US FDA accepts for priority review Bristol Myers’s BLA for LAG-3-blocking antibody relatlimab & nivolumab FDC to treat unresectable or metastatic melanoma


Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for the LAG-3-blocking antibody relatlimab and nivolumab fixed-dose combination, administered as a single infusion, for the treatment of adult and pediatric patients (12 years and older and weighing at least 40 kg) with unresectable or metastatic melanoma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022.

“Although we’ve seen significant advances in the treatment of melanoma since the introduction of immune checkpoint inhibitors, there continue to be patients who could benefit from a novel dual immunotherapy approach,” said Jonathan Cheng, senior vice president and head of oncology development, Bristol Myers Squibb. “Based on the results of the RELATIVITY-047 trial, we believe that the relatlimab and nivolumab fixed-dose combination has the potential to improve outcomes for patients with metastatic or unresectable melanoma. We look forward to potentially introducing the first LAG-3-blocking antibody, and Bristol Myers Squibb’s third distinct checkpoint inhibitor, to help patients in need.”

The BLA submission was based on the efficacy and safety results of the phase 2/3 RELATIVITY-047 trial, which demonstrated a statistically significant and clinically meaningful progression-free survival benefit of a combination therapy over standard of care anti-PD-1 monotherapy in metastatic melanoma. Relatlimab is the first LAG-3-blocking antibody to demonstrate a clinical benefit for patients with phase 3 data. Primary results from the RELATIVITY-047 trial were presented in an oral session during the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2021 and were selected for the official ASCO press program.

The fixed-dose combination of relatlimab and nivolumab is an investigational therapy and is not approved for use in any country.

RELATIVITY-047 (CA224-047) is a global, randomized; double-blind phase 2/3 study evaluating the fixed-dose combination of relatlimab and nivolumab in patients with previously untreated metastatic or unresectable melanoma versus Opdivo alone. The primary endpoint of the trial is progression-free survival (PFS) by Blinded Independent Central Review (BICR) and the secondary endpoints are overall survival (OS) and objective response rate (ORR). A total of 714 patients were randomized 1:1 to receive a fixed-dose combination of relatlimab 160 mg and nivolumab 480 mg or Opdivo 480 mg by intravenous infusion every four weeks (Q4W) until disease recurrence, unacceptable toxicity or withdrawal of consent. Follow-up for the secondary endpoints of OS and ORR is ongoing.

Lymphocyte-activation gene 3 (LAG-3) is a cell-surface molecule expressed on effector T cells and regulatory T cells (Tregs) and functions to control T-cell response, activation and growth. Preclinical studies indicate that inhibition of LAG-3 may restore effector function of exhausted T cells and potentially promote an anti-tumor response. Early research demonstrates that targeting LAG-3 in combination with other potentially complementary immune checkpoints may be a key strategy to more effectively potentiate anti-tumor immune activity.

Bristol Myers Squibb is evaluating relatlimab, its LAG-3-blocking antibody, in clinical trials in combination with other agents in a variety of tumor types.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including phase 3, in a variety of tumor types.



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