Ibrutinib Plus Venetoclax Shows Favorable Benefit-Risk Profile in MCL

The combination of ibrutinib plus venetoclax significantly improved progression-free survival (PFS), complete response (CR) rates, and time to next treatment (TTNT) compared with ibrutinib plus placebo in patients with relapsed or refractory mantle cell lymphoma (MCL). The study was presented at the 65th ASH Annual Meeting & Exposition.

Michael Wang, MD, of the University of Texas MD Anderson Cancer Center, and colleagues reported the results from the multinational, randomized, double-blind, phase III SYMPATICO study. A total of 267 patients were randomized to receive ibrutinib with (n=134) or without (n=133) venetoclax.

At 24 months, PFS and CR rates were 57% and 54% with ibrutinib plus venetoclax, respectively, versus 45% and 32% for ibrutinib plus placebo. The median TTNT was not reached for the combination cohort and was 35.4 months in the placebo cohort. The median overall survival was 44.9 months with ibrutinib plus venetoclax versus 38.6 months in the ibrutinib plus placebo cohort.

Grade ≥3 adverse events (AEs) occurred in 84% of patients receiving ibrutinib plus venetoclax versus 76% in those receiving ibrutinib plus placebo. The most common AEs were neutropenia, pneumonia, thrombocytopenia, anemia, diarrhea, leukopenia, MCL, atrial fibrillation, COVID-19, and hypertension.

“The safety profile of [ibrutinib plus venetoclax] was consistent with known AEs for each agent, with no new safety signals observed,” the researchers noted.

Reference

Wang M, Jurczak W, Trněný M, et al. Ibrutinib combined with venetoclax in patients with relapsed/refractory mantle cell lymphoma: primary analysis results from the randomized phase 3 sympatico study. Abstract LBA2. Presented at the 65th ASH Annual Meeting and Exposition; December 9-12, 2023; San Diego, California.