1448P First-line nivolumab (NIVO) plus ipilimumab (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

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. 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. 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, and 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). Table: 1448PPatient characteristics∗ (N = 256), n (%) unless notedAge group, years <66 66–75 >75120 (46.9) 102 (39.8) 33 (12.9)Smoking status Current Former Never98 (38.3) 111 (43.4) 28 (10.9)Eastern Cooperative Oncology Group performance status 0 1 2 374 (28.9) 142 (55.5) 26 (10.2) 5 (2.0)Number of metastases, median (range)2 (0–12)Histology Squamous Non-squamous89 (34.8) 163 (63.7)Metastasis stage M1a (contralateral lung) M1b/M1c (extrathoracic metastasis)39 (15.2) 173 (67.6)Metastasis site Brain Liver51 (19.9) 49 (19.1)Radiotherapy No/yes204 (79.7)/48 (18.8)Surgery No/yes208 (81.2)/44 (17.2)Systemic therapy/chemo No/yes/unknown217 (84.8)/33 (12.9)/2 (0.8)∗Excludes missing data. Open table in a new tab ∗Excludes missing data. The FINN study will describe patient characteristics, efficacy, safety profile, 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.