Drug Development

Bruised by a punishing Opdivo failure, Bristol-Myers looks to shake up the business, accelerate R&D

Giovanni Caforio, Bristol-Myers Squibb CEO

Giovanni Caforio, Bristol-Myers Squibb CEO

Fresh off one of the biggest clinical trial setbacks of the year, Bristol-Myers Squibb $BMY is planning to regroup and accelerate on the R&D side as part of a broad reorganization, shifting more money into research after hunting out savings in the rest of the business.

The details are sparse, but the company says in its newly released Q3 update that it plans to create a “competitive and more agile R&D organization that can accelerate the pipeline, streamlined operations and realigned manufacturing capabilities that broaden biologics capabilities to reflect current and future portfolio. The new operating model will enable the company to deliver the strategic, financial and operational flexibility necessary to invest in the highest priorities across the company.”

The executive crew stayed focused on broad generalities in the call with analysts Thursday morning. CEO Giovanni Caforio emphasized that the company will “continuing to allocate resources driven by opportunities we see in the portfolio.” Over the next three to five years, he expects that the opportunities for revenue growth with stay focused primarily on Opdivo, Yervoy and Eliquis.

“At same time,” he adds, “we’re advancing the early pipeline,” ready to back programs that emerge as high potential performers. Bristol plans to increase R&D spending next year, focusing even more on its core areas, while squeezing operating expenses, infrastructure and manufacturing costs wherever possible.

The R&D spotlight now shifts to Checkmate-227, testing a combination of Opdivo and Yervoy. Immuno-oncology chief Fouad Namouni says that the company has learned from the Checkmate-026 setback, doubling the number of patients it’s recruiting for ‘227 in order to avoid a repeat of what Bristol views was a poor selection of patients tested in ‘026.

Bristol-Myers suffered a damning Phase III failure with their flagship drug, the checkpoint inhibitor Opdivo. Easily the dominant checkpoint on the market, Opdivo flunked a late-stage trial that tried and failed to demonstrate an advantage for a broad population of non-small cell lung cancer patients as a frontline therapy. Even more damning, the subpopulation breakdown in the study — reviewed at ESMO — looked bad for Opdivo.

Merck, which had had to accept a runner-up position in the market, was able to quickly leapfrog Bristol-Myers by demonstrating Keytruda was effective among high PD-L1 expressers, and the FDA swiftly followed up with a pioneering frontline approval in that key group.

What remains to be seen is how Bristol-Myers plans to make its R&D group “more agile.” The company has been pouring money into its immuno-oncology work, hiring new staffers and adding a campus in California.



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Biomanufacturing