EMA, Regulatory

Bristol-Myers takes another hit on Opdivo/Yervoy combo as CHMP turns thumbs down on frontline kidney cancer

BIO 2018 Panelist Thomas Lynch CSO of Bristol-Meyers Squibb
Photo: Rob Tannenbaum, Endpoints News

Bristol-Myers Squibb $BMY continues to run into some stiff headwinds with its combination of Opdivo and Yervoy.

During their quarterly call with analysts Thursday, the top executive crew revealed that the EMA’s Committee for Medicinal Products for Human Use in Europe had settled on a negative opinion for the frontline use of the combination for kidney cancer. And that took a bite out of the company’s stock, while dinging their rep on I/O as Merck continues to chew up market terrain on its way to frontrunner status.

Bristol-Myers, which has a champion’s title at stake, is not taking this lying down. R&D chief Tom Lynch, who learned about the setback on Wednesday, is prepping an appeal — but the odds are not in its favor. 

Bristol-Myers shares took a quick hit on the negative read through.

Why would the EU turn thumbs down on the combo after the FDA approved it in April based on the CheckMate-214 study, which demonstrated significant help for poor-risk patients over sunitinib?

“(T)he basis for their finding or their discussion was really that they did not feel that we had demonstrated the contribution of components sufficiently well to grant this,” Lynch told analysts. “And they were worried about establishing a precedent in that setting.”

He continued:

We believe strongly that the combination of Opdivo/Yervoy is an extremely important regimen, something doctors are going to want to be able to treat their patients with. And when we designed the study, we seriously considered whether or not a single agent arm would make sense. And after discussing with key opinion leaders around the world, we felt it did not make sense given the low single agent activity we had seen. Now, our reaction to this is we’re going to proceed with asking for a re-examination and we look forward to a discussion with the CHMP regarding this application.

There’s been endless discussion about checkpoint/CTLA-4 combinations, driven in part by the CTLA-4 class’ well known profile on severe toxicity. That has also hurt AstraZeneca as the pharma giant continues to try to prove that Imfinzi plus tremelimumab has a big commercial future ahead.

That’s not going to be easy, especially as Merck continues to make progress with their strategy combining Keytruda with chemo.

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