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Abstract Background: The real-world survival outcomes of first-line (1L) immunotherapy (IO) -based regimens for the treatment of advanced non-small cell lung cancer (aNSCLC) were assessed utilizing the Flatiron Health database from January 2011 to June 2023. Methods: Adult patients (pts) with aNSCLC receiving 1L IO monotherapy or single-agent IO + chemotherapy on or after January 1, 2016, were identified. Pts were excluded if they had EGFR/ALK mutations or unknown histological type. Overall survival (OS) and real-world progression-free survival (rwPFS) of 1L IO monotherapy and IO + chemotherapy were described using Kaplan-Meier analyses. Results: A total of 14, 320 pts were included (5, 166 pts receiving IO monotherapy; 9, 154 pts receiving IO + chemotherapy). Among pts receiving IO monotherapy, the 1-, 2-, 3-, and 4-year OS rates were 52. 3%, 36. 5%, 27. 4%, and 21. 9%, respectively. The corresponding rwPFS rates were 29. 2%, 17. 5%, 12. 7%, and 9. 2%. Among pts receiving IO + chemotherapy, the 1-, 2-, 3-, and 4-year OS rates were 50. 7%, 32. 6%, 23. 9%, and 19. 2%. The corresponding rwPFS rates were 27. 0%, 15. 1%, 10. 3%, and 7. 8%. Table 1 presents the 4-year OS and rwPFS rates stratified by histological type, tumor programmed death ligand 1 (PD-L1) expression level, and Eastern Cooperative Oncology Group (ECOG) performance status. Patients with lower PD-L1 expression level (1%), worse ECOG performance status (≥2), and squamous cell carcinoma had worse survival outcomes, regardless of the type of 1L treatment received. Conclusions: The real-world survival rates for patients with aNSCLC who were treated with 1L IO-based regimens were lower than those observed in pivotal trials, which indicates an unmet need for the management of newly-diagnosed aNSCLC. However, on average approximately 1 in 11 pts receiving IO monotherapy and 1 in 13 pts receiving IO + chemotherapy remained progression-free at the four year landmark and achieved an extended period of survival. Table: 4-year OS and rwPFS rates 1L IO monotherapy 1L IO + chemotherapy PD-L1 1% PD-L1 ≥1-49% PD-L1 ≥50% PD-L1 1% PD-L1 ≥1-49% PD-L1 ≥50% OS by histological type (sample size; 4-year rate, %) Squamous 122; 12. 7 329; 14. 0 814; 15. 1 585; 11. 7 647; 15. 1 295; 23. 3 Non-squamous 231; 16. 7 516; 20. 0 2563; 26. 3 2263; 14. 9 2058; 20. 8 1313; 28. 9 OS by ECOG performance status (sample size; 4-year rate, %) 0-1 193; 17. 0 439; 20. 8 1880; 27. 6 1852; 16. 8 1802; 21. 9 1065; 28. 0 ≥2 89; 6. 7 261; 14. 5 840; 12. 7 478; 5. 6 452; 11. 1 241; 22. 8 rwPFS by histological type (sample size; 4-year rate, %) Squamous 122; 7. 6 329; 4. 4 814; 6. 8 585; 5. 2 647; 8. 3 295; 9. 2 Non-squamous 231; 5. 1 516; 10. 0 2563; 11. 2 2263; 4. 3 2058; 6. 3 1313; 14. 7 rwPFS by ECOG performance status (sample size; 4-year rate, %) 0-1 193; 6. 9 439; 10. 4 1880; 11. 9 1852; 5. 4 1802; 6. 8 1065; 14. 5 ≥2 89; NA 261; 3. 7 840; 5. 0 478; 2. 2 452; 3. 9 241; 8. 2 Citation Format: David Waterhouse, Saurabh Ray, Keith A. Betts, Sophie Gao, Yong Yuan, Manasvi Sundar, Shumin Rui, David Stenehjem. Real-world long-term survival outcomes of first-line immunotherapy-based regimens in advanced non-small cell lung cancer abstract. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts) ; 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84 (6Suppl): Abstract nr 3819.
Waterhouse et al. (Fri,) studied this question.