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Poster session 20

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

Date

21 Oct 2023

Session

Poster session 20

Topics

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Jonas Kuon

Citation

Annals of Oncology (2023) 34 (suppl_2): S755-S851. 10.1016/S0923-7534(23)01943-9

Authors

J.B. Kuon1, E. von der Heyde2, S. Wilop3, D.M. Behringer4, W. Blau5, G. Huebner6, D. Flieger7, H. Forstbauer8, M. Groschek9, H. Laack10, H. Mueller-Huesmann11, C. Schumann12, D. Waldenberger13, S. Gütz14

Author affiliations

  • 1 Department Of Thoracic Oncology, SLK Fachklinik Löwenstein, 74245 - Löwenstein/DE
  • 2 Medical Oncology, Internal Medicine, Onkologie am Raschplatz, 30161 - Hannover/DE
  • 3 Department Of Hämatologie-onkologie, MVZ West GmbH Würselen, 52146 - Würselen/DE
  • 4 Hematology, Oncology & Palliative Care Department, Augusta Kranken Anstalt gGmbH, 44791 - Bochum/DE
  • 5 Oncology, Hematology And Palliative Care, Helios Dr. Horst Schmidt Kliniken Wiesbaden, 65199 - Wiesbaden/DE
  • 6 Hematology And Medical Oncology Department, ohO-ostholstein Onkologie, 23758 - Oldenburg in Holstein/DE
  • 7 I.medizinische Klinik, GPR Klinikum Rüsselsheim, 65428 - Rüsselsheim/DE
  • 8 Hematology And Oncology Department, GOSPL Gesellschaft für onkologische Studien, Praxismanagement und Logistik, 53840 - Troisdorf/DE
  • 9 Hämatologie Und Onkologie Und Palliativmedizin, Clinical Research Stolberg GmbH, 52222 - Stolberg/DE
  • 10 Internal Medicine And Hematology And Oncology, Studiengesellschaft Hämato-Onkologie Hamburg, 21075 - Hamburg/DE
  • 11 Klinik Für Hämatologie Und Onkologie, Brüderkrankenhaus St. Josef Paderborn, 33098 - Paderborn/DE
  • 12 Klinik Für Pneumologie, Thoraxonkologie, Schlaf-und Beatmungsmedizin, Klinikverbund Allgaeu gGmbH, 87439 - Kempten and Immenstadt/DE
  • 13 Medizinische Abteilung, Bristol Myers Squibb, 80636 - Munich/DE
  • 14 Innere Medizin 1, St. Elisabeth-Krankenhaus Leipzig, 04277 - Leipzig/DE

Resources

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Abstract 1448P

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.

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, 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: 1448P

Patient characteristics (N = 256), n (%) unless noted

Age group, years <66 66–75 >75 120 (46.9) 102 (39.8) 33 (12.9)
Smoking status Current Former Never 98 (38.3) 111 (43.4) 28 (10.9)
Eastern Cooperative Oncology Group performance status 0 1 2 3 74 (28.9) 142 (55.5) 26 (10.2) 5 (2.0)
Number of metastases, median (range) 2 (0–12)
Histology Squamous Non-squamous 89 (34.8) 163 (63.7)
Metastasis stage M1a (contralateral lung) M1b/M1c (extrathoracic metastasis) 39 (15.2) 173 (67.6)
Metastasis site Brain Liver 51 (19.9) 49 (19.1)
Radiotherapy No/yes 204 (79.7)/48 (18.8)
Surgery No/yes 208 (81.2)/44 (17.2)
Systemic therapy/chemo No/yes/unknown 217 (84.8)/33 (12.9)/2 (0.8)

Excludes missing data.

Conclusions

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.

Clinical trial identification

NCT04794010.

Editorial acknowledgement

Writing and editorial assistance was provided by Christy Chao, 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, Personal, Speaker, Consultant, Advisor, Honoraria: BMS, AstraZeneca, Pfizer. E. von der Heyde: Financial Interests, Personal, Speaker, Consultant, Advisor, Honoraria: BMS, Novartis, AstraZeneca, Pierre Fabre; Financial Interests, Personal, Advisory Board: AstraZeneca, BeiGene. S. Wilop: Financial Interests, Personal, Advisory Board, Advisory Board Multiple Myeloma: Amgen. G. Huebner: Financial Interests, Personal, Speaker, Consultant, Advisor, Honoraria: Roche, Amgen, Servier, Pierre-Fabre; Financial Interests, Personal, Other, Travel/Accommodations: Roche, BeiGene, Octapharma; Financial Interests, Personal, Advisory Board: Alexion, AstraZeneca. D. Flieger: Financial Interests, Personal, Speaker, Consultant, Advisor, Honoraria - Roundtable Finn: BMS. H. Forstbauer: Financial Interests, Personal, Speaker, Consultant, Advisor, Honoraria: BMS, Roche, iOMEDICO. M. Groschek: Financial Interests, Institutional, Other, Study contract for present abstract: BMS; Financial Interests, Personal, Speaker, Consultant, Advisor, Honoraria: Ipsen; Financial Interests, Personal, Other, Travel/Accommodations: Roche, Ipsen, Onkovis, Gilead; Financial Interests, Personal, Advisory Board: Roche, BMS, Ipsen, GSK. H. Mueller-Huesmann: Financial Interests, Institutional, Research Grant: Roche, BMS, Janssen, MSD, Boehringer Ingelheim, Pfizer, Servier, AstraZeneca, Seagen, 420-Pharma; Financial Interests, Personal, Speaker, Consultant, Advisor, Honoraria: Roche, BMS, Janssen, MSD, Pfizer, AstraZeneca, Seagen, 420-Pharma; Financial Interests, Personal, Other, Travel/Accommodations: Roche, AstraZeneca; Financial Interests, Personal, Advisory Board: Roche, BMS, AstraZeneca, Seagen. C. Schumann: Financial Interests, Personal and Institutional, Speaker, Consultant, Advisor, Honoraria: BMS, AstraZeneca, Sanofi; Financial Interests, Personal, Other, Attending Meeting: BMS; Financial Interests, Personal, Other, Travel and Congress: AstraZeneca; Financial Interests, Personal, Other, Congress: Sanofi; Financial Interests, Personal and Institutional, Advisory Board: AstraZeneca, BMS, Roche, MSD; Financial Interests, Institutional, Advisory Board: DSMB. D. Waldenberger: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. S. Gütz: Financial Interests, Personal, Other, Consulting: Bristol Myers Squibb, MSD, Sanofi Aventis Deutschland GmbH, Novartis Pharma GmbH; Financial Interests, Personal, Speaker, Consultant, Advisor, Honoraria: Bristol Myers Squibb, Amgen, AstraZeneca, Sanofi Aventis Deutschland GmbH, Roche Pharma, Pfizer, Lilly Deutschland, MSD, Takeda; Financial Interests, Personal, Expert Testimony: Roche Pharma, AstraZeneca; Financial Interests, Personal, Other, Travel/Accommodations: Takeda, Lilly, Roche; Non-Financial Interests, Personal, Leadership Role, Co-Coordinator S3-Guidelines Lung Cancer: Misc. All other authors have declared no conflicts of interest.

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