WCLC 2025 - Posters & ePosters-P1.17.57 Estimates of Clinical Endpoints in Matched Patients Between the French Cancer Cohort (FCC) and Durvalumab Stage III NSCLC Eap

P1.17.57 Estimates of Clinical Endpoints in Matched Patients Between the French Cancer Cohort (FCC) and Durvalumab Stage III NSCLC Eap

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This study assesses the comparability of clinical outcomes between the French Cancer Cohort (FCC)—a national health claims database extract—and an Early Access Program (EAP) follow-up study involving durvalumab-treated stage III unresectable non-small cell lung cancer (NSCLC) patients in France. The objective was to evaluate whether FCC data can substitute EAP follow-up for estimating overall survival (OS) and treatment duration, and whether time to first subsequent therapy or death (TFST) from FCC can act as a surrogate for progression-free survival (PFS).<br /><br />Using deterministic linkage, 278 matched patients treated with durvalumab between October 2017 and December 2018 were analyzed from both data sources. Clinical outcomes were measured from the first durvalumab dose until last contact in EAP or November 30, 2020, in FCC. OS rates at one and two years were nearly identical in both cohorts: 87.1% and ~71%, respectively, confirming concordance and validating FCC's reliability to document real-world OS. Median treatment duration was longer in EAP (328.5 days) compared to FCC (295 days), possibly due to underreporting in FCC of free-of-charge or compassionate use treatments.<br /><br />However, TFST rates from FCC, though close to EAP's PFS at two years, showed inconsistencies and numerous discordances in therapy dates, limiting TFST’s utility as a PFS proxy in claims data. The linkage achieved an 81.4% match rate, with limited discrepancies in treatment dates.<br /><br />In conclusion, FCC data effectively estimates OS in real-world durvalumab use but may underestimate treatment duration. TFST from health claims cannot currently replace PFS assessment. Longer follow-up studies are recommended for further evaluation. This linkage approach supports French health technology assessment practices integrating real-world evidence from early access programs and national claims databases.

Asset Subtitle

CHARKAOUI Icherak

Meta Tag

Speaker CHARKAOUI Icherak

Topic Global Health, Health Services, and Health Economics

Keywords

French Cancer Cohort

Early Access Program

durvalumab

stage III unresectable non-small cell lung cancer

overall survival

treatment duration

time to first subsequent therapy or death

progression-free survival

deterministic linkage

real-world evidence