Peregrine announces Ohase II clinical data of bavituximab with sorafenib Peregrine Pharmaceuticals announced the presentation of clinical data related to the company's immuno-oncology development program and its lead investigational immunotherapy drug candidate bavituximab at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium. In this single-center, single-arm, open-label investigator-sponsored trial, 38 patients with advanced HCC received bavituximab weekly and sorafenib twice daily until disease progression or toxicity. Data show that the combination of bavituximab and sorafenib is associated with an improved time to progression of 6.7 months, a disease specific survival of 8.7 months, a disease control rate of 58% and a 4-month progression-free survival of 62%. Two patients achieved a partial response according to Response Evaluation Criteria In Solid Tumors. The secondary endpoint of median overall survival was 6.2 months. The combination of bavituximab and sorafenib was well-tolerated in patients with advanced HCC with no indications of autoimmune adverse events that have been seen with other checkpoint immunotherapies.