On May 14, 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 that positive data from envafolimab in a pivotal trial in China for the treatment of MSI-H/dMMR cancer will be presented by the Company’s corporate partners, 3D Medicines and Alphamab, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program (Press release, Tracon Pharmaceuticals, MAY 14, 2020, View Source [SID1234558059]).

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ASCO abstract #3021 entitled "Envafolimab (KN035) in Advanced Tumors with Mismatch-Repair Deficiency" reviewed data available on December 17, 2019 from the ongoing pivotal Phase 2 trial of envafolimab given by subcutaneous injection without an adjuvant in MSI-H/dMMR cancer. The trial enrolled 103 patients with MSI-H colorectal (CRC) or gastric cancer (GC) or with dMMR in other advanced solid tumors, in an open label format with efficacy endpoints, including the primary endpoint of confirmed objective response rate (ORR) determined by independent central review. MSI-H/dMMR status was assessed centrally for CRC and GC and locally for other tumors.

Key highlights included:

The confirmed ORR in 50 patients with CRC who failed a fluoropyrimidine, oxaliplatin and irinotecan (n=39) plus those with advanced GC who failed at least one prior systemic treatment (n=11), with at least two on-study tumor assessments, was 30% (95% CI: 18%, 45%), of whom 80% were responding with median follow-up of 7.5 months at the time of the data cutoff.
The confirmed ORR in the overall population (n=103) was 34% (95% CI: 25%, 44%), of whom 86% were responding with median follow-up of 6.7 months at the time of the data cutoff.
The confirmed ORR in 24 patients with CRC who failed a fluoropyrimidine and oxaliplatin or irinotecan (n=24) was 54% (95% CI: 33%, 74%) of whom 85% were responding at the time of the data cutoff.
Envafolimab was well tolerated with a safety profile similar to that of approved PD-(L)1 checkpoint inhibitors but without infusion related reactions.
"We are impressed by the confirmed ORR of envafolimab from its pivotal trial in Chinese patients with MSI-H/dMMR cancer, which is a genetically defined tumor type," said Charles Theuer, M.D., Ph.D., President and CEO. "We believe these data are important in assessing the potential of this novel subcutaneously administered product candidate in TRACON’s initial indications in the U.S. of undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS), two soft tissue sarcoma subtypes which have responded to treatment with other checkpoint inhibitors. Moreover, these data indicate that envafolimab’s activity in MSI-H cancer is similar to other checkpoint inhibitors, such as Keytruda or Opdivo but without infusion related reactions. We look forward to initiating our pivotal ENVASARC trial for envafolimab in UPS and MFS in the second half of 2020, for which we recently reached agreement on the key elements with the U.S. FDA."

The complete abstract is available at: View Source

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/dMMR tumor patients, and in combination with gemcitabine and oxaliplatin in a Phase 3 registration trial in biliary tract cancer. 3D Medicines plans to file a BLA in China for envafolimab in 2020 based on overall response rate and duration of response in MSI-H/dMMR patients. The filing would be based on the the ongoing pivotal phase 2 trial data of envafolimab in MSI-H/dMMR cancer.