FDA Approves Osimertinib for Patients with Advanced-Stage EGFR-Mutated NSCLC After Chemoradiotherapy

Figure 1. The FDA has approved osimertinib (Tagrisso) for the treatment of unresectable stage III non-small cell lung cancer (NSCLC) in adult patients whose disease has not progressed during or after platinum-based chemoradiotherapy and who have EGFR exon 19 or exon 21 L858R mutations. 

STUDY DETAILS

In the LAURA trial, patients were randomized 2:1 to receive osimertinib (80 mg daily) or placebo. Progression-free survival (PFS) was the primary endpoint of the study, assessed by an independent review committee. Overall survival (OS) was also evaluated, but the data were not yet mature at the time of the final analysis.

The results showed that osimertinib prolonged PFS to a statistically significant degree compared with placebo, with a hazard ratio of 0.16 (95% confidence interval, 0.10-0.24; P<.001). Median PFS in the osimertinib group was 39.1 months (95% confidence interval, 31.5 months to not estimable), compared with 5.6 months (95% confidence interval, 3.7-7.4 months) in the placebo group.

THE SIGNIFICANCE OF OSIMERTINIB

The results of this study were presented at the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO). According to experts at the conference, osimertinib could replace standard chemoradiotherapy followed by durvalumab in this patient group.

Dr. Suresh S. Ramalingam of the Winship Cancer Institute at Emory University, Atlanta, commented: "Based on the results of this study, osimertinib will become the new standard of care for patients with advanced non-small cell lung cancer after chemoradiotherapy. Stage III patients should be tested for EGFR mutations to achieve optimal treatment outcomes."

ADVERSE EFFECTS AND TREATMENT CONSIDERATIONS

Common adverse effects, occurring in at least 20% of patients, included: lymphopenia, leukopenia, interstitial lung disease/pneumonitis, thrombocytopenia, neutropenia, rash, diarrhea, nail lesions, musculoskeletal pain, cough, and COVID-19. Serious adverse effects occurred more frequently in the osimertinib group, with radiation pneumonitis occurring in 48% of patients receiving osimertinib compared with 38% of patients receiving placebo. The rate of treatment discontinuation due to adverse effects was 13% in the osimertinib group, compared with 5% in the placebo group.

Osimertinib is a tyrosine kinase inhibitor indicated for EGFR-mutated NSCLC in the metastatic setting and in early-stage NSCLC after surgical resection. The recommended dose is 80 mg daily, taken with or without food, and treatment is continued until disease progression or unacceptable toxicity.

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Source: www.oncologynewscentral.com