AbbVie: Phase 3 Venetoclax/Dexamethasone Study Falls Short in Multiple Myeloma

By Colin Kellaher

AbbVie on Friday said a Phase 3 study evaluating the safety and efficacy of its venetoclax cancer drug in combination with dexamethasone missed its key goal in certain patients with the blood cancer multiple myeloma.

The North Chicago, Ill., biopharmaceutical company said the combination didn't show significantly improved progression-free survival in patients with t(11;14)-positive relapsed or refractory multiple myeloma who have received two or more prior treatments, missing the primary endpoint.

AbbVie noted that patients receiving the combination showed improvement in median progression-free survival of 9.9 months, compared to 5.8 months with the combination of study comparator pomalidomide and dexamethasone, but that the results didn't reach statistical significance.

AbbVie said that given potential favorable trends it saw in the study, it plans to discuss the data with health authorities in the near future to further understand the potential of venetoclax as a biomarker-driven therapy in multiple myeloma, the second most common blood cancer in the world.

AbbVie and Swiss drug giant Roche Holding are jointly developing venetoclax, which is sold under the brand names Venclexta and Venclyxto and approved for indications in chronic lymphocytic leukemia and acute myeloid leukemia. The drug is jointly marketed by AbbVie and Roche's Genentech in the U.S., and by AbbVie alone outside the U.S.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

September 29, 2023 08:00 ET (12:00 GMT)

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