China-based InventisBio (Shanghai) Co., Ltd announced receiving breakthrough therapy designation (BTD) status for its KRAS G12C inhibitor D-1553 from the Center for Drug Evaluation (CDE), marking the first such recognition in China.
Drug Profile and Clinical Trials
D-1553 is a highly efficient and selective KRAS G12C inhibitor undergoing a global multi-center Phase I clinical study in non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and other advanced solid tumors with the KRAS G12C mutation. Preclinical studies highlighted its selectivity, tumor inhibition, and synergistic anti-tumor effects.
Clinical Data
InventisBio first published clinical study results for D-1553 at the American Association for Cancer Research (AACR) annual meeting in April. An open Phase I/II study in NSCLC patients with the KRAS G12C mutation showed an objective remission rate of 40.4% and a disease control rate of 90.4% among 52 assessable patients.
Market Context
Globally, only Amgen’s Sotorasib (AMG510) is available, approved in the US in May 2021 for NSCLC with KRAS G12C mutation. In China, Junshi Bio’s JS116 and Innovent/GenFleet’s GFH925 have received clinical trial approvals. Zelgen Bio’s ZG19018, a KRAS G12C covalent inhibitor, is in Phase II trials after US clinical approval.-Fineline Info & Tech
