Clinical Trial: LOXO-305 Faces Off Against FDA-Approved Covalent BTK Inhibitors

Title: Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) (BRUIN-MCL-321)

Principal Investigator: Jennifer Kherani, MD, Loxo Oncology

Description:

Following Loxo Oncology’s presentation of data demonstrating LOXO-305’s promising activity in mantle cell lymphoma (MCL) at the 2020 American Society of Hematology (ASH) Annual Meeting, researchers are preparing to initiate the global, randomized, BRUIN MCL-321 superiority study (NCT04662255). In the phase 3 clinical trial, BRUIN MCL-321 investigators will compare the safety and efficacy of LOXO-305 with that of 3 FDA-approved covalent Bruton tyrosine kinase (BTK) inhibitors: ibrutinib, acalabrutinib, and zanubrutinib.

The open-label study seeks to enroll 500 adults with MCL who have received 1 prior line of systemic therapy for their disease. Participants must have measurable disease per Lugano criteria, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, and BTK inhibitor-naïve disease. Patients whose prior treatment intervention included BTK inhibitor therapy will not be permitted to enroll on BRUIN MCL-321.

The primary end point of the BRUIN MCL-321 trial is progression-free survival. Secondary end points include event-free survival, time to treatment failure, time to worsening of MCL-related symptoms, overall response rate, duration of response, overall survival, and comparative tolerability.

The BRUIN MCL-321 trial is not yet recruiting.

Reference

Clinicaltrials.gov. Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) (BRUIN-MCL-321). NCT04662255. Accessed February 19, 2021. https://www.clinicaltrials.gov/ct2/show/NCT04662255?term=BRUIN&draw=2&rank=1