Tracon announces results of six-month IDMC review of ENVASARC Phase 2 trial

TRACON Pharmaceuticals announced the positive results of a six-month independent data monitoring committee, IDMC, review for the ongoing ENVASARC Phase 2 pivotal trial. The IDMC reviewed interim safety and efficacy data from more than 80 patients equally randomized into cohort C of single agent envafolimab or cohort D of envafolimab given in combination with Yervoy. Patients in cohort C who had at least two on study CT scans continued to demonstrate a double-digit ORR assessed by investigator and blinded independent central review. Envafolimab was well tolerated without a single greater than grade 2 drug related adverse event. A planned interim analysis in the third quarter will be conducted after the 46th patient treated with envafolimab has completed a minimum of 12 weeks of efficacy evaluations and includes a futility rule that is currently being exceeded based on available data. The combination of envafolimab with Yervoy did not demonstrate synergy when compared to single agent envafolimab and the Company will terminate enrollment in cohort D. This is expected to result in a reduction in trial costs and acceleration of the timeline to final ENVASARC data.