Bristol-Myers, Infinity team up for Opdivo-PI3K combo trial

Bristol-Myers Squibb ($BMY) has added another study to its burgeoning roster of combination trials featuring PD-1 drug Opdivo. The latest deal will see Bristol-Myers add Opdivo to an existing trial of Infinity Pharmaceuticals’ ($INFI) PI3K-gamma inhibitor IPI-549 in solid tumors.

Infinity is currently testing IPI-549 as a monotherapy in a Phase I dose-escalation study in patients with advanced solid tumors. That part of the study will continue. In parallel, Infinity is working to get an Opdivo-IPI-549 combination dose-escalation cohort going. Enrollment of that cohort will mark the start of efforts to show IPI-549 can boost the effectiveness of Opdivo by holding back macrophages in the tumor microenvironment.

This idea has been central to Infinity’s strategy for IPI-549 since it unveiled preclinical data on the asset in September 2015. The link to Bristol-Myers is new, though.


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On the record for the dose-escalation study, Inifity states it will test IPI-549 in combination with Keytruda, the Merck ($MRK) PD-1 drug competing for market share with Opdivo. Other differences between the studies include a 17% increase in the enrollment target to 175 and addition of squamous cell carcinoma of the head and neck (SCCHN) to list of targeted indications.

SCCHN patients will join subjects with non-small cell lung cancer and melanoma in the study once Infinity wraps up the dose-escalation stage of the trial. By Infinity’s calculation, the three indications account for 17% of new cancer cases in the U.S. That makes the indications key battlegrounds for Opdivo against Keytruda. And it magnifies the impact of Bristol-Myers’ faltering attempts to deliver data showing the superiority of its asset.

Infinity’s IPI-549 joins Innate Pharma’s lirilumab on the list of drugs Bristol-Myers is hoping will give Opdivo an edge. But, while Bristol-Myers paid $35 million upfront to get its mitts on lirilumab, the release detailing the deal with Infinity makes no mention of financial terms.

Even so, the news was enough to give Infinity a bump in premarket trading. The biotech has endured a tough year. AbbVie ($ABBV) walked away from an $805 million pact with Infinity for duvelisib in June. And the depths to which perceptions of that drug have fallen became clear earlier this month when Verastem ($VSTM) picked it up without paying a dollar upfront.

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