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Osimertinib Plus Chemo Approved for EGFR-Mutated NSCLC
The US Food and Drug Administration has approved osimertinib (Tagrisso, AstraZeneca) in combination with platinum-based chemotherapy for first-line treatment of patients with EGFR-mutated locally advanced or metastatic non–small-cell lung cancer (NSCLC). The EGFR mutations, specifically EGFR exon 19 deletions or exon 21 L858R mutations, can be detected by an FDA-approved test.
The EGFR-tyrosine kinase inhibitor already carries a monotherapy indication for first-line locally advanced or metastatic EGFR-mutated NSCLC.
"With the choice of two highly effective osimertinib-based options, physicians can better tailor treatment to an individual's needs and help ensure the best possible outcome for each patient," Pasi Jänne, MD, PhD, a medical oncologist at Dana-Farber Cancer Institute, Boston, Massachusetts, and principal investigator on the osimertinib trial, said at an AstraZeneca press release.
The approval was based on the FLAURA 2 trial in 557 patients with EGFR exon 19 deletions or exon 21 L858R mutations and no previous systemic therapy. Participants were randomized equally to either osimertinib with platinum-based chemotherapy or osimertinib monotherapy.
Median progression-free survival was 25.5 months in the combination arm vs 16.7 months in the osimertinib monotherapy group, a 38% improvement. Overall survival was immature at the time of the analysis (41% maturity with a hazard ratio of 0.75; 95% CI, 0.57-0.97).
In patients with brain metastases at baseline, 74% in the combination arm were free of CNS progression or death at 2 years vs 54% in the monotherapy group.
Adverse events were higher with the combination due to chemotherapy-related side effects. The most common adverse events with osimertinib plus chemotherapy, occurring in ≥ 20% of patients, 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, the same as in the trial.
M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@mdedge.com.
