On December 14, 2022 TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported that 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 Yervoy (ipilimumab) (Press release, Tracon Pharmaceuticals, DEC 14, 2022, View Source [SID1234625272]).
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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 double-digit ORR assessed by blinded independent central review in each cohort more than satisfied the prespecified futility rule. Envafolimab monotherapy and in combination with Yervoy was well tolerated, with only a single 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.
"We are pleased with the activity of the 600 mg dose of envafolimab that has demonstrated a double-digit objective response rate both as a single agent and in combination with Yervoy, even at this early 12-week time point," said James Freddo, M.D., TRACON’s Chief Medical Officer. "We are also encouraged with the safety data showing that envafolimab monotherapy and in combination with Yervoy are well tolerated. This interim analysis is a positive milestone and we look forward to the next interim analysis which will be conducted after the 46th patient in each cohort has completed a minimum of 12 weeks of efficacy evaluations. Importantly, accrual in ENVASARC remains ahead of projections and we are excited by the emerging data and for envafolimab’s potential to become a differentiated treatment for sarcoma patients."
"Achieving a double-digit ORR with a well tolerated safety profile, as both monotherapy and in combination, positions envafolimab to become a potential treatment option for patients with refractory UPS and MFS," said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. "The sole approved treatment for these patients is Votrient, which achieved a 4% ORR and carries a black box warning for fatal liver toxicity."
About Envafolimab
Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese 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 ENVASARC Phase 2 pivotal trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. In September 2022, TRACON received fast track designation from the U.S. Food and Drug Administration for envafolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy.
About ENVASARC (NCT04480502)
The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON expects the trial to enroll more than 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.