TRACON Pharmaceuticals (NASDAQ:TCON) Inc has announced that the first patient has been dosed (with higher dosage envafolimab) following the approval of the amended ENVASARC protocol by the U.S. Food and Drug Administration (FDA).
"We are pleased to have initiated envafolimab dosing at 600 mg following FDA approval of the amended ENVASARC protocol," said Charles Theuer, CEO of TRACON, in a statement. "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.”
He noted that the new envafolimab dose is higher than the dose that produced the 45% ORR in MSI-H/dMMR (High levels of MicroSatellite Instability deficient MisMatch Repair) 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."
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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.
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 (undifferentiated pleomorphic sarcoma) or MFS (myxofibrosarcoma) 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 milligrams every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy.
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