Peregrine Pharmaceuticals has announced that it is discontinuing its phase 3 SUNRISE trial of bavituximab in patients with previously treated, locally advanced or metastatic nonsquamous non–small-cell lung cancer (NSCLC). The decision to stop the trial was based on the recommendation of the study’s independent data monitoring committee following a prespecified interim analysis.
Results of the analysis demonstrated that the bavituximab-plus-docetaxel group did not show a sufficient improvement in overall survival (OS) compared with the docetaxel group to warrant continuation of the study. The interim analysis showed that the bavituximab/docetaxel group was performing as expected according to the original trial assumptions in terms of OS, whereas the docetaxel group was dramatically outperforming OS expectations based on the original trial assumptions and as compared with recently published studies.
Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab is believed to override PS-mediated immunosuppressive signaling by blocking the engagement of PS with its receptors as well as by sending an alternate immune- activating signal. PS-targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and antitumor immune responses.
Source: Peregrine Pharmaceuticals; February 25, 2016.