147P - Baseline characteristics and molecular testing of Australian patients with IDH1 mutated cholangiocarcinoma: initial results from the phase IIIb ProvIDHe study

Background

Ivosidenib (IVO) has demonstrated efficacy in patients (pts) with isocitrate dehydrogenase 1 (mIDH1)-mutated cholangiocarcinoma (CCA).¹ The ProvIDHe study is an international, single-arm, early access phase IIIb study, enabling pts with CCA access to IVO treatment. Currently, the study involves 11 countries in Europe and Australia. We hereafter focus on the Australian pts.

Methods

Adult pts with locally advanced or metastatic mIDH1 CCA who had received at least one prior line of systemic treatment are eligible. 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 study primary endpoint is safety.

Results

As of the cut-off date of 9 February 2024 for this analysis, 158 pts were enrolled in 10 countries, including 10 pts in Australia (1 pt did not take any treatment therefore only 9 pts were included in the safety analysis set). Regarding Australian pts (Table), all pts had stage IV disease at screening (liver metastases, 90%). The median age was 63 year-old with 60% of female pts. Next-generation sequencing was the main molecular testing method used (88.9%) with a median turnaround time of 10 days. 77.8% of patients had mIDH1 R132C. No Australian pts had FGFR2 co-alteration. The most common prior first-line regimens were gemcitabine + cisplatin alone (44.4%) or with immunotherapy (33.3%) Table: 147P

Baseline characteristics

CCA, Cholangiocarcinoma; ECOG PS, eastern cooperative oncology group performance score*n=9 (Safety Set)

Conclusions

The baseline characteristics of Australian pts in the ProvIDHe study, including their prior treatment regimens and molecular testing results, align with those observed in the international study population. The study is ongoing, and future analyses will focus on patient outcomes.

Clinical trial identification

NCT05876754.

Editorial acknowledgement

Legal entity responsible for the study

Servier Affaires Médicales, France.

Funding

Servier.

Disclosure

H. Sim: Financial Interests, Personal, Other, Honoraria: Lilly, Servier; Financial Interests, Institutional, Research Funding: AbbVie, Bristol Myers Squibb. S. McLachlan: Financial Interests, Personal, Advisory Board: BMS. A. Dean: Financial Interests, Personal, Stocks or ownership: A2A Pharmaceuticals; Financial Interests, Personal, Other, Honoraria: Amgen, Juniper Pharmaceuticals; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Juniper Biologics, Novartis, Servier; Financial Interests, Personal, Non remunerated activity: A2A Pharamaceuticals. T.J. Price: Financial Interests, Personal, Advisory Board, Global advisory board on MSS CRC: MSD; Financial Interests, Personal, Invited Speaker: AMGEN; Non-Financial Interests, Personal, Advisory Role, Advisory board uncompensated: MSD; Non-Financial Interests, Personal, Advisory Role: Takeda, Servier. M. Eastgate: Financial Interests, Personal, Speaker, Consultant, Advisor: MSD; Financial Interests, Personal, Advisory Board: MSD. L. Rimassa: Financial Interests, Personal, Advisory Board, Consulting and advisory role: AbbVie, AstraZeneca, Basilea, Bayer, Elevar Therapeutics, Exelixis, Genenta, Hengrui, Incyte, Ipsen, IQVIA, Jazz Pharmaceuticals, MSD, Nerviano Medical Sciences, Roche, Servier, Taiho Oncology; Financial Interests, Personal, Invited Speaker, Lecture fees: AstraZeneca, Bayer, BMS, Guerbet, Incyte, Ipsen, Roche, Servier; Financial Interests, Personal, Other, Travel expenses: AstraZeneca; Financial Interests, Personal, Advisory Board: Zymeworks, BMS; Financial Interests, Institutional, Steering Committee Member: AstraZeneca, Exelixis, Incyte, Ipsen, Nerviano Medical Sciences, Roche, Servier; Financial Interests, Institutional, Coordinating PI, National (Italian) coordinating PI: AstraZeneca, BeiGene, Zymeworks; Financial Interests, Institutional, Local PI: Agios, Eisai, Fibrogen, Lilly, MSD, Roche, Servier; Financial Interests, Institutional, Funding: Ipsen; Financial Interests, Institutional, Coordinating PI, European PI: AstraZeneca, TransThera Sciences, Taiho Oncology; Non-Financial Interests, Personal, Leadership Role, Treasurer: ILCA; Non-Financial Interests, Personal, Leadership Role, Chair: EORTC GITCG HPB/NET Task Force; Non-Financial Interests, Personal, Other, Special Expert Clinical Trials Europe: NCI HB Task Force. 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 and Dhome, 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, AstraZecena, 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. D. Malka: Financial Interests, Personal, Other, Honoraia: Amgen; Financial Interests, Personal, Other, Honoraria: AstraZeneca, Bayer, Bristol Myers Squibb, Foundation Medicine, Incyte, LEO Pharma, Merck Serono, MSD Oncology, Pierre Fabre, Roche, Sanofi, Servier, Veracyte; Financial Interests, Personal, Advisory Role: AbbVie, Amgen, AstraZeneca, Bayer, Bionest Partners, Bristol-Meyer Squibb, Incyte, Merck Serono, MSD, Pierre Fabre, Roche, Sanofi, Servier, Simon-Kucher and Partners, Taiho Oncology; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Amgen, Bayer, Bristol Myers Squibb, Pfizer, Merck Serono, MSD, Pierre Fabre, Roche, Sanofi, Servier, Viatris. H. Gharbi, R. Robert, A. Sullivan: Financial Interests, Personal, Full or part-time Employment: Servier. A. Vogel: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Böhringer Mannheim, Eisai, INCYTE, Ipsen, MSD, Roche, Servier, Tyra, Taiho, AbbVie; Financial Interests, Personal, Invited Speaker: BMS, Eisai, Ipsen, MSD, Roche, AstraZeneca; Financial Interests, Personal, Steering Committee Member: Roche, MSD, Beigene, Boehringer-Ingelheim.