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Primary results of phase II/III RELATIVITY-047 trial evaluating the fixed-dose of relatlimab and Opdivo for metastatic melanoma.- BMS

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Published:27th Mar 2021
Bristol Myers Squibb announced primary results from the Phase II/III RELATIVITY-047 (CA224-047) trial evaluating the fixed-dose combination of relatlimab, an anti-LAG-3 antibody, and Opdivo (nivolumab) versus Opdivo alone in patients with previously untreated metastatic or unresectable melanoma The trial met its primary endpoint of progression-free survival (PFS). Follow up for overall survival, a secondary endpoint, is ongoing. The fixed-dose combination was well-tolerated and there were no new safety signals reported in either the relatlimab and Opdivo combination arm or the Opdivo arm. These are the first Phase III data to be reported from a trial evaluating an anti-LAG-3 antibody. Relatlimab is the third distinct checkpoint inhibitor (anti-PD-1, anti-CTLA-4 and anti-LAG-3) for Bristol Myers Squibb and, with Opdivo, the first fixed-dose combination to demonstrate a benefit for patients. About RELATIVITY-047 (CA224-047): RELATIVITY-047 (CA224-047) is a randomized, double-blind Phase II/III study evaluating the fixed-dose combination of relatlimab and Opdivo 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 Opdivo 480 mg or Opdivo 480 mg by intravenous infusion every four weeks until disease recurrence, unacceptable toxicity or withdrawal of consent. Follow up for the secondary endpoints of OS and ORR is ongoing. Relatlimab turns off a protein on immune cells called LAG-3 that stops them from attacking tumor cells. In completing a late-stage trial, Bristol Myers is ahead of Regeneron and Merck & Co. in showing evicence of a drug that blocks LAG-3.
Condition: Metastatic Melanoma
Type: drug

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