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A Randomized, Open-label, Controlled, Phase 2 Study of Pevonedistat, Venetoclax, and Azacitidine Versus Venetoclax Plus Azacitidine in Adults With Newly Diagnosed Acute Myeloid Leukemia Who Are Unfit for Intensive Chemotherapy

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A Randomized, Open-label, Controlled, Phase 2 Study of Pevonedistat, Venetoclax, and Azacitidine Versus Venetoclax Plus Azacitidine in Adults With Newly Diagnosed Acute Myeloid Leukemia Who Are Unfit for Intensive Chemotherapy

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 04 Apr 2025

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At a glance

  • Drugs Pevonedistat (Primary) ; Azacitidine; Azacitidine; Venetoclax
  • Indications Acute myeloid leukaemia
  • Focus Therapeutic Use
  • Acronyms PEVENAZA
  • Sponsors Takeda; Takeda Oncology

    • Most Recent Events

    • 01 Mar 2025 Primary endpoint (Event-Free Survival (EFS)) has not been met, as per results published in the Leukemia and Lymphoma.
    • 01 Mar 2025 Status changed from active, no longer recruiting to discontinued (stopped early following negative results from PANTHER, which evaluated pevonedistat in higher-risk myelodysplastic syndromes/chronic myelomonocytic leukemia or low-blast AML).
    • 01 Mar 2025 Results investigating whether adding pevonedistat to a combination of azacitidine and venetoclax would improve outcomes in patients with newly diagnosed acute myeloid leukemia (AML) who were ineligible for intensive chemotherapy were published in the Leukemia and Lymphoma.

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