NEW YORK – Amgen said on Monday that its investigational drug sotorasib showed positive results in the Phase II portion of the CodeBreak-100 trial in patients with KRAS G12C-mutant advanced non-small cell lung cancer.
The company said it will begin discussing the results of this "potentially registrational" study with the US Food and Drug Administration and other regulators.
CodeBreak-100 is a Phase I/II trial. The experimental treatment demonstrated an objective response rate in the Phase II portion that was consistent with previously reported Phase I data, according to Amgen, as was the drug’s safety and tolerability.
In the Phase II portion, sotorasib was tested in 126 patients with KRAS G12C-mutant, advanced NSCLC who had failed a median of two prior lines of treatment. More than half of the patients who responded were still on treatment and continuing to respond as of the data cutoff date.
In the Phase I portion of CodeBreak-100, sotorasib had an overall response rate of 35 percent and a disease control rate of 91 percent in NSCLC patients. The treatment is also being tested in patients with colorectal cancer and other solid tumors.
"Targeting KRAS has been a 40-year quest that has left patients with limited options," David Reese, executive VP of research and development at Amgen, said in a statement. "These topline data underscore our belief in the potential for sotorasib to become the standard of care for non-small cell lung cancer patients with the KRAS G12C mutation who remain in need of new treatment options."
Amgen will present detailed results of this trial at an upcoming lung cancer conference in January 2021. The company is also conducting a Phase III trial comparing sotorasib to docetaxel in KRAS G12C-mutant NSCLC, dubbed CodeBreak-200, and is already recruiting patients.