Pirtobrutinib monotherapy in Bruton tyrosine kinase inhibitor-intolerant patients with B-cell malignancies: results of the phase I/II BRUIN trial

Pirtobrutinib monotherapy in Bruton tyrosine kinase inhibitor-intolerant patients with B-cell malignancies: results of the phase I/II BRUIN trial

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Bruton tyrosine kinase inhibitors (BTKi) have transformed the treatment of B-cell malignancies, but intolerance has often led to their discontinuation.The phase 1/2 BRUIN study evaluated pirtobrutinib, a highly selective non-covalent (reversible) BTKi, in patients with R/R B-cell malignancies (NCT03740529).Pirtobrutinib was investigated in 127 patients with intolerance to at least one prior BTKi therapy in the absence of progressive disease.

The most common adverse event Course a pied - Homme - Vetements - Manteau - Nylon (AE) leading to BTKi discontinuation was cardiac disorders (n=40, 31.5%), specifically atrial fibrillation (n=30, 23.6%).

The median follow-up was 17.4 months and the median time on pirtobrutinib was 15.3 months.

The most common reasons for pirtobrutinib discontinuation were progressive disease (26.8%), AE (10.2%), or death (5.

5%).The most frequent treatment-emergent AEs were fatigue (39.4%) and neutropenia (37.

0%).Among patients who discontinued a prior BTKi for a cardiac issue, 75% had no recurrence of their cardiac AE.No ORG THIRD TRIMESTER TEA patient discontinued pirtobrutinib for the same AE that led to discontinuation of the prior BTKi.

In 78 CLL/SLL and 21 MCL patients intolerant to prior BTKi, ORR to pirtobrutinib was 76.9% and 81.0%, respectively.

Median PFS for CLL/SLL was 28.4 months and was not estimable for MCL.These results suggest that pirtobrutinib was safe, well-tolerated, and an efficacious option in patients with prior BTKi-intolerance.