TRACON Updates ENVASARC Phase 2 Trial Following IDMC's Recommendation to Proceed

TRACON Pharmaceuticals, a biopharmaceutical company, has announced that the independent data monitoring committee (IDMC) has recommended the continuation of the ENVASARC Phase 2 pivotal trial as planned. The trial, which completed enrollment in March 2024 with 82 patients, is set to release its final data in the third quarter of the same year.

The IDMC's decision came after an evaluation of interim safety and efficacy data from 73 patients who had completed at least 12 weeks of treatment. The objective response rate (ORR) was reported to be 11% based on investigator review, with a confirmed ORR of 5.5% by blinded independent central review (BICR). Notably, the median duration of response was found to be over six months. The drug, envafolimab, has shown a favorable safety profile with no serious adverse events of grade 3 or higher related to the drug.

Envafolimab is being tested as a single agent at a dosage of 600 mg SQ administered every three weeks. The primary goal of the study is to achieve an objective response in 11% of the 82 patients treated with envafolimab, as confirmed by BICR, with a median duration of response exceeding six months being a significant secondary goal.

James Freddo, M.D., Chief Medical Officer of TRACON, highlighted the drug's tolerability and durable single-agent activity in a subset of sarcoma patients. He stated that five more objective responses confirmed by central review are necessary to meet the trial's goals.

Charles Theuer, M.D., Ph.D., CEO of TRACON, expressed optimism that achieving the primary endpoint in the ENVASARC trial could position envafolimab as a strong treatment option for patients with UPS and MFS, which are refractory sarcoma subtypes.

The ENVASARC pivotal trial is a multicenter, open-label, randomized study conducted at 30 leading cancer centers in the United States and the United Kingdom. It began dosing in December 2020 and is fully enrolled. The study's primary endpoint is the ORR by blinded central review, with the duration of response being a key secondary endpoint.

TRACON operates a cost-efficient product development platform that is independent of contract research organizations (CROs). The company is advancing its pipeline of novel targeted cancer therapeutics and seeks to partner with other life science companies. TRACON aims to provide a solution for companies lacking clinical capabilities to become CRO-independent.