AstraZeneca, Pharmacyclics, Inc. and Janssen Research & Development LLC have announced a clinical trial collaboration to assess the efficacy and safety of combining AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor, MEDI4736, with IMBRUVICA (ibrutinib), an oral Bruton’s tyrosine kinase inhibitor, co-developed by Pharmacyclics and Janssen Biotech, Inc.
The combination therapy will be evaluated in patients suffering with hematologic cancers, such as Diffuse Large B-Cell Lymphoma and Follicular Lymphoma.
“We are committed to progressing our strong immuno-oncology pipeline as rapidly as possible. Our partnership with Pharmacyclics and Janssen supports our exploration of the potential of anti-PD-L1 in hematological cancers and is further evidence of our belief that combination therapies have the potential to be one of the most effective ways of treating cancer,” Briggs Morrison, Executive Vice President, Global Medicines Development & Chief Medical Officer, AstraZeneca, said in a press release.
MEDI4736 is an investigational human monoclonal antibody that binds to the PD-L1 ligand, present on the surface of tumor cells and responsible for immune tumor evasion. This drug is currently in development as a monotherapy for solid tumors, including non-small cell lung cancer and squamous cell carcinoma of the head of neck.
Ibrutinib is a first-in-class, oral therapy that inhibits Bruton’s tyrosine kinase (BTK), a protein responsible for sending cellular signals that allow malignant B cells to proliferate and grow.
Several clinical studies have already demonstrated the efficacy of combining these two drugs in the treatment of hematologic malignancies, resulting in enhanced anti-tumoral immune responses.
In the Phase I part of the trial, which will be conducted by Pharmacyclics, dosage of both drugs are expected to be defined, while in Phase II, researchers will evaluate the safety and efficacy of the combination treatment.
Bob Duggan, Chairman & CEO, Pharmacyclics added, “We are delighted by our strategic collaboration with AstraZeneca as we explore the potential of IMBRUVICA in combination with immunotherapy to address a variety of hematologic cancers in which we already have deep experience and an ongoing scientific interest. We look forward to working with our partners as we advance our understanding of different ways by which to continue to evolve treatment paradigms and expand treatment options for patients with certain B-cell malignancies.”
“This collaboration reflects the common goal of all three companies to better understand new treatment options and combinations – with the ultimate goal of making a difference to the lives of people with hematologic malignancies,” concluded Peter Lebowitz, MD, PhD, Global Oncology Head, Janssen.