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 approved 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.