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.

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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

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.

Topics:

Lung Cancer Non-Small Cell Lung Cancer