FDA gives green light for ENVASARC trial
SAN DIEGO—The FDA has cleared the pivotal ENVASARC trial protocol, TRACON Pharmaceuticals announced in August. The company plans to begin enrolling participants in the trial, which will evaluate envafolimab, in the fourth quarter of this year. ENVASARC will be a multi-center, open-label, randomized study of sarcoma patients with one or two prior cancer therapies and no prior immune checkpoint inhibitor therapies. The trial has an enrollment goal of 160, with patients randomized evenly into two cohorts: one that will evaluate envafolimab as a single agent, and one that will evaluate the combination of evafolimab and Yervoy. Objective response rate will be the primary endpoint.
“We are pleased to receive clearance from the FDA to initiate the pivotal ENVASARC trial of envafolimab in sarcoma and look forward to dosing the first patient in the fourth quarter of this year,” said Dr. James Freddo, chief medical officer of TRACON. “Immunotherapy has radically changed the treatment paradigm for a number of cancers, and our hope is envafolimab will do the same for sarcoma patients who have few treatment options.”