A Phase 1/1b Study of the All-Oral Regimen CC-486 and Venetoclax in Acute Myeloid Leukemia.
The first all-oral blood cancer treatment combining two drugs offers older patients a simpler alternative to injections, potentially improving quality of life without sacrificing effectiveness.
This Phase 1/1b trial from Pollyea's group (CU Denver) establishes the safety profile and recommended Phase 2 dose for the first fully oral azacitidine (CC-486) plus venetoclax regimen in AML. An all-oral HMA/BCL-2 inhibitor backbone could substantially improve quality of life for elderly and unfit AML patients who currently require IV or subcutaneous azacitidine administration.
What the study was
- Study design
- Phase 1/1b dose-escalation trial
- Population
- Patients with newly diagnosed or relapsed/refractory AML
- Category
- Drug Development
- Maturity
- Exploratory
- Journal
- Blood advances
Why it surfaced
Phase 1/1b report of first fully oral AML induction regimen (CC-486+venetoclax) from Pollyea group. If tolerable at scale, oral regimen would be transformative for elderly/unfit AML patients. Supports Phase 2 advancement.
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