SillaJen and Lee’s Pharmaceutical launch Phase 3 trial of Pexa-Vec in China for advanced liver cancer

In a significant development in the fight against liver cancer, South Korean biotech company SillaJen, in partnership with Hong Kong-based Lee’s Pharmaceutical, has announced the enrollment of the first patient in China for their phase 3 trial, named PHOCUS. This trial will assess the oncolytic immunotherapy Pexa-Vec for the treatment of advanced liver cancer and aims to enroll 600 patients globally who have not received any prior systemic treatment for their condition.

The PHOCUS trial is being conducted at nearly 86 sites across North America, Asia, Europe, Australia, and New Zealand. It involves a randomized study design where patients are divided into two groups: one receiving Pexa-Vec followed by sorafenib, and the other receiving only sorafenib. This approach aims to provide comprehensive data on the efficacy and safety of Pexa-Vec when combined with standard treatment.

Dr. Benjamin Li, CEO of Lee’s Pharmaceutical, emphasized the significance of the trial, stating, “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 this important study.”

The primary goal of the PHOCUS study is to measure the overall survival rates of the patients in both treatment arms. Secondary objectives include safety evaluations and assessments for tumor responses, such as time to progression, progression-free survival, overall response rate, and disease control rate.

Shukui Qin, vice president of Nanjing Bayi Hospital and principal investigator of the PHOCUS trial in China, shared his insights: “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.”

This phase 3 trial marks a critical step forward in the development of new treatment options for liver cancer, particularly in regions like China where the disease burden is exceptionally high. By focusing on innovative therapies like Pexa-Vec, SillaJen and Lee’s Pharmaceutical hope to bring new hope and improved outcomes to patients affected by this challenging disease.