Bristol Myers Squibb receives positive opinion for approval of anti-LAG-3 antibody Opdualag

Bristol Myers Squibb has announced that the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency (EMA) recommended approval of the fixed-dose combination ofand nivolumab and relatlimab for first-line treatment of advanced melanoma (unresectable or metastatic) in adults and adolescents from 12 years of age with <1% PD-L1 expression in tumor cells. The European Commission (EC), which is responsible for approving medicines for the European Union (EU), will now review the CHMP opinion.

“We are very proud of the role we have played in advancing the treatment of advanced melanoma over the years. As part of our mission to bring new medicines to patients, we continued to develop new dual immunotherapy combinations“, he indicated Paul Basciano, Director of Relatlimab Development at Bristol Myers Squibb.

The favorable opinion is based on the efficacy and safety results of the phase 2/3 RELATIVITY-047 trial. The trial showed that treatment with the fixed-dose combination of nivolumab and relatlimab more than doubled the median progression-free survival (PFS), even in patients with <1% PD-L1 expression in tumor cells, compared to nivolumab monotherapy– an established reference treatment. The proposed indication in the EU is based on an exploratory analysis of data in patients with <1% PD-L1 expression on tumor cells. No new safety events were identified with the combination versus nivolumab monotherapy.

RELATIVITY-047 is a global Phase 2/3, randomized, double-blind study evaluating the fixed-dose combination of nivolumab and relatlimab versus nivolumab monotherapy in patients with previously untreated metastatic or unresectable melanoma. Patients were included regardless of PD-L1 expression on tumor cells. Trial excluded patients with active autoimmune disease, medical conditions requiring systemic corticosteroid therapy at moderate or high doses or immunosuppressants, active or untreated uveal melanoma and cerebral or leptomeningeal metastases. The primary endpoint of the trial is progression-free survival (PFS) as determined by blinded independent central review (ICR) using Response Endpoints in Solid Tumors (RECIST v1 .1) in the entire registered population. Secondary endpoints are overall survival (OS) and objective response rate (ORR) in the entire included population.

A total of 714 patients were randomized 1:1 to receive a fixed-dose combination of nivolumab (480 mg) and relatlimab (160 mg) or nivolumab (480 mg) by intravenous infusion every four weeks until disease progression, unacceptable toxicity or withdrawal of consent.

Lymphocyte activation gene 3 (LAG-3) is a cell surface molecule that is expressed on effector T cells and regulatory T cells (Tregs) and acts to control lymphocyte response, activation, and growth T. Preclinical studies indicate that inhibition of LAG-3 could restore effector function to depleted T cells and potentially promote an antitumor response.

Early research shows that targeting LAG-3 in combination with other potentially complementary immune checkpoints could be a key strategy to more effectively enhance antitumor immune activity.

Bristol Myers Squibb is assess relatlimabits LAG-3 blocking antibody, in clinical trials in combination with other agents in various tumor types.

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 the cancer spreads beyond the surface of the skin to other organs.

The company’s cancer research goal is to provide medicines that give every patient a better, healthier life and make a cure a possibility. Building on a legacy across a wide variety of tumors that has changed the survival prospects of many patients, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, transforming data in information.

Opdualag™ (nivolumab and relatlimab-rmbw) is indicated for the treatment of adult and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb extended its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to Opdivo. time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize several immunotherapies, as single agents and combination regimens, for cancer patients in Japan, South Korea and Taiwan.