Beijing, Shanghai, Boston, May 1 2024— Jacobio Pharma (1167.HK) announced that the data from the Phase II registrational study of the KRAS G12C inhibitor glecirasib were offically reported at the April ASCO Plenary Series, which was held online. 

Prof. Yuankai Shi, chief physician of Cancer Hospital Chinese Academy of Medical Sciences, the lead principal investigator of this clinical trial, presented the data in the form of an online oral presentation (Abstract 468214).

The efficacy data showed that among second-line non-small cell lung cancer patients receiving monotherapy treatment, the confirmed objective response rate (cORR) was 47.9% (56/117), including 4 patients achieved a complete response (CR) and 36 patients with tumor reduction exceeding 50%. Disease control rate (DCR) was 86.3%.

The median progression-free survival (mPFS) was 8.2 months, and median overall survival (mOS) was 13.6 months. The median duration of response (mDoR) has not been reached:6-month and 12-month DOR rates were 73.6% and 56.6%, respectively.

Safety data showed that glecirasib has a manageable safety profile. No grade 5 treatment related adverse event (TRAE) was observed, and only 5.0% of patients discontinued the treatment due to TRAEs. Gleciasib has a favorable gastrointestinal (GI) profile compared to other KRAS G12C inhibitors. 

“If glecirasib can match or even bypass current efficacy data with an overall improved side effect profile, this agent would be an attractive treatment option.” commented Julia Rotow, MD, of the Dana-Farber Cancer Institute, who critiqued the glecirasib findings. She said that the unique toxicity profile of glecirasib may offer the potential for combination with agents that cannot be readily combined with other existing KRAS G12C inhibitors due to overlapping toxicities.

“The trend in the treatment of lung cancer is to reduce the use of chemotherapy. Currently, for lung cancer patients harboring the KRAS G12C mutation who fail first-line treatment, chemotherapy such as docetaxel is the main second-line treatment in China. The ORR is 14%, mPFS is 3.0 months, and OS is 9.1 months. Existing clinical data show that glecirasib is more effective and safer than chemotherapy and is expected to bring more treatment options to patients.” Said Prof. Yuankai Shi. 

About Glecirasib
Glecirasib is a KRAS G12C inhibitor developed by Jacobio. A number of Phase I/II clinical trials of glecirasib are currently ongoing in China, the United States and Europe for patients with advanced solid tumors harboring KRAS G12C mutation. These include a pivotal clinical trial in NSCLC in China; a monotherapy study for STK11 co-mutated NSCLC in the front-line setting, and combination therapy trials with SHP2 inhibitor JAB-3312 in NSCLC and with Cetuximab in colorectal cancer. The pancreatic cancer indication has obtained orphan drug designation in the United States and breakthrough therapy designation in China.

About Jacobio