Final Overall Survival (Os) and Safety Analysis of the Phase 3 Alex Study of Alectinib Vs Crizotinib in Patients with Previously Untreated, Advanced Alk-Positive (Alk Plus ) Non-Small Cell Lung Cancer (Nsclc)
Recommended Citation
Buchmeier EL, Mok T, Camidge D, Dziadziuszko R, Gadgeel S, Shaw AT, Kim D, Perol M, Rosell R, Cheema P, Lim D, Lin JJ, Pavlakis N, Seok Ahn J, Zhang L, Henschel V, Higgerson A, McNally V, Lohmann TO, Smoljanovic V, Peters S. Final Overall Survival (Os) and Safety Analysis of the Phase 3 Alex Study of Alectinib Vs Crizotinib in Patients with Previously Untreated, Advanced Alk-Positive (Alk Plus ) Non-Small Cell Lung Cancer (Nsclc). Oncol Res Treat 2026; 49(Suppl. 1):288-289.
Document Type
Conference Proceeding
Publication Date
2-13-2026
Publication Title
Oncol Res Treat
Keywords
Oncology
Abstract
Background: Results from ALEX (NCT02075840), a randomised phase 3 study, led to the global approval of first-line (1L) alectinib in patients (pts) with advanced ALK+ NSCLC. Final PFS data from ALEX were previously published (median 34.8 months alectinib; 10.9 months crizotinib); OS was immature. Here, we report final OS, duration of response (DoR) and safety data from ALEX. Methods: Eligible pts ≥ 18 years old with previously untreated, advanced ALK+ NSCLC were randomised 1:1 to receive alectinib (600 mg; BID) or crizotinib (250 mg; BID) until disease progression (PD), toxicity, withdrawal or death; no crossover was permitted before PD. Stratification factors: ECOG performance status (0/1 vs 2); race (Asian vs non-Asian); baseline CNS mets (yes vs no). Key secondary endpoints: OS; DoR; safety. Results: At data cutoff (April 28, 2025), 303 pts were enrolled (alectinib, n=152; crizotinib, n=151). After median follow-ups of 53.5 (alectinib) and 23.3 months (crizotinib), median OS (mOS) was 81.1 (95% CI 62.3–NE) and 54.2 months (95% CI 34.6–75.6), respectively. In pts with baseline CNS mets and prior radiation, mOS was 92.0 months with alectinib vs 39.5 months with crizotinib; in pts with baseline CNS mets and no prior radiation, mOS was 46.9 vs 23.7 months, and in pts without baseline CNS mets, mOS was 94.0 vs 69.8 months, respectively. Median DoR was 42.3 months (alectinib) vs 11.1 months (crizotinib). Median treatment duration was 28.1 vs 10.8 months. No new or unexpected safety concerns were reported. Discussion: Final data from ALEX show 1L alectinib induced a clinically meaningful OS benefit (regardless of baseline CNS mets status) and DoR compared with crizotinib in pts with previously untreated, advanced ALK+ NSCLC. Safety data were in line with the known safety profile of alectinib. Conclusion: These data continue to support 1L alectinib as a standard of care in pts with advanced ALK+ NSCLC.
Volume
49
Issue
Suppl. 1
First Page
288
Last Page
289
