Abstract 1105P
Background
ICIs are the standard of care for aNSCLC with PD-L1 ≥50%, with trials reporting median survival of ≥20 months. Here, we describe outcomes in RW pts initiating 1L ICIs including a subgroup meeting key ICI pivotal trial eligibility criteria.
Methods
A retrospective cohort study using the Flatiron Health nationwide de-identified electronic health record-derived aNSCLC database (2018/01/01–2021/07/31) was conducted. Pts initiating 1L ICI ± chemo with PD-L1 ≥50% without ALK/EGFR/ROS1 alterations and a “trial-like” subgroup with ECOG 0–1, adequate organ function, and no brain metastases/other cancers were identified. Progression free survival (PFS) and overall survival (OS) were estimated using Kaplan–Meier methods. Cox proportional hazard models were used to examine the association between ICI regimen and OS stratified by PD-L1 level in the overall cohort, adjusting for demographic and baseline clinical factors.
Results
A total of 2631 pts with aNSCLC initiating ICI + chemo (n=992) or ICI monotherapy (mono; n=1639) were included; median (Q1–Q3) age was 71 (63–78) years and 51.6% were male; 1029 were trial-like. The trial-like pts generally had better outcomes vs the overall cohort; those receiving ICI + chemo had longer median OS vs ICI mono (Table). In multivariable analyses, there was no association (HR: 95%CI) between ICI regimen and OS among pts with PD-L1 70–89% (1.1 [0.9–1.4]) or 90–100% (1.1 [0.9–1.3]), but pts with PD-L1 50–69% treated with ICI + chemo had longer OS (1.3 [1.1–1.7]). Table: 1105P
Outcomes following 1L ICI for aNSCLC with PD-L1 expression 50%
| PD-L1 level, % | 1L therapy | Median (95%CI), months | |||||
| Overall | Trial-like | ||||||
| N | PFS | OS | N | PFS | OS | ||
| All, ≥50 | ICI mono | 1639 | 5 (5-6) | 13 (12-15) | 605 | 6 (5-7) | 18 (15-21) |
| ICI+chemo | 992 | 7 (7-8) | 17 (14-19) | 424 | 8 (7-9) | 19 (16-22) | |
| 50-69 | ICI mono | 199 | 4 (3-5) | 11 (8-13) | 133 | 5 (4-7) | 15 (10-19) |
| ICI+chemo | 124 | 7 (5-7) | 15 (11-20) | 104 | 6 (5-8) | 16 (11-21) | |
| 70-89 | ICI mono | 651 | 5 (4-6) | 13 (11-15) | 163 | 6 (4-8) | 17 (13-23) |
| ICI+chemo | 423 | 7 (6-8) | 13 (10-19) | 127 | 7 (6-11) | 20 (11-28) | |
| 90-100 | ICI mono | 789 | 6 (6-8) | 18 (13-21) | 309 | 7 (6-9) | 21 (16-26) |
| ICI+chemo | 445 | 9 (8-10) | 19 (16-23) | 193 | 10 (8-13) | 22 (16-27) |
Conclusions
Our findings suggest that outcomes in RW trial-like pts approach those reported in key pivotal ICI trials in high expressors and ICI mono may offer a potential alternative in those with PD-L1 levels ≥70%, while ICI + chemo may benefit those 50–69%. Further evaluation is warranted due to limitations of observational research.
Clinical trial identification
Editorial acknowledgement
Editorial support was provided by Daniel Himmel, PhD, of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc, and Sanofi.
Legal entity responsible for the study
Regeneron Pharmaceuticals, Inc., and Sanofi.
Funding
Regeneron Pharmaceuticals, Inc., and Sanofi.
Disclosure
W. Ge, N. Wu, R. Quek, J.J. Jalbert, P. Rietschel: Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc. J. Liu: Financial Interests, Personal, Full or part-time Employment: Genesis Research, LLC. J. Feliciano: Financial Interests, Personal, Research Grant: AstraZeneca, Bristol-Myers Squibb, Pfizer; Financial Interests, Personal, Advisory Role: AstraZeneca, Coherus, Eli Lilly, Genentech, Merck, Regeneron Pharmaceuticals Inc., Takeda. J. Harnett: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. All other authors have declared no conflicts of interest.
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