AstraZeneca's Imfinzi Debuts In Bladder Cancer With Combo Coming Soon
As many as five PD-1/L1 inhibitors will be approved for second-line metastatic disease by the end of 2017, but AstraZeneca hopes to stand apart with the combination of Imfinzi (durvalumab) with its CTLA-4 inhibitor tremelimumab.
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Full PACIFIC data show strong overall survival benefit in all comers, though not in a post hoc analysis of those with low PD-L1 expression, about 20% of the population.
FDA’s most recent accelerated approvals for Merck’s Keytruda call for confirmatory trials in a broader patient population than the approved indications, in the latest example of FDA’s growing comfort with multi-purpose confirmatory trials in the PD-1/PD-L1 inhibitor space.
Unlike other indications PD-1/L1 inhibitors are shooting for, Stage III non-small cell lung cancer is an untapped market and AstraZeneca will have the space to itself for a while.