Pharmacyclics Inc., a wholly-owned subsidiary of AbbVie, 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 US.
Imbruvica is currently approved for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, all CLL patients (including treatment-naive) who have del 17p, a genetic mutation that occurs when part of chromosome 17 has been lost, and all patients (including treatment-naive) 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. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.
Imbruvica (ibrutinib) is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton's tyrosine kinase (BTK).1 Imbruvica was one of the first medicines to receive US FDA approval via the new Breakthrough Therapy Designation pathway, and is the only product to have received three Breakthrough Therapy Designations.
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. Imbruvica blocks signals that tell malignant B cells to multiply and spread uncontrollably.
Imbruvica is being studied alone and in combination with other treatments in several blood cancers. More than 6,100 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 67 trials are registered on www.clinicaltrials.gov.
Pharmacyclics, a wholly-owned subsidiary of AbbVie, is focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune-mediated diseases.