1348P - 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): Results from an interim analysis of the German non-interventional study (NIS) FINN

Background

In CheckMate 9LA, 1L N + I + C significantly improved OS vs C alone in pts with mNSCLC. NIS FINN aims to evaluate this tx in clinical practice in Germany. Pt characteristics and safety data for 273 of 348 pts from the interim analysis (31 Jul 2023) were reported previously. Here, we report baseline (BL) characteristics for all 348 pts; 1^st disclosure of effectiveness data (OS) and updated safety data with a minimum follow-up (f/u) of 6 mo (database lock [DBL]: Jun 2024) will be presented.

Methods

This ongoing, prospective study plans to enroll 650 pts from 90 German sites. Adults with mNSCLC are eligible if they initiated 1L N + I + C tx per the approved label. F/u will be for up to 5 y (from tx start until death, withdrawal of consent, loss of f/u, or end of study), with pts assessed per routine local clinical practice. The primary endpoint is OS. Secondary endpoints include OS in subgroups by BL characteristics, PFS, tx duration, BL characteristics, tx patterns, and safety.

Results

Among analyzed pts (N = 348), median age was 67 (range 43–86) y; 45.4%, 39.7%, and 14.7% of pts were <66, 66–75, and >75 y old, respectively. Most pts were white (99.1%), current/former smokers (80.2%), and had ECOG PS 0–1 (84.8%); 60.9% were males and 62.1% had non-squamous (NSQ) histology. The median no. of distant metastases was 2.0 (range 0–12), with metastases mostly observed in the contralateral lung (35.6%), bones (33.0%), and extrathoracic lymph nodes (26.7%); 19.5% of pts had brain metastasis. Among pts with evaluable tumor PD-L1 status (n = 259), 55.2% had PD-L1 <1% and 44.0% had PD-L1 ≥1%. Among pts evaluated for both tumor PD-L1 status and histology type (n = 257), 19.4% and 36.2% of pts with PD-L1 <1% and 17.1% and 27.2% of pts with PD-L1 ≥1% had squamous and NSQ histology, respectively.

Conclusions

The NIS FINN will help 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. While 1^st interim data showed safety results consistent with prior studies, data from the Jun 2024 DBL will report on the real-world effectiveness of 1L N + I + C in Germany for the 1^st time.

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

J.B. Kuon: Financial Interests, Institutional, Research Funding: AstraZeneca, BMS; Financial Interests, Personal, Speaker, Consultant, Advisor: Amgen, AstraZeneca, BMS, Pfizer. E. Von der Heyde: Financial Interests, Personal, Speaker, Consultant, Advisor, Honoraria: AstraZeneca, BMS, Novartis. P. Sadjadian: Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, BMS, Boehringer Ingelheim, Oncopeptides, Roche, Sanofi; Financial Interests, Personal, Other, Travel/Meeting Support: AstraZeneca, Lilly. M. Bischoff: Financial Interests, Personal, Other, Travel/Accommodations: AbbVie, Janssen, AstraZeneca, GSK, Roche, BMS, Boehringer Ingelheim, Merck. S. Wilop: Financial Interests, Personal, Advisory Board, Advisory Board, Multiple Myeloma: Amgen. D.M. Behringer: Financial Interests, Personal, Speaker, Consultant, Advisor, Honoraria: Novartis. G. Hübner: Financial Interests, Personal, Speaker, Consultant, Advisor, Honoraria: Alexion, Amgen, AstraZeneca, Pierre-Fabre, Roche, Servier; Financial Interests, Personal, Other, Travel/Accommodations: AbbVie, BeiGene, Daiichi Sankyo, GSK, Octapharma, Roche. D. Flieger: Financial Interests, Personal, Other, Roundtable FINN: BMS. M. Groschek: Financial Interests, Personal, Speaker, Consultant, Advisor, Honoraria: Ipsen; Financial Interests, Personal, Other, Travel/Accommodations: Gilead, Ipsen, Onkovis, Roche; Financial Interests, Personal, Advisory Board: BMS, GSK, Ipsen, Roche. H. Laack: Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, GSK, Lilly, MSD, Novartis, Roche, Takeda. H. Mueller-Huesmann: Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Personal, Speaker, Consultant, Advisor, Honoraria: AstraZeneca; Financial Interests, Personal, Advisory Board, Honoraria: BMS, Ipsen, MSD, Roche; Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, BMS, Ipsen, MSD, Roche, Sanofi; Financial Interests, Personal, Other, Travel/Accommodations: Lilly, Roche. C. Schumann: Financial Interests, Personal, Speaker, Consultant, Advisor, Honoraria: AstraZeneca, BMS, MSD, Roche, Sanofi; Financial Interests, Institutional, Research Funding: AstraZeneca, BMS, Daiichi Sankyo, MSD; Financial Interests, Personal, Other, Travel/Accommodations: AstraZeneca, BMS, MSD. D. Waldenberger: Financial Interests, Personal, Full or part-time Employment: BMS; Financial Interests, Personal, Stocks or ownership: BMS. S. Gütz: Financial Interests, Personal, Speaker, Consultant, Advisor, Honoraria: BMS, MSD, Sanofi Aventis Deutschland GmbH, Amgen, AstraZeneca, Lilly Deutschland, Pfizer, Roche Pharma, Takeda; Financial Interests, Personal, Speaker, Consultant, Advisor: Novartis Pharma GmbH; Financial Interests, Personal, Expert Testimony: AstraZeneca, Roche Pharma; Financial Interests, Personal, Other, Travel/Accommodations: Lilly, Roche, Takeda; Non-Financial Interests, Personal, Leadership Role, Co-Coordinator: S3-Guidelines Lung Cancer. All other authors have declared no conflicts of interest.