The Chinese Society of Clinical Oncology (CSCO) Guidelines are recognized as the most authoritative clinical guidance and the “golden standard” in the clinical practice for Chinese oncology clinicians. The CSCO Guidelines Conference held on April 23-24 2022 interpreted the updates of 2022 CSCO Diagnosis and Treatment Guidelines. Envafolimab and Trilaciclib, two of the new products in Simcere’s oncology portfolio were included in 4 CSCO 2022 guidelines.
Envafolimab, the world's first subcutaneously administered PD-L1 antibody co-developed in China under strategic partnership of Simcere with Alphamab Oncology and 3DMed, was approved for market since November 2021. It has been well acknowledged by the Chinese oncology community and recommended by 3 updated CSCO 2022 guidelines, including:
1."CSCO Guidelines for the Diagnosis and Treatment of Gastric Cancer 2022 Edition" (Class I recommendation, Class 2A evidence)
2."CSCO Guidelines for the Diagnosis and Treatment of Colorectal Cancer 2022 Edition" (Class II recommendation, Class 2A evidence)
3. "CSCO Guidelines for Clinical Application of Immune Checkpoint Inhibitors 2022 Edition" (Class I recommendation, Class 2A evidence)
Based on its unique design that allows rapid subcutaneous injection, Envafolimab has advantages of improved safety, convenience in drug administration, and treatment compliance. Patients do not need an intravenous infusion, which lowers medical costs.
Trilaciclib, the novel short-acting CDK4/6 inhibitor jointly developed in China by Simcere and G1 Therapeutics has entered the "CSCO Guidelines for the Diagnosis and Treatment” for the first time, as a level II recommendation, class 2A evidence for the supportive care of extensive-stage small-cell lung cancer (ES-SCLC).
Trilaciclib is currently at phase III registration clinical study in China, where the primary endpoint in small cell lung cancer indication was met. The data of this study will be presented in a poster presentation at American Society of Clinical Oncology (ASCO) 2022 annual conference.
It has already been approved by the FDA for market in the United States and has entered the 2021 edition of the NCCN Guidelines for Small Cell Lung Cancer. In December 2021, Trilaciclib was included in the priority review by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration.