Patients with relapsed or refractory mantle cell lymphoma (R/R MCL) may have a new treatment option, based on positive results from a Phase 1/2 trial of Zanubrutinib published in Blood Advances. This tyrosine kinase inhibitor yielded a high response rate, extended survival benefit, and positive activity.
About the Study
This Phase 1/2 study enrolled patients with different forms of B-cell malignancies to evaluate the safety and efficacy of Zanubrutinib. 37 R/R MCL patients were enrolled, 32 of which were administered 320 mg of Zabrutinib daily. This dosage was either split into two doses of 160 mg or taken in one sitting. The remaining five patients started at varying daily dosages, such as 40 mg, 80 mg, or 160 mg.
These patients received Zanubrutinib for a median duration of 15.4 months, with a median study time of 18.8 months. By the end of the trial, 18 patients discontinued the treatment while 14 remained on it. 12 patients passed away from disease progression and AEs.
AEs were the primary reason for the discontinuation of the trial, with effects such as pneumonia, acute kidney injury with anti-neutrophil cytoplasmic autoantibody vasculitis, peripheral edema, cerebral infarction, and worsening congestive heart failure. In the end, these AEs led a total of 16 patients to interrupt their dosing schedule, with an additional patient requiring dose reduction. Three patients experienced AEs that resulted in death.
Results of this study include:
- Overall response rate: 84%
- No difference based on dosing regimens
- Complete response rate: 25%
- Median time to complete response: 5.5 months
- Median progression-free survival: 21.1 months
- Median duration of response: 18.5 months
- 83.3% of patients responding to treatment by six months, 78.7% at 12 months
- 12-month survival rate: 83%
- 24-month survival rate: 64.4%
About MCL
Mantle cell lymphoma (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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