Transgene Announces First Patient Randomized in Multinational Phase 3 Trial

Transgene S.A. has initiated 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). Transgene reported that the trial is being led by its partner, SillaJen, Inc. and will be using Pexa-Vec to treat HCC patients who are eligible for treatment with sorafenib (Nexavar®), the only approved drug for advanced HCC.
According to the company’s press release:

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.

Philippe Archinard, Chairman and Chief Executive Officer of Transgene commented:

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. 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.

Click here to view the full press release.