Lung cancer is the most common cancer afflicting the people of China, with 828,000 new cases and 657,000 deaths each year, according to the Chinese National Cancer Center. November is International Lung Cancer Awareness Month and, as one of the leading biopharmaceutical companies in China, we ask ourselves: how can we bring the latest anticancer therapies to Chinese patients as soon as possible?
The 25th National Congress of Clinical Oncology and the 2022 Chinese Society of Clinical Oncology (CSCO) Annual Meeting was held in Xiamen from Nov. 5 to 12, 2022. At the meeting, new data from the Real World Study (RWS) of Cosela® (Trilaciclib Hydrochloride for Injection), the world's first drug that protects the bone marrow from toxicity caused by chemotherapy drugs for lung cancer, were published in a poster presentation.
This first-in-class product was jointly developed by Simcere Pharmaceutical Group and G1 Therapeutics, Inc. in China. Registration of this drug in China has been accelerated through synergistic collaboration of Simcere with Lecheng International Medical Tourism Pilot Zone, Hainan Province. Leveraging the special local policy called the "Lecheng Real World Study," which enables patients a route to use international new drugs that are not yet on the Chinese market, the data derived from the RWS of Cosela were able to support the clinical evaluation of this product and further accelerated the approval process.
The RWS data published at CSCO further validated the safety and efficacy of this drug while also demonstrates the potential of this innovative collaboration with the region as a promising step forward to bringing future medicines at an accelerated pace.
RWS data : good safety and efficacy
A total of 30 Chinese patients with small cell lung cancer were enrolled in the study. They received at least one cycle of trilaciclib and conventional cancer therapies to evaluate the protective effect of trilaciclib against myelosuppression, a severe myelotoxic side effect induced by chemotherapy drugs.
Statistics showed that in the first treatment cycle after dosing, only one patient developed severe neutropenia (SN), the most typical myelosuppression induced by chemotherapy, with an incidence of 3.3% and no febrile neutropenia (FN) occurred. Trilaciclib had an equally good effect on myelosuppression in all chemotherapy cycles completed by all patients.
The incidence of adverse events (TEAE) during treatment was 93.3%, the incidence of ≥ grade 3 TEAE was 46.7%, and the incidence of drug-related AE was 33.3%, all of which were related to chemotherapy. Incidence of all SAE was 30%. Chemotherapy drug reduction occurred in 26.7% of patients. There were no grade ≥3 AEs, SAEs, and AEs leading to death related to trilaciclib.
The principal investigator, Professor Chen Yongxing from Hainan Provincial People's Hospital concluded that trilaciclib has a good overall myeloprotection effect in Chinese patients with extensive-stage small cell lung cancer (ES-SCLC) receiving multiple treatment regimens, with a consistent efficacy trend, a good safety profile, and no new safety signals.