Tracon Pharmaceuticals provides update on ENVASARC Phase 2 trial

TRACON Pharmaceuticals announced that the ongoing pivotal Phase 2 ENVASARC trial has enrolled more than 70 of the 80 planned patients in Cohort C of single agent envafolimab treatment at a dose of 600 mg subQ every three weeks. Additional safety and efficacy data were reviewed for 46 patients enrolled into cohort C who were the subject of the September independent data monitoring committee review. At that time, patients had completed a minimum of 12 weeks of efficacy evaluations and the objective response rate was 13% by investigator review and 8.7% by blinded independent central review. Since then, an additional patient has achieved an objective response by investigator review, which increased the ORR by investigator review to 15%. The most recent objective response has not yet been confirmed by BICR and the patient remains on treatment. Median duration of response by BICR remains greater than six months. In addition, envafolimab remains well tolerated and grade greater than 3 related toxicity has not been reported to date. “We continue to believe that these data position envafolimab to become a potentially compelling treatment option for patients with the refractory sarcoma subtypes of UPS and MFS based on the ORR and tolerability data to date,” said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. “ENVASARC enrollment continues to be brisk, reflecting the high unmet need that exists for these patients.”