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Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Wednesday, February 21, 2024
On February 16, 2024, the U.S. Food and Drug Administration (FDA) approved osimertinib (Tagrisso) with platinum-based chemotherapy for patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
Efficacy was evaluated in the randomized phase III FLAURA2 trial of 557 patients with EGFR exon 19 deletion or exon 21 L858R mutation–positive locally advanced or metastatic NSCLC and no prior systemic therapy for advanced disease. Patients were randomly assigned 1:1 to receive either osimertinib with platinum-based chemotherapy or osimertinib monotherapy.
The major efficacy outcome measure was progression-free survival, as assessed by the investigator, with overall survival as a key secondary outcome measure. Osimertinib plus platinum-based chemotherapy demonstrated a statistically significant improvement in progression-free survival compared with osimertinib monotherapy, with a hazard ratio of 0.62 (95% confidence interval [CI] = 0.49–0.79; two-sided P < .0001). The median progression-free survival was 25.5 months (95% CI = 24.7 months to not estimable) and 16.7 months (95% CI = 14.1–21.3 months) in the respective arms. Although overall survival results were immature at the current analysis, with 45% of prespecified deaths for the final analysis reported, no trend toward a detriment was observed.
The most common adverse reactions (≥ 20% incidence) in patients receiving osimertinib plus platinum-based chemotherapy were leukopenia, thrombocytopenia, neutropenia, lymphopenia, rash, diarrhea, stomatitis, nail toxicity, dry skin, and increased blood creatinine.
The recommended osimertinib dose is 80 mg orally once daily, with or without food, until disease progression or unacceptable toxicity.
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