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05-Aug-2019

Transgene Provides Update on PHOCUS Study of Pexa-Vec in Liver Cancer Following Planned Interim Futility Analysis

Strasbourg, France, August 2, 2019 – Transgene (Euronext Paris: TNG), a biotech company designing and developing virus-based immunotherapies for the treatment of solid tumors, today announces that the independent Data Monitoring Committee (“IDMC”) of the PHOCUS study of Pexa-Vec in Liver Cancer has completed a planned interim futility analysis.  Sillajen has informed Transgene of the IDMC’s recommendation to stop enrolment in the study, as the study is unlikely to meet its primary objective by the time of the final analysis. SillaJen has not reported safety concerns. Transgene will provide an update in an upcoming conference call.

The PHOCUS trial is a Phase 3 clinical trial evaluating the oncolytic immunotherapy Pexa-Vec for advanced liver cancer patients who have not received prior systemic treatment for their cancer. The study is being conducted by Transgene’s partner, SillaJen.

In the PHOCUS study, patients were randomized to one of two treatment groups: one receiving Pexa-Vec followed by sorafenib and one receiving sorafenib alone. The primary objective of the study was to determine the overall survival of patients treated with Pexa-Vec, followed by sorafenib versus sorafenib alone. Secondary objectives included 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. 

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Last Updated: 05-Aug-2019