Abstract 6655: A real world analysis: Impact of clinical trial eligibility criteria on clinical outcomes among patients with advanced non-small cell lung cancer (aNSCLC) receiving second line (2L) immune checkpoint inhibitor (ICI) therapy
Authors: Mohammed Hina , Kim Miso , Teka Mahder , Izano Monika , Wolf Frank , Brown Thomas 
Published: April 2023

Abstract
Background. Clinical trials (CT) include patients (pts) satisfying eligibility criteria including normal organ function and low comorbidity. Real-world outcomes for pts with aNSCLC receiving ICIs in 2L were compared based on whether pts met CT eligibility criteria.
Methods. 2L- associated outcomes were compared between pts with aNSCLC diagnosed between 04/01/2015 - 12/31/2020 in US community health systems that fulfilled or failed to fulfill CT eligibility criteria. CT-eligible (CTE) pts had at 2L: performance status of 0-1; normal renal, hepatic, and bone marrow function; no evidence of Hepatitis B or C, HIV, rheumatic diseases, or interstitial lung disease. Pts were CT-ineligible (CTI) if they failed to meet one or more of these criteria. Follow-up spanned 2L start to the first of: outcome of interest, death, or study end on 06/30/2021. Outcomes were evaluated in pts receiving ICI monotherapy (monotherapy) or ICI + chemotherapy (combination).
Results. Of the 505 pts in this analysis, 81% and 19% received monotherapy and combination, respectively; 19% of pts were CTE (76% monotherapy, 24% combination, Table). Overall, in ICI subgroups among monotherapy pts, pembrolizumab-treated pts had longer OS and TTNT; time to treatment discontinuation (TTD) was less variable across subgroups. CTE pts in the monotherapy group had longer OS, shorter TTNT, and similar TTD compared to CTI. Among combination pts, CTE had similar OS and TTD, but shorter TTNT compared to CTI.
Conclusions. CTE pts appear to have longer survival than CTI pts with aNSCLC receiving ICI monotherapy, but not among pts receiving combination. TTNT was longer for CTI pts in both groups. In addition to CTE pts, some CTI pts appear to benefit from 2L ICI therapy.
Time-to-event outcomes (months), median (95% CI) in the study cohort Monotherapy (N = 412) Monotherapy (N = 412) Monotherapy (N = 412) Monotherapy (N = 412) Combination (N = 93) Combination (N = 93) Combination (N = 93) Combination (N = 93) N (%) OS TTNT TTD N (%) OS TTNT TTD Atezolizumab 37 (9%) 7 (3-16) 9 (7-NA) 2 (1-3) 9 (10%) 6 (5-NA) NA (5-NA) 2 (1-NA) Nivolumab 234 (57%) 14 (9-18) 20 (15-NA) 2 (2-3) 9 (10%) 36 (6-NA) 23 (6-NA) 5 (3-NA) Pembrolizumab 138 (34%) 20 (16-28) NA (31-NA) 2 (1-3) 75 (80%) 12 (8-NA) 20 (15-NA) 1 (1-3) Overall - 15 (13-18) 23 (18-NA) 2 (2-2) - 11 (7-NA) 20 (10-NA) 2 (1-3) Trial-Eligible (all regimens) 72 (18%) 20 (12-NA) 19 (10-NA) 2 (2-3) 23 (25%) 11 (5-NA) 10 (7-NA) 3 (1-6) Trial-Ineligible(all regimens) 292 (70%) 13 (8-16) 26 (18-NA) 2 (2-2) 64 (69%) 11 (7-NA) 20 (9-NA) 2 (1-3) Unknown Trial Eligibility 47 (12%) - - - 6 (6%) - - -
Citation Format: Hina Mohammed, Miso Kim, Mahder Teka, Monika Izano, Frank Wolf, Thomas Brown. A real world analysis: Impact of clinical trial eligibility criteria on clinical outcomes among patients with advanced non-small cell lung cancer (aNSCLC) receiving second line (2L) immune checkpoint inhibitor (ICI) therapy [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 6655.