TRACON Pharmaceuticals (NASDAQ:TCON) Inc has shared positive results from the Independent Data Monitoring Committee (IDMC) review of interim safety and efficacy data from its ongoing ENVASARC pivotal trial for envafolimab in soft tissue sarcoma, a rare type of cancer that begins in the tissues.
The San Diego company, which utilizes a capital-efficient product development platform to develop its clinical-stage pipeline of cancer therapies, said that for the ongoing ENVASARC pivotal trial, the IDMC 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 objective response rate (ORR) by blinded independent central review (BICR) in each cohort satisfied the prespecified futility rule,” said the company.
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“Envafolimab was well tolerated, with only a single Grade 3 related adverse event reported in 36 patients,” noted the company.
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 every three weeks, which is twice the current envafolimab dose of 300 mg every three weeks.
“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 US Food and Drug Administration (FDA) through a protocol amendment,” said the company.
“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,” TRACON’s Chief Medical Officer James Freddo said in a statement.
“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,” he added.
Freddo noted that the 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,” he added. “We are excited by the emerging data and for envafolimab’s potential to become a differentiated treatment for sarcoma patients.”
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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