Envafolimab (KN035)

Envafolimab is a novel, single-domain antibody against PD-L1 that is administered by subcutaneous injection without the need for an adjuvant at a dose of 300 mg on a every 2 week or every 4 week schedule. 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 from separate clinical trials per the product package inserts.

ASCO 2019: Phase I study of KN035, the first subcutaneously administered, novel fusion anti-PD-L1 antibody in patients with advanced solid tumors in China

ASCO 2019: 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: A phase I, open, multiple dose, dose escalation and expansion study to evaluate the safety, tolerability, and pharmacokinetics of KN035 (anti-PD-L1 antibody) administered in subcutaneous injection as a single agent to Chinese subjects with advanced solid tumors