Combination Therapy With Venetoclax in Resistant Multiple Myeloma
Posted: Thursday, November 7, 2019
According to the results of a phase III trial presented at the 2019 International Myeloma Workshop in Boston (Abstract OAB-045), venetoclax and bortezomib plus dexamethasone improved progression-free survival in patients with relapsed or refractory multiple myeloma. However, Shaji Kumar, MD, of the Mayo Clinic, Minnesota, and colleagues suggest that future studies are needed.
“The BELLINI study, where venetoclax was combined with bortezomib, did demonstrate an added benefit in terms of disease control but was associated with increased deaths due to infection, suggesting that the combination approach may not be the right one for all patients,” said Dr. Kumar, in an interview with JNCCN 360.
A total of 291 patients, who previously received up to 3 lines of therapy, were randomly assigned to receive venetoclax with bortezomib plus dexamethasone (n = 194) or placebo with bortezomib plus dexamethasone (n = 97). The median age of patients was 66 years, and 79% had high BCL2 expression (as determined by immunohistochemistry ).
With a median follow-up of 18.7 months, the median progression-free survival was 22.4 months for the venetoclax group and 11.5 months for the placebo group (hazard ratio = 0.630). In addition, those treated with the venetoclax combination therapy had a higher overall response rate (82% vs. 68%) as well as a very good partial or better response rate (59% vs. 36%). Although the median overall survival was not reached, it seems to favor placebo. Low BCL2 expression and high-risk cytogenetics were linked to poorer outcomes, based on subgroup analyses.
The safety population had 51 deaths, the venetoclax group had 40 deaths, and the placebo group had 11 deaths. Patients with t(11;14) in the venetoclax group had a “consistent” clinical benefit with the addition of venetoclax.
Disclosure: The authors’ disclosure information can be found at imw2019boston.org.