Jacobio Pharma presented clinical results for glecirasib, a KRAS G12C inhibitor, at the 2024 ASCO Gastrointestinal Cancers Symposium in San Francisco. The data highlighted the potential of glecirasib in treating patients with pancreatic cancer and other solid tumors harboring KRAS G12C mutations.
Glecirasib's Clinical Development in Pancreatic Cancer
Glecirasib's registrational pivotal study for pancreatic cancer received approval from China's Center for Drug Evaluation (CDE) in July 2023. This marks the first global pancreatic cancer KRAS G12C registrational clinical study. Jacobio Pharma intends to use the study results to support a New Drug Application (NDA) for pancreatic cancer.
In August 2023, based on clinical efficacy and safety data from ongoing clinical trials, glecirasib was granted Breakthrough Therapy Designation (BTD) by the CDE for pancreatic cancer patients with a KRAS G12C mutation who have progressed after frontline standard care treatment. Pancreatic cancer is a highly aggressive malignancy with a five-year overall survival rate of only 5%, underscoring the urgent need for effective treatments. The BTD is expected to accelerate the clinical development of glecirasib and facilitate earlier access for patients.
Ongoing Clinical Trials
Jacobio Pharma is currently conducting several Phase I/II clinical trials of glecirasib in China, the United States, and Europe. These trials are evaluating glecirasib in patients with advanced solid tumors harboring KRAS G12C mutations. The trials include:
- A pivotal clinical trial in NSCLC in China.
- A monotherapy study for STK11 co-mutated NSCLC in the front-line setting.
- Combination therapy trials with SHP2 inhibitor JAB-3312 in NSCLC.
- Combination therapy trials with Cetuximab in colorectal cancer.
- A registrational pivotal clinical trial in pancreatic cancer.
Glecirasib is being investigated both as a monotherapy and in combination with other agents to address various KRAS G12C-mutated cancers. These studies aim to provide comprehensive data on the efficacy and safety of glecirasib across different tumor types and treatment settings.
