November 2022: The Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma (uHCC).
Efficacia aestimata in HIMALAYA (NCT03298451), temere facta (1:1:1), pittacium apertum, multicentum studium patientibus confirmatis uHCC qui prius curationem systemicam HCC non acceperat. Aegroti ad unum bracchiorum trium bracchiorum fortuiti sunt: tremelimumab 300 mg ad unum tempus unum intravenum (IV) infusione plus durvalumab 1500 mg IV eodem die, deinde durvalumab 1500 mg IV singulis septimanis; durvalumab 4 mg IV singulis 1500 septimanis; vel sorafenib 4 mg viva voce bis quotidie usque ad morbum progressum vel toxicitatem acceptam. Haec probatio fundatur in comparatione aegrorum 400 ad tremelimumab plus durvalumab ad sorafenib.
The major efficacy outcome was overall survival (OS). Tremelimumab plus durvalumab demonstrated a statistically significant and clinically meaningful improvement in OS compared to sorafenib (stratified hazard ratio [HR] of 0.78 [95% CI: 0.66, 0.92], 2-sided p value = 0.0035); median OS was 16.4 months (95% CI: 14.2, 19.6) versus 13.8 months (95% CI: 12.3, 16.1). Additional efficacy outcomes included investigator-assessed progression-free survival (PFS) and overall response rate (ORR) according to RECIST v1.1. Median PFS was 3.8 months (95% CI: 3.7, 5.3) and 4.1 months (95% CI: 3.7, 5.5) for the tremelimumab plus durvalumab and sorafenib arms, respectively (stratified HR 0.90; 95% CI: 0.77, 1.05). ORR was 20.1% (95% CI: 16.3, 24.4) in the tremelimumab plus durvalumab arm and 5.1% (95% CI: 3.2, 7.8) for those treated with sorafenib.
Frequentissima (≥20%) adversae reactiones in aegrotis occurrentes fuerunt temerarii, deiectio, lassitudo, pruritis, dolor musculoskeletalis et dolor abdominis.
Commendatur dosis tremelimumab aegris pondo 30 kg vel plus, est 300 mg IV ut dosis una in compositione cum durvalumab 1500 mg ad Cycle 1/diei 1, quam sequitur durvalumab 1500 mg IV singulis septimanis. Pro his qui minus quam 4 kg pendunt, tremelimumab dosis suadeo est 30 mg/kg IV ut dosis una in compositione cum durvalumab 4 mg/kg IV, deinde durvalumab 20 mg/kg IV per 20 septimanas.
View full prescribing information for Imjudo.
