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Phase I/II BRUIN study: Pirtobrutinib monotherapy in cBTKi-intolerant patients with R/R B-cell malignancies
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A significant number of patients with B-cell malignancies report discontinuation of cBTKi owing to toxicities and disease progression. The BRUIN open-label, multicenter, phase I/II trial (NCT03740529) evaluated the safety and efficacy of pirtobrutinib, a selective non-cBTKi, in patients with R/R B-cell malignancies who discontinued prior cBTKi as a result of intolerance. Data were published in Haematologica by Shah et al.1 A total of 127 patients with R/R B-cell malignancies (CLL/SLL [n = 78], MCL [n = 21], WM [n = 16], RT [n = 8], FL/MZL [n = 4]), who were intolerant to prior BTKi and who had no PD, received pirtobrutinib monotherapy at 25–300 mg once daily in 28-day cycles in phase I and later 200 mg once daily during phase II. Outcomes included safety, ORR, PFS, and OS.1
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| Key learnings |
| The most common AEs that led to prior cBTKi discontinuation were cardiac disorders (31.5%; primarily AF [23.6%]), infections (10.2%), neutropenia (9.4%), rash (8.7%) arthralgias/myalgias (7.9%), bleeding/haemorrhage (7.1%), GI disorders (6.3%), fatigue (4.7%), and pain (4.7%). |
| The most frequent TEAEs of any grade were fatigue (39.4%), neutropenia (37.0%), and diarrhea (29.9%). Discontinuation of pirtobrutinib as a result of TRAEs occurred in 5.5% of patients. Patients also discontinued pirtobrutinib as a result of PD (26.8%), AEs (15.7%), or death (5.5%). |
| Pirtobrutinib monotherapy resulted in an ORR of 81% and 76.9% in patients with MCL and CLL/SLL, respectively. Median PFS in patients with CLL/SLL was 28.4 months and was not estimable in patients with MCL. |
| The results from the BRUIN trial show that pirtobrutinib is a safe, well-tolerated, and effective treatment option for patients with R/R B-cell malignancies who previously experienced intolerance to BTKi therapy. |
Abbreviations: AE, adverse event; AF, atrial fibrillation; BTKi, Bruton tyrosine kinase inhibitors; c, covalent; CLL, chronic lymphocytic lymphoma; FL, follicular lymphoma; GI, gastrointestinal; MCL, mantle cell lymphoma; MZL, marginal zone lymphoma; ORR, overall response rate; PD, progressive disease; R/R, relapsed/refractory; RT, Richter transformation; SLL, small lymphocytic lymphoma; TRAE, treatment-related AE; WM, Waldenstrom’s macroglobulinemia.
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