On September 29, AbbVie announced the Bcl-2 inhibitorVenetoclax（Results of the Phase III CANOVA Study of Venetoclax (VenDex) in Combination with Dexamethasone for the Treatment of t(11;14)-Positive Relapsed or Refractory Multiple Myeloma (R/R MM) PatientsProgression-Free Survival (PFS)The primary endpointDid not show significant improvement。The CANOVA study is a randomized, open-label, multi-center 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.Results ShowThe PFS of the Pomalidomide and Dexamethasone (PomDex) treatment group assessed by the Independent Review Committee (IRC) was 5.8 months, and 9.9 months for the VenDex group, but the result was not statistically significant [HR = 0.823, 95% CI: (0.596, 1.136); p=0.237].In terms of secondary endpoints, the overall response rates (ORR) for the VenDex group and PomDex group were 62% and 35%, respectively, and the very good partial response rates (VGPR) were 39% and 14%, respectively. The median overall survival (OS)...32.4 months and 24.5 months.Other pre-specified analyses showed that the median PFS assessed by investigators was 9.1 months in the VenDex group and 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,Venetoclax andThe safety profile of the dexamethasone combination was generally consistent with the known safety profiles of the individual agents when used alone, 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 is a product jointly developed by AbbVie and Roche.Bcl-2 InhibitorIn April 2016, it was launched in the United States, becoming the world's first approved BCL-2 inhibitor. It has currently obtained three hematological tumor indications: chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and acute myeloid leukemia (AML). AbbVie and Genentech, a subsidiary of Roche, are responsible for the commercialization of the product in the United States, while AbbVie is responsible for commercialization outside the United States.Currently, global developmentCompanies with Bcl-2 inhibitors also include Fochon Pharmaceuticals, Zhengda Tianqing, Ascentage Pharma, BeiGene, and Novartis.Copyright © 2023 PHARMCUBE. All Rights Reserved.
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