Bristol-Myers Squibb Company BMY announced long-term pooled efficacy and safety results from the phase III CheckMate-017 and CheckMate-057 studies in patients with previously-treated, advanced non-small cell lung cancer (NSCLC).
Shares of the company have lost 3.2% in the year so far against the industry’s growth of 1.9%.
At five years, patients treated with Opdivo (nivolumab) continuedto experience long-term overall survival (OS) benefit versus docetaxel. Treatment with Opdivo was associated with a 5-year OS rate of 13.4% compared with 2.6% with docetaxel in previously-treated NSCLC patients.
The OS benefit with the drug was observed across all patient subgroups, including those with PD-L1 expression on <1% of tumor cells. Further, the safety profile for Opdivo was consistent with prior findings in the second-line setting, and no new safety signals were observed with the longer follow-up. Only two of the 70 patients currently on study experienced a new treatment-related select adverse event (AE) between years 3 and 4. There were no new treatment-related select AEs reported between years 4 and 5 among the 55 patients still on study.
This pooled analysis represents the longest follow-up of previously-treated NSCLC patients treated with Immuno-Oncology therapy in phase III randomized studies.
Opdivo is Bristol-Myers’ primary growth driver. It is currently approved in the United States, the EU, Japan and other countries for several cancer indications. The company is working on expanding the label of the drug further.
Nevertheless, competition is stiff in the NSCLC market. Merck’s MRK PD-L1 inhibitor, Keytruda, commands a strong place in the first-line NSCLC market. Other PD-L1 inhibitors available in the market are AstraZeneca’s AZN Imfinzi and Roche’s RHHBY Tecentriq.
Bristol-Myers currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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