MedPath

Relatlimab

Generic Name
Relatlimab
Brand Names
Opdualag
Drug Type
Biotech
Chemical Formula
-
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
Associated Therapies
-
targetedonc.com
·

PD-L1 vs LAG-3 Expression in Non–Small Cell Lung Cancer

The RELATIVITY-104 study evaluated nivolumab, relatlimab, and platinum doublet chemotherapy as a first-line treatment for metastatic NSCLC. The combination therapy showed higher overall response rates (ORR) compared to nivolumab and chemotherapy alone, especially in patients with PD-L1 expression ≥ 1% and nonsquamous histology. The safety profile was manageable, and further studies are needed to confirm long-term benefits.
pharmavoice.com
·

Regeneron takes the long-haul approach to oncology, stumbles and all

Regeneron, despite being a latecomer in cancer therapies, aims to leverage its packed pipeline to become a leader in the next wave of oncology treatments. Dr. Israel Lowy, senior vice president of translational and clinical sciences in oncology, highlights the company's focus on combinations like Libtayo and fianlimab, which could rival existing treatments like Opdualag and Keytruda. Regeneron's journey includes pioneering bispecific antibodies and facing early challenges, but with ongoing clinical trials and collaborations, the company seeks to establish itself as a major player in cancer therapy.
oncnursingnews.com
·

Nurses Are 'Critical Partners' in the Clinical Trial Process

Oncology nurses are crucial in guiding patients through clinical trials, including biomarker testing. Elizabeth Burton discussed a longitudinal biomarker analysis from a phase 2 trial of neoadjuvant nivolumab and relatlimab in resectable melanoma, highlighting the importance of gene expression profiling and the potential of B7-H3 protein in predicting response.
globenewswire.com
·

Global LAG 3 Antibody FDA Approval Clinical Trials

Global LAG-3 Inhibitors Market expected to exceed USD 3 billion by 2029; Opdualag, first LAG-3 therapy, approved for melanoma. LAG-3 inhibitors show potential in combination therapies for various cancers and diseases. Key players include Bristol Myers Squibb, Roche, and Regeneron. Market valued at USD 625 million in 2023, projected to grow significantly.
finance.yahoo.com
·

Global LAG 3 Antibody FDA Approval Clinical Trials LAG 3 Inhibitors Market Future Growth

Global LAG-3 inhibitors market to exceed USD 3 billion by 2029, driven by the approval of Opdualag, the first LAG-3 therapy, and ongoing clinical trials evaluating LAG-3 inhibitors in combination therapies. Key players include Bristol Myers Squibb, Symphogen A/S, and Hoffmann-La Roche.
nature.com
·

Neoadjuvant immunotherapy for dMMR and pMMR colorectal cancers

Studies explore colorectal cancer recurrence, immunotherapy response, and biomarker development, focusing on microsatellite instability, mismatch repair deficiency, and tumor mutational burden. Key findings include the efficacy of PD-1 blockade in mismatch repair-deficient cancers, the role of gut microbiota in immunotherapy, and the predictive value of tumor mutational burden for immune checkpoint inhibitor response.
statnews.com
·

News from ESMO: An AstraZeneca win in bladder cancer, and more

AstraZeneca's Imfinzi in bladder cancer reduced death risk by 25%; Merck and Eisai's combo in liver cancer cut progression or death risk by a third; Bristol's lung cancer approach faced criticism for 'cherry-picking' subgroups.
nature.com
·

Neoadjuvant nivolumab and relatlimab in locally advanced MMR-deficient colon cancer

NICHE-3 study, approved by NedMec, enrolled adults with dMMR resectable colon adenocarcinoma. Patients received nivolumab and relatlimab, followed by surgery. Primary endpoint was pathologic response (≤50% RVT), with secondary endpoints including safety and survival. Study used a Simon’s two-stage design, aiming for a response rate of 85%. Pathologic response was assessed by central histopathologic review. Safety and efficacy populations were defined, with binary endpoints reported as proportions. MMR status was assessed via immunohistochemistry.
© Copyright 2025. All Rights Reserved by MedPath