First-line nivolumab (NIVO) plus ipilmumab (IPI) with two cycles of chemotherapy in patients with metastatic non-small cell lung cancer (NSCLC): Results from an interim analysis of the non-interventional FINN study

Background The CheckMate 9LA study showed that NIVO + IPI with 2 cycles of chemotherapy (chemo) vs chemo alone significantly improved overall survival (OS) for patients (pts) with metastatic NSCLC. The FINN real-world study (NCT04794010) aims to evaluate this regimen in clinical practice in Germany.

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Methods Enrollment for the prospective, observational study is ongoing, with 90 sites and 650 pts planned in Germany. Pts ≥18 years old with metastatic NSCLC are eligible if they began first-line NIVO + IPI with 2 cycles of chemo according to the approved EMA label. During the planned ≤5-year follow-up period (from treatment [tx] initiation until death, withdrawal of consent, loss of follow-up, or end of study), assessments will be conducted per routine local clinical practice. The primary endpoint is OS. Secondary endpoints include progression-free survival, tx duration, patient characteristics, and safety.

Results At the interim analysis (Jan 31, 2023), 256 pts were enrolled (median follow-up duration: 5.6 months). Median (range) age was 67 (43–86) years and 60.9% were male. Other patient characteristics are presented (Table). Tx-related adverse events (AEs) of all grades occurred in 53.9% of pts; tx-related severe AEs occurred in 17.6% of pts. There was 1 tx-related death from immune-mediated hepatitis. We will present an update of the data with longer follow-up (data cutoff July 2023).

Conclusions The FINN study will describe patient characteristics, efficacy, safety, and tx patterns of first-line NIVO + IPI with 2 cycles of chemo in clinical practice in Germany. At interim analysis, pts had a manageable safety profile.

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Artikel online veröffentlicht:
01. März 2024