medwireNews: Patients with stage IB–IIIA non-small-cell lung cancer (NSCLC) harboring EGFR mutations derive a significant disease-free survival (DFS) benefit from adjuvant treatment with osimertinib, shows the phase 3 ADAURA trial.
The third-generation EGFR–tyrosine kinase inhibitor was associated with a significant 79% reduction in the risk for relapse or death relative to placebo in these patients, reported Roy Herbst, from the Yale School of Medicine in New Haven, Connecticut, USA, at the virtual 2020 ASCO Annual Meeting.
Lecia Sequist explains why the ADAURA trial could be practice changing (5:17).
“Therefore, adjuvant osimertinib provides a highly effective, practice changing treatment for patients with stage IB/II/IIIA EGFR-mutation positive non-small-cell lung cancer after complete tumor resection,” he said in a press briefing.
The trial – which was unblinded early on the recommendation of the Independent Data Monitoring Committee – included 682 patients with either the EGFR exon 19 deletion or exon 21 L858R mutation. The patients were randomly assigned to receive osimertinib 80 mg/day or placebo for up to 3 years following complete resection.
The primary endpoint was DFS in patients with stage II and IIIA disease (69% in each group), and the risk for relapse or death was reduced by a significant 83% with osimertinib versus placebo, which Herbst said was “much better than expected.” The respective 2-year DFS rates were 90% and 44%.
The decreased risk associated with osimertinib treatment remained significant when all study participants, including those with stage IB disease, were considered, with a risk reduction of 79% and 2-year DFS rates of 89% and 53% for the osimertinib and placebo groups, respectively.
Herbst highlighted that the results were consistent across all subgroups, with patients deriving a DFS benefit from osimertinib treatment regardless of sex, age, race, disease stage, smoking status, EGFR mutation subtype, and receipt of adjuvant chemotherapy.
Additionally, osimertinib was “very well tolerated,” said the presenter, with low rates of grade 3–4 adverse events, mainly diarrhea and stomatitis, each of which occurred in 2% of osimertinib-treated participants.
He pointed out that prolonged QTc was observed in 7% of patients in the osimertinib group versus 1% of those in the placebo group, but Herbst pointed out that the adverse event was mostly low grade.
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