On June 20, 2013, the exciting results of a phase 2 clinical trial of ibrutinib in patients with previously treated mantle cell lymphoma (MCL) were published in the New England Journal of Medicine. Ibrutinib is an oral inhibitor of Bruton’s Tyrosine Kinase (BTK), an enzyme that plays a critical role in the survival and growth of some lymphomas, including MCL, CLL/SLL, follicular lymphoma, DLBCL, and Waldenstrom’s macroglobulinemia.
In this trial, 111 patients with MCL received oral ibrutinib at a dose of 560 mg daily. Despite a high number of prior therapies, 68% of patients experienced a significant response to ibrutinib, including 21% of patients experiencing a complete response. The estimated average response duration was almost 18 months. Overall, the treatment was well tolerated. The study authors concluded that ibrutinib is highly effective in treating relapsed and refractory MCL, achieving responses comparable to intensive chemotherapy regimens with less toxicity. Weill Cornell’s Dr. Peter Martin, one of the study’s lead authors, commented, “It has been tremendously gratifying to be able to offer ibrutinib to our patients with mantle cell lymphoma. We are all working hard so that this drug can be made available to all patients in the near future.”
The Lymphoma Program at Weill Cornell will be participating in an early access trial that will help provide ibrutinib to patients with MCL pending its official FDA approval. Look to this space for further updates.