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Servier Publishes Results of Tibsovo (ivosidenib) in P-III (AGILE) Trial for IDH1-Mutated Acute Myeloid Leukemia in NEJM

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Servier Publishes Results of Tibsovo (ivosidenib) in P-III (AGILE) Trial for IDH1-Mutated Acute Myeloid Leukemia in NEJM

Servier Publishes Results of Tibsovo (ivosidenib) in P-III (AGILE) Trial for IDH1-Mutated Acute Myeloid Leukemia in NEJM

Shots:

  • The P-III (AGILE) trial evaluates Tibsovo + azacitidine vs PBO + azacitidine in adults with prior untreated IDH1-mutated AML who are not candidates for intensive CT or who have comorbidities that preclude the use of intensive induction CT
  • The study met its 1EPs & 2EPs i.e., improvement in EFS & OS with a m-OS of 24.0mos. vs 7.9mos., CR rate (47.2% vs 14.9%), CR + CRh rate (52.8% vs 17.6%), ORR (62.5% vs 18.9%)
  • Tibsovo is the 1st approved therapy for patients with prior treated IDH1-mutated cholangiocarcinoma & has been approved in the US as monothx. for IDH1-mutant r/r AML & IDH1-mutant AML. The company works with the US FDA & health authorities globally to bring the therapies to market

Ref: PR Newswire | Image: Servier

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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