Jacobio Pharma receives CDE approval for pancreatic cancer study in China

Betsy Goodfellow | July 5, 2023 | News story | Medical Communications |  CDE, China, Jacobio Pharma, Oncology, Pancreatic cancer, clinical trial 

Jacobio Pharma has announced that its novel KRAS G12C inhibitor glecirasib’s pivotal study for pancreatic cancer has been approved by the Center for Drug Evaluation (CDE) in China. This trial is already the first global pancreatic cancer registrational clinical study for KRAS G12C.

The multi-centre, single-arm, open-label clinical trial will evaluate the efficacy and safety of glercirasib as a single agent for the second line treatment or above of pancreatic cancer patients with a KRAS G12C.

Results from this study are expected to be used to submit a New Drug Application (NDA) for the treatment of pancreatic cancer.

Currently the five-year overall survival rate for pancreatic cancer is only 5%, with 90% of patients having various KRAS mutations, so new treatments are needed.

Jacobio is additionally developing KRASmulti and KRAS G12D, along with other projects intended to benefit more pancreatic cancer patients.

Dr Andrea Wang-Gillam, chief medical officer of Jacobio Pharma, commented: “The pivotal study of pancreatic cancer is the second approved registrational study after non-small cell lung cancer (NSCLC). We hope to work with clinical study investigators to jointly advance the clinical trials and strive to bring more treatment options to cancer patients with KRAS G12C-mutated as soon as possible.”

Betsy Goodfellow