ADAURA: osimertinib demonstrates significant clinical benefit in adjuvant NSCLC therapy
The first interim results of the Phase III ADAURA study evaluating adjuvant osimertinib in stage IB-IIIA EGFR-mutated non-small cell lung cancer (NSCLC) were presented at the plenary session during the ASCO 2020 virtual meeting. Osimertinib was shown to improve disease-free survival by 90% in patients with stage II-IIIA EGFR-mutant NSCLC (NCT02511106).
Osimertinib is a third generation EGFR tyrosine kinase inhibitor (TKI) that is already approved by the U.S. Food and Drug Administration for the treatment of patients with metastatic EGFR 1790M mutation-positive NSCLC, based on results from the randomized, multicenter, open-label, AURA3 trial (NCT012151981).1 Osimertinib has shown greater efficacy compared to previous EGFR TKIs including erlotinib and gefitinib as evaluated in the FLAURA study (NCT02296125).2 Therefore, it is hoped that data from the ADAURA study will highlight the benefit of osimertinib in the adjuvant setting for NSCLC patients who have received complete surgical resection.
Patients (n = 682) with stage IB-IIIA NSCLC with EGFR exon 19 deletion or L858R mutations from the US, Asia and Europe were enrolled in the Phase III, double-blind, placebo-controlled trial and randomized 1:1 to receive either osimertinib (n = 339) or placebo (n = 343) after complete surgical resection. The primary endpoint of the study was disease-free survival (DFS) after three years of treatment. The DFS hazard ratio for patients with stage II-IIIA disease reported at ASCO was 0.17 (95% CI 0.12, 0.23); p<0.0001 (156/470 events); 2-year DFS rate was 90% with osimertinib compared with 44% in patients treated with the placebo. The percentage of patients with a 2-year DFS was lower (79%; 196/682 events) in the overall population (stage IB-IIIA disease).
“In this analysis, these results are just better than we could ever expect. It’s too early to really say much about survival, but as for disease-free survival, these patients have tremendous results when they are on osimertinib”Lead investigator of the ADAURA study, Roy Herbst, MD, PhD, of the Yale Cancer Center, New Haven, CT
Furthermore, the drug was found to be well tolerated by patients, with typical grade 1 and 2 toxicities associated with EGFR inhibitor use, such as rash and diarrhea. Additionally, there were no deaths as a result of interstitial lung disease.
The results of the ADAURA study are promising, with a meaningful and significant clinical benefit in disease-free survival for EGFR-mutated NSCLC patients after complete tumor resection.
Written by Solyana Yohannes
- Mok T, Wu Y, Ahn M, Garassino M, Kim H, Ramalingam S et al. Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer. New England Journal of Medicine. 2017;376(7):629-640.
- Soria J, Ohe Y, Vansteenkiste J, Reungwetwattana T, Chewaskulyong B, Lee K et al. Osimertinib in UntreatedEGFR-Mutated Advanced Non–Small-Cell Lung Cancer. New England Journal of Medicine. 2018;378(2):113-125.