China-based Jacobio Pharma (HKG: 1167) has announced that its novel KRAS G12C inhibitor, glecirasib, has entered into the breakthrough therapy review process for the treatment of locally advanced or metastatic pancreatic cancer with the KRAS G12C mutation. The drug is being developed as a second-line treatment in combination with gemcitabine and albumin paclitaxel, or the FOLFIRINOX regimen.
Development and Clinical Trials of Glecirasib
Glecirasib, developed in-house by Jacobio, is the subject of numerous Phase I/II clinical trials in China, the US, and Europe for patients with advanced solid tumors harboring the KRAS G12C mutation. This includes a pivotal clinical trial in non-small cell lung cancer (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, anti-PD-1 antibody, and cetuximab. Earlier this month, the drug was cleared for a pivotal study in pancreatic cancer in China, marking a world first for a KRAS G12C inhibitor.
Breakthrough Potential and Significance
The breakthrough therapy designation in China for glecirasib highlights its potential to address a significant unmet medical need for patients with KRAS G12C mutated pancreatic cancer. This development is a testament to Jacobio Pharma’s commitment to advancing targeted therapies for hard-to-treat cancers and underscores the importance of glecirasib as a potential new treatment option in the global oncology space.-Fineline Info & Tech
