced HPV-negative head and neck cancer patients.
• The innovative treatment approach, which included response-adaptive chemo-radiation therapy, showed improved survival outcomes and reduced toxic side effects, particularly in patients who responded well to initial treatment.
• Higher PD-L1 expression levels were associated with better treatment responses, suggesting its potential as a biomarker for predicting treatment outcomes in this patient population.
Robust Pipeline of 220+ Drugs Advancing for Gastric Cancer Treatment, Led by Major Pharmaceutical Companies
• DelveInsight's comprehensive analysis reveals over 200 companies actively developing 220+ pipeline therapies for gastric cancer treatment, indicating significant industry investment in addressing this disease.
• Key players including BeiGene, Bristol-Myers Squibb, and AstraZeneca are advancing promising candidates like tislelizumab, relatlimab-nivolumab combination, and trastuzumab deruxtecan through clinical trials.
• Multiple therapeutic approaches are being explored, from monoclonal antibodies to small molecules, with several drugs in late-stage development including Catumaxomab in Phase III and Tivumecirnon in Phase II trials.
Novel Triple Immunotherapy Approach Shows Promise in Glioblastoma Treatment
• A groundbreaking experimental treatment combining three checkpoint inhibitor immunotherapies before surgery has shown promising results in glioblastoma, with one patient remaining cancer-free for over 18 months.
• The innovative approach, developed by Professor Georgina Long AO, demonstrated increased immune cell activation and diversity in the treated tumor, suggesting an enhanced immune response against cancer cells.
• An Australian-led international clinical trial is being planned to evaluate double immunotherapy, with some patients receiving additional chemotherapy, to validate this potential breakthrough in glioblastoma treatment.
Experts Debate Value of ctDNA Testing in Muscle-Invasive Bladder Cancer Management
• Leading oncologists discuss the current limitations of circulating tumor DNA (ctDNA) testing in muscle-invasive bladder cancer, highlighting the need for more evidence before routine clinical implementation.
• The IMvigor011 trial is exploring ctDNA's potential to guide immunotherapy decisions, with experts suggesting its greatest value may lie in predicting treatment response rather than early detection.
• While some clinicians use Signatera ctDNA testing between scans, experts caution against replacing standard imaging without stronger evidence of improved patient outcomes.
Immunocore Reports Strong KIMMTRAK Sales Growth and Advances Clinical Pipeline in 2024
• KIMMTRAK achieved $310 million in net sales for 2024, with $84.1 million in Q4, marking 11 consecutive quarters of growth and launches in 14 new territories.
• The company advanced its PRAME portfolio with first patient randomization in Phase 3 PRISM-MEL-301 trial and continued enrollment in combination studies for ovarian cancer and NSCLC.
• Immunocore maintained strong financial position with $820.4 million in cash and marketable securities, while progressing autoimmune and infectious disease programs.
LAG-3 Immunotherapies Market Poised for Explosive Growth with Next-Generation Therapies Advancing Across Major Markets
• The LAG-3 next-generation immunotherapies market is projected to grow from $463.6 million in 2024 to $5.5 billion by 2035, driven by increasing solid tumor cases and expanding treatment options.
• Bristol Myers Squibb's Opdualag (nivolumab/relatlimab) has established a foundation for LAG-3 therapies, with promising candidates from Merck, Regeneron, and Immutep advancing through clinical trials.
• Biomarker-driven precision medicine and strategic regulatory support are accelerating development of novel LAG-3 therapies, including monoclonal antibodies, bispecific antibodies, and soluble LAG-3 molecules.
Bristol Myers Squibb Provides Update on Phase 3 RELATIVITY-098 Trial for LAG-3 Inhibitor
• LAG-3 is a key immune checkpoint molecule found on immune cells that can inhibit T cell function and allow tumors to evade immune system attack.
• Preclinical studies suggest that combining LAG-3 and PD-1 inhibition may enhance anti-tumor immune responses beyond PD-1 blockade alone.
• Bristol Myers Squibb is evaluating relatlimab in combination with other agents across multiple tumor types to potentially expand treatment options.
Clinical Trials Support Immunotherapy-First Approach in Advanced BRAF+ Melanoma Treatment
• Phase 2 SECOMBIT and Phase 3 DREAMseq trials demonstrate superior overall survival when initiating treatment with immune checkpoint inhibitors versus targeted therapy in BRAF-mutant melanoma patients.
• Research indicates that using targeted therapy first may compromise the effectiveness of subsequent immunotherapy treatments in advanced melanoma cases.
• A novel "sandwich" approach combining short-term targeted therapy followed by immunotherapy shows promise for specific patient subgroups with high tumor burden or elevated LDH levels.
FDA Approves ORLYNVAH™: First New Oral Treatment for Uncomplicated UTIs in 25 Years
• Iterum Therapeutics receives FDA approval for ORLYNVAH™, marking the first branded uncomplicated UTI treatment to enter the U.S. market in over 25 years and the first oral penem antibiotic approved in the country.
• The drug demonstrates significant potential against multi-drug resistant pathogens, specifically targeting Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis in adult women with limited treatment options.
• Iterum reports $24.1 million in cash reserves as of December 2024, with funding projected to sustain operations into the second half of 2025 while pursuing pre-commercialization activities.
MSD Discontinues Development of TIGIT and LAG-3 Cancer Immunotherapy Programs
MSD has terminated the development of its anti-TIGIT antibody vibostolimab and anti-LAG-3 antibody favezelimab following disappointing clinical trial results. This decision represents another setback in the industry's efforts to develop effective checkpoint inhibitors that can complement existing PD-1/PD-L1 therapies, impacting MSD's strategy to diversify its oncology portfolio beyond Keytruda.
Nivolumab/Relatlimab Combination Demonstrates Sustained Overall Survival Benefit in Advanced Melanoma
• Extended analysis of the RELATIVITY-047 trial shows nivolumab/relatlimab significantly improves overall survival compared to nivolumab alone in advanced melanoma patients.
• Median overall survival reached 51.0 months with the combination therapy versus 34.1 months with nivolumab monotherapy, indicating a substantial survival advantage.
• The study also reported improved progression-free survival and melanoma-specific survival with the nivolumab/relatlimab combination.
• No new safety signals were identified, reinforcing the combination's manageable safety profile in previously untreated advanced melanoma.
FDA Approves Subcutaneous Opdivo Qvantig for Multiple Solid Tumors
• The FDA approved Opdivo Qvantig, a subcutaneous injection of nivolumab, for adult solid tumors previously approved for intravenous Opdivo.
• CheckMate-67T trial data showed non-inferior pharmacokinetic exposures, similar efficacy, and comparable safety to intravenous Opdivo.
• Opdivo Qvantig offers a faster 3-5 minute administration time, providing convenience and flexibility for patients.
• The approval helps Bristol Myers Squibb maintain market share amid patent expirations and increasing biosimilar competition.
Roche's Vabysmo Prefilled Syringe Approved in EU for Retinal Conditions
• The European Medicines Agency (EMA) has approved Roche's Vabysmo prefilled syringe (PFS) for treating three retinal conditions: nAMD, DME, and RVO.
• Vabysmo PFS offers a convenient, ready-to-use format for ophthalmologists, potentially reducing treatment burden for both patients and specialists.
• This approval marks the EU's first prefilled syringe containing a bispecific antibody for vision-threatening retinal diseases, offering a CE-labelled needle for intravitreal injection.
• Vabysmo targets Ang-2 and VEGF-A, stabilizing blood vessels and addressing key factors contributing to vision loss in these conditions.
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