enasidenib (IDH2 inhibitor) + azacitidina and ivosidenib (IDH1 inhibitor) + azacitidina in 1L mIDH unfit AML patients

On Nov 22^nd, 2022, Celgene uploaded data from its P1/2 trial of enasidenib (IDH2 inhibitor) + AZA and ivosidenib (IDH1 inhibitor) + AZA in 1L mIDH unfit AML, on ClinicalTrials.gov

• • The study consisted of a P1b dose-finding and expansion portion evaluating ivosidenib + AZA and two doses of enasidenib (100mg and 200mg) + AZA, followed by a P2 randomized portion evaluating enasidenib + AZA vs. AZA monoTx
• The dataset includes previously published data from the pre-specified interim analysis (Aug 20^th, 2019) of the P2 portion of this study (N=101)
  • ORR: enasidenib + AZA (N=68) 73.5% vs. AZA monoTx (N=33): 36.4%
  • Participants ≥1 Gr 3-4 TEAS
    • Enasidenib (100mg) + AZA: 73.5% (50/68 pts)
    • AZA monoTx: 62.5% (20/32 pts)
• Safety data from the P1b portion was also included:
  • Participants ≥1 Gr 3-4 TEAS
    • Enasidenib (100mg) + AZA: 66.7% (2/3 pts)
    • Enasidenib (200mg) + AZA: 66.7% (2/3 pts)
    • Ivosidenib + AZA (dose finding): 57.1% (4/7 pts)
    • Ivosidenib + AZA (dose expansion): 62.5% (10/16 pts)

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