Jacobio Pharma (HKG: 1167), a China-based biopharmaceutical company, has announced the submission of a New Drug Application (NDA) to China’s Center for Drug Evaluation (CDE) for its investigational drug glecirasib. The KRAS G12C inhibitor is being sought after for approval as a treatment for second-line and above advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation.
The NDA filing is supported by a regulatory Phase II study in China designed to evaluate the efficacy and safety of glecirasib as a monotherapy in NSCLC patients harboring the KRAS G12C mutation. The study results demonstrated a confirmed objective response rate (ORR) of 47.9% (56/117 patients), with 4 patients achieving a complete response (CR). Additionally, 36 patients experienced a tumor reduction of over 50%, leading to a disease control rate of 86.3%. The median progression-free survival (mPFS) was recorded at 8.2 months, and the median overall survival (mOS) was 13.6 months. The median duration of response (mDoR) data is not yet mature, with response duration ratios of 73.6% and 56.6% at 6 and 12 months, respectively.
Developed in-house by Jacobio, glecirasib is currently under investigation in multiple studies across China, the US, and Europe for its potential use in treating NSCLC, colorectal cancer, and pancreatic cancer. The drug was granted breakthrough therapy designation (BTD) in China in December 2022 for the NSCLC indication, reflecting its promising efficacy and safety profile.- Flcube.com
