Key clinical point: The ibrutinib + bortezomib combination shows durable efficacy and manageable safety in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), including high-risk patients.
Major finding: The combination led to an objective response rate of 81.8% (90% CI 71.1%-89.8%), which increased to 87.3% (90% CI 77.4%-93.9%) with ibrutinib maintenance. At a 25.4-month median follow-up, the median duration of response and progression-free survival were 22.7 (95% CI 12.3-not achieved) and 18.6 (95% CI 12.5-not achieved) months, respectively. The adverse event profile was consistent with the known safety profiles of individual drugs.
Study details: This phase 2 trial included 55 ibrutinib-naive and bortezomib-naive patients with R/R MCL previously treated with ≤2 lines of chemotherapy (of whom 75.6% had ≥1 high-risk features) who received 6 cycles of ibrutinib + bortezomib followed by ibrutinib maintenance.
Disclosures: This study was supported by Janssen and others. Some authors declared serving on the advisory boards of or receiving research funding, consulting fees, honoraria, or meeting or travel support from various sources, including Janssen.
Source: Novak U et al. Combined therapy with ibrutinib and bortezomib followed by ibrutinib maintenance in relapsed or refractory mantle cell lymphoma and high-risk features: A phase 1/2 trial of the European MCL network (SAKK 36/13). EClinicalMedicine. 2023;64:102221 (Sep 21). doi: 10.1016/j.eclinm.2023.102221