2022 Nopémber: The Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma (uHCC).
Efficacy ieu dievaluasi dina HIMALAYA (NCT03298451), a randomized (1: 1: 1), buka-labél, ulikan multicenter di penderita uHCC dikonfirmasi anu teu acan nampi perlakuan sistemik prior pikeun HCC. Pasén anu randomized ka salah sahiji tilu leungeun: tremelimumab 300 mg salaku hiji-waktos tunggal ka jero nadi (IV) infusion tambah durvalumab 1500 mg IV dina dinten anu sami, dituturkeun ku durvalumab 1500 mg IV unggal 4 minggu; durvalumab 1500 mg IV unggal 4 minggu; atawa sorafenib 400 mg oral dua kali sapoé nepi ka progression panyakit atawa karacunan unacceptable. Persetujuan ieu dumasar kana ngabandingkeun tina 782 pasien anu diacak kana tremelimumab ditambah durvalumab kana 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.
Réaksi ngarugikeun anu paling umum (≥20%) dina pasien nyaéta ruam, diare, kacapean, pruritus, nyeri musculoskeletal sareng nyeri beuteung.
Dosis tremelimumab anu disarankeun pikeun penderita beuratna 30 kg atanapi langkung nyaéta 300 mg IV salaku dosis tunggal dina kombinasi sareng durvalumab 1500 mg dina Siklus 1 / Poé 1, dituturkeun ku durvalumab 1500 mg IV unggal 4 minggu. Pikeun anu beuratna kirang ti 30 kg, dosis tremelimumab anu disarankeun nyaéta 4 mg / kg IV salaku dosis tunggal digabungkeun sareng durvalumab 20 mg / kg IV, dituturkeun ku durvalumab 20 mg / kg IV unggal 4 minggu.
View full prescribing information for Imjudo.
