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FDA Approves Osimertinib for Unresectable EGFR-Mutated Lung Cancer
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The decision is based on positive results from the phase 3 LAURA trial.
Osimertinib (Tagrisso; AstraZeneca) was approved by the FDA for the treatment of patients with unresectable, stage III, epidermal growth factor receptor-mutated (EGFRm) non–small cell lung cancer (NSCLC) whose disease has not progressed during or following platinum-based chemoradiation therapy (CRT). The decision is based on clinically meaningful results demonstrated in the phase 3 LAURA trial (NCT03521154), which were published in The New England Journal of Medicine.1,2
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Approximately 2.4 million individuals are diagnosed with lung cancer around the globe every year. Of this population, 80% to 85% have NSCLC, the most common form of the disease. Standard of care treatment for patients with NSCLC that have EGFRm mutations are EGFR-tyrosine kinase inhibitors (EGFR-TKI). These block mutated EGFR proteins, thereby slowing tumor growth. Osimertinib is a third-generation tyrosine kinase inhibitor (TKI) oral therapy that has demonstrated significant success extending progression-free survival (PFS) for early stage, locally advanced, and late-stage disease in clinical study.3
Osimertinib was given priority review by the FDA in June 2024 based on significant improvements in PFS. The double-blind, placebo-controlled LAURA trial included 216 participants across 145 global centers with unresectable stage 3 EGFRm NSCLC who have L858R mutations after chemoradiotherapy (CRT). The participants were randomly assigned to receive 80 mg daily of osimertinib (n = 143) or placebo (n = 73) until disease progression or discontinuation of treatment occurred. The primary end point of the study was PFS.3
The study showed that osimertinib reduced risk of disease progression by 84%(95% CI, 75 to 89) compared with placebo (hazard ratio 0.16; 95% confidence interval 0.10-0.24; p<0.001). Additionally, there was an observed median PFS of 39.1 months for the osimertinib arm versus the placebo arm (95% confidence interval [CI], 0.10 to 0.24; P<0.001).2,4
The safety and tolerability of osimertinib were consistent, and no new safety concerns emerged. Adverse events of grade 3 or higher were present in both the osimertinib (35%) and placebo (12%) groups, and radiation pneumonitis (majority grade 1 to 2) was reported in 48% and 38%, respectively.2,4
With the approval, osimertinib is indicated for the treatment of patients with EGFR-mutated NSCLC with exon 19 or exon 21 (L858R) mutations.4
“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,” Suresh Ramalingam, MD, executive director of Winship Cancer Institute of Emory University, Atlanta, Geogria, said in a news release. “Patients treated with osimertinib lived without disease progression by more than 3 years in the LAURA trial, and this impressive benefit underscores the importance of diagnosing and testing lung cancer patients as early as possible.”3
