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COSELA® received upgraded evidence-based medicine designation in the CSCO Guidelines for Small Cell Lung Cancer

Release time:2024-04-30

On April 28, 2024, Simcere Zaiming, an innovative oncology company and a subsidiary of Simcere Pharmaceutical Group Ltd., announced that the Chinese Society of Clinical Oncology (CSCO) has included COSELA (Trilaciclib hydrochloride for injection) in the 2024 CSCO guidelines for the diagnosis and treatment of Small Cell Lung Cancer (SCLC) with an enhanced recommendation.

The revised guidelines now include updated primary treatment recommendations for extensive-stage small cell lung cancer (ES-SCLC), which have been informed by the latest data from a randomized, double-blinded, clinical phase III study. Recommendations for the prophylactic use of Trilaciclib prior to platinum-based chemotherapy ± immune checkpoint inhibitors have been upgraded from Class II recommendation and Class 2A evidence, to Class I recommendation with Class 1A evidence. In the second-line treatment of recurrent SCLC, the recommendation of Trilaciclib has also been upgraded from Class 2A evidence to Class 1A evidence.

Data from a randomized, double-blind, placebo-controlled Phase III clinical trial (TRACES study) in Chinese patients with ES-SCLC, led by Professor Cheng Ying of Jilin Cancer Hospital, has demonstrated that Trilaciclib has clinically and statistically significantly reduced the duration of severe neutropenia (DSN) in the first cycle chemotherapy, lowering the incidence of severe neutropenia (SN), febrile neutropenia (FN) and grade 3-4 hematologic toxicities compared with the placebo group. The complete results of the TRACES study were published in the February 2024 issue of Lung Cancer. Based on this, the latest CSCO guideline elevated the recommend grade of Trilaciclib.

COSELA® is a first-in-class short-acting and reversible cyclin-dependent kinase CDK4/6 inhibitor co-developed by Simcere and G1 Therapeutics, and currently marketed in China by Simcere Zaiming.

The product has been endorsed by several key guidelines in China and the US, including:

• NCCN Guideline for Hematopoietic Growth Factors (2022) 

• NCCN Guideline for Small Cell Lung Cancer (2022) 

• CSCO Guidelines for the Diagnosis and Treatment of Small Cell Lung Cancer (2024) 

• Chinese Expert Consensus on Diagnosis and Treatment of Neutropenia Caused by Cancer Chemotherapy (2023) 

• Chinese Medical Association Clinical Diagnosis and Treatment Guidelines for Lung Cancer (2023) 

• Systemic Therapy for Small-Cell Lung Cancer: ASCO-Ontario Health (Cancer Care Ontario) Guideline