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Venclexta Success In Second VIALE Study Sets Up Potential Full Approval In AML

 
• By Joseph Haas

Weeks after their first combo study with Venclexta in first-line AML failed, AbbVie and Genentech reported top-line data showing that the BCL-2 inhibitor plus azacitidine improved survival and remission rates.

Leukemia
New data may position Venclexta for full approval in acute myeloid leukemia

The second of two Phase III studies testing Venclexta (venetoclax) with a chemotherapy agent in first-line acute myeloid leukemia has hit both of its co-primary endpoints and the results will be reported early, sponsors AbbVie Inc. and Genentech Inc. said on 23 March. The data position the BCL-2 inhibitor for a full approval in first-line, transplant-ineligible AML patients after a US accelerated approval in 2018.

The companies announced that in the 433-patient VIALE-A study, Venclexta plus azacitidine achieved statistical significance compared to azacitidine and placebo in both overall survival and composite complete remission rate

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