Jacobio Pharma's KRAS G12C Inhibitor Meets Primary Endpoint

Jacobio Pharma (1167.HK) has disclosed the data from their Phase II registrational study on the KRAS G12C inhibitor, glecirasib, during the April ASCO Plenary Series, which was conducted online. The study was led by Prof. Yuankai Shi, the chief physician at Cancer Hospital Chinese Academy of Medical Sciences, who presented the findings through an online oral presentation (Abstract 468214).

The efficacy data from the study are promising. Among the second-line non-small cell lung cancer (NSCLC) patients treated with glecirasib monotherapy, the confirmed objective response rate (cORR) reached 47.9% (56 out of 117 patients), with 4 patients achieving a complete response and 36 patients showing a tumor reduction of over 50%. The disease control rate (DCR) was recorded at 86.3%. Further, the median progression-free survival (mPFS) was reported to be 8.2 months, and the median overall survival (mOS) stood at 13.6 months. Notably, the median duration of response (mDoR) has not yet been reached, with 6-month and 12-month DOR rates being 73.6% and 56.6%, respectively.

Safety data also highlight that glecirasib is generally well-tolerated. No grade 5 treatment-related adverse events (TRAEs) were observed, and only 5.0% of patients discontinued the treatment due to TRAEs. Glecirasib also demonstrated a favorable gastrointestinal (GI) profile compared to other KRAS G12C inhibitors.

Julia Rotow, MD, from the Dana-Farber Cancer Institute, commented on these findings, indicating that glecirasib could potentially be an attractive treatment option if it can match or surpass current efficacy data while also offering an improved side effect profile. She added that the unique toxicity profile might make glecirasib a candidate for combination therapy with agents that are typically not combined with other existing KRAS G12C inhibitors due to overlapping toxicities.

Prof. Yuankai Shi highlighted the shifting trend in lung cancer treatment towards reducing chemotherapy usage. He noted that for lung cancer patients with the KRAS G12C mutation who do not respond to first-line treatment, chemotherapy such as docetaxel is the main second-line treatment in China, with an ORR of 14%, mPFS of 3.0 months, and an OS of 9.1 months. Prof. Shi emphasized that existing clinical data indicate that glecirasib is not only more effective but also safer than chemotherapy, and it is expected to provide more treatment options for patients.

Glecirasib, a KRAS G12C inhibitor developed by Jacobio, is currently undergoing multiple Phase I/II clinical trials across China, the United States, and Europe for patients with advanced solid tumors harboring the KRAS G12C mutation. These trials include a pivotal study in NSCLC in China, a monotherapy study for STK11 co-mutated NSCLC in the frontline setting, and combination therapy trials with SHP2 inhibitor JAB-3312 in NSCLC and with Cetuximab in colorectal cancer. Additionally, the pancreatic cancer indication has obtained orphan drug designation in the United States and breakthrough therapy designation in China.

Jacobio Pharma is dedicated to developing innovative products to improve health. The company’s pipeline focuses on novel molecular targets across six major signaling pathways: KRAS, immune checkpoints, tumor metabolism, P53, RB, and MYC. Aiming for global leadership in drug R&D, Jacobio strives for its key projects to be among the top three worldwide. The company operates R&D centers in Beijing, Shanghai, and Boston, utilizing their Induced Allosteric Drug Discovery Platform (IADDP) and iADC Platform.