Relatlimab-nivolumab combination extends PFS in metastatic melanoma
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A trial designed to evaluate the addition of relatlimab to nivolumab for untreated metastatic or unresectable melanoma met its primary endpoint of improved PFS, according to topline data released by the agent’s manufacturer.
Relatlimab (Bristol Myers Squibb) is a lymphocyte-activation gene 3 (LAG-3)-blocking antibody. Nivolumab (Opdivo, Bristol Myers Squibb) is a PD-1 inhibitor approved for certain patients with a variety of malignancies, including melanoma, non-small cell lung cancer, renal cell carcinoma, hepatocellular carcinoma, and head and neck squamous cell carcinoma.
The randomized phase 2/phase 3 RELATIVITY-047 trial 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.
The study met its primary endpoint of PFS by blinded independent central review.
Follow-up will continue for OS and objective response rate, both of which served as secondary endpoints. Complete results of RELATIVITY-047 will be submitted for presentation at a medical meeting.
“Immune checkpoint inhibitors alone or in combination have transformed treatment and improved survival rates for patients with metastatic or unresectable melanoma,” Jonathan Cheng, MD, senior vice president and head of oncology development with Bristol Myers Squibb, said in a company-issued press release. “However, there remain a considerable number of patients who could benefit from a novel combination therapy that leverages potentially complementary pathways to improve antitumor activity. The results of this study suggest that targeting the LAG-3 pathway in combination with PD-1 inhibition may be a key strategy to enhance the immune response and help improve outcomes for these patients.”
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