In label expansion bid, AbbVie and Roche's Venclexta falls short in multiple myeloma subset

After establishing Venclexta as a treatment for chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML), AbbVie and Roche were hoping to demonstrate the med's promise in a subset of multiple myeloma. But that effort just hit a setback.

Combined with dexamethasone, Venclexta couldn’t significantly keep the disease from progressing in patients with t(11;14)-positive relapsed or refractory multiple myeloma who have tried at least two prior treatments. The treatment combo was dubbed VenDex for the study.

Patients on VenDex experienced a median of 9.9 months of progression-free survival. While that was higher than the 5.8 months for those on the combo of Bristol Myers Squibb’s Pomalyst and dexamethasone (PomDex), the result didn't reach statistical significance, AbbVie reported Friday.

Other than the missed primary endpoint, VenDex showed an overall response rate of 62% compared with PomDex’s 35%, AbbVie said. 

Median overall survival was 32.4 months for the VenDex group, compared with 24.5 months for PomDex. 

Given the “potential favorable trends” observed in the study, the partners will discuss the data with health authorities in “the near future,” AbbVie's oncology/hematology head Mariana Cota Stirner, M.D., Ph.D., said in a statement.

Venclexta is a first-in-class drug that works by selectively binding and inhibiting the B-cell lymphoma-2 protein, helping to restore the process of apoptosis that's hindered in some blood cancers.

The med was originally approved in 2016 to treat CLL in patients who have a chromosomal abnormality called 17p deletion. It was the first approved drug to target the B-cell lymphoma 2 protein.

More recently, Venclexta, combined AbbVie and Johnson & Johnson's Imbruvica, gained a recommendation from England’s National Institute for Health and Care Excellence (NICE) for treating untreated CLL.

In the U.S., it can also be used as a monotherapy or in combination with Roche's Rituxan to treat CLL in patients who have already received one prior therapy, or in combination with Roche’s Gazyva for previously untreated CLL.

Outside of CLL, the med was approved in 2020 as a treatment for AML when combined with azacitidine. That indication was converted from a 2018 accelerated approval based on “significant results” in two phase three studies, Genentech’s chief medical officer Levi Garraway, M.D., Ph.D., said in a statement at the time.