Nuwamba 2022: Hukumar Abinci da Magunguna ta amince da tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) a haɗe tare da durvalumab ga manya marasa lafiya tare da ciwon hanta da ba a iya gano su ba (uHCC).
An kimanta inganci a cikin HIMALAYA (NCT03298451), bazuwar (1: 1: 1), lakabin buɗewa, binciken da yawa a cikin marasa lafiya tare da tabbatar da uHCC waɗanda ba su karɓi maganin rigakafi na farko don HCC ba. An bazuwar marasa lafiya zuwa ɗaya daga cikin makamai uku: tremelimumab 300 MG a matsayin jiko guda ɗaya (IV) jiko tare da durvalumab 1500 mg IV a wannan rana, sannan durvalumab 1500 mg IV a kowane mako 4; durvalumab 1500 MG IV kowane mako 4; ko sorafenib 400 MG na baki sau biyu a rana har sai cutar ta ci gaba ko rashin yarda da guba. Wannan amincewa ya dogara ne akan kwatancen marasa lafiya 782 da aka bazu zuwa tremelimumab da durvalumab zuwa sorafenib.
Babban sakamako mai inganci shine gaba ɗaya rayuwa (OS). Tremelimumab tare da durvalumab sun nuna ingantaccen ƙididdiga da haɓaka mai ma'ana na asibiti a cikin OS idan aka kwatanta da sorafenib (raɗin haɗarin haɗari [HR] na 0.78 [95% CI: 0.66, 0.92], ƙimar p mai gefe 2 = 0.0035); Tsakanin OS ya kasance watanni 16.4 (95% CI: 14.2, 19.6) tare da watanni 13.8 (95% CI: 12.3, 16.1). Ƙarin sakamako masu tasiri sun haɗa da mai bincike-ƙimanci ci gaba-kyauta rayuwa (PFS) da kuma jimlar amsa (ORR) bisa ga RECIST v1.1. Median PFS shine watanni 3.8 (95% CI: 3.7, 5.3) da watanni 4.1 (95% CI: 3.7, 5.5) don tremelimumab da durvalumab da makamai na sorafenib, bi da bi (HR 0.90; 95% CI: 0.77). ORR ya kasance 1.05% (20.1% CI: 95, 16.3) a cikin tremelimumab da durvalumab hannu da 24.4% (5.1% CI: 95, 3.2) ga waɗanda aka bi da su tare da sorafenib.
Mafi na kowa (≥20%) mummunan halayen da ke faruwa a cikin marasa lafiya sun hada da kurji, zawo, gajiya, pruritis, ciwon musculoskeletal da ciwon ciki.
Matsakaicin shawarar tremelimumab ga marasa lafiya masu nauyin kilogiram 30 ko fiye shine 300 MG IV a matsayin kashi ɗaya a hade tare da durvalumab 1500 MG a Cycle 1/Day 1, sannan durvalumab 1500 mg IV ya biyo baya kowane mako 4. Ga waɗanda basu da nauyin kilogiram 30, shawarar tremelimumab shawarar shine 4 mg/kg IV a matsayin kashi ɗaya a hade tare da durvalumab 20 mg/kg IV, sannan durvalumab 20 mg/kg IV kowane mako 4.
View full prescribing information for Imjudo.
