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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
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