Beijing, Shanghai, Chicago, June 2, 2024—Jacobio Pharma (1167.HK), a clinical-stage oncology company focusing on undruggable targets, presented updated data of a KRAS G12C inhibitor glecirasib (JAB-21822) in combination with a SHP2 inhibitor (JAB-3312) in frontline non-small cell lung cancer (NSCLC) patients harboring KRAS G12C mutation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting as form of oral presentation. Jacobio also presented updated data of pivotal phase II study of glecirasib as form of oral presentation at an education session. 

As of April 7, 2024, 194 patients participated in a phase II trial of using glecirasib combined with JAB-3312 (NCT05288205), of which 102 patients were frontline NSCLC. The median follow-up time was 10.1 months.

In the oral abstract session (Abstract No. 3008), Professor Jun Zhao, chief physician of Beijing Cancer Hospital, the principal investigator of glecirasib combined with JAB-3312 study, presented the clinical data. About 102 frontline NSCLC patients have been enrolled in 7 dose groups. The confirmed objective response rate (cORR) was 64.7% (66/102), the disease control rate (DCR) was 93.1% (95/102), and the median progression-free survival (mPFS) was 12.2 months, respectively.

This trial explored a total of 7 different dose cohorts, and the optimal dose group was glecirasib at 800mg daily combined with JAB-3312 at 2mg daily one week on and one week off. The cORR of the optimal dose group was 77.4% (24/31), and 54.8% (17/31) of patients achieved a deep response with tumors shrinking by more than 50%. The mPFS was not yet mature.

Regarding on the safety data, among the 194 patients, the incidence of grade 3 or 4 treatment-related adverse events (TRAE) was 43.8%, and there was no treatment-related death. Common TRAEs treatment-related adverse events include anemia, hypertriglyceridemia, etc. The safety profile in the frontline NSCLC is similar to that of the overall study population, and the overall safety is manageable. 

Professor Jie Wang, chief physician of Beijing Cancer Hospital, commented, "from the above data, it can be seen that the combination therapy of glecirasib and JAB-3312 has a good safety profile, and the efficacy data shows positive therapeutic potential. If the combination of the two oral drugs can show superiority to the existing standard therapy (immunotherapy combined with chemotherapy) in subsequent trials, we anticipate  that patients can avoid the side effects of chemotherapy or immunotherapy.”

The combination therapy of glecirasib and JAB-3312 is being tested in a Phase III clinical trial of frontline NSCLC with KRAS G12C mutation in China. Andrea Gillam-Wang M.D., Ph.D., Chief Medical Officer and Global Head of R&D of Jacobio, said: "Our R&D efforts have been focusing on patient needs. We look forward to testing this novel combination against standard care chemotherapy and immunotherapy in NSCLC, and potentially replace standard care regimen consisted of multiple intravenous agents with two oral agents.”

The new drug application (NDA) of glecirasib monotherapy for the second-line NSCLC with KRAS G12C mutation was granted Priority Review designation by China CDE on May 21, 2024 In the education session of ASCO, Professor Yuankai Shi, chief physician of Cancer Hospital Chinese Academy of Medical Sciences, updated the data of the Phase II registration trial of NSCLC with KRAS G12C mutation in an oral report. 

Jacobio Pharma will hold a data discussion call at 20:00 Beijing time on June 3. Please click the link to register: https://s.comein.cn/A9SRr.

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 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 JAB-3312
JAB-3312 is a highly selective SHP2 allosteric inhibitor with best-in-class potential. Jacobio is currently conducting clinical trials of JAB-3312 in monotherapy and combination therapies with glecirasib and other agents in China, the United States and Europe. The phase III study in combination with KRAS G12C inhibitor Glecirasib has been approved by China CDE in Feb 2024. 
 

About Jacobio