On July 16, 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 filing of the pivotal ENVASARC protocol with the U.S. Food and Drug Administration (FDA) as part of an Investigational New Drug (IND) application (Press release, Tracon Pharmaceuticals, JUL 16, 2020, http://ir.traconpharma.com/news-releases/news-release-details/tracon-pharmaceuticals-announces-filing-protocol-envasarc [SID1234561969]). The application cross references the open envafolimab IND maintained by TRACON’s corporate partners 3D Medicines and Alphamab Oncology.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
TRACON previously reported results of a May 8 teleconference with the FDA whereby the agency 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 at 25 sites in the U.S. in the second half of 2020.
ENVASARC Study Design
Key elements for the ENVASARC pivotal trial include:
Multi-center, open-label, randomized, non-comparative, parallel cohort study.
Eligible patients will have received one or two prior cancer therapies, but no prior immune checkpoint inhibitor therapy.
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 of treatment 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 efficacy endpoint data.
About Envafolimab
Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in registrational trials. Envafolimab is currently dosing in a Phase 2 registration trial as a single agent in MSI-H/dMMR advanced solid tumor patients and a Phase 3 registration trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China. 3D Medicines and Alphamab Oncology, TRACON’s corporate partner for this program, plan to submit a BLA to NMPA in China for envafolimab in 2020 based on the ORR in MSI-H/dMMR advanced solid tumor patients. The confirmed ORR in MSI-H/dMMR colorectal cancer patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan reported at ASCO (Free ASCO Whitepaper) 2020 was 28.2%, which was nearly identical to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR colorectal cancer patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 27.9% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164.