Gacos-B (01167) announced that the company's self-developed KRAS G12C inhibitor Gl...
According to the Zhitong Finance App, Gacos-B (01167) announced that the new drug marketing application (NDA) for Glecirasib (JAB-21822), a KRAS G12C inhibitor developed independently by the company, has been officially submitted to the China National Drug Administration (NMPA) Drug Evaluation Center (CDE) to treat second-line and above patients with advanced or metastatic non-small cell lung cancer with KRAS G12C mutations.
The NDA submitted is based on the results of a phase II registered clinical study (NCT05276726) conducted in China. The study aimed to evaluate the efficacy and safety of Glecirasib as a single agent for non-small cell lung cancer patients with KRAS G12C mutations. The registered clinical results were officially announced in the American Society of Clinical Oncology (ASCO) Full Series (ASCO) in April 2024 and the Education Session (Education Session) of the American Society of Clinical Oncology Annual Meeting in June 2024. According to the Glecirasib Phase II registered clinical trial data released by ASCO Vaccination Series in April 2024, the confirmed objective remission rate (CoRR) was 47.9% (56/117) among single-agent second-line non-small cell lung cancer patients, including 4 patients who achieved complete remission (CR), 36 patients had tumors shrunk by more than 50%, and the disease control rate (DCR) was 86.3%. The median progression-free survival (mPFs) was 8.2 months, and the median overall survival (MoS) was 13.6 months. The median duration of remission (MDoR) data are not yet mature; the 6- and 12-month duration of remission (DoR) ratios are 73.6% and 56.6%, respectively.
In December 2022, based on its good efficacy and safety characteristics, Glecirasib was awarded a breakthrough therapeutic drug certification for second-line treatment of patients with advanced or metastatic non-small cell lung cancer with KRAS G12C mutations by the Drug Evaluation Center.
In addition, multiple studies of Glecirasib as a single agent and in combination are being carried out globally, including registered clinical studies on treatment of non-small cell lung cancer in combination with SHP2 inhibitor JAB-3312, treatment of colorectal cancer in combination with cetuximab, and single-agent treatment of pancreatic cancer.