LOXO-305 is an investigational Bruton’s tyrosine kinase (BTK) inhibitor which is currently in development for the treatment of mantle cell lymphoma (MCL). The next step is to evaluate LOXO-305 in a phase 3 trial, which is officially open to patients.

About the Trial

Referred to as the BRUIN trial, this phase 3 study intends to enroll 500 patients with MCL who have received prior treatment. They will go on to receive one of four treatment options at the researchers’ discretion: LOXO-305, Calquence, Imbruvica, or Brukinsa. The goal is to investigate progression-free survival (PFS), time to treatment failure, event-free survival, objective response rate (ORR), tolerability, time to worsening of MCL-related symptoms, overall survival, and duration of response (DOR).

These results are expected after the trial completes, which is planned for February 2025. Hopefully, data is positive, just as it was in the phase 1/2 trial, from which results were shared at the 2020 American Society of Hematology Annual Meeting. This data included:

• An ORR of 52%
• 14 complete responses
• 15 partial responses
• 1.8 months was the median time to initial patient response
• The most common adverse effects (AEs) were fatigue, bruising, and diarrhea

About Mantle Cell Lymphoma (MCL)

MCL is a form of non-Hodgkin’s lymphoma that forms in the region of lymphocytes known as the mantle zone. Medical professionals are unsure as to why these lymphocytes become malignant and multiply out of control, but they do know that something triggers the release of the cyclin D1 protein, which causes B-cell growth and leads to MCL.

Symptoms of this cancer typically begin with swelling of the lymph nodes in the neck, shoulders, elbows, and chest. Other effects include bowel issues, fever, nausea, vomiting, indigestion, bloating, heartburn, unintentional weight loss, pressure/pain in the lower back, lack of appetite, and a false sense of fullness. This cancer may spread throughout the body, and if it reaches the brain or spinal cord, additional symptoms may include poor balance, headaches, confusion, irritability, dizziness, and personality changes. Treatment may consist of monitoring if one’s cancer is in its earlier stages. Upon progression, treatment options are stem cell transplants, chemotherapy, targeted therapy, and immunotherapy.

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