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Disease-Free Survival With Adjuvant Osimertinib in Resected EGFR-Mutant NSCLC: ADAURA Trial


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As reported in The New England Journal of Medicine by Wu et al, the phase III ADAURA trial has shown significantly prolonged disease-free survival with adjuvant osimertinib vs placebo in patients with resected EGFR-mutant non–small cell lung cancer (NSCLC). These findings were also presented during the Presidential Symposium at the ESMO Virtual Congress 2020 (Abstract LBA1).

Study Details

In the international double-blind trial, 682 patients with completely resected stage IB to IIIA disease were randomly assigned between November 2015 and February 2019 to receive osimertinib at 80 mg once daily (n = 339) or placebo (n = 343) for 3 years. Disease stage was IB in 212 patients (32% of each group), stage II in 236 (34% of each group), and stage IIIA in 234 (35% vs 34%). Overall, 60% of patients in each group received adjuvant chemotherapy. The primary endpoint was investigator-assessed disease-free survival among patients with stage II to IIIA disease. Secondary endpoints included disease-free survival in the overall population of patients with stage IB to IIIA disease and overall survival.

Disease-Free Survival

At 24 months, disease-free survival rates among patients with stage II to IIIA disease were 90% (95% confidence interval [CI] = 84%–93%) in the osimertinib group vs 44% (95% CI = 37%–51%) in the placebo group (hazard ratio [HR] = 0.17, 99.06% CI = 0.11–0.26, P < .001). Median disease-free survival was not reached (95% CI = 38.8 months–not estimable) in the osimertinib group vs 19.6 months (95% CI = 16.6–24.5 months) in the placebo group.

KEY POINTS

  • Disease-free survival was significantly prolonged with osimertinib vs placebo in patients with stage II to IIIA disease.
  • Disease-free survival was significantly prolonged with osimertinib in the total population.

At 24 months, disease-free survival rates in the overall population were 89% (95% CI = 85%–92%) in the osimertinib group vs 52% (95% CI = 46%–58%) in the placebo group (HR = 0.20, 99.12% CI = 0.14–0.30, P < .001). Median disease-free survival was not reached (95% CI = not estimable–not estimable) in the osimertinib group vs 27.5 months (95% CI = 22.0–35.0 months) in the placebo group.

The disease-free survival benefit of osimertinib was consistent across all predefined subgroups, including disease stages IB (HR = 0.39, 95% CI = 0.18–0.76), II (HR = 0.17, 95% CI = 0.08–0.31), and IIIA (HR = 0.12, 95% CI = 0.07–0.20); and use (HR = 0.16, 95% CI = 0.10–0.26) and no use (HR = 0.23, 95% CI = 0.13­–0.40) of adjuvant chemotherapy.

At 24 months, 98% (95% CI = 95%–99%) of patients in the osimertinib group vs 85% (95% CI = 80%–89%) of patients in the placebo group were alive without central nervous system (CNS)-related disease (HR for CNS disease recurrence or death = 0.18, 95% CI = 0.10–0.33).

Overall survival data were immature at time of analysis. As of data cutoff, death had occurred in 9 patients in the osimertinib group and 20 in the placebo group.

Adverse Events

The most common adverse events of any grade in the osimertinib group were diarrhea (46% vs 20% in placebo group), paronychia (25% vs 1%), and dry skin (23% vs 6%). Grade ≥ 3 adverse events occurred in 20% of patients in the osimertinib group and 13% of patients in the placebo group. Serious adverse events were reported in 16% vs 12% of patients. Adverse events led to discontinuation of treatment in 11% vs 3%. No fatal adverse events were reported in the osimertinib group; one fatal adverse event (pulmonary embolism) occurred in the placebo group.

The investigators concluded, “In patients with stage IB to IIIA EGFR mutation–positive NSCLC, disease-free survival was significantly longer among those who received osimertinib than among those who received placebo.”

Disclosure: The study was funded by AstraZeneca. For full disclosures of the study authors, visit nejm.org.

 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
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