Dr. Herbst on the Approval of Adjuvant Osimertinib in EGFR+ NSCLC

Roy S. Herbst, MD, PhD, Ensign Professor of Medicine and professor of pharmacology, chief of medical oncology at Yale Cancer Center and Smilow Cancer Hospital, and associate cancer center director for Translational Research at Yale Cancer Center, discusses the approval of adjuvant osimertinib (Tagrisso) in EGFR-positive non–small cell lung cancer (NSCLC).

On December 18, 2020, the FDA approved osimertinib for use as an adjuvant treatment following tumor resection in patients with NSCLC whose tumors harbor EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. The approval was based on findings from the international, phase 3 ADAURA trial in which osimertinib induced a statistically significant improvement in disease-free survival (DFS) among patients with stage IB/II/IIIA disease. Osimertinib led to a 80% reduction in the risk of disease recurrence or death in this patient population and an 83% reduction in the risk of disease recurrence or death in patients with stage II to IIIA disease.

Although overall survival data are immature, osimertinib also demonstrated a significant reduction in central nervous system (CNS) disease compared with placebo. At 24 months, 98% of patients who received osimertinib were alive and did not have CNS disease versus 85% of patients who received placebo, concludes Herbst.