Pexa-Vec pexastimogene devacirepvec: Phase IIb discontinued

Transgene stopped the open-label, international Phase IIb TRAVERSE trial after data from 80 patients with advanced HCC who have failed sorafenib showed that Pexa-Vec plus best supportive care (BSC) missed the primary endpoint of improving OS vs. BSC alone. The company said the pre-specified number of patients required for the OS analysis was >73. The trial planned to enroll about 126 patients. Pexa-Vec was generally well tolerated. Transgene said in 4Q13 it will determine whether to move Pexa-Vec into Phase III testing for first-line HCC, which would start next year. Pexa-Vec is also in a Phase IIa trial for patients with sorafenib-naïve HCC, a Phase IIa trial for treatment-refractory kidney cancer, a Phase I/II trial for treatment-refractory colorectal cancer and an exploratory trial for ovarian cancer. The product has Orphan Drug designation in the U.S. and Europe for HCC...