News Feature | November 6, 2014

AstraZeneca, Pharmacyclics, And J&J Join Forces On Immuno-Oncology Trials

By Estel Grace Masangkay

AstraZeneca, Pharmacyclics, and Johnson & Johnson company Janssen Research & Development announced that the companies have inked a clinical trial partnership deal to investigate the safety and efficacy of AZ’s MEDI4736 in combination with Imbruvica (ibrutinib), co-developed by Janssen and Pharmacyclics.

MEDI4736 is AstraZeneca’s investigational anti-PD-L1 immune checkpoint inhibitor. The drug is a type of immunotherapy that recruits the patient’s immune system to counter tumors that slip past the immune system’s radar. MEDI4736 is currently in Phase 3 development as a treatment for patients with non-small cell lung cancer. Earlier this year, AZ announced its partnership with Advaxis to co-develop MED14736 with a cancer vaccine.

Imbruvica is an oral Bruton’s tyrosine kinase inhibitor indicated for the treatment of three different cancers. The drug has received three Breakthrough Therapy Designations from the U.S. Food and Drug Administration (FDA). Janssen and Pharmacyclics recently filed another supplemental New Drug Application (sNDA) for Imbruvica as a treatment for rare type of B-cell lymphoma, WaldenstrÓ§m's macroglobulinemia (WM).

The companies agreed to investigate the combination of MEDI4736 and Imbruvica as treatment for hematological cancers including diffuse large B-cell lymphoma and follicular lymphoma — both of which are currently investigational uses for the drugs. Preclinical data show that the combo treatment may result in a greater anti-tumor immunity response. The Phase 1 stage of the trials will aim to establish a recommended dose regimen for the combo immunotherapy, while the Phase 2A part will study its safety and efficacy. As part of the agreement, Pharmacyclics will conduct the two-part trial.

Briggs Morrison, EVP of Global Medicines Development & CMO at AstraZeneca, said, “Our partnership with Pharmacyclics and Janssen supports our exploration of the potential of anti-PD-L1 in hematological cancers – an area of significant unmet need as many lymphoma patients still progress despite treatment. It is also further evidence of our belief that combination therapies have the potential to be one of the most effective ways of treating cancer.”

Dr. Peter Lebowitz, Global Oncology Head at Janssen, said, “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 hematological malignancies.”