September 26, 2024, Cambridge, UK — AstraZeneca’s osimertinib has received approval in the United States for the treatment of adult patients with unresectable Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). These patients have disease that has not progressed following concurrent or sequential platinum-based chemoradiation therapy (CRT). Osimertinib is indicated for patients whose tumors have been confirmed to harbor exon 19 deletions or exon 21 (L858R) mutations, as detected by an FDA-approved test.
This approval was granted under the U.S. Food and Drug Administration’s (FDA) Priority Review pathway. The review was based on results from the Phase III LAURA trial, which were presented during a Plenary Session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in *The New England Journal of Medicine*.
Based on assessment by blinded independent central review, osimertinib reduced the risk of disease progression or death by 84% compared to placebo (Hazard Ratio [HR] 0.16; 95% Confidence Interval [CI] 0.10–0.24; p<0.001). The median progression-free survival (PFS) for patients treated with osimertinib was 39.1 months, compared to 5.6 months for the placebo group.
At the time of this analysis, overall survival (OS) data were not yet mature. The trial will continue to evaluate OS as a secondary endpoint. Suresh Ramalingam, MD, Executive Director of the Winship Cancer Institute at Emory University in Atlanta, USA, and the principal investigator of the trial, stated: "This approval represents a major breakthrough for patients with Stage III EGFR-mutated lung cancer, who will now have the opportunity to benefit from osimertinib treatment. In the LAURA trial, patients treated with osimertinib achieved a progression-free survival exceeding three years; this remarkable efficacy underscores the importance of early diagnosis and testing for lung cancer patients."
Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, commented: "The approval of osimertinib for the treatment of patients with unresectable Stage III EGFR-mutated non-small cell lung cancer addresses an urgent need for these patients, who previously had no targeted therapy options available to them. The results of the LAURA trial demonstrate the powerful impact of osimertinib as a foundational therapy for this disease. With this approval, patients with EGFR-mutated non-small cell lung cancer across all stages can now benefit from this treatment."
Osimertinib is already approved for: the first-line treatment of patients with metastatic EGFR mutations (either as monotherapy or in combination with chemotherapy), and as adjuvant therapy for early-stage disease. Regarding the newly approved indication for unresectable Stage III disease, osimertinib is currently under regulatory review by authorities in other countries worldwide.
