- TRACON Pharmaceuticals Inc TCON announced the IDMC for the ongoing ENVASARC Phase 2 pivotal trial recommended continued accrual as planned in both cohorts: single agent envafolimab and envafolimab in combination with Bristol‑Myers Squibb Co BMY Yervoy (ipilimumab).
- The IDMC reviewed interim safety and efficacy data from 18 patients in each cohort who completed a minimum of 12 weeks of efficacy evaluations (two on-treatment scans).
- The double-digit Objective Response Rate (ORR) in each cohort more than satisfied the prespecified futility rule.
- Envafolimab monotherapy and in combination with Yervoy was well tolerated, with only one related serious adverse event reported in 36 patients.
- Responses were noted in patients regardless of weight at the 600 mg dose of envafolimab that was instituted following the previous IDMC review of interim safety and efficacy data from patients in the ENVASARC trial treated at the 300 mg dose of envafolimab.
- Enrollment continues ahead of schedule, with the next interim analysis expected in mid-2023 and full accrual now expected before the end of 2023.
- Price Action: TCON shares are down 1.52% at $1.29 on the last check Wednesday.
© 2023 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.