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Pirtobrutinib in patients with Richter transformation: Results from the phase I/II BRUIN trial
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The phase I/II BRUIN trial (NCT03740529) assessed the safety and efficacy of pirtobrutinib, a highly selective, non-covalent, Bruton tyrosine kinase inhibitor (BTKi), in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or non-Hodgkin lymphoma.1 The Lymphoma Hub previously reported results from this trial for a CLL/SLL cohort, B-cell malignancy cohort, and Waldenstrom’s macroglobulinemia cohort. Results from this trial led to pirtobrutinib approval by the U.S. Food and Drug Administration (FDA) for R/R CLL/SLL and mantle cell lymphoma after ≥2 prior lines of therapy, including a BTKi. Below we summarize results of a subgroup analysis from this trial of 82 patients with Richter transformation, the majority of whom were previously treated with a covalent BTKi, which were published in Lancet Hematology by Wierda, et al.1
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The overall response rate (ORR), complete response rate, partial response rate, and stable disease rate were 50%, 13%, 37%, and 13%, respectively, in patients with Richter transformation, while the ORR was 48.6% in patients treated with previous Richter transformation directed therapy. |
| Pirtobrutinib was associated with treatment discontinuation due to adverse events in five patients and dose reduction in three patients, highlighting its favorable safety profile and tolerability compared with other treatment options such as chemoimmunotherapy regimens, which are associated with higher toxicity. |
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The ORR in patients with clonally related Richter transformation was 61.1% with pirtobrutinib, underscoring the potential clinical value of clonal assessments in guiding treatment decisions and potentially improving outcomes. |
| The findings of the study have led to the inclusion of pirtobrutinib in the National Comprehensive Cancer Network (NCCN) Guidelines as a treatment option for Richter transformation, but further research to explore its full potential in R/R patients post-BTKi therapy is needed. |
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