105P Interim data on first-line (1L) nivolumab (N) + ipilimumab (I) with 2 cycles of platinum-based chemotherapy (C) in patients (pts) with metastatic non-small cell lung cancer (mNSCLC) from the German non-interventional study (NIS) FINN
Methods: Adult (18 y) patients (pts) with incident advanced NSCLC receiving 1 TKI prescription (2018)(2019)(2020)(2021)(2022)(2023) were identified from hospital discharge records, outpatient care and pharmacy claims.Pts were classified into a TKI cohort or an ICI-TKI cohort based on treatment sequencing.No causal comparisons were intended; AEs incidence was descriptively assessed.Severe AEs were defined by 1 related hospitalization, while chronic AEs were defined as AE-related medication or procedures lasting 3 months.Results: A total of 12,477 pts constituted the TKI cohort (mean age 68.1 y [SD 12.5]; 35.0 % male) and 896 the ICI-TKI cohort (64.4 y [SD10.2];49.7% male).The incidence of severe pneumonitis was higher in the ICI-TKI cohort (6.1% vs 3.7%), whereas chronic pneumonitis rates were similar (2.5% vs 2.4%).Severe gastrointestinal (GI) AEs occurred in 1.9% and 2.0% in the ICI-TKI and TKI cohorts, respectively, while chronic GI AEs were uncommon (0.76% vs <0.1%).Severe psychiatric (psy) AEs were rare in both cohorts (0.6% vs 0.5%), whereas chronic psy AEs were more frequent in the ICI-TKI cohort (3.5% vs 2.4%). Conclusions:In this nationwide descriptive cohort, severe pneumonitis occurred almost twice as frequently in the ICI-TKI cohort, consistent with published data.No signal of GI AEs was observed when sequencing TKIs after ICIs.As expected, prior ICIs exposure did not increase the burden of chronic toxicity overall.The higher incidence of chronic psy AEs in the ICI-TKI cohort represents a previously underreported realworld finding that warrants further investigation.Exploratory analysis by TKI class is ongoing.
Authors
- M.K. Welslau
- D. Waldenberger
- Matthias Groschek
- Tobias Bluhmki (ORCID: https://orcid.org/0000-0003-2625-4167)
- Stephan Kreher (ORCID: https://orcid.org/0000-0002-8948-8297)
- A. Althoff
- Carsten Ziske
- J.B. Kuon
- Auguste Hassler (ORCID: https://orcid.org/0000-0003-3004-4680)
- S Gütz
- Michael P. Link
- G. Hübner
- D. Flieger
- S. Wilop
- D.M. Behringer
- C. Schumann
- E. von der Heyde
- W. Blau
- P. Sadjadian
- I. Dittrich
Institutions
- Bristol-Myers Squibb (Germany) (DE)
- Helios Dr. Horst Schmidt Kliniken Wiesbaden (DE)
- Beilstein-Institut (DE)
- Löwenstein Medical (Germany) (DE)
- Ortenau Klinikum (DE)
- Gesellschaft für Klinische Forschung (DE)
- St. Elisabeth-Krankenhaus Leipzig (DE)
- Accadis Hochschule Bad Homburg (DE)
- Klinikum Aschaffenburg (DE)
- Liebherr (Germany) (DE)
- Klinikverbund Südwest (DE)
- Augusta-Kranken-Anstalt (DE)
- DRK Kliniken Berlin (DE)
- Sana Klinikum Offenbach (DE)
- Bethlehem Gesundheitszentrum Stolberg (DE)
- Johannes Wesling Klinikum Minden (DE)
Publication Details
- Journal
- ESMO Open
- Published
- 2026-03-17
- DOI
- https://doi.org/10.1016/j.esmoop.2026.106412
- Primary Topic
- Cancer Immunotherapy and Biomarkers
- Type
- article
- Field-Weighted Citation Impact
- 0.00