November 2022: The Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma (uHCC).
Kubudirira kwakaongororwa muHIMALAYA (NCT03298451), yakasununguka (1: 1: 1), yakazaruka-label, multicenter kudzidza kune varwere vane HCC yakasimbiswa vakanga vasati vagamuchira kare systemic kurapwa kweHCC. Varwere vakarongedzerwa kune imwe yemaoko matatu: tremelimumab 300 mg senguva imwe chete intravenous (IV) infusion plus durvalumab 1500 mg IV pazuva rimwechete, inoteverwa ne durvalumab 1500 mg IV masvondo ose e4; durvalumab 1500 mg IV masvondo ose e4; kana sorafenib 400 mg nemuromo kaviri zuva nezuva kusvikira kufambira mberi kwechirwere kana kutyisa kusingagamuchirwi. Mvumo iyi inobva pakuenzanisa kwevarwere ve782 vakarongerwa kune tremelimumab pamwe nedurvalumab kune 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.
Zvakanyanya kuitika (≥20%) maitiro asina kunaka anoitika muvarwere aive mapundu, manyoka, kuneta, pruritis, marwadzo emusculoskeletal uye kurwadziwa mudumbu.
Iyo yakakurudzirwa tremelimumab dose yevarwere vanorema 30 kg kana kupfuura ndeye 300 mg IV seyero imwe chete pamwe chete nedurvalumab 1500 mg paCycle 1 / Zuva 1, inoteverwa nedurvalumab 1500 mg IV masvondo mana ose. Kune avo vanoyera zvishoma kudarika 4 kg, iyo yakakurudzirwa tremelimumab dose ndeye 30 mg / kg IV seyero imwe chete pamwe chete ne durvalumab 4 mg / kg IV, inoteverwa ne durvalumab 20 mg / kg IV masvondo mana ose.
View full prescribing information for Imjudo.
