Immuno-oncology, Results

Bristol-Myers concedes a PhIII lung cancer flop for Opdivo as competition heats up in SCLC

Bristol-Myers Squibb $BMY has run into another dead end in exploring the lung cancer market. 

The big biotech reported that its Phase III study of Opdivo failed the CheckMate-331 study, unable to beat the standard of care for treating second-line small cell lung cancer.

We don’t know yet just what the data are, just that the readout doesn’t measure up to a win. And the setback comes just months after Roche’s combo using Tecentriq and chemo won out on first-line cases of SCLC, a tough field that accounts for about 15% of the overall lung cancer market.

Evercore ISI’s Umer Raffat and several other analysts have pegged Roche’s IMpower133 as one of the most significant readouts in SCLC this year, with Bristol-Myers lining up another try with Checkmate-451, where they are studying their I/O-I/O combo of Opdivo and Yervoy as a maintenance therapy.

AbbVie, meanwhile, recently conceded that their try against SCLC with Rova-T was a flop. And Merck also has failed to ignite much enthusiasm so far with its basket study results for Keynote-158 as a second-line therapy for SCLC.

Merck, meanwhile, is aggressively moving to challenge Roche here, with pivotal results being assembled in Keynote-604 for a combination of Keytruda and chemo.

Today, Raffat sized up the results as a headache for Bristol-Myers, which is OK’d to market in this area.

Opdivo is already approved in relapsed SCLC based on smaller trials and CKM-331 was intended to be confirmatory.  There is no denying that this is a disappointing outcome.

Bristol-Myers had jumped out to an early lead on non-small cell lung cancer, but was recently overtaken by an aggressive bunch of developers at Merck, who have been hustling Keytruda along with a series of successes in pivotal trials. AstraZeneca has also enjoyed some important niche successes in lung cancer, while Roche has earned the lead spot in SCLC.

At this stage of the great checkpoint game, we now have 6 approved PD-1/L1 drugs on the market, with scores more crowding the pipeline behind them. The early successes have been key to spawning a multibillion-dollar market, which has inspired hundreds of combination and mono therapy trials in search of a market slice in oncology.

“Small cell lung cancer is a highly aggressive disease in which significant unmet need remains,” said Bristol-Myers’ Sabine Maier in a statement. “We are focused on researching innovative oncology therapies to improve outcomes for patients with lung cancer. We thank the patients, their families, and the physicians involved in the CheckMate -331 study.”


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