Pharmacyclics initiates ibrutinib-MEDI4736 combination multi-center study for R/R DLBCL or FL

Pharmacyclics, Inc. today announced the initiation of PCYC-1136-CA, a multi-center study that will investigate the use of ibrutinib (IMBRUVICA^®) in combination with MEDI4736, an investigational anti-PD-L1 immune checkpoint inhibitor being developed by AstraZeneca. The Phase Ib/II study will examine the safety, tolerability and effectiveness of this investigational combination in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL). IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc.

"While there has been a great deal of progress in developing therapies to treat certain B-cell malignancies, additional treatment options for the most refractory types of blood cancers are still needed," said Darrin Beaupre, M.D., Ph.D., Head of Early Development and Immunotherapy at Pharmacyclics. "Given the pre-clinical activity we have observed by combining therapies such as ibrutinib and immunotherapy agents, we are excited to investigate the potential to improve the outcomes of patients who are no longer benefitting from the currently available therapies."

The Phase Ib portion of the study will primarily seek to determine the safety, tolerability, and appropriate dose of ibrutinib when combined with MEDI4736 to treat individuals with R/R DLBCL or FL. The Phase II portion of the study will be conducted in two distinct cohorts to determine the safety and effectiveness of the treatment combination in patients with these types of blood cancer.

The clinical study will aim to enroll approximately 109 patients at several sites in the U.S. To learn more about the clinical study, visit: www.clinicaltrials.gov or call Pharmacyclics Medical Information at 877-877-3536.