ASCO, AstraZeneca, Author Interviews, Cancer Research, Lung Cancer, Yale / 13.06.2020
ASCO20: TAGRISSO® (osimertinib) as Adjuvant Therapy for EGFRm Non-Small Cell Lung Cancer
MedicalResearch.com Interview with:
Roy S. Herbst, MD, PhD
Ensign Professor of Medicine (Medical Oncology)
Professor of Pharmacology
Chief of Medical Oncology, Yale Cancer Center and
Smilow Cancer Hospital; Associate Cancer Center Director for Translational Research
Yale Cancer Center
MedicalResearch.com: What is the background for this study? What are the main findings?
- ADAURA is the first global trial for an EGFR tyrosine kinase inhibitor to show statistically significant and clinically meaningful benefit in adjuvant treatment of Stage IB, II, and IIIA EGFRm NSCLC. The results demonstrated unprecedented disease free survival (DFS) in the adjuvant treatment of these patients after complete tumor resection with curative intent. Osimertinib was assessed against placebo for a treatment duration of up to three years and then unblinded two years earlier than expected at the recommendation of the Independent Data Monitoring Committee (IDMC), based on its determination of overwhelming efficacy during a planned safety analysis.
- In the primary endpoint of DFS in patients with Stage II and IIIA disease, adjuvant (after surgery) treatment with osimertinib reduced the risk of disease recurrence or death by 83% (based on a hazard ratio [HR] of 0.17; 95% confidence interval [CI] 0.12, 0.23; p<0.0001).
- DFS results in the overall trial population, Stage IB through IIIA, a key secondary endpoint, demonstrated a reduction in the risk of disease recurrence or death of 79% (based on a HR of 0.21; 95% CI 0.16, 0.28; p<0.0001).