In a phase 2 clinical study, patients with advanced hepatocellular carcinoma displayed improved progression-free survival and time to progression survival rates after treatment with bavituximab and nexavar, according to data presented at the 2015 Society of Surgical Oncology Annual Cancer Symposium.
“These clinical outcomes of time to progression, disease control rate and 4-month progression-free survival are quite encouraging, especially in this heavily pretreated patient cohort with very poor prognosis due to their unfavorable disease biology including a high rate of macrovascular invasion,” Adam Yopp, MD, assistant professor of surgery, surgical oncology division at UT Southwestern Medical Center and surgical oncologist at University Hospital Surgical Oncology Clinic at Simmons Cancer Center, Dallas, told Healio.com/Hepatology. “I was also pleased to see an extended tail in the survival curve that is typical of emerging immunotherapies for cancer.”
Yopp and colleagues assigned 38 patients with advanced HCC to receive 3 mg/kg of bavituximab (PGN401, Peregrine Pharmaceuticals, Inc.) per week intravenously and 400 mg of Nexavar (sorafenib, Bayer Healthcare) twice daily until disease progression or toxicity. The median age of the patients was 60.5 years, 74% were male and 79% had HCV.
Overall results showed that the combination of bavituximab and sorafenib was 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%, according to Yopp.
Five percent of patients (n = 2) achieved a partial response and the secondary endpoint of median overall survival was 6.2 months. Fifty-three percent of patients experienced treatment-related adverse events, with the most common grade 1 events being fatigue (16%), diarrhea (18%) and anorexia (16%), according to the abstract.
“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,” Yopp said. “The positive data from this study should be considered as rationale for future randomized trials to further evaluate the potential of bavituximab in liver cancer.” – by Melinda Stevens
Yopp A. A phase II study of bavituximab and Sorafenib in advanced hepatocellular carcinoma. Abstract 86. Presented at: 2015 Society of Surgical Oncology Annual Cancer Symposium; March 25-28, 2015; Houston.
Disclosure: Yopp reports he is a speaker for Bayer/Onyx. Peregrine Pharmaceuticals, Inc. provided funds for the study.