AbbVie Says Phase 3 CANOVA Trial Fails To Meet Primary Endpoint

(RTTNews) - AbbVie (ABBV) announced Friday data from its Phase 3 CANOVA study evaluating the safety and efficacy of venetoclax (VENCLEXTA®/ VENCLYXTO®) plus dexamethasone (VenDex) for patients with t(11;14)-positive relapsed or refractory (R/R) multiple myeloma who have received two or more prior treatments.

The data did not demonstrate that the treatment combination significantly improved progression-free survival (PFS), the primary endpoint of the trial.

Patients receiving VenDex showed improvement in median PFS of 9.9 months compared to 5.8 months with the combination of study comparator pomalidomide and dexamethasone (PomDex). However, the results did not reach statistical significance.

AbbVie will now 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.

Venetoclax is not approved by any regulatory authority in any country for the treatment of multiple myeloma. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.