By Patrick Daly Last Updated: November 21, 2023
Outpatient triplet therapy with zanubrutinib, obinutuzumab, and venetoclax (BOVen) was well-tolerated and induced high rates of both response and measurable residual disease-negativity among patients with untreated mantle cell lymphoma (MCL) with TP53 mutations, according to phase II trial data.
Lead author, Anita Kumar, MD, of the Memorial Sloan Kettering Cancer Center in Short Hills, New Jersey, presented the findings during the 65th ASH Annual Meeting and Exposition in San Diego, California.
The study’s initial estimates for progression-free survival (PFS) and overall survival (OS) among participants “compare favorably with historical outcomes of chemoimmunotherapy in this high-risk subset of MCL,” Dr. Kumar stated.
Researchers enrolled a full 25 planned patients with a median age of 65 years (range, 29-82), among which 15 had conventional MCL, five had non-nodal leukemic MCL, and five had blastoid variant MCL. The study protocol included a minimum treatment duration of two years and a primary endpoint of PFS at year two.
At the data cutoff of May 15, 2023, the median follow-up was 16.1 months. Investigators reported BOVen was well-tolerated and the most common treatment-related adverse events (AEs) in 20% or more of patients were diarrhea in 52%, neutropenia in 28%, infusion-related reaction in 24%, and bruising, COVID-19 infection, nausea, thrombocytopenia, and rash each in 20%.
The best overall response rate was 95% (n=24), including a complete response rate of 88% (n=22). The OS and PFS at one year were 96% (95% CI, 89-100) and 84% (95% CI, 71-100), respectively, and at 16 months were 87% (95% CI, 75-100) and 75% (95% CI, 60-95), respectively.
“Based on this data, BOVen emerges as a promising treatment option for TP53-mutant MCL and, therefore, the study was expanded to include an additional 25 (total 50) TP53-mutant MCL patients,” Dr. Kumar and colleagues added in closing.
Reference
Kumar A, Soumerai J, Abramson J, et al. A multicenter phase 2 trial of zanubrutinib, obinutuzumab, and venetoclax (BOVen) in patients with treatment-naïve, TP53-mutant mantle cell lymphoma. Abstract #738. Presented at the 65th ASH Annual Meeting and Exposition; December 9-12, 2023; San Diego, California.
Original Source: Outpatient MCL Treatment Regimen Induces Responses in Mutated MCL | Blood Cancers Today