Summary

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• Jaypirca (pirtobrutinib) is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor, and for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
• This summary is based on the review of one randomized controlled trial(s). ^[1]
• The study aims to evaluate the effectiveness of pirtobrutinib versus the investigator's choice of covalent BTKi (ibrutinib, acalabrutinib, or zanubrutinib) primarily by comparing Progression-Free Survival (PFS), assessed by an independent review committee using the Lugano criteria.
• Secondary endpoints include Overall Response Rate (ORR), Duration of Response (DoR), Overall Survival (OS), Event-Free Survival (EFS), Time to Treatment Failure (TTF), Time to Next Treatment (TTNT), and PFS2, with assessments of both investigator-assessed PFS and patient-reported outcomes.
• Stratification factors in the trial include sMIPI risk (low/intermediate vs. high), the specific covalent BTKi comparator, and the number of prior lines of therapy (1 vs. ≥2), which may influence the evaluation of effectiveness across different subgroups.
• There is no safety information available in the reviewed studies.
• There is no population types or subgroups information available in the reviewed studies.