The Food and Drug Administration (FDA) has placed sotorasib (formerly AMG 510; Amgen), a first-in-class molecule that specifically and irreversibly inhibits KRAS G12C, under priority review for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy.1,2 Under the Prescription Drug User Fee Act (PDUFA), the FDA is scheduled to issue a decision on the agent’s new drug application (NDA) by August 16, 2021.1

The Priority Review is supported by data from the phase 2 CodeBreaK 100 trial (NCT03600883), findings from which were presented at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC). The single-arm study enrolled 126 patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who experienced disease progression on a prior anti-PD-1/PD-L1 immunotherapy and/or platinum-based combination chemotherapy. Patients with untreated active brain metastases were excluded.2

Data reported at the medical meeting showed that at a median follow-up of 12.2 months, the median progression-free survival was 6.8 months. The objective response rate was 37.1% (95% CI, 28.6%-46.2%) and included 3 complete responses. The disease control rate was 80.6% (95% CI, 72.6%-87.2%) and the median duration of response was 10.0 months.

These CodeBreaK 100 findings prompted the FDA to award sotorasib a breakthrough therapy designation for the same patient population for which the agent is now under priority review on December 8, 2020.3


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References

  1. FDA grants sotorasib priority review designation for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer. [press release]. Thousand Oaks, CA: Amgen; February 16, 2021.
  2. Li BT, Skoulidis F, Falchook G, et al. CodeBreaK 100: registrational phase 2 trial of sotorasib in KRAS p.G12C mutated non-small cell lung cancer. Presented at: International Association for the Study of Lung Cancer 2020 World Conference on Lung Cancer; January 28-31, 2021. Abstract PS01.07.
  3. Amgen’s sotorasib granted breakthrough therapy designation for advanced or metastatic non-small cell lung cancer patients with KRAS G12C mutation. [press release]. Thousand Oaks, CA: Amgen; December 8, 2020.