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Ivosidenib en monothérapie (ClarIDHy) — 2L+ cholangiocarcinome mutant IDH1

Vue déterministe de l'entité source de la LJAM. L'autorité clinique demeure avec les ID de la source cités et l'état d'approbation de l ́examinateur.

Contenu clinique provisoire : il ne s'agit pas d'une ordonnance. Un oncologue doit vérifier les sources originales, l'applicabilité et le statut de révision.

Source YAML: dossier complet

Notes

ClarIDHy phase 3 (Abou-Alfa et al. Lancet Oncol 2020): ivosidenib 500 mg PO daily continuous vs placebo in advanced/metastatic IDH1-mutant cholangiocarcinoma post ≥1L systemic therapy (typically gemcitabine/cisplatin ± durvalumab in modern practice). N=185 randomized 2:1 (ivo n=124, pbo n=61). mPFS 2.7 vs 1.4 mo, HR 0.37 (95% CI 0.25–0.54), p<0.0001. Disease control rate 53% vs 28%. ORR 2% (no CR; 2 PR by independent review). mOS HR 0.79 ITT (NS, with 70.5% placebo-arm crossover); RPSFT-adjusted mOS HR 0.49 — OS benefit recognized in label. FDA-approved August 2021; EMA approved 2023. Toxicity well tolerated overall (G≥3 AE 30% ivo vs 22% pbo); notable AEs: ascites (G≥3 7% ivo vs 5% pbo, attributable to disease progression in part), fatigue, nausea, QTc prolongation (any grade ~9%, G≥3 ~1%). Differentiation syndrome — boxed warning class effect — not observed in ClarIDHy cholangio cohort but possible per labelling and AML experience; clinicians should remain aware. STUB pending Clinical Co-Lead sign-off; SRC-CLARIDHY-ABOU-ALFA-2020 ingested as primary citation (W0-CHOLANGIO PR #456).

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Indication

• IND-CHOLANGIO-2L-IDH1-IVOSIDENIB - IND-CHOLANGIO-2L-IDH1-IVOSIDENIB