The FDA has granted priority review to sotorasib (formerly AMG 510) for the treatment of patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer (NSCLC), after at least 1 previous systemic therapy.The decision was based on data from the phase 2 CodeBreaK 100 trial (NCT03600883), which showed that treatment with KRAS G12C inhibitor elicited a 6.8-month median progression-free survival (PFS) in patients with KRAS G12C–mutated NSCLC.2

Moreover, at a median follow-up of 12.2 months, sotorasib induced an objective response rate (ORR) of 37.1% (95% CI, 28.6%-46.2%) and a disease control rate (DCR) of 80.6% (95% CI, 72.6%-87.2%). The median duration of response (DOR) was 10 months. The FDA is slated to make a decision on the agent by August 16, 2021 per the Prescription Drug User Fee Act; this is 4 months earlier than the standard review cycle, according to Amgen, the drug developer.

“These results are encouraging and clinically meaningful for patients with advanced disease harboring the KRAS G12C mutation,” Bob T. Li, MD, PhD, MPH, lead study author and medical oncologist a Memorial Sloan Kettering Cancer Center, said during a presentation of the data delivered at the International Association for the Study of Lung Cancer 2020 World Conference on Lung Cancer. “These are the patients who have progressive disease after standard treatment, so they need additional treatments, and the fact that we are seeing rapid tumor shrinkages and durable responses in these patients, is for me, a step forward and a win for patients.”

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