TRACON Pharmaceuticals (NASDAQ: TCON) has confirmed the Independent Data Monitoring Committee for its current ENVASARC pivotal study recommended for the ongoing accrual as planned in cohort A of single-agent envafolimab and cohort envafolimab combined with Yervoy.
IDMC evaluated safety and efficacy data
The IDMC looked at interim efficacy and safety data from 18 individuals in each cohort who had undergone at least 12 weeks of efficacy testing (two on-treatment scans). Each cohort’s ORR by BICR met the predetermined futility rule. In 36 individuals, Envafolimab was well tolerated, with only one Grade 3 associated adverse event noted. Therefore, the IDMC suggested increasing the envafolimab dose to 600 mg Q3W, which is double the existing envafolimab dose of 300 mg Q3W, based on the extremely tolerated safety profile and the much greater ORR found in lower weight individuals.
TRACON agrees with the IDMC guidance and will recommend this dose to the US FDA through a protocol amendment, based on the robust activity demonstrated by high doses of envafolimab in finalized studies, including the pivotal trial in MSI-H/dMMR cancer that was the basis for approval in China.
Chief Medical Officer James Freddo stated, “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.”
Envafolimab has the potential of becoming a sarcoma treatment
Freddo added, “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.”
