Pre-specified Interim Analysis Concluded with Recommendation to Continue the ENVASARC Trial
Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) in Each Cohort Satisfied the Bar for Futility and Supports Continued Accrual
Envafolimab Well Tolerated as a Single Agent and in Combination with Yervoy
SAN DIEGO, Dec. 27, 2021 (GLOBE NEWSWIRE) — TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics today announced the Independent Data Monitoring Committee (IDMC) for the ongoing ENVASARC pivotal trial recommended continued accrual as planned in both cohort A of single agent envafolimab and cohort B of envafolimab given with Yervoy (ipilimumab).
The IDMC reviewed interim safety and efficacy data from 18 patients enrolled into each cohort who completed a minimum of 12 weeks of efficacy evaluations (two on-treatment scans). The ORR by BICR in each cohort satisfied the prespecified futility rule. Envafolimab was well tolerated, with only a single Grade 3 related adverse event reported in 36 patients.
Based on the highly tolerable safety profile and the significantly higher ORR observed in lower weight patients, the IDMC recommended increasing the envafolimab dose to 600 mg Q3W, which is twice the current envafolimab dose of 300 mg Q3W. Given the robust activity demonstrated by higher doses of envafolimab in completed studies, including in the pivotal trial in MSI-H/dMMR cancer that was the basis for approval in China, TRACON agrees with the IDMC guidance and will recommend this dose to the U.S. Food and Drug Administration (FDA) through a protocol amendment.
“We are pleased that envafolimab has demonstrated clear activity as a single agent and in combination with Yervoy even at this early 12-week time point. The increase in dose is supported by the safety profile observed to date, which we believe may further differentiate envafolimab from the current standard of care. Envafolimab has been dosed safely at doses that are eight-fold higher than those currently used in ENVASARC. We therefore believe a doubling of the dose can be administered safely and result in higher envafolimab exposures, thereby potentially optimizing envafolimab’s efficacy for the greatest number of sarcoma patients,” said James Freddo, M.D., TRACON’s Chief Medical Officer. “This interim analysis is an important milestone for Tracon. We look forward to working closely with the FDA on an amendment to implement the IDMC’s recommendations. We are excited by the emerging data and for envafolimab’s potential to become a differentiated treatment for sarcoma patients.”
Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology, is the first subcutaneously injected PD-(L)1 inhibitor approved by the NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal …….