China’s Jacobio Pharmaceuticals Group Co., Ltd (HKG: 1167) has received approval from the National Medical Products Administration (NMPA) to launch a pivotal Phase II trial of its KRAS G12C inhibitor, JAB-21822, for advanced or metastatic non-small cell lung cancer (NSCLC) with the KRAS G12C mutation. The company plans to file a new drug application (NDA) if the study succeeds.
Study Design and Objectives
The multi-center, single-arm, open-label Phase II trial will evaluate JAB-21822’s efficacy and safety in NSCLC patients with KRAS G12C mutations. The study builds on Phase I data, which showed a 56.3% objective response rate (ORR) and 90.6% disease control rate (DCR) in 32 NSCLC patients, presented at the 2022 ASCO annual meeting.
Global Development and Combination Strategies
JAB-21822 is under investigation in multiple regions, including China, the U.S., and Europe, for NSCLC, pancreatic ductal carcinoma, and colorectal cancer with KRAS G12C mutations. The drug is also being tested in combination with EGFR monoclonal antibodies, Jacobio’s SHP2 inhibitor JAB-3312, and other therapies. A Phase IIa trial for first-line KRAS/STK11 co-mutated tumors began last week.-Fineline Info & Tech
