On May 11, 2020 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 U.S., reported the successful completion of a Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA) (Press release, Tracon Pharmaceuticals, MAY 11, 2020, View Source [SID1234557523]). The FDA agreed with TRACON’s proposals regarding key elements of the pivotal ENVASARC trial for envafolimab in the soft tissue sarcoma subtypes of undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS). TRACON expects to initiate enrollment in the ENVASARC trial in the second half of 2020.
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"We appreciate the valuable discussions and guidance from our Type B meeting discussion with the FDA and concurrence on the design for the pivotal trials of envafolimab in sarcoma," said Charles Theuer, M.D., Ph.D., President and CEO. "Following the successful completion of the regulatory meeting, we are focused on advancing envafolimab as a single agent and in combination with Yervoy (ipilimumab) for the treatment of the sarcoma subtypes of UPS and MFS, both of which have been shown to be responsive to immune checkpoint inhibition treatment. We look forward to initiating ENVASARC later this year."
Type B Meeting and ENVASARC Study Design
The FDA determined the acceptability of the following key aspects of the proposed pivotal trial:
Multi-center, open-label, randomized, non-comparative, parallel cohort study.
Planned total enrollment of 160 patients, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B with envafolimab and Yervoy.
Primary endpoint of objective response rate (ORR) with duration of response a key secondary endpoint.
Open-label format with blinded independent central review of endpoint data.
Eligible patients will have received one prior cancer therapy, but no prior checkpoint inhibitor therapy.
About Envafolimab
Envafolimab is a novel, single-domain antibody against PD-L1 that is administered by subcutaneous injection without the need for an adjuvant. Envafolimab is currently dosing in Phase 1 trials in the U.S. and Japan and is being studied in China in a Phase 2 registration trial as a single agent in MSI-H tumor patients, and in a Phase 3 registration trial in combination with gemcitabine and oxaliplatin in biliary tract cancer. Subject to positive data from the MSI-H registrational trial, 3D Medicines, TRACON’s corporate partner for this program, plans to file a BLA in China for envafolimab in 2020 based on ORR in MSI-H patients. The filing would be based on the principle that the response rate required for approval in China is similar to the response rate seen with Keytruda and Opdivo in MSI-H patients from separate clinical trials per their U.S. product package inserts.