Abstract 42P
Background
In CheckMate 9LA, 1L N + I + C significantly improved overall survival (OS) vs C alone in pts with mNSCLC. The NIS FINN aims to evaluate this treatment (tx) in clinical practice in Germany. Previous interim data (15 Jun 2024) from 348 pts were reported. Here, we report baseline (BL) characteristics and updated effectiveness (progression-free survival [PFS]) and safety data for 489 pts (database lock: 7 Nov 2024).
Methods
Enrollment for the prospective NIS FINN is complete, with 652 pts from 90 sites enrolled in Germany. Adults with mNSCLC were eligible if the decision to initiate 1L N + I + C per the approved label had been made. In the ≤5 y follow-up (f/u) period (from tx start until death, withdrawal of consent, loss to f/u, or end of study), pts were assessed per routine local clinical practice. Primary endpoint: OS. Secondary endpoints included BL characteristics, tx duration, PFS, and safety.
Results
Among enrolled pts (N=489), the median age was 67 (range 43–86) y; 44.0%, 41.1%, and 14.9% of pts were 75 y old, respectively. Most pts were current/formersmokers (81.8%) and had ECOGPS 0–1 (85.3%); 62.2% of pts were male, 62.2% had non-squamous histology, 49.3% had tumor PD-L1
Conclusions
The NIS FINN helps address an unmet need for real-world insights on 1L N + I + C in mNSCLC. At interim analysis, pt characteristics were reflective of clinical practice. Results on effectiveness were consistent with the results from CheckMate 9LA.
Clinical trial identification
NCT04794010.
Editorial acknowledgement
Writing and editorial assistance was provided by Vidya Rajagopalan, PhD, of Evidence Scientific Solutions Inc., funded by Bristol Myers Squibb.
Legal entity responsible for the study
Bristol Myers Squibb, Princeton, NJ, USA.
Funding
Bristol Myers Squibb, Princeton, NJ, USA.
Disclosure
C.C. Schumann: Financial Interests, Personal, Funding: AstraZeneca, Bristol Myers Squibb, MSD, Roche, Sanofi; Financial Interests, Personal, Advisory Role: AstraZeneca, Bristol Myers Squibb, MSD, Roche; Financial Interests, Personal, Research Grant: Daiichi Sankyo, AstraZeneca, Bristol Myers Squibb, MSD; Financial Interests, Personal, Leadership Role: Working Group S3-Guidelines Lung Cancer; Financial Interests, Personal, Other, Travel/Accommodations: AstraZeneca, Bristol Myers Squibb, MSD. D.M. Behringer: Financial Interests, Personal, Funding: MSD, Novartis, Roche. J.B. Kuon: Financial Interests, Personal, Research Grant: AstraZeneca, Bristol Myers Squibb; Financial Interests, Personal, Advisory Role: Amgen, AstraZeneca, Bristol Myers Squibb, Pfizer. P. Sadjadian: Financial Interests, Personal, Advisory Board: Bristol Myers Squibb. S. Wilop: Financial Interests, Personal, Advisory Board, Multiple Myeloma: Amgen. D. Flieger: Financial Interests, Personal, Funding, Roundtable FINN: Bristol Myers Squibb. M. Groschek: Financial Interests, Personal, Funding: Ipsen; Financial Interests, Personal, Other, Travel/Accommodations: Gilead, Ipsen, Onkovis, Roche; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, GSK, Ipsen, Roche. G. Hübner: Financial Interests, Personal, Funding: Alexion, Amgen, AstraZeneca, Pierre-Fabre, Roche, Servier; Financial Interests, Personal, Advisory Role: AstraZeneca, Roche; Financial Interests, Personal, Other, Travel/Accommodations: AbbVie, BeiGene, Daiichi Sankyo, GSK, Octapharma, Roche. I. Dittrich: Financial Interests, Personal, Funding: Bristol Myers Squibb, MSD, Janssen-Cilag, BeiGene, Novocure, Roche, Amgen. M. Link: Financial Interests, Personal, Advisory Role: AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Ipsen, Janssen-Cilag, Novartis, SOBI, TAD Pharma; Financial Interests, Personal, Other, Travel/Accommodations: AstraZeneca, BeiGene, Janssen-Cilag. T. Bluhmki: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. D. Waldenberger: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. S. Gütz: Financial Interests, Personal, Other, Consulting: Bristol Myers Squibb, MSD, Novartis, Sanofi Aventis Deutschland GmbH; Financial Interests, Personal, Funding: Amgen, AstraZeneca, Bristol Myers Squibb, Lilly Deutschland, MSD, Pfizer, Roche, Sanofi Aventis Deutschland GmbH, Takeda; Financial Interests, Personal, Expert Testimony: AstraZeneca, Roche; Financial Interests, Personal, Other, Travel/Accommodations: Lilly, Roche, Takeda; Non-Financial Interests, Personal, Leadership Role, Co-Coordinator: S3-Guidelines Lung Cancer. E. von der Heyde: Financial Interests, Personal, Funding, Consulting: AstraZeneca, Novartis; Financial Interests, Personal, Funding: Bristol Myers Squibb. All other authors have declared no conflicts of interest.