Osimertinib in Treatment of EGFR-Mutated NSCLC: From the ADAURA Trial
Posted: Monday, December 14, 2020
Patients with resected stage IB to IIIA EGFR-mutated non–small cell lung cancer (NSCLC) appeared to derive a disease-free survival benefit from treatment with the third-generation EGFR tyrosine kinase inhibitor osimertinib, according to Roy S. Herbst, MD, PhD, of the Yale Cancer Center, New Haven, Connecticut, and colleagues. The results of the phase III ADAURA trial were published in The New England Journal of Medicine.
“Osimertinib is standard-of-care therapy for previously untreated EGFR mutation–positive advanced NSCLC,” the investigators remarked. “The efficacy and safety of osimertinib as adjuvant therapy are unknown.”
In a 1:1 allocation ratio, a total of 682 patients with completely resected EGFR-mutated NSCLC were randomly assigned to receive either 80 mg of osimertinib daily (n = 339) or a placebo (n = 343) for 3 years. According to the investigators, 90% of the patients with stage II to IIIA disease in the experimental group and 44% of those in the placebo group were alive and disease-free at 24 months (P < .001). In the overall population, more patients in the experimental group were alive and disease-free at 24 months than those in the placebo group (89% vs. 52%; P < .001). At 24 months, the majority of patients in the experimental (98%) and placebo (85%) groups were alive and did not have central nervous system disease.
The study remains immature for overall survival analysis. A total of 9 and 20 deaths were reported in the experimental and placebo groups, respectively. The safety profile of osimertinib appeared to be congruent with previous reports.
“Future considerations for the ADAURA trial include subsequent treatment, longitudinal assessment of minimal residual disease, and acquired resistance mechanisms at relapse,” the investigators commented.
Disclosure: For full disclosures of the study authors, visit www.nejm.org.