AbbVie presents results from Phase 3 CANOVA study of venetoclax + VenDex

AbbVie announced data from its Phase 3 CANOVA study evaluating the safety and efficacy of venetoclax plus dexamethasone for patients with t(11;14)-positive relapsed or refractory multiple myeloma who have received two or more prior treatments. Data did not demonstrate that the treatment combination significantly improved progression-free survival, 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. Select prespecified secondary endpoints from the CANOVA trial include the following: Overall response rate: 62% in VenDex vs. 35% in PomDex. Rate of very good partial response or better at 39% in VenDex vs. 14% in PomDex. Median overall survival was 32.4 months in VenDex vs. 24.5 months in PomDex (HR of 0.697. Additional prespecified analyses include: PFS per investigator which resulted in a median PFS of 9.1 months with VenDex vs 4.9 months with PomDex. Median time to next treatment which was longer in the VenDex arm 21.2 months vs. 8.3 months in the PomDex arm. The safety profile of the combination of venetoclax and dexamethasone in the trial was generally consistent with the known safety profiles when used as single agents and no new safety signals have emerged. The most common adverse events experienced by patients treated with VenDex included any infection (61%), diarrhea (41%), lymphopenia (24%) and nausea (22%). The most common AEs experienced by subjects treated with PomDex included neutropenia (63%), any infection (57%), thrombocytopenia (39%) and anemia (35%).