Jacobio Pharma's glecirasib, an in-house KRAS G12C inhibitor, has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for pancreatic cancer. The designation targets patients with KRAS G12C mutations who have experienced disease progression following frontline standard care. This regulatory milestone is based on promising clinical efficacy and safety data observed in ongoing glecirasib clinical trials.
The BTD is designed to expedite the development and review of innovative drugs that demonstrate a significant clinical advantage over existing therapies for serious or life-threatening conditions. According to the CDE, this designation provides opportunities for more intensive guidance and discussion with respect to clinical trials and development strategy, and for priority review later.
Glecirasib Clinical Development
The pivotal study for glecirasib in pancreatic cancer, approved by the CDE in July 2023, is the first global registrational clinical study targeting KRAS G12C in this indication. This multi-center, single-arm, open-label trial will assess the efficacy and safety of glecirasib monotherapy in patients with locally advanced or metastatic pancreatic cancer harboring KRAS G12C mutations who have progressed on frontline treatment. Pancreatic cancer is a highly aggressive malignancy with a five-year overall survival rate of only 5%.
Prior Designations and Ongoing Trials
This is glecirasib's second BTD in China. In December 2022, the drug received BTD for second-line and beyond treatment of advanced or metastatic non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations. Jacobio Pharma is currently conducting Phase I/II clinical trials of glecirasib in China, the United States, and Europe for patients with advanced solid tumors harboring KRAS G12C mutations. These trials include a pivotal study in 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 in NSCLC and with Cetuximab in colorectal cancer.
