Investigational Therapy Granted Breakthrough Designation for Lung Cancer Subset


The decision was based on data that demonstrated sotorasib induced anticancer activity and achieved a positive benefit-risk profile in patients with locally advanced or metastatic non-small cell lung cancer whose disease harbors a KRAS G12C mutation.

The Food and Drug Administration (FDA) recently granted breakthrough therapy designation for sotorasib, an investigational KRASG12C inhibitor, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease harbors a KRAS G12C mutation, as identified by an FDA-approved test, following at least one previous systemic therapy, according to the agent’s manufacturer, Amgen.

“Breakthrough therapy designation and real-time oncology review bring Amgen closer to potentially providing a targeted therapy to patients with a KRAS G12C mutation and establishing sotorasib as the foundational therapy in KRAS G12C-driven cancers,” said Amgen’s executive vice president of research and development Dr. David M. Reese in a company-issued press release.

Of note, approximately 13% of patients with NSCLC harbor the KRAS G12C mutation and 25,000 new people within the United States are diagnosed with this form of lung cancer every year.

The breakthrough therapy designation was based on phase 2 data from the CodeBreaK 100 trial, which demonstrated that treatment with sotorasib in patients with advanced NSCLC whose disease progressed despite prior treatment with chemotherapy and/or immunotherapy elicited durable anticancer activity and achieved a positive benefit-risk profile.

The first-in-human, multicenter phase 1/2 CodeBreaK study enrolled patients with KRAS G12C-mutated solid tumors. Measuring objective response rates (complete or partial responses to therapy) was the main goal of the study. While the trial has enrolled more than 600 patients across 13 tumor types since its inception, the portion of the trial that led to this breakthrough designation consisted of 126 patients.

“For more than 40 years, scientists have been trying to target KRAS. Today's news is a welcome update for the many non-small cell lung cancer patients with the KRAS G12C mutation, who currently have no targeted therapies,” said Bonnie J. Addario, cofounder and board chair of the GO2 Foundation for Lung Cancer, in the release. “We are pleased that the FDA and Amgen recognize the unmet need for these patients and are working to make new treatment options available as quickly as possible.”

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