AbbVie's BCL-2 Inhibitor Venetoclax Fails to Meet Primary Endpoint in Phase III CANOVA Trial for Relapsed/Refractory Multiple Myeloma with t(11;14) Translocation

On September 29, AbbVie announced the results of the Phase III CANOVA study of Bcl-2 inhibitor Venetoclax (Venetoclax) in combination with dexamethasone (VenDex) for the treatment of t(11;14) positive relapsed or refractory multiple myeloma (R/R MM) patients. The primary endpoint of progression-free survival (PFS) did not show significant improvement.

The CANOVA study is a randomized, open-label, multicenter Phase III clinical trial designed to evaluate the efficacy and safety of VenDex in t(11;14) positive R/R MM patients. A total of 263 adult subjects were enrolled, all of whom had previously received two or more prior lines of therapy.

The results showed that the median PFS assessed by the Independent Review Committee (IRC) was 5.8 months in the pomalidomide and dexamethasone (PomDex) group and 9.9 months in the VenDex group, but the difference was not statistically significant [HR = 0.823, 95% CI: (0.596, 1.136); p=0.237].

For secondary endpoints, the overall response rates (ORR) were 62% in the VenDex group and 35% in the PomDex group, the very good partial response rates (VGPR) were 39% and 14%, respectively, and the median overall survival (OS) was 32.4 months and 24.5 months.

Other pre-specified analyses showed that the investigator-assessed median PFS in the VenDex group was 9.1 months, compared to 4.9 months in the PomDex group. The median time to next treatment (TTNT) was 21.2 months in the VenDex group and 8.3 months in the PomDex group.

In terms of safety, the combination of Venetoclax and Dexamethasone is generally consistent with the known safety profiles of each drug when used individually, with no new safety signals identified. The most common adverse events (AEs) in the VenDex group (>20%) included any infection (61%), diarrhea (41%), lymphopenia (24%), and nausea (22%).

Venetoclax, a Bcl-2 inhibitor jointly developed by AbbVie and Roche, was launched in the United States in April 2016, becoming the world's first approved BCL-2 inhibitor. It has already secured three hematological cancer indications: chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and acute myeloid leukemia (AML). Genentech, under Roche, and AbbVie are responsible for the commercialization of the product in the United States, while AbbVie handles commercialization outside the United States.

At present, companies globally developing Bcl-2 inhibitors include Fochon Pharmaceuticals, CT Tianqing, Ascentage Pharma, BeiGene, and Novartis, among others.

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