Amgen's KRAS Inhibitor AMG 510 Granted Clinical Approval in China for Previously Treated KRAS G12C-Mutated NSCLC

Text | Baihuawen

On April 29, Amgen’s AMG510 was approved in China for clinical trials to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the KRAS p.G12C mutation who have received prior treatment.

RAS is the first oncogene identified in human tumors and remains one of the most prevalent oncogenic mutations, with its discovery dating back more than 30 years. The RAS gene family currently includes three known members: KRAS, NRAS, and HRAS, among which KRAS mutations are the most common, accounting for approximately 85%. KRAS G12C mutations occur in approximately 13% of non-small cell lung cancer (NSCLC) cases, 3%–5% of colorectal cancer cases, and 1%–2% of other solid tumors. In the United States, approximately 30,000 new cases of KRAS G12C-mutant cancers are diagnosed annually.

Amgen previously announced the Phase I clinical results of AMG 510 for the treatment of solid tumors at the ESMO 2019 Congress: Among 12 patients with colorectal cancer treated with AMG 510 (960 mg/day), one patient achieved a partial response, 10 patients achieved stable disease, and the disease control rate was 92%. Among 13 patients with non-small cell lung cancer treated with AMG 510 (960 mg/day), seven patients achieved a partial response, six patients achieved stable disease, and the disease control rate was 100%. Among two patients with appendiceal cancer, one achieved a partial response and one achieved stable disease.

Currently, Amgen has initiated a Phase III clinical trial (NCT04303780) of AMG 510 in patients with locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) harboring KRAS p.G12C mutations.