Peregrine Pharmaceuticals, a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer, has expanded its ongoing cancer immunotherapy clinical collaboration with AstraZeneca to include a second, later-stage trial.
The companies now also will evaluate the immunotherapy combination of Peregrine’s phosphatidylserine (PS)-targeted immune-activator, bavituximab, and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), in a global phase II study in patients with previously treated squamous or non-squamous non-small cell lung cancer (NSCLC). The randomized phase II trial will be conducted by Peregrine.
As part of the phase II bavituximab and durvalumab combination trial, patients will be evaluated retrospectively for the correlation between their PD-L1 levels and clinical outcomes. The new study builds on the non-exclusive collaboration initiated between the companies in August 2015 to conduct a phase I/Ib basket clinical trial evaluating the combination of bavituximab and durvalumab with chemotherapy in multiple solid tumors.
Joseph Shan, MPH, vice president, clinical and regulatory affairs of Peregrine, said, “We expect this extension of our collaboration with AstraZeneca will allow us to run a much more cost-effective and time-efficient trial than would have been possible under our previously planned study using Opdivo as the combination drug in the same lung cancer population. This phase II study offers several key advantages including a supply of durvalumab that will enable us to conduct a global trial that can enroll patients more rapidly. In addition, the expanded collaboration provides for a more cohesive clinical program utilizing the same PD-L1 and other biomarker analysis across both the new phase II trial and the already planned phase I/Ib study combining durvalumab and bavituximab in multiple indications.”