Transgene starts Phase I/IIa of Pexa-Vec plus Opdivo for HCC

Transgene S.A. (Euronext:TNG) began an open-label, French Phase I/IIa trial to evaluate Pexa-Vec pexastimogene devacirepvec (JX-594, TG6006) plus PD-1 inhibitor Opdivo nivolumab as first-line treatment in up to 36 patients with advanced hepatocellular carcinoma (HCC). Patients will receive intratumoral injections of 10⁹ PFUs Pexa-Vec given on day 1 and at week 2 and 4 plus Opdivo every 2 weeks starting at week 2.

The Phase I primary endpoints are safety and dose-limiting toxicities (DLTs), and the Phase IIa primary endpoint is overall response rate (ORR). Secondary endpoints include disease control rate (DCR) and overall survival (OS)...