Bristol/Agios AML Drug Idhifa Fails In Phase III

IDHENTIFY Studied The IDH2 Inhibitor In Its Approved Indication

 
• By Mandy Jackson
  
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Idhifa is approved in the US for relapsed or refractory AML patients with IDH2 mutations based on Phase I/II complete responses but did not meet the overall survival endpoint in the Phase III IDHENTIFY.

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Idhifa missed the overall survival endpoint in Phase III

Bristol-Myers Squibb Company reported on 25 August that its IDH2 inhibitor Idhifa (enasidenib), developed under a Celgene Corporation partnership with Agios Pharmaceuticals, Inc., did not meet the primary endpoint of overall survival (OS) in the Phase III IDHENTIFY clinical trial in patients with relapsed or refractory acute myeloid leukemia. Although that is the same population that the drug is cleared to treat in the US, the IDHENTIFY result may not change its approval status as Idhifa received full, not accelerated approval.

Agios told Scrip it does not expect Idhifa’s FDA approval status to change based on the missed OS endpoint. The...

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