Ivosidenib: A Review in Advanced Cholangiocarcinoma

Vogel A, Bridgewater J, Edeline J, et al. Biliary tract cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(2):127–40.

Article  CAS  PubMed  Google Scholar 

Banales JM, Marin JJG, Lamarca A, et al. Cholangiocarcinoma 2020: the next horizon in mechanisms and management. Gastroenterol Hepatol. 2020;17:557–88.

Google Scholar 

Rimini M, Puzzoni M, Pedica F, et al. Cholangiocarcinoma: new perspectives for new horizons. Expert Rev Gastroenterol Hepatol. 2021;15(12):1367–83.

Article  CAS  PubMed  Google Scholar 

Lee Y-P, Oh SY, Kim KM, et al. Modified FOLFIRINOX as a second-line treatment for patients with gemcitabine-failed advanced biliary tract cancer: a prospective multicenter phase II study. Cancers (Basel). 2022;14(8):1950.

Article  CAS  PubMed  Google Scholar 

Adeva J, Sangro B, Salati M, et al. Medical treatment for cholangiocarcinoma. Liver Int. 2019;39(Suppl. 1):123–42.

Article  PubMed  Google Scholar 

Cheng C-Y, Chen C-P, Wu C-E. Precision medicine in cholangiocarcinoma: past, present and future. Life. 2022;12(6):829.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Boscoe AN, Rolland C, Kelley RK. Frequency and prognostic significance of isocitratdehydrogenase 1 mutations in cholangiocarcinoma: a systematic literature review. J Gastrointest Oncol. 2019;10(4):751–65.

Article  PubMed  PubMed Central  Google Scholar 

Kendre G, Murugesan K, Brummer T, et al. Charting co-mutation patterns associated with actionable drivers in intrahepatic cholangiocarcinoma. J Hepatol. 2023;78(3):614–26.

Article  CAS  PubMed  Google Scholar 

Makawita S, Borad MJ, Carapeto F, et al. IDH1 and IDH2 driven intrahepatic cholangiocarcinoma (IHCC): a comprehensive genomic and immune profiling study [abstract no. 4009]. J Clin Oncol. 2021;39(15 suppl):4009.

Article  Google Scholar 

Dang L, White DW, Gross S, et al. Cancer-associated IDH1 mutations produce 2-hydroxyglutarate. Nature. 2009;462(7274):739.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Wu M-J, Shi L, Merritt J, et al. Biology of IDH mutant cholangiocarcinoma. Hepatology. 2022;75(5):1322–7.

Article  CAS  PubMed  Google Scholar 

Wu M-J, Shi L, Dubrot J, et al. Mutant IDH inhibits IFNγ-TET2 sgnaling to promote immunoevasion and tumor maintenance in cholangiocarcinoma. Cancer Discov. 2022;12(3):812–35.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Notarangelo G, Spinelli JB, Perez EM, et al. Oncometabolite d-2HG alters T cell metabolism to impair CD8(+) T cell function. Science. 2022;377:1519–29.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Saatcioglu HD, Valle J, Macarulla T, et al. Characteristics of the tumor microenvironment in IDH1-mutated cholangiocarcinoma patients from ClarIDHy trial [abstract no. 552]. J Immunother Cancer. 2022;10(Suppl 2):A576–7.

Google Scholar 

Saha SK, Parachoniak CA, Ghanta KS, et al. Mutant IDH inhibits HNF-4α to block hepatocyte differentiation and promote biliary cancer. Nature. 2014;513(7516):110–4.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Popovici-Muller J, Lemieux RM, Artin E, et al. Discovery of AG-120 (ivosidenib): a first-in-class mutant IDH1 inhibitor for the treatment of IDH1 mutant cancers. ACS Med Chem Lett. 2018;9(4):300–5.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Les Laboratoires Servier. Tibsovo (ivosidenib): EU prescribing information. 2023. https://www.ema.europa.eu/. Accessed 30 Sept 2023.

