Deals

Bristol-Myers, Clovis leap into PhIII combo studies in a PD-1/PARP play as rivals circle

The checkpoint combo deal frenzy continues this morning with a tie-up between Bristol-Myers Squibb and Clovis that will marry their PD-1/PARP drugs and leap straight into Phase III registration studies.

Clovis CEO Patrick Mahaffy

As we learned again at the end of last week, as AstraZeneca buckled under the weight of a failed primary endpoint in its in-house combination study of durvalumab and tremelimumab, pivotal combination bets loom large these days as key players race to conquer — or stay ahead of — a megamarket. This time Clovis will look to quickly check intense rivalry from Tesaro and AstraZeneca in the PARP business, with Bristol-Myers coming along as a partner.

Bristol-Myers may have been badly dented by its own recent setbacks in immuno-oncology with key failures for Opdivo, but it remains a dominant player in the field.

Now Bristol and Clovis will pair their drugs — Opdivo and Rubraca — in Phase III programs for advanced ovarian cancer as well as triple-negative breast cancer. A Phase II study will also get underway for castration-resistant prostate cancer. In the deal, Bristol-Myers will take the lead on the breast and prostate cancer studies while Clovis helms the ovarian cancer work, where it is making its first big splash.

Alongside the bad news for durvalumab/tremelimumab last week, AstraZeneca also unveiled a deal with Merck that includes an independent focus for both on Lynparza combinations with Keytruda as well as AstraZeneca’s durvalumab. Tesaro has its own PD-1 in a registration study now, part of a huge second wave of checkpoints in the clinic as companies line up their own programs rather than partner with others.

The news today may douse some of the buzz that’s been circulating that Celgene may look to buy Clovis after bagging rights to BeiGene’s PD-1 in a rich deal.

“We are very enthusiastic about studying Rubraca and Opdivo in combination, and the potential to create new treatment options for patients with multiple tumor types, as well as for patients beyond those with BRCA mutations,” said Patrick J. Mahaffy, the CEO of Clovis Oncology, in a prepared statement. “This substantial clinical collaboration in ovarian, triple-negative breast and prostate cancers represents a significant effort by Clovis and Bristol-Myers Squibb to realize that potential.”


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RAPS Regulatory Convergence 2017