60P - Baseline characteristics and molecular testing of patients with IDH1-mutated cholangiocarcinoma: Initial results from the phase IIIb ProvIDHe study

Background

Ivosidenib (IVO) has demonstrated efficacy as an oral inhibitor of the protein encoded by the mutant isocitrate dehydrogenase 1 (mIDH1) gene in patients (pts) with cholangiocarcinoma (CCA) in the phase 3 ClarIDHy study. To further consolidate safety and efficacy data of IVO in the real world, the ProvIDHe study was initiated. The study is in a setting similar to daily practice, enabling access to treatment with IVO for pts with CCA.

Methods

Adult pts with locally advanced or metastatic mIDH1CCA who had received at least one prior line of systemic treatment are eligible for inclusion in this international, single-arm phase 3b study. Pts receive 500 mg IVO orally once daily and continue treatment as long as clinical benefit is observed, until unacceptable toxicity, or until IVO is accessible via medical prescription. The primary endpoint of the study is safety. Baseline characteristics and molecular testing outcomes are presented here.

Results

As of the cut-off date of 9 February 2024, 158 pts from 10 countries were enrolled. 131 pts were included in the safety analysis set. Baseline characteristics are presented (Table). Most pts were 2 37 (28.2)30 (22.9)39 (29.8)

CCA, Cholangiocarcinoma; ECOG PS, eastern cooperative oncology group performance score ^‡Unless otherwise stated, *n=131, 25 pts did not receive prior therapy in this setting

Conclusions

This first interim analysis focused on baseline characteristics of pts enrolled in the ProvIDHe study, including previous treatment regimens for advanced/metastatic disease and molecular testing. The study is still enrolling, and future analyses will focus on patient outcomes.

Clinical trial identification

NCT05876754.

Editorial acknowledgement

Editorial assistance was provided by Emily Eagles of Empowering Strategic Performance Ltd.

Legal entity responsible for the study

Servier.

Funding

Servier.

Disclosure

L. Rimassa: Financial Interests, Advisory Role: AbbVie, AstraZeneca, Basilea, Bayer, Elevar Therapeutics, Exelixis, Genenta, Hengrui, Incyte, Ipsen, IQVIA, Jazz Pharmaceuticals, MSD, Nerviano Medical Sciences, Roche, Servier, Taiho Oncology, Zymeworks; Financial Interests, Other, Honoraria/lectures: AstraZeneca, Bayer, BMS, Guerbet, Incyte, Ipsen, Roche, Servier; Financial Interests, Other, Travel expenses: AstraZeneca; Financial Interests, Institutional, Research Funding: Agios, AstraZeneca, BeiGene, Eisai, Exelixis, FibroGen, Incyte, Ipsen, Lilly, MSD, Nerviano Medical Sciences, Roche, Servier, Zymeworks. J.A. Bridgewater: Financial Interests, Other, Speaker's Fee's: Incyte, Servier; Financial Interests, Other, Consultancy: BMS, Roche, Bayer, AstraZeneca, Incyte, Taiho, Basilea; Financial Interests, Research Funding: Incyte. A. Casadei Gardini: Financial Interests, Other, consulting fees: AstraZeneca, Bayer, BMS, Eisai, Incyte, Ipsen, IQVIA, MSD, Roche, Servier; Financial Interests, Other, lecture fees: AstraZeneca, Bayer, BMS, Eisai, Incyte, Ipsen, Roche, Servier; Financial Interests, Other, Travel expenses: AstraZeneca; Financial Interests, Institutional, Research Grant: AstraZeneca, Eisai. H. Wilmink: Financial Interests, Other, Consultancy: AstraZeneca, MSD, Servier; Financial Interests, Institutional, Research Funding: Servier, MSD, Nordic. H. Sim: Financial Interests, Other, Honoraria: Eli Lilly, Servier; Financial Interests, Institutional, Research Funding: AbbVie, Bristol Myers Squibb. J. de Vos-Geelen: Financial Interests, Institutional, Research Grant: Servier. 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, Hallozyme, 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 of Oncology. D. Malka: Financial Interests, Advisory Role: AbbVie, Amgen, AstraZeneca, Bayer, BMS, Incyte, Merck Serono, MSD, Pierre Fabre Oncologie, Roche, Sanofi, Servier, Taiho, Viatris; Financial Interests, Other, Honoraria for lectures, presentations, or educational events: Amgen, AstraZeneca, Bayer, BMS, Foundation Medicine, Incyte, Leo Pharma, Medscape, Merck Serono, MSD, Pierre Fabre Oncologie, Roche, Sanofi, Servier, Veracyte, Viatris; Financial Interests, Other, Support for attending meetings and/or travel: Amgen, Bayer, BMS, Merck Serono, MSD, Pierre Fabre Oncologie, Roche, Sanofi, Servier, Viatris. H. Gharbi, R. Robert, A. Sullivan: Financial Interests, Full or part-time Employment: Servier. A. Vogel: Financial Interests, Advisory Role: AbbVie, AstraZeneca, Amgen, BeiGene, Boehringer Mannheim, BMS, Eisai, Incyte, MSD, Pierre Fabre, Roche, Servier, Taiho.