In Oct 2022, the Chinese Society of Clinical Oncology (CSCO) officially published the CSCO Guidelines for Diagnosis and Treatment of Endometrial Cancer (2022 Edition) and CSCO Guidelines for Diagnosis and Treatment of Cervical Cancer (2022 Edition). This is the first time CSCO issued guidelines for these two major gynecological tumors.
恩维达®(Envafolimab injection) is recommended in both guidelines, as second-line treatment (Class II recommendation) for recurrent and metastatic endometrial cancer or cervical cancer with high microsatellite instability/mismatch repair deficiency (MSI-H/dMMR) .
Envafolimab is the world's first subcutaneously administered Immuno-Oncology PD-L1 antibody drug developed through a strategic cooperation of Simcere，3DMed, and Alphamab, Envafolimab. It has displayed comparable efficacy in clinical studies to that of other marketed PD-(L)1 drugs while maintains advantages of better convenience and safety.The subcutaneous administration route, which can be given within 30 seconds, greatly improves treatment compliance and lowers medical costs.
Launched in China since Nov 2021, 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, as well as FDA Fast Track designation. One year after its launch, Envafolimab has now helped more than 15,000 patients and entered a total of five CSCO guidelines, covering clinical areas of gastric cancer, colorectal cancer, immune checkpoint inhibitors, endometrial cancer, and cervical cancer.
The clinical evidence-based guidance will further facilitate normalized application of Envafolimab that may benefits more patients.