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

 

Results:

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.

 

Conclusion:

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.

 

Commentary:

They published outstanding results. You don't see so often in oncology. ADAURA trial sets a new standard of treatment in adjuvant EGFR NSCLC.

Note: The therapeutics segment is experiencing significant NSCLC clinical trial activity, which is further expected to drive Non-Small Cell Lung Caner market growth in the coming years.

Refer to Non Small Cell Lung Cancer Market report for detailed Insights.