On September 6, 2022 Jacobio Pharma (1167.HK) reported that it has received Phase II pivotal study approval of KRAS G12C inhibitor JAB-21822 from the Center for Drug Evaluation (CDE) of China in September 5, 2022 (Press release, Jacobio Pharmaceuticals, SEP 6, 2022, View Source [SID1234619113]). This study aims to treat advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation as a second line or beyond therapy. Jacobio aims to apply for the new drug marketing application (NDA) for JAB-21822 after the successful completion of this pivotal study.

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"JAB-21822 is the first product entered into pivotal stage since 2015, the year of Jacobio founded, it’s a milestone for the company. We hope to work with clinical study investigators to jointly advance the clinical trials and strive to bring more treatment options to patients with KRAS G12C-mutated non-small cell lung cancer as soon as possible," said Dr. WANG Yinxiang, Chairman and CEO of Jacobio.

The Phase II pivotal clinical trial approved in China will evaluate the efficacy and safety of JAB-21822 as a single agent for the treatment of NSCLC patients with a KRAS G12C mutation. This is a multi-center, single-arm, open-label study.

JAB-21822 is the best-in-class potential project for KRAS G12C inhibitors. The preliminary clinical date of the Phase I study of JAB-21822 published at the 2022 annual meeting of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) shows that as of April 1, 2022, a total of 72 patients with advanced solid tumors were enrolled, and efficacy was assessed for 32 NSCLC patients with KRAS G12C mutation. The overall response rate (ORR) was 56.3% (18/32) and the disease control rate (DCR) was 90.6% (29/32).

Currently, JAB-21822 is simultaneously undergoing clinical trials for monotherapy and combination therapy in China, the United States and Europe, including the monotherapy for NSCLC with KRAS G12C mutation, pancreatic ductal carcinoma and colorectal cancer; the combination therapy with EGFR monoclonal antibody; and the combination therapy with JAB-3312, a self-developed SHP2 inhibitor of the Company.

About JAB-21822

JAB-21822 is a KRAS G12C inhibitor independently developed by the Company. The Company has initiated a number of Phase I/II clinical trials in China, the United States and Europe for patients with advanced solid tumors, including monotherapy for STK11 co-mutated non-small cell lung cancer in the front-line setting; combination therapy with SHP2 inhibitor, anti-PD-1 monoclonal antibody and Cetuximab.