On January 19, 2024 Jacobio Pharmaceuticals (1167.HK), a clinical-stage oncology company focusing on undruggable targets, reported data of glecirasib in patients with pancreatic cancer and other solid tumors in the oral abstract session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium ("2024 ASCO (Free ASCO Whitepaper) GI") (Press release, Jacobio Pharmaceuticals, JAN 19, 2024, View Source [SID1234639369]).

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As of December 6, 2023, the monotherapy global study of glecirasib enrolled 52 patients with pancreatic cancer and other solid tumors harboring KRAS G12C mutation in China, the United States, Europe, Israel and other regions, including 31 patients with pancreatic cancer, and 21 patients with other solid tumors (8 with biliary tract tumors, 3 with gastric cancer, 3 with small bowel cancer, 2 with appendix cancer, and 5 with other solid tumors).

Among 50 patients with evaluable solid tumors, the confirmed objective response rate (cORR) was 48% (24/50) and the disease control rate (DCR) was 90% (45/50). For second-line and above KRAS G12C mutated pancreatic cancer patients, the cORR was 41.9% (13/31) and the DCR was 93.5% (29/31). The median progression-free survival (mPFS) was 5.6 months, and the median overall survival (mOS) was 10.7 months. In other solid tumor patients, the cORR was 57.9% (11/19), DCR was 84.2% (16/19), the mPFS was 7.0 months, and the mOS has not yet matured. The above safety and efficacy data are better than the published data of similar studies.

Glecirasib has good tolerability and safety characteristics, the majority of treatment-related adverse events (TRAEs)are grades 1-2, and grade 3 or above TRAEs occurred in 25% of patients. No patient has permanently withdrawn from the study due to TRAE.

Professor Lin Shen, director of Peking University Cancer Hospital gastroenterology department, is the principal investigator for this trial. She introduced at the conference, "Pancreatic cancer is a highly malignant tumor, and current patients lack effective standardized treatment methods, with a five-year overall survival rate of only 5%. Every year in China, nearly 1-2% of pancreatic cancer patients carry a KRAS G12C mutation, and the mutation rate in other solid tumors is also around 1%. The clinical data of glecirasib have preliminarily confirmed the efficacy in patients with pancreatic cancer and other solid tumors. Compared with the standard chemotherapy treatment, the ORR of glecirasib is higher, and the safety and tolerance is better. It is expected that glecirasib will accelerate the clinical development in pancreatic cancer and other solid tumors, bringing a better treatment option beyond chemotherapy for patients."

Jacobio continues to explore the application of glecirasib in pancreatic cancer. Glecirasib’s registrational pivotal study for pancreatic cancer was approved by CDE in July 2023, which became the first global pancreatic cancer KRAS G12C registrational clinical study. The study results will be used to submit NDA (New Drug Application) for pancreatic cancer.

Based on the clinical efficacy and safety data from ongoing clinical trials, glecirasib was granted breakthrough therapy designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the pancreatic cancer patients with a KRAS G12C mutation who have progressed after frontline standard care treatment. Pancreatic cancer is a malignant tumor and there is a lack of effective treatment currently. The five-year overall survival rate is only 5%-10%. The BTD will expedite the clinical development of glecirasib and accelerate its early access to the patients.

For more information, please visit the official website of the ASCO (Free ASCO Whitepaper) GI: View Source

Conference Call Information

Jacobio will host a live conference call on Jan. 23, 2024, at 9:30-10:30 (UTC+8). Participants must register in advance of the conference call.
Registration Link: View Source

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. This includes a pivotal clinical trial in NSCLC in China (patients enrollment has been completed); a monotherapy study for STK11 co-mutated NSCLC in the front-line setting, combination therapy trials with SHP2 inhibitor JAB-3312 in NSCLC and with Cetuximab in colorectal cancer, and a registrational pivotal clinical trial in pancreatic cancer.