Pharmacyclics Initiates Study Investigating ibrutinib in Combination with AstraZeneca's MEDI4736 for Diffuse Large B-Cell Lymphoma and Follicular Lymphoma

Pharmacyclics, Inc. has initiated a Phase Ib/II study to investigate the safety, tolerability, and effectiveness of combining ibrutinib (IMBRUVICA) with AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor MEDI4736 in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL). The study aims to enroll approximately 109 patients at several sites in the U.S. and will explore the potential of this combination to improve patient outcomes in these aggressive blood cancers.

Key Takeaways:

• The study, PCYC-1136-CA, will investigate the safety, tolerability, and effectiveness of combining ibrutinib with MEDI4736 in patients with R/R DLBCL or FL.
• The Phase Ib portion of the study will primarily seek to determine the safety, tolerability, and appropriate dose of ibrutinib when combined with MEDI4736.
• The Phase II portion will determine the safety and effectiveness of the treatment combination in patients with DLBCL or FL.
• Approximately 109 patients will be enrolled at several sites in the U.S.
• The study will include two distinct cohorts to evaluate the treatment combination in patients with DLBCL and FL.
• Darrin Beaupre, M.D., Ph.D., Head of Early Development and Immunotherapy at Pharmacyclics, cited the need for additional treatment options for refractory blood cancers.
• IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc.

Statistics:

• The study aims to enroll a total of 109 patients.
• The study is a multi-center effort, with several sites in the U.S.
• ibrutinib has shown pre-clinical activity when combined with immunotherapy agents.

Sources:

• Pharmacyclics
• www.clinicaltrials.gov
• Pharmacyclics Medical Information at 877-877-3536