Jacobio Pharma's glecirasib, a KRAS G12C inhibitor, has demonstrated promising results in a registrational Phase II clinical trial for patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC). The data, published in Nature Medicine, highlight the drug's efficacy and manageable safety profile in a patient population with limited treatment options.
The pivotal trial evaluated glecirasib monotherapy in patients with NSCLC who had progressed on prior lines of therapy. Key findings include a confirmed objective response rate (ORR) of 47.9% (56 out of 117 patients), a median progression-free survival (mPFS) of 8.2 months, and a median overall survival (mOS) of 13.6 months. These results suggest a clinically meaningful benefit for patients with this specific genetic alteration.
Safety and Tolerability
In terms of safety, glecirasib was observed to have a manageable profile, with a favorable gastrointestinal safety profile compared to other KRAS G12C inhibitors currently available. This is a notable advantage, as gastrointestinal toxicities can often limit the use of other agents in this class.
Regulatory Status and Future Directions
The New Drug Application (NDA) for glecirasib is currently under evaluation by the Center for Drug Evaluation of the National Medical Products Administration of China and has been granted Priority Review Designation. This designation could expedite the approval process and make the drug available to patients in China sooner.
Dr. Yinxiang Wang, Chairman and CEO of Jacobio, stated, "It's our great honor to present the data from our pivotal trial in such a prestigious journal as Nature Medicine. The development of KRAS-related inhibitors is still in the early stages. We will continue to explore registration clinical trials with our partners of glecirasib in combo with SHP2 inhibitor JAB-3312 for the treatment of first-line NSCLC and accelerate the development of our other RAS programs such as Pan-KRAS inhibitor."
Ongoing Clinical Trials
Jacobio Pharma is also conducting ongoing clinical trials of glecirasib in combination with other agents, such as the SHP2 inhibitor JAB-3312 in NSCLC and cetuximab in colorectal cancer. Furthermore, glecirasib has received orphan drug designation in the United States and breakthrough therapy designation in China for pancreatic cancer, indicating its potential in addressing other cancers driven by KRAS G12C mutations.
