Dr. Eyre on the Design of the BRUIN-MCL-321 Trial in MCL

Toby Eyre, MBChB, DipMedEd, MRCP, FRCPath, MD, consultant hematologist, Oxford University Hospitals, discusses the design and the rationale of the phase 3 BRUIN-MCL-321 trial (NCT04662255) in mantle cell lymphoma (MCL).

BRUIN-MCL-321 is evaluating the noncovalent BTK inhibitor pirtobrutinib (LOXO-305) vs approved BTK inhibitors, including ibrutinib (Imbruvica), acalabrutinib (Calquence), and zanubrutinib (Brukinsa), in previously treated patients with MCL.

Treatment in the control arm will be investigator’s choice of ibrutinib, acalabrutinib, or zanubrutinib, based on what is available in various locations, Eyre explains. Althoughpatients are required to have undergone prior treatment for MCL, they must be BTK inhibitor naïve, Eyre notes.

Once enrolled, patients will be randomized 1:1 to receive oral pirtobrutinib at 200 mg once daily, or standard of care. The trial expects to enroll approximately 500 patients, Eyre concludes.