First patient enrolled in phase 3 trial of liver cancer immunotherapy
SillaJen and Lee’s Pharmaceutical Holdings announced the first patient enrolled in China in the phase 3 PHOCUS trial Pexa-Vec, an oncolytic immunotherapy for advanced liver cancer, according to a press release.
“The PHOCUS trial is actively enrolling patients in 10 countries around the world at this point,” Ghassan Abou-Alfa, MD, PHOCUS study global principle investigator, said in the release. “We are keenly aware of the unmet need in liver cancer in China, and it is our sincere hope that we will be able to offer Pexa-Vec to these patients in the years ahead.”
The investigators plan to enroll 600 patients from international centers who have not received prior treatment for liver cancer. The study will include two treatment arms: treatment with Pexa-Vec followed by Nexavar (sorafenib, Bayer) or treatment with sorafenib alone.
The primary objective is overall survival of patients treated with Pexa-Vec with sorafenib vs. sorafenib alone. Secondary objectives include safety and assessments for tumor response between the two groups.
“With more than 460,000 patients diagnosed with liver cancer in China each year, combined with the promise we have seen with Pexa-Vec in this patient population, we are happy to have enrolled the first patient in China in this important study,” Benjamin Li, PhD, CEO Lee’s Pharma, added in the release.