In a phase 1-2 trial, nearly 3 in 4 patients with relapsed or refractory CLL or SLL had an overall response to the selective BTK inhibitor pirtobrutinib.
or small lymphocytic leukemia had an overall response to the selective Bruton tyrosine kinase inhibitor pirtobrutinib.The trial included 317 patients with relapsed or refractory CLL or SLL who received pirtobrutinib, but it focused largely on the 247 patients who had already received at least one BTK inhibitor over a median of three previous lines of therapy.
Among the 247 patients, almost 88% had also received an anti-CD20 antibody, 79% had received chemotherapy, and 40.5% had received aDoses ranged from 25 to 300 mg once daily in 28-day cycles in the phase 1 part of the study; patients received the recommended dose of 200 mg once daily in the phase 2 part.The primary endpoint was overall response to pirtobrutinib; secondary endpoints included progression-free survival, overall survival, and safety.
Among those who had received a previous BTK inhibitor, median progression-free survival was 19.6 months over a median follow-up of 19.4 months. In this group, the 12-month overall survival was 86% over a median follow-up of 22.6 months; 18-month overall survival was 80.5%., but only 2.8% of patients discontinued the drug because of a treatment-related adverse event.The phase 1-2 findings indicate that"pirtobrutinib showed efficacy in patients with CLL or SLL who had previously received a BTK inhibitor," the authors concluded.
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