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