Osimertinib extends survival in early EGFR-mutated non-small cell lung cancer
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Osimertinib conferred a statistically significant and clinically meaningful improvement in OS compared with placebo among patients with early-stage EGFR-mutated non-small cell lung cancer, according to the agent’s manufacturer.
Results of randomized, phase 3 ADAURA trial showed the survival benefit with osimertinib (Tagrisso, AstraZeneca), a third-generation, irreversible EGFR tyrosine kinase inhibitor, among patients who underwent complete tumor resection with curative intent.
The ADAURA trial included 682 patients with stage IB, stage II or stage IIIA EGFR-mutated NSCLC who received adjuvant treatment with 80 mg osimertinib orally once a day or placebo for 3 years or until disease recurrence.
DFS among patients with stage II and stage IIIA disease served as the primary endpoint. Key secondary endpoints included DFS among stage IB, stage II and stage IIIA patients, as well as OS in both the primary and overall populations.
Results released in September showed median DFS of nearly 5 and a half years, according to an AstraZeneca press release.
“These new survival data for osimertinib reinforce the unprecedented ADAURA disease-free survival results and confirm its potential to extend patients’ lives in early-stage disease,” Roy S. Herbst, MD, PhD, deputy director and chief of medical oncology at Yale Cancer Center and principal investigator in the ADAURA trial, said in a press release. “The ADAURA results provide powerful evidence that osimertinib offers the best possible care for patients with early-stage EGFR-mutated non-small cell lung cancer who historically faced high rates of recurrence and previously had no targeted options after surgery.”
The safety and tolerability of osimertinib appeared consistent with the established profile, with no new safety concerns identified.
AstraZeneca also reported positive results of the randomized, phase 3 AEGEAN trial, which is examining the anti-PD-L1 antibody durvalumab (Imfinzi, AstraZeneca) in combination with neoadjuvant chemotherapy and as adjuvant monotherapy vs. and neoadjuvant chemotherapy and surgery alone for patients with resectable stage IIA to stage IIIB NSCLC. Findings from a planned interim analysis of the trial showed a statistically significant and clinically meaningful improvement in EFS with the durvalumab regimen. Key secondary endpoints of OS and DFS will be assessed as the trial continues, according to a press release.
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