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New Indication: Ivosidenib for IDH1 mutant advanced cholangiocarcinoma

New Indication: Ivosidenib for IDH1 mutant advanced cholangiocarcinoma
Study:
  • Double-blind, randomized Phase III trial (ClarIDHy)
  • Advanced cholangiocarcinoma with IDH1 mutation, progressed after 1 or 2 lines of therapy
  • Ivosidenib 500 mg daily (n=124) vs. placebo (n=61)
Efficacy:
  • Median PFS: 2.7 vs. 1.4 mos (HR: 0.37 [0.25-0.54])
  • Median OS: 10.3 vs. 7.5 mos (HR: 0.79 [0.56-1.12])
Safety:
  • Grade >= 3 AEs: Ascites (9% vs. 7%), anemia (7% vs. none), increased serum bilirubin (6% vs. 2%), hyponatremia (6% vs. 10%)

JAMA Oncol. Published online September 23, 2021

Zhu AX, et al. Final Overall Survival Efficacy Results of Ivosidenib for Patients With Advanced Cholangiocarcinoma With IDH1 Mutation: The Phase 3 Randomized Clinical ClarIDHy Trial

https://doi.org/10.1001/jamaoncol.2021.3836

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