ASCO20: ‘Extraordinary’ Results With Adjuvant Osimertinib in Early-Stage EGFR-Mutant NSCLC
Posted: Monday, June 1, 2020
According to the first interim analysis of the phase III ADAURA trial, presented as a Plenary Session during the ASCO20 Virtual Scientific Program (Abstract LBA5), adjuvant osimertinib significantly improved disease-free survival compared with placebo in patients with stage IB to IIIA non–small cell lung cancer (NSCLC) who underwent complete resection of the primary tumor. “The disease-free survival results are extraordinary,” stated Roy S. Herbst, MD, PhD, of Yale Cancer Center, in an ASCO press release. “We can now treat patients earlier.”
The multinational study enrolled 682 patients with NSCLC. All participants had undergone complete resection of the primary tumor and received chemotherapy if indicated. Patients were randomly treated with osimertinib (n = 339) via an 80-mg tablet once daily for up to 3 years or a placebo (n = 343).
In patients with stage II to IIIA NSCLC, the median disease-free survival was not reached with osimertinib versus 20.4 months with placebo (hazard ratio = 0.17, P < .0001). Patients treated with osimertinib had a 2-year disease-free survival rate of 90%, whereas patients treated with placebo had a 44% 2-year disease-free survival. In the entire study population (including those with stage IB disease), the median disease-free survival was not yet reached with osimertinib versus 28.1 months with placebo (hazard ratio = 0.21; P < .0001). The 2-year disease-free survival rate was 89% with osimertinib and 53% with placebo. The authors noted overall survival statistics are as yet immature.
“Adjuvant osimertinib is the first targeted agent in a global trial to show a statistically significant and clinically meaningful improvement in disease-free survival in patients with stage IB/II/IIIA EGFR-mutant NSCLC after complete tumor resection and adjuvant chemotherapy, when indicated,” concluded the research team.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.