BRUIN MCL-321: phase III study of pirtobrutinib versus investigator choice of BTK inhibitor in BTK inhibitor naive mantle cell lymphoma

Author:

Eyre Toby A1ORCID,Shah Nirav N2,Dreyling Martin3,Jurczak Wojciech4,Wang Yucai5,Cheah Chan Y6,Song Yuqin7,Gandhi Mitul8,Chay Christopher9,Sharman Jeff10,Andorsky David J11,Messersmith Hannah M12,Ruppert Amy S12,Muthig Valerie A12,Ito Rodrigo12,Wang Michael L13

Affiliation:

1. Oxford University Hospitals NHS Foundation Trust, Churchill Cancer Center, Oxford, UK

2. Medical College of Wisconsin, Milwaukee, WI 53226, USA

3. Department of Medicine III, LMU University Hospital, Munich, Germany

4. Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland

5. Division of Hematology, Mayo Clinic, Rochester, MN 55902, USA

6. Linear Clinical Research & Sir Charles Gairdner Hospital, Perth, Australia

7. Key Laboratory of Carcinogenesis & Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China

8. Virginia Cancer Specialists, Fairfax, VA 22031, USA

9. Messino Cancer Centers, Asheville, NC 28806, USA

10. Willamette Valley Cancer Institute & Research Center, US Oncology Research, Eugene, OR 97401, USA

11. Rocky Mountain Cancer Centers, US Oncology Research, Boulder, CO 80303, USA

12. Eli Lilly & Company, Indianapolis, IN 46225, USA

13. University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA

Abstract

Treatment with covalent Bruton tyrosine kinase inhibitors (BTKi) represents an important advance in the management of relapsed or refractory mantle cell lymphoma, but these treatments are not curative and many patients ultimately relapse. Pirtobrutinib, a highly selective, noncovalent (reversible) BTKi, inhibits both wild type and C481-mutant BTK with equal low nM potency, and has favorable oral pharmacology that enables continuous BTK inhibition throughout the dosing interval regardless of intrinsic rate of BTK turnover. Pirtobrutinib is well tolerated and has demonstrated promising efficacy in patients with poor prognosis B-cell malignancies following prior therapy, including covalent BTKi. This phase III, head-to-head, randomized study (NCT04662255) will evaluate whether pirtobrutinib is superior to investigator’s choice of covalent BTKi in patients with previously treated, BTKi-naive mantle cell lymphoma.

Funder

Eli Lilly and Company

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

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