Solid Tumor Study Investigating Ibrutinib in Combination with Anti-PD-L1 Antibody Commences in Patients

Pharmacyclics, Inc. PCYC today announced the initiation of PCYC-1135-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 individuals with relapsed or refractory (R/R) non-small cell lung cancer (NSCLC), breast cancer, and pancreatic cancer. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc. "Based on the results of pre-clinical studies, we are extremely excited to investigate the potential safety and effectiveness of ibrutinib in combination with MEDI4736 in a subset of individuals who no longer are benefitting from other therapies and whose disease continues to progress," said Darrin Beaupre, M.D., Ph.D., Head of Early Development and Immunotherapy at Pharmacyclics. "We believe that combination strategies with exciting therapies such as ibrutinib and immunotherapy agents will be important toward driving future advancements in difficult-to-treat cancers." 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 these cancers. The Phase II portion of the study will be conducted in three distinct cohorts to determine the safety and effectiveness of the treatment combination in individuals with R/R NSCLC, breast and pancreatic cancers. The clinical study will aim to enroll approximately 160 subjects at approximately 20 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.