FDA grants priority review to relatlimab-nivolumab regimen for advanced melanoma
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The FDA granted priority review to relatlimab and nivolumab for treatment of unresectable or metastatic melanoma.
The designation applies to use of a fixed-dose combination as a single infusion for patients aged 12 years or older.
Relatlimab (Bristol Myers Squibb) is a lymphocyte-activation gene 3 (LAG-3)-blocking antibody. Nivolumab (Opdivo, Bristol Myers Squibb) is a PD-1 inhibitor.
The FDA based priority review on results of the phase 2/phase 3 RELATIVIITY-047 trial, which included 714 patients with previously untreated metastatic or unresectable melanoma.
Researchers assigned half of the patients to a fixed-dose combination of 160 mg relatlimab and 480 mg nivolumab by IV infusion every 4 weeks. The other half received nivolumab alone. Treatment continued until disease recurrence, unacceptable toxicity or withdrawal of consent.
As Healio previously reported, the study met its primary endpoint. Results presented at this year’s virtual ASCO Annual Meeting showed a statistically significant PFS benefit among patients assigned relatlimab and nivolumab. Follow-up for OS and objective response rate is ongoing.
“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,” Jonathan Cheng, senior vice president and head of oncology development for Bristol Myers Squibb, said in a company-issued press release. “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 FDA is expected to make a decision on this application by March 19.
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