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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