Bristol-Myers Squibb's Opdivo secures a lung cancer niche with small-cell green light

Bristol-Myers Squibb may be trailing rival Merck in the non-small cell lung cancer market, but it has landed a niche of its own in the small cell arena.

On Friday, the New Jersey drugmaker said the FDA had greenlighted immuno-oncology star Opdivo as a treatment for small cell lung cancer patients who have already received platinum chemo and at least one other form of therapy. Tough-to-treat small cell lung cancer accounts for about 10% to 15% of all lung cancers, BMS said, and about 27,000 new cases in the U.S. are expected this year.

The approval comes based on data from a phase 1/2 trial that showed that just 12% of patients responded to treatment. But among that group, the median response lasted 17.9 months, BMS said.

“At Bristol-Myers Squibb, we recognize the critical need to provide patients with cancer therapies that may offer more durable responses—particularly for those living with hard-to-treat, aggressive diseases like small cell lung cancer,” Sabine Maier, M.D., BMS’ development lead for thoracic cancers, said in a statement. 

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With the go-ahead, Opdivo becomes the first drug in the hypercompetitive PD-1/PD-L1 class to enter the previously treated small cell field. And that’s important for Bristol-Myers, which is staring at the back of Merck’s Keytruda; that drug’s two FDA approvals in previously untreated NSCLC has rocketed it to the front of the pack.  

That’s not to say BMS can’t still reap significant lung cancer sales, though. It’s working to bring a combination of Opdivo and fellow I-O drug Yervoy into the front-line setting, and in second-line, Opdivo is holding up better than analysts expected, the company revealed late last month on its second-quarter earnings call.

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Meanwhile, Roche’s Tecentriq, another member of Opdivo’s class, could soon make its mark in small cell lung cancer, too—though it’s in line for a different indication. In June, the Swiss pharma giant said a Tecentriq-chemo pairing had topped solo chemo at helping previously untreated, extensive-stage small cell lung cancer patients live longer.