Adjuvant Osimertinib Significantly Improved Overall Survival Among Patients With EGFR-Mutated NSCLC

Final Analysis of the Phase 3 ADAURA Trial

According to final analysis of the phase 3, double-blind ADAURA trial, adjuvant osimertinib significantly improved overall survival (OS) among patients with completely resected, EGFR-mutated, stage 1B to 2A non-small cell lung cancer (NSCLC), with a similar safety profile as seen in the primary analysis.

As determined previously by primary analysis, administration of adjuvant osimertinib with or without the addition of previous adjuvant chemotherapy significantly lengthened disease-free survival compared to placebo.

In this phase 3 trial, there were 682 patients were randomized on a 1-to-1 basis to receive either 80 mg osimertinib once daily (n = 339) or placebo (n = 343) until disease recurrence, completion of trial regimen at 3 years, or discontinuation criteria was met. In this planned final analysis, researchers aimed to determine safety and OS of adjuvant osimertinib alone compared to placebo.

At a follow up of 5 years, patients with stage 2 to 3A disease experienced an OS of 85% in the osimertinib arm and 73% in the placebo arm (hazard ratio [HR] for death, 0.49; 95.03% confidence interval [CI] 0.33 to 0.73; P < .001). In the overall population, patients experienced an OS of 88% in the osimertinib arm and 78% in the placebo arm (HR for death 0.49; 95.03% CI, 0.34 to 0.70; P < .001).

While adjuvant osimertinib displayed a safety profile consistent with that of primary analysis results, researchers identified 1 new serious adverse event of pneumonia related to COVID-19 after the previously published data-cutoff point. Despite this, investigators did not believe the event was related to the trial regimen and the patient fully recovered.

Study authors concluded, “Adjuvant osimertinib provided a significant overall survival benefit among patients with completely resected, EGFR-mutated, stage IB to IIIA NSCLC.”

Source:

Tsuboi M, Herbst RS, John T, et al. Overall survival with osimertinib in resected EGFR-mutated NSCLC. N Engl J Med. Published online June 4, 2023. doi:10.1056/NEJMoa2304594