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 US 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 combination with gemcitabine and oxaliplatin in a Phase 3 registration trial in biliary tract cancer. Subject to positive data from the MSI-H registrational trial, 3D Medicines plans to file a BLA in China for envafolimab in 2020 based on overall response rate in MSI-H patients. The filing would be based on the principle in China that the response rate is required to be similar to the response rate for Keytruda and Opdivo in MSI-H patients. The confirmed objective response rate (ORR) in MSI-H/dMMR colorectal (CRC) patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 28.2%, which was nearly identical to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan.
ASCO 2020: Envafolimab (KN035) in advanced tumors with mismatch-repair deficiency
ASCO 2019 poster: Phase I Safety and Pharmacokinetic Study of KN035, the first subcutaneously administered, novel fusion Anti-PD-L1 Antibody in Japanese Patients with Advanced Solid Tumors
ASCO 2019 poster: Phase I Study of KN035, the first subcutaneously administered, novel fusion Anti-PD-L1 Antibody in Patients with Advanced Solid Tumors in China
ESMO 2018 poster: Phase 1 Study of KN035, a novel fusion anti-PD-L1 antibody administered subcutaneously in Patients with Advanced Solid Tumors in the USA
Cell Discovery publication