Envafolimab is a novel, single-domain PD-L1 antibody that is administered by subcutaneous injection without the need for an adjuvant. Envafolimab is currently dosing in the ENVASARC pivotal Phase 2 trial in the US sponsored by TRACON and has been accepted for priority review by the Chinese National Medical Products Administration for the treatment of MSI-H cancer patients. Envafolimab is also being studied in combination with gemcitabine and oxaliplatin in a Phase 3 registration trial in biliary tract cancer. The confirmed objective response rate (ORR) in MSI-H/dMMR colorectal (CRC) patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 33% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164.
AACR 2021: Pivotal ENVASARC Trials-in-Progress Poster
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