On April 1, 2015 Pharmacyclics reported 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 (Press release, Pharmacyclics, APR 1, 2015, View Source [SID:1234502906]). 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.

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"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.

About IMBRUVICA
IMBRUVICA (ibrutinib) is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton’s tyrosine kinase (BTK).1 BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells.1,2 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.1

IMBRUVICA is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, CLL patients with del 17p, a genetic mutation that occurs when part of chromosome 17 has been lost, and patients with Waldenstrom’s macroglobulinemia.1

IMBRUVICA is also approved for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Accelerated approval was granted for the MCL indication based on overall response rate (ORR). Continued approval for the MCL indication may be contingent upon verification of clinical benefit in confirmatory trials.1

IMBRUVICA is being studied alone and in combination with other treatments in several blood cancers. Over 5,100 patients have been treated in clinical trials of IMBRUVICA conducted in 35 countries by more than 800 investigators. Currently, 13 Phase III trials have been initiated with IMBRUVICA and 58 trials are registered on www.clinicaltrials.gov.

IMBRUVICA was one of the first medicines to receive U.S. FDA approval via the new Breakthrough Therapy Designation pathway, and is the only product to have received three Breakthrough Therapy Designations.

To learn more about the medical terminology used in this news release, please visit View Source

IMPORTANT SAFETY INFORMATION

Warnings and precautions include hemorrhage, infections, cytopenias, atrial fibrillation, second primary malignancies, Tumor Lysis Syndrome and embryo-fetal toxicity.

The most common adverse reactions ( > 25%) in patients with B-cell malignancies (MCL, CLL, WM) were thrombocytopenia, neutropenia, diarrhea, anemia, fatigue, musculoskeletal pain, bruising, nausea, upper respiratory tract infection, and rash. For additional important safety information, please see Important Safety Information to the right and the full Prescribing Information at www.imbruvica.com/downloads/Prescribing_Information.pdf.