Venclexta misses in Phase III multiple myeloma study

2 October 2023

US pharma major AbbVie (NYSE: ABBV) saw its shares dip 2.1% to $149.06 on Friday after it announced disappointing data from its Phase III CANOVA study evaluating the safety and efficacy of Venclexta (venetoclax) 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.

AbbVie noted that 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 [HR = 0.823, 95% CI: (0.596, 1.136); p-value of 0.237].

Select prespecified secondary endpoints from the CANOVA trial include the following:

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