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IDHENTIFY phase III trial fails to meet primary end point

Aug 27, 2020
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On August 25, 2020, it was announced that the phase III IDHENTIFY trial (NCT02577406), evaluating enasidenib plus best supportive care (BSC) versus conventional care regimens (CCR), failed to meet its primary endpoint of overall survival (OS) for elderly patients with relapsed/refractory acute myeloid leukemia (R/R AML) with an isocitrate dehydrogenase 2 (IDH2) mutation. However, the safety profile of enasidenib was consistent with previous reports.1

IDH2 mutations affect ~19% of patients with AML, and enasidenib is the only U.S. Food and Drug Administration (FDA)-approved therapy for this group of patients with R/R disease.1

IDHENTIFY trial design2

  • Phase III, open-label, multicenter, randomized trial comparing enasidenib plus BSC versus CCR
  • 319 patients ≥ 60 years of age with late stage R/R IDH2-mutated AML after second- or third-line therapy recruited
  • BSC included
    • hydroxyurea for leukocytosis and/or differentiation-like syndrome
    • anti-infectives
    • analgesics
    • antiemetics
    • antipyretics
    • transfusions
    • nutritional support
  • CCR included
    • BSC only
    • azacitidine (75 mg/m2/day subcutaneously for 7 days) plus BSC
    • low-dose cytarabine (20 mg subcutaneously twice a day for 10 days) plus BSC
    • intermediate-dose cytarabine (0.5–1.5 g/m2/day intravenously for 3–6 days) plus BSC
  • Enasidenib: 100 mg once daily, orally, for 28-day cycles
  • All therapies administered in continuous 28-day cycles
  • Primary endpoint: OS
  • Key secondary endpoints: Overall response rate, event-free survival, duration of response, and time to response

Enasidenib1

  • Oral inhibitor of IDH2
  • Approved by the FDA in 2017 for patients with R/R, IDH2-mutated AML
  • Also approved in Australia and Canada for this group of patients

The results of this trial are due to be published at a future conference. For further information on enasidenib for the treatment of AML, read our collated articles here.

  1. Bristol Myers Squibb. Bristol Myers Squibb provides update on Phase 3 IDHENTIFY trial in patients with relapsed or refractory acute myeloid leukemia. https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-provides-update-phase-3-idhentify-trial-p. Published Aug 25, 2020. Accessed Aug 26, 2020.
  2. Clinicaltrials.gov. An efficacy and safety study of AG-221 (CC-90007) versus conventional care regimens in older subjects with late stage acute myeloid leukemia harboring an isocitrate dehydrogenase 2 mutation (IDHENTIFY). https://clinicaltrials.gov/ct2/show/NCT02577406. Updated Jun 23, 2020. Accessed Aug 26, 2020.