AstraZeneca and Pharmacyclics announced that they have agreed to enter into multiple clinical trial collaborations to investigate drug combo therapies in solid tumors and several hematological cancers.
The first collaboration will assess the safety and efficacy of Imbruvica (ibrutinib), Pharmacyclics’ oral Bruton's tyrosine kinase inhibitor, in combination with AstraZeneca’s anti-PD-L1 antibody, MEDI4736. Imbruvica is approved by the U.S. Food and Drug Administration (FDA) and received Breakthrough Therapy status as treatment for three types of cancer. MED14736 is currently being developed by AstraZeneca in a Phase 3 clinical program for patients with non-small cell lung cancer.
The second collaboration will explore separate combinations of two of AZ’s investigational PI3 kinase pathway inhibitors together with Imbruvica in hematological cancers, specifically relapsed or refractory diffuse large B-cell lymphomas. The companies said that preclinical data demonstrate the potential of the combination therapy to improve treatment in patients.
As part of the agreement, the company will work together on a non-exclusive basis and will consider conducting several Phase 1 and Phase 2A studies. Pharmacyclics will take the lead in conducting studies in solid tumors, while AZ will be responsible for developing the combo therapy in hematological cancers. The early stage phase of both studies will aim to establish a recommended safe and tolerable dose, as well as a schedule for the combination treatment. The Phase 2A stage will evaluate the safety and efficacy of the combo treatment in an expanded patient population. Results from both studies will be used to guide further clinical development of the various combinations.
Susan Galbraith, Head of AstraZeneca’s Oncology Innovative Medicines Unit, said that the company is increasingly focusing its attention on hematological malignancies. “There is a clear and significant unmet need in the treatment of hematological malignancies… Our partnership with Pharmacyclics will allow us to explore new and potentially potent treatment combinations, which could have a positive impact on patient outcomes.”
Bob Duggan, Chairman and CEO of Pharmacyclics, said, “We are optimistic that combining our oral once-per-day Imbruvica with other agents has the potential to enhance efficacy and duration across the landscape of hematological cancers. In addition, we are extremely interested in the potential for Imbruvica in combination with an anti-PD-L1 antibody to improve the treatment of solid tumors in patients who need better therapeutic options.”
The announcement was made concurrent with a separate collaboration deal between AstraZeneca, Pharmacyclics, and Janssen to investigate MEDI4736 and Imbruvica in hematological cancers, namely diffuse large B-cell lymphoma and follicular lymphoma.