On March 10, 2022 TRACON Pharmaceuticals (Nasdaq: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the United States, reported that the first patient has been dosed following the approval of the amended ENVASARC protocol by the U.S. Food and Drug Administration ("FDA") (Press release, Tracon Pharmaceuticals, MAR 10, 2022, View Source [SID1234609854]).
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In December 2021, based on the highly tolerable safety profile and the significantly higher objective response rate (ORR) observed in lower weight patients in ENVASARC, the IDMC recommended increasing the dose of envafolimab to 600 mg every three weeks (Q3W), which is double the original envafolimab dose of 300 mg Q3W. Given the robust activity demonstrated by higher doses of envafolimab in previously completed studies, including in the pivotal trial in MSI-H/dMMR cancer that was the basis for approval of envafolimab in China, TRACON submitted the amended ENVASARC protocol in January that was cleared by the FDA in February. Patient dosing is now underway at this 600 mg Q3W dose.
"We are pleased to have initiated envafolimab dosing at 600 mg following FDA approval of the amended ENVASARC protocol," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Given the ENVASARC data to date, particularly the highly tolerable safety profile and response rate in lower weight patients, we believe a doubling of the dose will be well tolerated and result in higher envafolimab exposures, thereby optimizing envafolimab’s efficacy for the largest number of sarcoma patients. The new envafolimab dose is higher than the dose that produced the 45% ORR in MSI-H/dMMR cancer that was the basis for approval in China. We look forward to the interim ENVASARC efficacy data review by the IDMC which we expect will occur in the second half of 2022."
About Envafolimab
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 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 pivotal ENVASARC Phase 2 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.
About ENVASARC (NCT04480502)
The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States 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 overall response rate by central review with duration of response a key secondary endpoint.