South Korean biotech company SillaJen and Hong Kong-based Lee’s Pharmaceutical have enrolled the first patient in China for a phase 3 trial called PHOCUS which will evaluate the oncolytic immunotherapy Pexa-Vec for the treatment of advanced liver cancer.
The PHOCUS trial will aim to have 600 patients on board across the world who did not get any prior systemic treatment for their cancer. The patients will be randomly divided into two treatment groups with one of the patient arms to be treated with Pexa-Vec followed by sorafenib and the other to receive sorafenib alone.
The randomized study in advanced liver cancer is presently being at nearly 86 sites in North America, Asia, Europe, Australia and New Zealand.
Commenting on the PHOCUS trial for Pexa-Vec in advanced liver cancer, Dr. Benjamin Li – CEO of Lee’s Pharma, said: “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.”
The primary objective of the phase 3 PHOCUS study will be to measure the overall survival of advanced liver cancer patients in both the patient arms.
Safety and assessments for tumor responses between the two arms as measured by the time to progression, progression-free survival, overall response rate and disease control rate will constitute some of the secondary objectives of the late-stage trial of Pexa-Vec.
Shukui Qin – vice president of Nanjing Bayi Hospital, and principal investigator on the PHOCUS trial in China, commenting on the phase 3 trial of Pexa-Vec in advanced liver cancer, said: “As a physician who treats many liver cancer patients per year, I understand the great unmet need for these patients in Asia and around the world.
“I look forward to evaluating this potential treatment option in my patients.”
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