Tracon says IDMC reccommends ENVASARC Phase 2 trial continue ‘as planned’

Tracon Pharmaceuticals announced the independent data monitoring committee or IDMC, following a review of ongoing safety and efficacy data on April 2, recommended the ENVASARC Phase 2 pivotal trial continue as planned. The ENVASARC Phase 2 pivotal trial completed enrollment in March 2024 with a total of 82 evaluable patients in cohort C of treatment with single agent envafolimab at 600 mg SQ every three weeks and final data are expected in the third quarter of 2024. The IDMC reviewed interim safety and efficacy data from 73 patients enrolled into cohort C who had the opportunity to complete two on-treatment scans. The primary endpoint of the study is achievement of an objective response in nine of 82 patients treated with envafolimab by BICR and median duration of response of greater than six months is a key secondary endpoint…. “We believe that achievement of the primary endpoint in the ENVASARC trial would position envafolimab to become a potentially compelling treatment option for patients with the refractory sarcoma subtypes of UPS and MFS,” said Charles Theuer, M.D., Ph.D., TRACON’s CEO.