ENWEIDA：Envafolimab Injection

Indications：

For adult patients with advanced solid tumors who have unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair gene-deficient (dMMR), including those patients with advanced colorectal cancer who have experienced disease progression after being treated with fluorouracil, oxaliplatin and irinotecan previously, as well as other patients with advanced solid tumors who have experienced disease progression after previous treatment and no satisfactory treatment alternatives.

A pivotal phase Ⅱ clinical study, led by Professor Lin Shen from Peking University Cancer Hospital and Institute，has evaluated the efficacy and safety of Envafolimab in patients with advanced dMMR/MSI-H tumors. The updated clinical data presented at CSCO 2021 showed that the Objective Response Rate (ORR) of patients who received Envafolimab as second or later-line treatment is 44.7%, including 12 (11.7%) cases of Complete Response (CR). The responses were durable, and the rates of durable response at 12 months in patients with advanced colorectal cancer (CRC), advanced gastric cancer, other advanced solid tumors, and all patients were 89.3%, 100%, 100%, and 93.2%, respectively. The median progression-free survival (PFS) was 11.1 months, 12-month overall survival (OS) rate was 73.6%. Envafolimab was well tolerated in this study with no cases of immune-related pneumonitis, immune-related colitis, immune-related nephritis, or infusion related reactions reported.

At present, Envafolimab is being studied in clinical trials in multiple tumor types in China, the United States and Japan, including registration/phaseⅢclinical trials in multiple indications. Envafolimab obtained orphan drug designation from the US FDA for the treatment of advanced biliary tract cancer and soft tissue sarcoma.