AbbVie's Leukemia Drug Falls Short In Late-Stage Study In Pretreated Blood Cancer Patients

AbbVie Inc ABBV released data from its Phase 3 CANOVA study evaluating 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. 

Data did not demonstrate that the treatment combination significantly improved progression-free survival (PFS), the trial's primary endpoint. 

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 include: 

• Overall response rate (ORR): 62% in VenDex vs. 35% in PomDex.
• Rate of very good partial response or better (VGPR) at 39% in VenDex vs. 14% in PomDex.
• Median overall survival (OS) was 32.4 months in VenDex vs. 24.5 months in PomDex.

Additional prespecified analyses include:

• PFS per investigator resulted in a median PFS of 9.1 months with VenDex vs. 4.9 months with PomDex.
• Median time to next treatment (TTNT), which was longer in the VenDex arm, 21.2 months vs. 8.3 months in the PomDex arm 
• Multiple myeloma is the second most common blood cancer in the world. 
• Venetoclax is approved for patients with previously untreated and treated chronic lymphocytic leukemia (CLL) and newly diagnosed acute myeloid leukemia (AML). 

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