Servier Pharmaceutical LLC. TIBSOVO (ivosidenib tablets), for oral use. 2022. https://www.accessdata.fda.gov/. Accessed 30 Sept 2023.

Lowery MA, Burris HA 3rd, Janku F, et al. Safety and activity of ivosidenib in patients with IDH1-mutant advanced cholangiocarcinoma: a phase 1 study. Lancet Gastroenterol Hepatol. 2019;4(9):711–20.

Article  PubMed  PubMed Central  Google Scholar 

Abou-Alfa GK, Macarulla T, Javle MM, et al. Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020;21(6):796–807.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Aguado-Fraile E, Tassinari A, Ishii Y, et al. Molecular and morphological changes induced by ivosidenib correlate with efficacy in mutant-IDH1 cholangiocarcinoma. Future Oncol. 2021;17(16):2057–74.

Article  CAS  PubMed  Google Scholar 

European Medicines Agency. Tibsovo assessment report. 2023. https://www.ema.europa.eu/. Accessed 30 Sept 2023.

Dai D, Yang H, Nabhan S, et al. Effect of itraconazole, food, and ethnic origin on the pharmacokinetics of ivosidenib in healthy subjects. Eur J Clin Pharmacol. 2019;75(8):1099–108.

Article  CAS  PubMed  Google Scholar 

Prakash C, Fan B, Altaf S, et al. Pharmacokinetics, absorption, metabolism, and excretion of [14C] ivosidenib (AG-120) in healthy male subjects. Cancer Chemother Pharmacol. 2019;83(5):837–48.

Article  CAS  PubMed  Google Scholar 

Fan B, Dai D, Cohen M, et al. Effect of mild and moderate hepatic impairment on the pharmacokinetics, safety, and tolerability of a single dose of oral ivosidenib in otherwise healthy participants. Clin Pharmacol Drug Dev. 2021;10(1):99–109.

Article  CAS  PubMed  Google Scholar 

Zhu AX, Macarulla T, Javle MM, et al. Final overall survival efficacy results of ivosidenib for patients with advanced cholangiocarcinoma with IDH1 mutation: the phase 3 randomized clinical ClarIDHy trial. JAMA Oncol. 2021;7(11):1669–77.

Article  PubMed  Google Scholar 

Zhu AX, Macarulla T, Javle MM, et al. Final results from ClarIDHy, a global, phase III, randomized, double-blind study of ivosidenib (IVO) versus placebo (PBO) in patients (pts) with previously treated cholangiocarcinoma (CCA) and an isocitrate dehydrogenase 1 (IDH1) mutation [abstract no. 266 plus presentation #GI21]. J Clin Oncol. 2021;39(3 Suppl.):266.

Article  Google Scholar 

Chamberlain CX, Hua Z, Gliser C, et al. Longitudinal trends in health-related quality of life (HRQoL) among patients treated with ivosidenib (IVO) for IDH1-mutated cholangiocarcinoma (CCA) in the ClarIDHy study [abstract no 388 plus poster]. J Clin Oncol. 2022;40(4 Suppl.):388.

Article  Google Scholar 

Abou-Alfa GK, Burris S, Adeva J, et al. Characterization of IDH-1 mutant cholangiocarcinoma patients who received ivosidenib treatment longer than a year [poster]. In: 10th Annual cholangiocarcinoma foundation conference, 2023.

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Biliary Tract Cancers Version 2.2023—May 10, 2023. https://www.nccn.org/. Accessed 30 Sept 2023.

Rimini M, Burgio V, Antonuzzo L, et al. Real-world data on ivosidenib in patients with previously treated isocitrate dehydrogenase 1-mutated intrahepatic cholangiocarcinomas: an early exploratory analysis. Target Oncol. 2022;17(5):591–6.

Article  PubMed  Google Scholar 

Reinbold R, Hvinden IC, Rabe P, et al. Resistance to the isocitrate dehydrogenase 1 mutant inhibitor ivosidenib can be overcome by alternative dimer-interface binding inhibitors. Nat Commun. 2022;13(1):4785.

Article  CAS  PubMed  PubMed Central  Google Scholar 

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