Combos, Deals

PhIII dealmaking frenzy in i/o continues as AstraZeneca follows PACIFIC with a new Incyte IDO1 combo

Incyte CEO Hervé Hoppenot made it clear a long time ago that he was happily fast and loose about which approved PD-(L)1 drug he partnered with on his IDO1 drug epacadostat. He launched pivotal combo studies with Merck and Bristol-Myers Squibb, and now he’s kicking off a new Phase III tie-up with AstraZeneca’s Imfinzi (durvalumab) in stage III non-small cell lung cancer, continuing a relationship that dates back three years.

Hervé Hoppenot

For AstraZeneca, this is a chance to follow up on its PACIFIC study after unveiling some (very badly needed) positive data in September for inoperable, locally advanced stage 3 lung cancer where the cancer had not advanced after chemo.

Stage 3 itself represents a third of NSCLC incidence, and AstraZeneca CEO Pascal Soriot with chief medical officer Sean Bohen explained at ESMO that it positioned Imfinzi as the lead checkpoint in the front half of the critical lung cancer market for stages 1 through 3, with a strategic advantage for moving into stage 4 cases.

That success was reported just two months after a major setback on their late-stage combo study using durvalumab with the CTLA-4 drug tremelimumab, which failed the first leg of a two-part pivotal trial. That helped raise new doubts about the future of CTLA-4 drug combinations, though AstraZeneca has considerable hope that the overall survival stats in the study will be positive.

Sean Bohen

The new combo study also highlights the frenzy of partnering that’s been going on in the checkpoint field. PD-(L)1 drugs can be used systemically against a wide range of oncology targets and have a lot of potential in terms of combinations with more targeted agents. It also follows closely on the heels of a new deal that Incyte struck with MacroGenics to in-license an experimental PD-1 drug after their own in-house program ran smack into some safety issues, essentially ruining its commercial potential.

“Imfinzi has shown exciting clinical potential in treating patients with locally-advanced lung cancer. We are pleased to build on recent data from the PACIFIC trial to further explore how Imfinzi, in combination with an IDO1 enzyme inhibitor, could provide additional benefit to patients with locally-advanced lung cancer,” said Sean Bohen, AstraZeneca’s chief medical officer.



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