Novemba 2022: I-Food and Drug Administration igunyaze i-tremelimumab (Imjudo, i-AstraZeneca Pharmaceuticals) ihlanganiswe ne-durvalumab yeziguli ezikhulile ezine-hepatocellular carcinoma (uHCC) engabukeki.
Ukusebenza kahle kuye kwahlolwa ku-HIMALAYA (NCT03298451), okungahleliwe (1:1:1), ilebula evulekile, isifundo se-multicenter ezigulini ezine-uHCC eqinisekisiwe ezazingazange zithole ukwelashwa okuhleliwe kwe-HCC. Iziguli zihlelwe ngokungahleliwe kwenye yezingalo ezintathu: i-tremelimumab 300 mg njenge-infusion yesikhathi esisodwa esisodwa se-intravenous (IV) kanye ne-durvalumab 1500 mg IV ngosuku olufanayo, kulandelwa i-durvalumab 1500 mg IV njalo emavikini e-4; i-durvalumab 1500 mg IV njalo emavikini angu-4; noma i-sorafenib 400 mg ngomlomo kabili ngosuku kuze kube yilapho isifo siqhubeka noma ubuthi obungamukeleki. Lokhu kugunyazwa kusekelwe ekuqhathanisweni kweziguli ezingama-782 ezingahleliwe ku-tremelimumab kanye ne-durvalumab kuya ku-sorafenib.
Umphumela omkhulu wokusebenza ngempumelelo kwaba ukusinda okuphelele (OS). I-Tremelimumab plus durvalumab ibonise ukuthuthuka okuphawulekayo kwezibalo nokunenjongo ngokomtholampilo ku-OS uma kuqhathaniswa ne-sorafenib (i-stratified hazard ratio [HR] engu-0.78 [95% CI: 0.66, 0.92], 2-sided p value = 0.0035); i-median OS yayiyizinyanga eziyi-16.4 (95% CI: 14.2, 19.6) uma iqhathaniswa nezinyanga eziyi-13.8 (95% CI: 12.3, 16.1). Imiphumela eyengeziwe yokusebenza ngempumelelo ihlanganise umphenyi-okuhloliwe kwe-progression-free survival (PFS) kanye nezinga lokuphendula eliphelele (ORR) ngokuya nge-RECIST v1.1. I-PFS emaphakathi kwakuyizinyanga ezingu-3.8 (95% CI: 3.7, 5.3) kanye nezinyanga ezingu-4.1 (95% CI: 3.7, 5.5) ngezingalo ze-tremelimumab plus durvalumab kanye ne-sorafenib, ngokulandelana (i-stratified HR 0.90; 95% CI, 0.77) . I-ORR yayingu-1.05% (20.1% CI: 95, 16.3) engalweni ye-tremelimumab plus durvalumab kanye no-24.4% (5.1% CI: 95, 3.2) kulabo abaphathwa nge-sorafenib.
Okuvame kakhulu (≥20%) ukusabela okungekuhle okwenzeka ezigulini kwakuwukuqubuka, isifo sohudo, ukukhathala, i-pruritis, ubuhlungu be-musculoskeletal kanye nobuhlungu besisu.
Umthamo onconyiwe we-tremelimumab ezigulini ezinesisindo esingu-30 kg noma ngaphezulu ngu-300 mg IV njengomthamo owodwa ohlanganiswe ne-durvalumab 1500 mg ku-Cycle 1/Usuku 1, kulandele i-durvalumab 1500 mg IV njalo emavikini ama-4. Kulabo abanesisindo esingaphansi kwama-30 kg, umthamo onconywayo we-tremelimumab ngu-4 mg/kg IV njengomthamo owodwa ohlanganiswe ne-durvalumab 20 mg/kg IV, kulandele i-durvalumab 20 mg/kg IV njalo emavikini ama-4.
View full prescribing information for Imjudo.
