KEY TAKEAWAYS
- The study aimed to investigate the comprehensive profile of pirtobrutinib, assessing pharmacokinetics, pharmacodynamics, safety, and efficacy in r/r MCL patients.
- Researchers noticed the promising safety and efficacy of pirtobrutinib, highlighting its potential as a valuable therapeutic option for r/r MCL patients.
Dominique D Davis and her team aimed to address the imperative need for effective treatments in relapsed/refractory mantle cell lymphoma (r/r MCL); this comprehensive review delves into the pharmacokinetics, pharmacodynamics, safety, and efficacy of pirtobrutinib, a recently FDA-approved Bruton’s tyrosine kinase inhibitor (BTKi).
Researchers performed an inclusive analysis to evaluate the accelerated approval of pirtobrutinib, a non-covalent Bruton’s tyrosine kinase inhibitor (BTKi), for the treatment of r/r MCL. The approval, granted on January 2023, was based on results from the open-label, multi-center phase 1/2 BRUIN trial.
In phase 1, 61 patients with r/r MCL received pirtobrutinib at 7 dose levels ranging from (25 to 300 mg). Notably, no maximum tolerated dose or dose-limiting toxicities were reported during this phase. Subsequently, in phase 2, 56 evaluable efficacy patients were administered a daily dose of 200 mg pirtobrutinib. The overall response rate (ORR) was 52% (95% CI 38-65), and for patients with a history of prior covalent BTKi, the ORR remained at 52% (95% CI 38-66). The most frequently reported adverse reaction of grade 3 or higher was neutropenia.
The study concluded with compelling evidence affirming the safety and efficacy of pirtobrutinib in extensively treated adults with r/r MCL. Notably, the drug’s utilization in cases resistant to current BTK inhibitors, coupled with favorable tolerability and response rates, underscores its promising therapeutic potential. Ongoing clinical trials investigating pirtobrutinib across various B-cell malignancies further emphasize its role as a versatile and valuable treatment option in the evolving landscape of targeted therapies.
Source: https://pubmed.ncbi.nlm.nih.gov/38043933/
Davis DD, Ohana Z, Pham HM, et.al (2024). Pirtobrutinib: A novel non-covalent BTK inhibitor for the treatment of adults with relapsed/refractory mantle cell lymphoma. J Oncol Pharm Pract. 2024 Jan;30(1):182-188. doi: 10.1177/10781552231216886. Epub 2023 Dec 3. PMID: 38043933.
