Clinical Trials

Sotorasib drug shows meaningful benefits clincally with advanced KRAS G12C mutation in non-small cell lung cancer patients.

Clinically Meaningful Benefit in Advanced KRAS G12C+ NSCLC Is Seen With Sotorasib

Sotorasib shows benefits clinically for KRAS G12C mutation: Patients with KRAS G12C–mutated advanced non–small cell lung cancer show antitumor response and survival benefit with the KRAS G12C inhibitor sotorasib, formerly AMG 510.

Patients with advanced non–small cell lung cancer (NSCLC) harboring KRAS G12C mutations benefitted from therapy with sotorasib (formerly AMG 510), an inhibitor of KRAS G12C, which induced a 6.8-month median progression-free survival. These results from the CodeBreaK 100 trial (NCT03600883) were presented at the International Association for the Study of Lung Cancer 2020 World Conference on Lung Cancer Singapore.

The confirmed objective response rate (ORR) and a disease control rate were 37.1% and 80.6%, respectively, at a median follow-up of 12.2 months. The median duration of response was 10 months.

These data show that sotorasib is the first KRAS G12C inhibitor to show PFS in a phase 2 study, stated Amgen, the manufacturer of the agent.

“These results are encouraging and clinically meaningful for patients with advanced NSCLC harboring the KRAS G12C mutation,” said lead investigator Bob T. Li, MD, PhD, MPH, medical oncologist at Memorial Sloan Kettering Cancer Center. “These are 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.”

KRAS G12C Patients Benefit from Sotorasib

In December 2020, the FDA granted a breakthrough therapy designation to sotorasib for use as a potential treatment in patients with KRAS G12C–mutated locally advanced or metastatic NSCLC, as determined via an FDA-approved test, after at least 1 prior systemic treatment.

Sotorasib had been accepted into the FDA’s Real-Time Oncology Review Pilot Program, which is designed to create a more effective review process dedicated to making safe and effective therapies available to patients quickly.

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