Sotorasib extends PFS in lung cancer subset
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Sotorasib prolonged PFS compared with standard chemotherapy for certain patients with non-small cell lung cancer, according to topline data released by the agent’s manufacturer.
Sotorasib (Lumakras, Amgen) is a KRASG12C inhibitor.
The agent received accelerated approval in the United States for treatment of adults with KRASG12C-mutated locally advanced or metastatic NSCLC who received at least one prior systemic therapy. The FDA granted accelerated approval based on overall response rate and duration of response, but continued approval may require confirmation of clinical benefit in a confirmatory trial.
Approximately 13% of patients with NSCLC harbor KRASG12C mutations. Treatment options are limited for those who do not respond to or progress after first-line treatment, and median PFS after second-line treatment with approved therapies is about 4 months, according to an Amgen-issued press release.
The randomized phase 3 CodeBreaK200 trial evaluated the efficacy and safety of once-daily sotorasib vs. IV docetaxel among 345 patients with previously treated KRASG12C-mutated NSCLC. All trial participants had received prior platinum-based doublet chemotherapy and checkpoint inhibitor therapy.
Results showed a statistically significant improvement in PFS — the trial’s primary endpoint — among sotorasib-treated patients.
Complete results will be submitted for presentation at a medical meeting.
“Further analyses of the data are ongoing, and we look forward to sharing detailed data,” David M. Reese, MD, executive vice president of research and development at Amgen, said in the press release.
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