Agusta 2023: Dostarlimab-gxly (Jemperli, GlaxoSmithKline), wanda dostarlimab-gxly ya biyo baya a matsayin wakili ɗaya, Hukumar Abinci da Magunguna ta amince da ita don maganin ciwon daji na farko ko na gaba na endometrial (EC) wanda ke da ƙarancin gyara gyara (dMMR), kamar yadda ƙaddara ta hanyar gwajin da aka yarda da FDA, ko rashin zaman lafiya-high (MSI-H).
RUBY (NCT03981796), bazuwar, cibiyar sadarwa da yawa, makafi biyu, gwaji mai sarrafa wuribo, kimanta ingancin inganci. Ƙungiya da aka riga aka ƙaddara na marasa lafiya 122 tare da ci gaba na farko ko dMMR/MSI-H EC sun sami kimanta ingancin inganci. Lokacin da ba a samu bayanan gida ba, gwajin tsakiya (IHC) na amfani da Ƙungiyar Ventana MMR RxDx an yi amfani da shi don tantance matsayin ƙwayar ƙwayar cuta ta MMR/MSI.
An sanya marasa lafiya bazuwar (1: 1) don karɓar ko dai placebo tare da carboplatin da paclitaxel, biye da placebo, ko dostarlimab-gxly tare da carboplatin da paclitaxel, sannan dostarlimab-gxly. Haɗin da aka ambata a baya yana ba da cikakken bayani game da ƙayyadaddun tsari na chemotherapy da yawa. Matsayin MMR/MSI, daɗaɗɗen iska na pelvic na waje, da kuma mataki na cuta (maimaituwa, mataki na farko na III, ko mataki na farko na IV) duk an yi la'akari da su lokacin da aka tsara tsarin bazuwar.
Rayuwar da babu ci gaba da aka tantance mai bincike (PFS) ta amfani da RECIST v. 1.1 shine babban ma'aunin sakamako mai inganci. Tare da matsakaicin PFS na 30.3 da watanni 7.7 (Hazard Ratio = 0.29 [95% CI: 0.17, 0.50]; p-value0.0001) don dostarlimab-gxly da placebo-dauke da tsarin, bi da bi, an ga ingantaccen PFS mai mahimmanci. a cikin ƙungiyar dMMR/MSI-H.
Pneumonitis, colitis, hepatitis, endocrinopathy irin su hypothyroidism, nephritis tare da gazawar koda, da kuma mummunan martani na fata su ne misalan halayen rashin lafiya na rigakafi wanda zai iya faruwa tare da dostarlimab-gxly. Rash, gudawa, hypothyroidism, da hauhawar jini sune mafi yawan abubuwan da suka faru (20%) tare da dostarlimab-gxly tare da carboplatin da paclitaxel. Don cikakken jerin abubuwan illa, koma zuwa bayanan da aka tsara.
Dostarlimab-gxly za a gudanar a kashi na 500 MG kowane mako uku don allurai shida tare da carboplatin da paclitaxel, sannan 1,000 MG sau ɗaya a kowane mako shida har sai rashin lafiya ya ci gaba ko kuma akwai guba maras haƙuri, wanda zai iya ɗaukar har zuwa shekaru uku. Lokacin da aka ba shi a rana ɗaya da chemotherapy, ya kamata a fara ba da dostarlimab-gxly.
Duba cikakken bayanin rubutawa na Jemperli.
