ESMO Asia 2025 | ProvIDHe: ivosidenib in Australian & South Korean patients with mIDH1 CCA

Yes, ProvIDHe is a phase 3B study that tested ivosidenib, that is an anti-IDH1 or IDH1 inhibitor, in patients with advanced biliary tract cancer or cholangiocarcinoma, previously treated with at least one line of systemic therapy and with IDH1 mutation. This phase 3B study was conducted after the pivotal or registrational phase 3 clarity study. And the reason why this study was conducted was to provide indeed the drug to the patients in countries where the ivosidenib was not yet approved or reimbursed, and also to collect further data, especially data in a setting that is more similar to clinical practice compared to the setting of a phase three trial. And some of the results of this study have already been presented, both in terms of enrollment, evaluation of the mutations, so molecular profiling and IHC, and some initial results also in terms of efficacy and safety. At ESMO Asia 2022, results in a population of patients from Australia and South Korea were presented. This data includes 44 patients, as I said, from Australia and South Korea treated with ivosidenib after previous treatment with chemotherapy or chemo-immunotherapy. Overall, the characteristics of the patients are similar to the overall population included in the PROVIDE study, and also the results are quite similar. Indeed, the objective response rate is low as expected with ivosidenib is around 7%, but the stable disease is 52%. So overall, the disease control rate is 59%, that is perfectly in line with the results of ivosidenib in the phase 3 trial or in the overall population of the ProvIDHe study. And also in terms of efficacy, the adverse events were, as expected, no new safety signals in this population and very similar to the overall population of patients included in the ProvIDHe study. So overall, this analysis presented at ESMO Asia 2022 focused on patients from Australia and South Korea enrolled in the ProvIDHe study. The study is still ongoing, so we don’t have the final results of the study. What we have seen is that the regimen the patients received most frequently before starting ivosidenib was the combination of cisplatin and gemcitabine plus or minus immunotherapy, and this was already seen also in the overall population. The median progression-free survival was six months, and the median overall survival is not yet available, not yet accessible. And as I said, the disease control rate is 59%. The safety profile was manageable and consistent with what was previously reported in the ProvIDHe study, in the CLARITY study, and in clinical practice. So overall, the results achieved in the Australian and South Korean population are similar or in line with the results observed in the overall population of the study.

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