Amgen has announced that it agreed with the U.S. Food and Drug Administration's proposed postmarketing requirement to conduct, as part of the ongoing development program, a multicenter randomized clinical trial to compare the safety and efficacy of sotorasib at 960 mg once daily vs a lower daily dose of the drug. Based on the preclinical, pharmacokinetic, and clinical data, Amgen intends to proceed with the previously disclosed study comparing 960 mg once daily to a 240 mg once daily dose.
Amgen anticipates the results from the study in late 2022 and does not expect any impact on the timelines of the ongoing Priority Review of the agent.
Priority Review for Sotorasib in KRAS G12C–Mutated Locally Advanced or Metastatic NSCLC
In February 21, the FDA granted Priority Review to sotorasib for the treatment of patients with KRAS G12C–mutated locally advanced or metastatic NSCLC, following at least one prior systemic therapy. The Prescription Drug User Fee Action date for sotorasib is August 16, 2021. Sotorasib is a KRAS G12C inhibitor.
The new drug application is based on phase II results from the CodeBreaK 100 clinical trial that studied patients with locally advanced or metastatic NSCLC whose cancer had progressed despite treatment with chemotherapy and/or immunotherapy. Full results from the study were presented during the Presidential Symposium at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC).
CodeBreaK 100, the phase II, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C–mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy consistent with their tumor type and stage of disease. The primary endpoint for the study was centrally assessed objective response rate. The phase II trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by Response Evaluation Criteria in Solid Tumors at baseline.