An exploratory analysis of the phase 3 ADAURA trial demonstrated that adjuvant osimertinib prolonged disease-free survival (DFS) regardless of prior adjuvant chemotherapy use and maintained quality of life among patients with EGFR-mutated non-small cell lung cancer (NSCLC), according to a press release.1
Previously reported results from the phase 3 trial (NCT02511106) demonstrated a 2-year DFS of 89% with adjuvant osimertinib compared with 52% with placebo.2
“This latest analysis shows the magnitude of that benefit is consistent with or without prior adjuvant chemotherapy, and regardless of disease stage, reinforcing the critical role of [osimertinib] in this setting,” principal investigator Yi-Long Wu, MD, FACS, of the Lung Cancer Institute at Guangdong Provincial People’s Hospital and Academy of Medical Sciences in China, said.1
The double-blind ADAURA study randomly assigned 682 patients with stage II to IIIA EGFR-mutated NSCLC to receive osimertinib monotherapy or placebo for a maximum of 3 years following complete resection of disease.2 The primary end point was DFS.
In this exploratory analysis, DFS was evaluated within the context of patients’ prior adjuvant chemotherapy use and disease stage.1 At baseline, 60% of patients across both arms had received prior adjuvant chemotherapy. Individuals younger than 70 years and those with more advanced disease were more likely to have received prior adjuvant chemotherapy.
DFS was found to be significantly prolonged with osimertinib compared with placebo among patients who had received prior adjuvant chemotherapy (HR, 0.16; 95% CI, 0.10-0.26) and those who had not (HR, 0.23; 95% CI, 0.13-0.40).
The DFS benefit with osimertinib was also present regardless of disease stage, with HRs ranging from 0.13 to 0.16 for patients who received prior chemotherapy and 0.10 to 0.38 among patients who did not.
A distinct exploratory post hoc analysis was also performed to examine patient-reported outcomes. Patient-reported outcomes demonstrated that osimertinib did not significantly affect quality of life in terms of physical or mental health measures vs placebo.
Grade 3 adverse events (AEs) occurred more frequently with osimertinib at 20% compared with 13% with placebo.
On December 18, 2020, osimertinib was approved as an adjuvant therapy for use after tumor resection in adults with EGFR exon 19 or exon 21 L858R-mutated NSCLC. The agent is also indicated for frontline use in this patient population.3
Disclosures: Some of the study authors disclosed financial relationships with the pharmaceutical industry and/or the medical device industry. For a full list of disclosures, please refer to the original study.
- TAGRISSO Extended Disease-Free Survival Regardless of Prior Adjuvant Chemotherapy in Early-Stage EGFR-Mutated Lung Cancer [press release]. AstraZeneca; January 29, 2021. Accessed February 9, 2021.
- Wu Y-L, Tsuboi M, He J, et al; ADAURA investigators. Osimertinib in resected EGFR-mutated non–small-cell lung cancer. N Engl J Med. 2020;383(18):1711-1723. doi:10.1056/NEJMoa2027071
- FDA approves osimertinib as adjuvant therapy for non-small cell lung cancer with EGFR mutations. FDA. Published December 18, 2020. Accessed February 9, 2021.