AbbVie (NYSE:ABBV) announced Friday that its FDA-approved blood cancer therapy venetoclax did not reach the primary endpoint in a Phase 3 trial for patients with multiple myeloma as a late-line combination regimen.
Citing data from its CANOVA study, the company said that venetoclax plus dexamethasone did not indicate a statistically significant improvement in progression-free survival (PFS), the trial’s primary endpoint.
Patients on venetoclax plus dexamethasone lived a median of 9.9 months without disease progression, compared to 5.8 months in those who received pomalidomide and dexamethasone in the comparator arm (p-value of 0.237).
There were no new safety signals, and the drug combo indicated a safety profile generally in line with the known safety profiles of individual drugs when used alone.
CANOVA involved 263 adults with relapsed or refractory (R/R) MM who had received at least two prior lines of therapy.
Venetoclax, a B-cell lymphoma-2 (BCL-2) protein inhibitor that ABBV markets with Roche (OTCQX:RHHBY) (OTCQX:RHHBF) is approved in the U.S. for chronic lymphocytic leukemia and myeloid leukemia as a first-line therapy.