Osimertinib as adjuvant therapy in patients (pts) with stage IB–IIIA EGFR mutation positive (EGFRm) NSCLC after complete tumor resection: ADAURA.
Abstract No : LBA5
Abstract Type : Plenary Session, Sun, 1:00 PM-4:00 PM
Indication : Non-Small Cell Lung Cancer
Intervention : Osimertinib
Company : AstraZeneca
Technology : Small molecule
Globally, 682 pts were randomized to treatment: osimertinib n=339, PBO n=343. Baseline characteristics were balanced across arms (osimertinib/PBO): stage IB 31/31%, stage II/IIIA 69/69%, female 68/72%, ex19del 55/56%, L858R 45/44%. In stage II–IIIA pts, DFS hazard ratio (HR) was 0.17 (95% CI 0.12, 0.23); p,0.0001 (156/470 events); 2-year DFS rate was 90% with osimertinib vs 44% with PBO. In the overall population, DFS HR was 0.21 (0.16, 0.28); p,0.0001 (196/682 events); 2-year DFS rate was 89% with osimertinib vs 53% with PBO. OS was immature (4% maturity) with 29/682 deaths (osimertinib n=9, PBO n=20) at DCO. The safety profile was consistent with the known safety profile of osimertinib.
Adjuvant osimertinib is the 1st targeted agent in a global trial to show a statistically significant and clinically meaningful improvement in DFS in pts with stage IB/II/IIIA EGFRm NSCLC after complete tumor resection and adjuvant chemotherapy when indicated. Adjuvant osimertinib provides an effective new treatment strategy for these pts.
They published outstanding results. You don't see so often in oncology. ADAURA trial sets a new standard of treatment in adjuvant EGFR NSCLC.