Pirtobrutinib shows activity in relapsed and refractory marginal zone lymphoma patients in a Phase 1/2 trial.
This Phase 1/2 clinical trial enrolled 36 patients with relapsed and refractory marginal zone lymphoma. The cohort included 6 patients with extranodal disease, 17 with nodal disease, and 13 with splenic disease. The study assessed pirtobrutinib monotherapy without a concurrent comparator arm. Follow-up duration was 32.4 months (IQR, 28.0-41.3).
The primary outcome was investigator-assessed objective response rate (ORR) by Lugano 2014 criteria. Overall, 20 out of 36 patients achieved an ORR of 55.6% (95% CI, 38.1-72.1). Complete responses were observed in 3 patients (8.3%), while partial responses occurred in 17 patients (47.2%). Among patients with prior cBTKi therapy, the ORR was 53.8% (95% CI, 33.4-73.4).
Secondary outcomes included duration of response, progression-free survival, and overall survival. The median duration of response was 17.8 months (95% CI, 7.4 to nonestimable). Median progression-free survival was 16.6 months (95% CI, 9.0-22.1). Overall survival was nonestimable (95% CI, 29.5-NE). The drug was generally well tolerated. Dose reductions occurred in 4 patients (11.1%), and permanent discontinuation due to treatment-emergent adverse events occurred in 4 patients (11.1%). Serious adverse events were not reported.
Key limitations include the small sample size, the absence of a control group, and the early-phase nature of the trial. Funding and conflicts of interest were not reported. These findings suggest potential efficacy but require validation in larger, randomized settings before changing standard practice.
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