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Bristol-Myers (BMY) Announces Results From Opdivo Combo Study

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Bristol-Myers (BMY - Free Report) announced positive primary results from the phase II/III RELATIVITY-047 (CA224-047) study. The study is evaluating a fixed-dose combination of relatlimab, an anti-LAG-3 antibody, and immuno-oncology drug, Opdivo (nivolumab), compared to Opdivo alone in patients with previously untreated metastatic or unresectable melanoma.

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.

The study met its primary endpoint of PFS. Follow-up for the secondary endpoints of OS and ORR 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.

Relatlimab is a LAG-3-blocking antibody that binds to LAG-3 on T cells, restoring effector function of exhausted T cells. The company is evaluating relatlimab, its LAG-3-blocking antibody, in clinical trials, in combination with other agents in a variety of tumor types.

The encouraging primary results of this study suggest that targeting the LAG-3 pathway in combination with PD-1 inhibition may enhance the immune response and help improve outcomes for these patients.

Approval of new drugs will add a new stream of revenues for Bristol Myers, which should propel growth in the coming quarters.

The company’s shares have gained 2.2% in the year so far against the industry's decline of 2.7%.

Opdivo, a key drug in the company’s portfolio, returned to growth in the fourth quarter after declining in the third quarter amid stiff competition from Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) Tecentriq in key indications.

Bristol-Myers currently carries a Zacks Rank #3 (Hold).  A better-ranked stock in the biotech sector is Moderna (MRNA - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Moderna’s earnings estimates for 2021 have increased to $22.72 from $14.74 in the past 30 days.

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