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Jeremy S. Abramson, MD, MMSc
Jeremy S. Abramson, MD, MMSc
Posted: Friday, January 31, 2025
Steven Le Gouill, MD, PhD, of Institut Curie, Paris, and colleagues conducted the phase II OASIS II study of the Bruton’s tyrosine kinase inhibitor ibrutinib plus an anti-CD20 monoclonal antibody with or without venetoclax in patients with untreated mantle cell lymphoma (MCL). Presented during the 2024 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 745), the results of this trial demonstrate that both regimens provided 80% confidence interval measurable residual disease (MRD)-negativity percentages of 65% and 89.7% for the doublet and triplet combinations, respectively.
A total of 102 patients with previously untreated MCL with stage II to IV nodal disease were enrolled. Participants were randomly assigned 1:1 to receive continuous ibrutinib plus an anti-CD20 monoclonal antibody with (arm A; n = 51) or without (arm B; n = 51) venetoclax. Arm B received venetoclax for a fixed duration of 2 years.
The first six cycles of treatment were completed by 46 patients in arm A and 45 patients in arm B. Dose adjustments of ibrutinib and venetoclax were required in 28% and 24% of patients in arm B, respectively. Of note, grade 3 or higher adverse events were more frequent in arm B, but serious adverse events of the same caliber occurred at similar rates in each arm; neutropenia was the most common grade 3 adverse event.
The median follow-up at the interim analysis was 13.5 months, and the 1-year progression-free and overall survival rates were 91% and 95.4%, respectively. MRD was assessed in 39 patients from each arm at the end of cycle 6. Most patients in arm B (n = 32) achieved MRD negativity, compared with 21 patients in arm A. Using Lugano criteria, the investigators determined that 21 of 39 patients in arm A (54%) and 27 of 39 patients in arm B (69%) were in a complete metabolic remission.
Disclosure: Dr. Le Gouill reported no conflicts of interest. For full disclosures of the other study authors, visit ash.confex.com.
2024 ASH Annual Meeting & Exposition
