Abstract 255P
Background
The phase III NAPOLI-1 trial showed improved overall survival (OS) and progression-free survival (PFS) with the combination of nal-IRI and 5-fluorouracil/leucovorin (5-FU/LV) in patients (pts) with mPDAC pre-treated with a gemcitabine-based regimen. Estimated 1-year OS rate reported in NAPOLI-1 study was 26% with nal-IRI 5-FU/LV. However, real-world data on clinical benefits and safety of this regimen are scarce. NALLONG study explores a real-world cohort of mPDAC pts who survived ≥1 year after initiation of nal-IRI therapy.
Methods
This international, longitudinal, retrospective chart review study was conducted on adult pts with mPDAC who received ≥1 nal-IRI/5FU/LV cycle after gemcitabine-based chemotherapy from January 2018 to December 2021 and were alive >1 year after initiation. Baseline demographic, efficacy and safety data for the full Asian cohort were analyzed. Endpoint data including OS and PFS.
Results
83 Asian pts from 3 sites in Japan and 4 in South Korea were analyzed. 3 (3.6%) pts initiated nal-IRI in 1L, 63 (75.9%) in 2L, and 17 (20.5%) in ≥3L. Median number of nal-IRI cycles received was 17 (min-max: 1-108), and median treatment duration was 9.7 (0-45) mo. 70 (84.3%) had discontinued nal-IRI, including 53 (75.7%) who progressed. Overall, 27 (32.5%) experienced grade 3/4 adverse drug reactions. Median OS from mPDAC diagnosis and nal-IRI initiation was 36.4 (CI 30.4-43.2) and 22.5 (19.2-27.0) mo, respectively. Median PFS in 1L was 10.2 (8.9-12.7) mo and median PFS with nal-IRI (any line) was 12.5 (9.8-15.8) mo Table: 255P
Pts characteristics, n=83
| Sex, n (%) | |
| Male | 42 (50.6) |
| Mean (SD) age at mPDAC diagnosis | 68.5 (7.9) |
| Metastasis site, n (%) | |
| Liver | 22 (51.2) |
| Previous treatment, n (%) | |
| Surgery | 49 (59.0) |
| Radiation | 27 (32.5) |
| Number of systemic treatments, median (min-max) | 4 (2-8) |
Conclusions
In this cohort of real-world mPDAC pts, we observed a population with exceptional response to systemic therapy. Importantly, nal-IRI achieved very favorable outcomes and efficacy was observed independently of the line of treatment. Future analyses aim to better define this exceptional response to paliative chemotherapy in mPDAC.
Clinical trial identification
NCT06155136.
Editorial acknowledgement
Nihar Masurkar and Sophia Costanza-Mcdonald, Oracle Life Sciences for medical writing support.
Legal entity responsible for the study
Servier.
Funding
Servier.
Disclosure
H. Imaoka: Financial Interests, Personal, Invited Speaker: Yakult Honsha, AstraZeneca, Nihon Servier, Kaneka Medix, SB Kawasumi Laboratories, Boston Scientific, Novartis; Financial Interests, Personal, Advisory Board: Nihon Servier, Kaneka Medix; Financial Interests, Personal, Writing Engagement: Medico's Hirata; Financial Interests, Institutional, Local PI: Ono Pharmaceutical, Novartis, Nihon Servier. T. Okusaka: Financial Interests, Personal, Advisory Board: Eisai, Nihon Servier, AstraZeneca, FUJIFILM Toyama Chemical; Financial Interests, Personal, Invited Speaker: AstraZeneca, Eisai, Chugai Pharma, Nihon Servier, Incyte, Novartis, Daiichi Sankyo, Taiho, Yakult, Myriad Genetics, Kyowa Kirin, Ono; Financial Interests, Institutional, Local PI: AstraZeneca, Eisai, Bristol Myers Squibb, Incyte, Syneos Health, Chiome