Nofeembar 2022: The Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma (uHCC).
Waxtarka waxaa lagu qiimeeyay HIMALAYA (NCT03298451), randomized (1:1:1), calaamad furan, daraasad xarun badan oo bukaanada la xaqiijiyay uHCC kuwaas oo aan helin daawaynta nidaamka hore ee HCC. Bukaan-socodka ayaa loo kala soocay mid ka mid ah saddexda gacmood: tremelimumab 300 mg sida hal mar oo xidid ah (IV) faleebo oo lagu daray durvalumab 1500 mg IV isla maalintaas, oo ay ku xigto durvalumab 1500 mg IV 4 kasta oo kasta; durvalumab 1500 mg IV 4tii toddobaadba; ama sorafenib 400 mg afka laba jeer maalintii ilaa cudurku ka sii socdo ama sunta aan la aqbali karin. Oggolaanshahan wuxuu ku salaysan yahay isbarbardhigga 782 bukaan ee loo kala soocay tremelimumab iyo durvalumab iyo 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.
Dareen-celinta xun ee ugu badan (≥20%) ee bukaannada ku dhaca waxay ahaayeen finan, shuban, daal, cuncun, xanuun murqo-xanuun iyo calool xanuun.
Qiyaasta lagu taliyey ee tremelimumab ee bukaannada miisaankoodu yahay 30 kg ama ka badan waa 300 mg IV sida hal qiyaas oo lagu daray durvalumab 1500 mg ee Wareegga 1/Maalinta 1, oo ay ku xigto durvalumab 1500 mg IV 4tii toddobaadba. Kuwa miisaankoodu ka yar yahay 30 kg, qiyaasta tremelimumab ee lagu taliyey waa 4 mg/kg IV sida hal qiyaas oo lagu daray durvalumab 20 mg/kg IV, oo ay ku xigto durvalumab 20 mg/kg IV 4tii toddobaadba.
View full prescribing information for Imjudo.
