Transgene S.A. has announced the initiation of a multinational, randomized Phase 3 open label study with the oncolytic immunotherapy, Pexa-Vec, in patients with advanced liver cancer, also known as hepatocellular carcinoma (HCC). This trial is being led by Transgene's partner, SillaJen, Inc. The trial is evaluating the use of Pexa-Vec to treat HCC patients who are eligible for treatment with sorafenib (Nexavar®), the only approved drug for advanced HCC.
The study, named the PHOCUS trial, is designed to enroll 600 patients who have not received prior systemic treatment for their cancer. Patients will be randomized 1:1 to one of two treatment groups: one which will receive Pexa-Vec followed by sorafenib and one which will receive sorafenib alone. The study will be conducted at approximately 140 sites worldwide, including in North America, Asia, Australia and Europe. SillaJen reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for this global Phase 3 clinical trial. The primary endpoint of the study will be overall survival. Secondary objectives will include safety, as well as assessments for tumor responses between the two groups as measured by the following endpoints: time to progression, progression-free survival, overall response rate and disease control rate. To learn more about the trial, please visit www.clinicaltrials.gov or www.pexavectrials.com.
"The initiation of the Phase 3 trial with Pexa-Vec in patients with advanced liver cancer is an important step forward in the development of this oncolytic immunotherapy," said Philippe Archinard, Chairman and Chief Executive Officer of Transgene. "The recent marketing approval of the first oncolytic immunotherapy has paved the way for this promising class of cancer treatments. We look forward to exploring Pexa-Vec's potential utility in treating advanced liver cancer, as well as other cancer types."
"We are pleased to be initiating this multinational Phase 3 trial for Pexa-Vec - an oncolytic immunotherapy which demonstrated antitumor activity in Phase 2 clinical trials for liver cancer," stated Eun Sang Moon, Chief Executive Officer of SillaJen. "Our primary focus at this time is to execute a well-run, successful clinical trial, and we believe that the SPA that we have in place with the FDA will allow us and our global partners a clear path to approval for Pexa-Vec."
"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," stated Ghassan Abou-Alfa, M.D., medical oncologist at Memorial Sloan Kettering Cancer Center and lead investigator on the Phase 3 trial.