Cibiyar Abinci da Drug ta amince da pembrolizumab (Keytruda, Merck) a hade tare da fluoropyrimidine- da platinum-dauke da chemotherapy a ranar 16 ga Nuwamba, 2023. Wannan amincewar ita ce farkon jiyya na manya tare da ci gaba na gida wanda ba a iya gyarawa ba ko metastatic HER2-negative gastric ko gastroesophageal junction. (GEJ) adenocarcinoma.
An yi la'akari da tasiri a cikin multicenter, bazuwar, makafi biyu, gwajin sarrafa wuribo mai suna KEYNOTE-859 (NCT03675737). Gwajin ya haɗa da marasa lafiya 1579 tare da HER2-negative Advanced Gastric ko GEJ adenocarcinoma wanda ba a yi amfani da tsarin tsarin magani don rashin lafiyar metastatic a baya ba. An ba da izini ga mahalarta don karɓar ko dai pembrolizumab 200 mg ko placebo tare da zaɓin mai binciken na haɗin chemotherapy, wanda ya haɗa da cisplatin 80 mg / m2 da 5-FU 800 mg / m2 / rana don kwanaki 5 (FP) ko oxaliplatin 130 mg. / m2 a ranar 1 da capecitabine 1000 mg / m2 sau biyu a rana don kwanaki 14 (CAPOX) a cikin kowane zagaye na kwanaki 21.
Babban ma'aunin inganci shine gaba ɗaya rayuwa (OS). Har ila yau, binciken ya kimanta ci gaba na rayuwa kyauta (PFS), jimlar amsawar amsawa (ORR), da tsawon lokacin amsawa (DOR) ta hanyar nazari na tsakiya mai zaman kanta (BICR) bisa ma'auni na RECIST v1.1, tare da iyakacin 10 manufa raunuka da 5 manufa raunuka a kowace gaba.
Pembrolizumab haɗe tare da chemotherapy ya haifar da ingantaccen ingantaccen ƙididdiga a cikin rayuwa gabaɗaya (OS), tsira mara ci gaba (PFS), da ƙimar amsa haƙiƙa (ORR). Tsakanin rayuwa gaba ɗaya shine watanni 12.9 (95% CI: 11.9, 14.0) tare da pembrolizumab da watanni 11.5 (95% CI: 10.6, 12.1) tare da placebo. Matsakaicin haɗari (HR) shine 0.78 (95% CI: 0.70, 0.87) tare da p-darajar <0.0001. Rayuwa ba tare da ci gaba ba (PFS) shine watanni 6.9 (95% CI: 6.3, 7.2) da watanni 5.6 (95% CI: 5.5, 5.7) a cikin ƙungiyoyin biyu, tare da rabon haɗari (HR) na 0.76 [95% CI: 0.67, 0.85] da p-darajar <0.0001. Matsakaicin amsawar haƙiƙa (ORR) shine 51% (95% CI: 48, 55) da 42% (95% CI: 38, 45) tare da ƙimar p-ƙididdigar ƙididdiga ta ƙasa da 0.0001 a cikin ƙungiyoyin jiyya guda biyu. Matsakaicin lokacin amsawa (DOR) shine watanni 8 (95% CI: 7.0, 9.7) don pembrolizumab da watanni 5.7 (95% CI: 5.5, 6.9) don placebo.
Wani ƙarin binciken ya nuna cewa marasa lafiya waɗanda aka ba da pembrolizumab kuma suna da ciwace-ciwacen da suka bayyana PD-L1 CPS> 1 da CPS ≥ 10 suna da ƙididdiga mafi girma na rayuwa gaba ɗaya (OS), tsira ba tare da ci gaba ba (PFS), da ƙimar amsawar haƙiƙa (ORR).
15% na marasa lafiya sun sami dakatarwar dindindin na jiyya na pembrolizumab saboda mummunan sakamako. Mummunan illolin da ke haifar da dainawa na dindindin a cikin aƙalla 1% na lokuta sun haɗa da cututtuka da gudawa.
Shawarar da aka ba da shawarar don pembrolizumab shine 200 MG kowane mako 3 ko 400 MG kowane mako 6 har sai cutar ta ci gaba ko rashin haƙuri. Gudanar da pembrolizumab kafin chemotherapy idan an ba su a rana ɗaya.