Bioscience, Sysmex. T. Macarulla Mercade: Financial Interests, Personal, Advisory Board: Ability Pharmaceutical, SL, AstraZeneca, Basilea Pharma, Batxer, BioLineRX Ltd, Celgene SLU, Eisai, IPSEN Pharma, Incyte; Financial Interests, Personal, Other, Direct research fund: Servier, Merck Sharp & Dohme, Novocure, QED Therapeutics Inc, Roche, Sanofi-Aventis, Zymeworks; Financial Interests, Personal, Invited Speaker: Lilly, Janssen; Financial Interests, Institutional, Research Grant: Amc Medical Research, Armo Biosciences, Basilea, Biokeralty Research Institute, Merck Sharp & Dohme, Oncomed Pharmaceuticals, QED Therapeutics, VCN Biosciences, AbbVie Farmaceútica, Ability Pharmaceuticals, Agios, Amgen, Aslan, AstraZeneca, Bayer, Beigene, Biolinerx, Blueprint Medicines, Boston Biomedical, Bristol Myers Squibb (BMS), Cantargia, Celgene, Eisai, Erytech Pharma, F. Hoffmann-la Roche, Fibrogen, Genentech, Hallozyme, Immunomedics, Incyte, Ipsen, Lab. Menarini, Lilly, Loxo Oncology, Medimmune, Merimarck, Millenim, Nelum, Novartis, Novocure, Pfizer, Pharmacyclics, Roche, Zymeworks; Non-Financial Interests, Personal, Member: American Society of Clinical Oncology - ASCO, “Sociedad Española de Oncología Médica” – SEOM, Sociedad Europea de Oncología Médica - ESMO; Other, Personal, Other, Editorial Board: GI Annals og¡f Oncology. C.B. Westphalen: Financial Interests, Personal, Invited Speaker: Bayer, BMS, Celgene, GSK, Roche, Servier, Sirtex, Taiho, Chugai, Amgen, Falk, MSD, Merck, Janssen, AstraZeneca; Financial Interests, Personal, Advisory Board: BMS, Celgene, Shire/Baxalta, Rafael, RedHill, Roche, Janssen, Incyte; Financial Interests, Personal, Other, Travel Support: Bayer, Celgene, RedHill, Roche, Servier, Taiho, Janssen; Financial Interests, Personal and Institutional, Research Grant: Roche; Non-Financial Interests, Personal, Officer: AIO - Arbeitsgemeinschaft Internistische Onkologie (Germany); Non-Financial Interests, Personal, Advisory Role, Member of the EU Commission Mission Board for Cancer: EU Commission - DG RTD; Non-Financial Interests, Personal, Advisory Role, Member Forum Zukunftsstrategie: German Federal Ministry of Education and Research. G. Prager: Financial Interests, Personal, Advisory Board: Merck, Amgen, Servier, Bayer, Pierre Fabre, CECOG, Daiichi Sankyo Austria, AstraZeneca; Financial Interests, Personal, Invited Speaker: Roche, Sanofi, Lilly, BMS, MSD, Incyte; Financial Interests, Personal, Advisory Board, Advisory: Takeda; Financial Interests, Institutional, Local PI: Incyte, Servier, BMS, Novartis. F. Hedouin-Biville: Financial Interests, Personal, Full or part-time Employment: Servier. B. Chevallier: Financial Interests, Personal, Full or part-time Employment: Servier. M. Ueno: Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai Pharmaceutical, Incyte, MSD, Nihon Servier, Ono Pharmaceutical, Taiho Pharmaceutical, Daiichi Sankyo, Takeda Pharmaceutical, J-pharma, Eisai, Yakult Honsha; Financial Interests, Personal, Advisory Board: Nippon Boehringer Ingelheim, Novartis; Financial Interests, Institutional, Local PI: Astellas Pharma, AstraZeneca, CHUGAI PHARMACEUTICAL, DFP, Daiichi Sankyo, Eisai, Incyte, MSD, Merck Biopharma, Ono Pharmaceutical, Taiho Pharmaceutical, Novartis, J-pharma, Novocure, Chiome Bioscience. All other authors have declared no conflicts of interest.