February 13, 2025--PRINCETON, N.J.--(BUSINESS WIRE)-- 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). The safety profile of Opdualag observed in this analysis was consistent with the known profiles of nivolumab and relatlimab.
“We are disappointed in the outcome of the RELATIVITY-098 trial and that LAG-3 inhibition in the adjuvant setting did not lead to the same improved efficacy outcomes seen in advanced melanoma,” said Jeffrey Walch, M.D., Ph.D., vice president, Opdualag global program lead, Bristol Myers Squibb. “Patients whose tumors are completely resected before treatment may not have sufficient antitumor T cells in place for Opdualag to have its maximal effect. However, Opdualag remains a standard of care in the first-line treatment of unresectable or metastatic melanoma, and we continue to explore its potential across tumor types, including in non-small cell lung cancer.”
In adjuvant melanoma, Opdivo® (nivolumab) remains a standard of care for adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. Moreover, Opdivo QvantigTM (nivolumab + hyaluronidase-nvhy), was recently approved in the U.S. as a subcutaneous option for the adjuvant treatment of adult patients with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.
BMS thanks the patients, families and investigators for their contributions to this important clinical trial.
About RELATIVITY-098
RELATIVITY-098 is a randomized Phase 3, double-blind study evaluating adjuvant immunotherapy with Opdualag, the fixed-dose combination of nivolumab and relatlimab, compared to Opdivo monotherapy after complete resection of stage III-IV melanoma.
The primary endpoint of the trial is recurrence-free survival (RFS). Secondary endpoints include overall survival (OS), distant metastasis-free survival (DMFS), and safety.
About Opdualag
Opdualag (nivolumab and relatlimab-rmbw) is a first-in-class, fixed-dose, dual immunotherapy combination of the programmed death-1 (PD-1) inhibitor nivolumab and the lymphocyte activation gene 3 (LAG-3) blocking antibody relatlimab.
With its approval by the FDA in 2022, Opdualag became the first LAG-3-blocking antibody containing combination to receive regulatory approval anywhere in the world.
About LAG-3
Lymphocyte-activation gene 3 (LAG-3) is a molecule found on the surface of several immune cell types including CD4+ and CD8+ T cells, regulatory T cells (Tregs), and natural killer (NK) cells. LAG-3 inhibits the function of T cells and reduces the activation and growth of the cell on which it is found. This T-cell dysfunction allows tumors to avoid attack from the immune system and grow unchecked.
Preclinical studies indicate that inhibition of LAG-3 may promote an anti-tumor response. Targeting both LAG-3 and PD-1 in combination may be a key strategy to help restore T cell activity, improving anti-tumor response in certain cancers that is greater than the effects of PD-1 monotherapy.
Bristol Myers Squibb is evaluating relatlimab in clinical trials in combination with other agents in a variety of tumor types.
About Melanoma
Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. Metastatic melanoma is the deadliest form of the disease and occurs when cancer spreads beyond the surface of the skin to other organs. Globally, the World Health Organization estimates that by 2035, melanoma incidence will reach 424,102, with 94,308 related deaths. Melanomas can be mostly treatable when caught in very early stages; however, survival rates can decrease as the disease progresses.
About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, X, YouTube, Facebook and Instagram.