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SillaJen initiates phase 3 trial of Pexa-Vec for advanced HCC
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SillaJen, Inc. announced it has initiated its phase 3 open-label study of Pexa-Vec and dosed its first patient with advanced hepatocellular carcinoma.
The clinical trial, known as PHOCUS, will enroll 600 patients from approximately 140 clinical sites worldwide including North America, Asia, Australia and Europe. Patients will undergo treatment with Pexa-Vec (SillaJen) in combination with Nexavar (sorafenib, Bayer HealthCare) or sorafenib alone.
Primary and secondary objectives of the study include determining the safety and efficacy of Pexa-Vec and sorafenib compared with sorafenib alone, as well as overall survival.
“We are still desperately in need of additional treatment options for advanced liver cancer. Cancer immunotherapy holds much promise, and I'm greatly looking forward to having the opportunity to evaluate Pexa-Vec in patients with advanced liver cancer,” Ghassan Abou-Alfa, MD, medical oncologist at Memorial Sloan Kettering Cancer Center, New York City, and investigator on the phase 3 trial, said in the release.
According to the SillaJen website, Pexa-Vec is the first engineered oncolytic virus that has demonstrated intravenous delivery to tumors, induced cancer targeting antibodies and improved survival in a randomized trial.
Disclosure: Healio.com/Hepatology was unable to confirm relevant financial disclosures at the time of publication.