A study of ibrutinib, an investigational drug that inhibits Bruton’s tyrosine kinase (BTK), conducted by Janssen Research & Development, LLC, was published online in The New England Journal of Medicine (NEJM). The patients with relapsed/refractory mantle cell lymphoma (MCL) were examined in the study, and it demonstrated a 68% overall response rate, 47% partial response rate, and a 21% complete response rate (the disappearance of all signs of cancer). The pre-treatment with bortezomib did not vary the response rate to ibrutinib.
A separate study was published in the same online edition, examining the safety and efficacy of ibrutinib for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL).
“The safety and efficacy results of ibrutinib as observed in the mantle cell lymphoma study have not been seen before with a single agent,” said lead author Michael Wang, M.D., Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center. “I am excited to see data demonstrating an increasing response to ibrutinib without an associated increase in adverse events over time.”
The progression-free survival of patients was 13.9 months, and the median overall survival is estimated to be 58% at 18 months. The most common non-hematologic events occurring in >30% of patients were diarrhea (50%), fatigue (41%) and nausea (31%). Other symptoms, such as pneumonia (6%), neutropenia (16%), thrombocytopenia (11%) and anemia (10%) were also observed.
“The results of this study add to the growing body of evidence supporting the safety and efficacy of ibrutinib in patients with MCL,” said Peter Lebowitz, M.D., Ph.D., Global Oncology Therapeutic Area Head, Janssen. “It’s positive news to have a compound like ibrutinib in development, especially as it continues to show promise as a much needed option for patients with relapsed/refractory MCL.”
For details about the complete ibrutinib clinical program, visit clinicaltrials.gov.
Watch the video below for an overview of Mantle Cell Lymphoma provided by the Lymphoma Research Foundation: