NEJM Study Finds Osimertinib Exhibits 18.9 Months Progression-Free Survival vs. 10.2 Months With Standard Treatment for NSCLC Patients

By Mia Garchitorena
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Results from a phase III trial found that previously untreated patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) experienced significantly longer progression-free survival when taking osimertinib compared with standard treatment.

An international team of researchers published results from the phase III FLAURA trial, which analyzed the efficacy of the 80mg, once-daily oral medication osimertinib (TAGRISSO) compared with the standard treatment EGFR-tyrosine kinase inhibitors (TKIs), erlotinib or gefitinib. The study found that not only did the drug result in longer patient survival, but it also showed that osimertinib has the potential to become first-line treatment.

The study was published in the New England Journal of Medicine and presented at the European Society for Medical Oncology (ESMO) Asia 2017 Congress in Singapore.  


Osimertinib. (Source: PubChem)

“The results of the FLAURA trial may herald a shift in how we treat patients with EGFR-mutated NSCLC. The data demonstrate superiority of osimertinib compared to current standard EGFR-TKIs in the first-line setting,” Suresh S. Ramalingam, MD, principal investigator, professor of hematology and medical oncology, and director of the division of medical oncology at the Winship Cancer Institute at Emory University School of Medicine in Atlanta, said in a press release.

For the study, a total of 994 patients from 29 countries who were previously untreated for their EGFR-mutated NSCLC were screened from Dec. 2014 through March 2016. Two hundred and seventy-nine patients were randomly assigned osimertinib and 277 patients were randomly assigned standard EGFR-TKI treatment, according to the study.

All randomly assigned patients were given at least one dose of trial treatment, according to the study. Patients receiving osimertinib had a median treatment exposure duration of 16.2 months, while the median duration for patients receiving standard treatment was 11.5 months. Approximately 144 (51%) patients continued to receive osimertinib after the data cutoff and 64 (23%) patients continued to receive standard EGFR-TKI treatment, the study states.

Patients who received osimertinib experienced a median progression-free survival of 18.9 months while the standard EGFR-TKI treatment group experienced 10.2 months of progression-free survival. The median follow-up progression-free survival among the osimertinib group was 15.0 months and 9.7 months for the standard treatment group. The osimertinib group also had a 54% lower risk of disease progression or death than the standard treatment group, according to the study.

Adverse events occurred less in the osimertinib group than the standard therapy group (34% vs. 45%). The most common adverse events that occurred were rash or acne, diarrhea, and dry skin. More serious adverse events included cardiac events (10% with osimertinib, 5% with standard treatment), interstitial lung disease (4% with osimertinib, 2% with standard).

A total of 6 patients died in the osimertinib group (pneumonia, respiratory tract infection, cerebral infarction, myocardial infarction, pulmonary embolism, and intestinal ischemia). However, according to the authors, none of the fatal adverse events were considered related to osimertinib. A total of 10 patients died in the standard EGFR-TKI group, with one incident of diarrhea possibly being related to a patient death.

Despite these findings, the researchers state that these results show that osimertinib is a beneficial treatment for patients with untreated EGFR-mutated NSCLC.

“Osimertinib treatment resulted in longer progression-free survival than did current standard first-line therapy for EGFR mutation-positive NSCLC, with a similar safety profile,” the authors state.