Primary endpoint met in Phase III clinical trial of Trilaciclib in Chinese patients with small cell lung cancer

HONG KONG,Feb. 24,2022 -- On February 23 2022,Simcere Pharmaceutical Group (2096.HK) announced that the phase III clinical registration study of Trilaciclib in patients with extensive-stage small cell lung cancer (ES-SCLC) has met its primary endpoint. The drug co-developed in China by Simcere and G1 Therapeutics is the world's first comprehensive myeloprotective drug in treating ES-SCLC. The latest data has shown a significantly decrease in duration of severe neutropenia of patients receiving chemotherapy in Cycle 1. Further data are scheduled to be presented in academic conferences later this year.

The principal investigator of the study,Professor Ying Cheng from Jilin Cancer Hospital commented: "Platinum based chemotherapy combined with etoposide is the first-line treatment for ES-SCLC. Chemotherapy-induced bone marrow suppression is an unavoidable toxic side effect of chemotherapy. On the one hand,it can directly lead to the occurrence of adverse events such as infection,sepsis and bleeding,reducing the quality of life of patients and increasing their economic burden; on the other hand,the occurrence of bone marrow suppression will also lead to dose reduction or delay in administration,thereby affecting the anti-tumor effect of chemotherapy. At present,there is no effective prevention therapy to protect bone marrow from chemotherapy. We are happy to see that this study has shown a positive result,confirming that trilaciclib has a bone marrow protection effect in Chinese patients with the potential of filling a clinical gap in the treatment of small cell lung cancer."

Dr. Bijoyesh Mookerjee,Simcere's Chief Medical Officer in Oncology said: "The latest clinical data supports the safety and effectiveness of trilaciclib in Chinese patients receiving chemotherapy,and hopefully will accelerate the NDA approval of this novel therapy in China. At Simcere,we are committed to accelerating the development of the world's latest breakthrough therapy to improve the overall benefits and quality of life in patients with small cell lung cancer. "

The Chinese phase III registrational trial of trilaciclib in ES-SCLC was approved in January 2021. Data from the first part of the study for safety and pharmacokinetics evaluation as well as real-world study in the Boao Lecheng International Medical Pilot Zone have supported the NDA submission of the first indication (small cell lung cancer) in China,and the new evidence will be a strong support to the NDA of Trilaciclib in China (myeloprotection for SCLC),which has received Priority Review Designation from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) on Dec 22 2021. The promising evidence obtained from this phase III trial further cofirmed the safety and efficacy of trilaciclib in Chinese patients receiving chemotherapy,and is expected to benefit Chinese small cell lung cancer patients as soon as possible.

About Trilaciclib

Trilaciclib is the world's first and only anti-tumor drug with comprehensive myeloprotective effect,which can reduce chemotherapy-induced myelosuppression (CIM). In August 2020,Simcere has reached a collaboration agreement with G1 Therapeutics,INC. to be responsible for the development and commercialization of trilaciclib in all indications in Greater China (Mainland China,Hong Kong,Macau and Taiwan).The Phase III registration clinical trials of trilaciclib in three indications in China including small cell lung cancer,colorectal cancer,and triple-negative breast cancer have all achieved patient enrollment. The NDA for the first indication (small cell lung cancer) submitted in China has been included in priority review by the State Drug Administration.

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