Adjuvant osimertinib shows ‘overwhelming efficacy’ for EGFR-mutated lung cancer
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Osimertinib demonstrated “overwhelming efficacy” for the adjuvant treatment of patients with stage IB, II and IIIA epidermal growth factor receptor-mutated non-small cell lung cancer after complete tumor resection, according to a press release issued by the agent’s manufacturer.
Results of the phase 3 ADAURA trial prompted an independent data monitoring committee to recommend the trial be unblinded sooner than anticipated.
Osimertinib (Tagrisso, AstraZeneca) — a third-generation, irreversible, EGFR-directed tyrosine kinase inhibitor — inhibits both EGFR-sensitizing and EGFR T790M-resistance mutations.
The double-blind, randomized, placebo-controlled, multicenter ADAURA study is designed to assess the safety and efficacy of adjuvant osimertinib among 682 patients with EGFR-mutated NSCLC after complete tumor resection.
Researchers assigned patients to 80 mg once-daily osimertinib or placebo for up to 3 years.
DFS serves as the trial’s primary endpoint.
The study will continue so the secondary endpoint of OS can be evaluated. The trial’s independent data monitoring committee did not report any new safety concerns.
The trial is the first of its kind to demonstrate a statistically significant and clinically meaningful benefit of an EGFR inhibitor in the adjuvant treatment of lung cancer, according to the press release.
Complete results will be presented at an upcoming medical meeting.
"We are thrilled by the recommendation to unblind the phase 3 ADAURA trial much earlier than expected and are incredibly excited with these unprecedented results in patients with early-stage EGFR-mutated NSCLC,” José Baselga, MD, PhD, executive vice president for oncology research and development at AstraZeneca, said in the release. “Lung cancer is a devastating diagnosis and for the first time an EGFR-targeted medicine can now provide the hope of cure."
Osimertinib has been approved in the United States for first-line treatment of EGFR-mutated advanced NSCLC and second-line treatment of EGFR T790M mutation-positive advanced NSCLC.