1519P - Real-world evidence on long-term survivors of metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with liposomal irinotecan: NALLONG study

Background

In the phase-3 NAPOLI-1 trial (NCT01494506), liposomal irinotecan (nal-IRI) with 5-fluorouracil/leucovorin (5-FU/LV) improved survival outcomes in mPDAC patients pre-treated with gemcitabine-based regimens. However, real-world data on clinical benefits and safety are scarce. This study gathered real-world evidence on patients who survived ≥1 year after initiation of nal-IRI following treatment with a gemcitabine-based regimen.

Methods

This retrospective non-interventional study was conducted in Austria, Belgium, Germany, Japan, and South Korea. Data were collected from mPDAC patients who received ≥1 nal-IRI/5-FU/LV after a gemcitabine-based chemotherapy from January 2018 to December 2021 and surviving >1 year after initiation of the combination. Descriptive analyses, treatment patterns summaries, and overall survival (OS) determination via Kaplan-Meier method were conducted.

Results

Of the 163 patients analyzed, 131 (80.4%) were deceased and 32 (19.6%) alive. Ten (6.1%) patients initiated nal-IRI in 1L, 123 (75.5%) in 2L, and 30 (18.4%) in ≥3L. The median number of nal-IRI cycles received was 14 (min-max: 1-108). The median treatment duration from initiation to end of treatment was 8.4 (min-max: 0-45) months. At data cut-off, 139 (85.3%) discontinued nal-IRI, with 98 (70.5%) of them due to progression. Overall, 44 (27.0%) experienced grade 3/4 adverse drug reactions. Median OS from mPDAC diagnosis and nal-IRI initiation was 34.3 (CI 30.4-37.5) and 21.0 (CI 19.0-23.7) months, respectively. Table: 1519P

Patients characteristics

Conclusions

In mPDAC, subgroups of patients with favorable OS exist, but are poorly understood. This real-world cohort had a median OS comparable to that of long-term treated NAPOLI-1 survivors, yet older with more prior lines of therapy. This real-world cohort will allow for further analyses exploring the underlying mechanisms of this population of long-term survivors.

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

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. C. Yoo: Financial Interests, Personal, Invited Speaker: Bayer, Celgene, Eisai, Ipsen, Servier, Roche, Novartis; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Research Grant: AstraZeneca, Bayer, Servier; Financial Interests, Institutional, Research Grant: Genentech. T. Macarulla Mercade: Financial Interests, Personal, Advisory Board: Ability Pharmaceutical, SL, AstraZeneca, Basilea Pharma, Baxter, 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, Halozyme, Immunomedics, Incyte, Ipsen, Lab. Menarini, Lilly, Loxo Oncology, MedImmune, Merrimack, Millenium, Nelum, Novartis, Novocure, Pfizer, Pharmacyclics, Roche, Zymeworks; Non-Financial Interests, Member: American Society of Clinical Oncology - ASCO, “Sociedad Española de Oncología Médica” – SEOM, Sociedad Europea de Oncología Médica - ESMO; 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, Officer: AIO - Arbeitsgemeinschaft Internistische Onkologie (Germany); Non-Financial Interests, Advisory Role, Member of the EU Commission Mission Board for Cancer: EU Commission - DG RTD; Non-Financial Interests, 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. 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. C. Verslype: Financial Interests, Personal, Advisory Board: Roche, Bayer, MSD; Financial Interests, Personal, Invited Speaker: Ipsen, Bayer; Financial Interests, Institutional, Research Grant, unrestricted: Bayer; Non-Financial Interests, Member, Lobby group: Pancreatic Cancer Europe. 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. F. Hedouin-Biville, B. Chevallier: Financial Interests, Personal, Full or part-time Employment: Servier. All other authors have declared no conflicts of interest.