Noyabr 2022: The Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma (uHCC).
Samaradorlik HIMALAYA (NCT03298451), tasodifiy (1:1:1), ochiq yorliqli, ko'p markazli tadqiqotda, HCC uchun oldindan tizimli davolanishni olmagan, tasdiqlangan uHCC bo'lgan bemorlarda baholandi. Bemorlar uchta qo'ldan biriga randomize qilindi: tremelimumab 300 mg bir martalik tomir ichiga (IV) infuzion plyus o'sha kuni 1500 mg IV durvalumab, so'ngra har 1500 haftada 4 mg IV durvalumab; durvalumab 1500 mg tomir ichiga har 4 haftada bir marta; yoki sorafenib 400 mg og'iz orqali kuniga ikki marta kasallikning kuchayishi yoki qabul qilinishi mumkin bo'lmagan zaharlanishgacha. Ushbu tasdiqlash tremelimumab va durvalumabni sorafenibga randomizatsiyalangan 782 bemorni taqqoslashga asoslangan.
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.
Bemorlarda eng ko'p uchraydigan (≥20%) nojo'ya reaktsiyalar toshma, diareya, charchoq, qichishish, mushak-skelet tizimining og'rig'i va qorin og'rig'i edi.
Og'irligi 30 kg va undan ko'p bo'lgan bemorlar uchun tavsiya etilgan tremelimumab dozasi 300-kunida 1500 mg durvalumab bilan birgalikda bir martalik 1 mg IV ni tashkil qiladi, so'ngra 1 haftada bir marta 1500 mg durvalumab. Og'irligi 4 kg dan kam bo'lganlar uchun tavsiya etilgan tremelimumab dozasi 30 mg/kg iv durvalumab bilan birgalikda bir martalik dozada 4 mg/kg iv, so'ngra har 20 haftada bir marta 20 mg/kg durvalumab.
View full prescribing information for Imjudo.
