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Bristol-Myers Up as Pivotal NSCLC Study Meets Primary Endpoint

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Bristol-Myers Squibb Company (BMY - Free Report) announced that the pivotal, phase III study — CheckMate-9LA — evaluating a combination regimen of its PD-1 inhibitor, Opdivo, in first-line advanced non-small cell lung cancer (NSCLC) met its primary endpoint of superior overall survival (“OS”) at a pre-specified interim analysis. Detailed data of the analysis will be presented at an upcoming congress.

Shares of the company were up almost 2.3% on Oct 22 following the data readout. The company’s shares have increased 4.7% so far this year against the industry’s decrease of 4.9%.

Although investors cheered the initial top-line data from the pivotal study as the Opdivo combination regimen targeted the lucrative first-line lung cancer indication, detailed data will be needed to access the actual benefit of the regimen over other approved PD-1/PD-L1 therapies for NSCLC.

The CheckMate-9LA study evaluated Opdivo plus low-dose Yervoy administered concomitantly with two cycles of chemotherapy in treatment-naive NSCLC patients regardless of PD-L1 expression compared to chemotherapy alone for up to four cycles followed by optional maintenance therapy.

Bristol-Myers is focused on developing Opdivo in combination with other therapies as a potential treatment for multiple types of lung cancer in different treatment setting. However, the progress had been disappointing in the past year. The drug has received approval for treating NSCLC and small-cell lung cancer (“SCLC”) in second or later-line setting. However, it is yet to be approved in first-line setting for any lung cancer indications. This has led to a competitive disadvantage for Bristol-Myers compared to competitor drugs – Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) Tecentriq. Keytruda and Tecentriq have already received approval as first-line treatment for certain lung cancer indications with Keytruda leading the segment.

However, successful completion of the CheckMate-9LA study on Opdivo resulted in a decline in share price of Merck and Roche as a potential approval for Opdivo is likely to increase competition in the lung cancer segment.

Other PD-L1 inhibitors, which are being developed for treating lung cancer, include Pfizer’s Bavencio and AstraZeneca’s (AZN - Free Report) Imfinzi.

Zacks Rank

Bristol-Myers currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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