AbbVie, Roche drug disappoints in phase 3 multiple myeloma trial

Last week, AbbVie reported findings from its phase 3 study, evaluating venetoclax combined with dexamethasone (VenDex) in patients with multiple myeloma who had undergone two or more prior treatments. 

Venetoclax was first approved in 2016 for chronic lymphocytic leukemia under the brand name Venclexta, and has since racked up various approvals as a monotherapy or combination treatment, including an approval for acute myeloid leukemia (AML) in 2018.

Co-development partners AbbVie and Roche's Genentech were hoping to expand the drug into a subset of multiple myeloma — patients with the t(11;14) biomarker.

But the latest results, presented at the International Myeloma Society Annual Meeting in Athens, Greece, revealed that the combination treatment did not significantly improve progression free survival compared to pomalidomide and dexamethasone (PomDex) in t(11;14)-positive relapsed or refractory multiple myeloma patients. 

In the VenDex group, more patients responded well with a 62% overall response rate, and 39% achieved very good partial responses or better, compared to the PomDex group, where these rates were 35% and 14%, respectively. Median overall survival was also longer in the VenDex group, at 32.4 months versus 24.5 months in the PomDex group.

Although the study’s primary endpoint wasn't met, AbbVie plans to discuss the data's potential with health authorities regarding venetoclax as a biomarker-driven therapy in multiple myeloma.