KEY TAKEAWAYS
- The BRUIN MCL-321 phase III trial registered under (NCT04662255) aimed to evaluate whether pirtobrutinib is superior to the investigator’s choice of covalent BTKi regarding progression-free survival (PFS).
- The study enrolled patients with previously treated BTKi-naive mantle cell lymphoma who will be randomized to receive either pirtobrutinib or the investigator’s choice of covalent BTKi.
- The ongoing BRUIN MCL-321 trial actively enrolls MCL patients who have undergone at least one prior therapy but have not yet received any BTK inhibitor treatment.
Covalent Bruton tyrosine kinase inhibitors (BTKi) have been a significant advancement in treating relapsed or refractory mantle cell lymphoma, but they are not curative, and many patients eventually relapse. Pirtobrutinib has an equal low nM potency and is a highly selective, noncovalent (reversible) BTKi that inhibits both wild-type and C481-mutant BTK.
The oral pharmacology of pirtobrutinib ensured continuous BTK inhibition throughout the dosing interval, regardless of the intrinsic rate of BTK turnover. It has been well-tolerated and demonstrated promising efficacy in patients with poor prognosis B-cell malignancies who have received prior therapy, including covalent BTKi. The randomized study aimed at this phase III to compare the effectiveness of pirtobrutinib with the investigator’s choice of covalent BTKi in patients previously treated with BTKi-naive mantle cell lymphoma.
Source: https://pubmed.ncbi.nlm.nih.gov/36377973/
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT04662255
Eyre TA, Shah NN, Dreyling M, Jurczak W, Wang Y, Cheah CY, Song Y, Gandhi M, Chay C, Sharman J, Andorsky DJ, Messersmith HM, Ruppert AS, Muthig VA, Ito R, Wang ML. BRUIN MCL-321: phase III study of pirtobrutinib versus investigator choice of BTK inhibitor in BTK inhibitor naive mantle cell lymphoma. Future Oncol. 2022 Nov;18(36):3961-3969. doi: 10.2217/fon-2022-0976. Epub 2022 Nov 15. PMID: 36377973.
