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Ivosidenib en monoterapia (ClarIDHy) — 2L+ colangiocarcinoma mutado IDH1

Vista determinista de la entidad fuente YAML. La autoridad clínica sigue con los ID de fuente citados y estado de firma del revisor.

Registro de base de conocimiento para la auditoría. Contenido clínico provisional: esto no es una prescripción. Un oncólogo debe verificar fuentes originales, aplicabilidad y estado de revisión.

Fuente YAML: registro completo

Notas

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).

Utilizado por

Indicación

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