August 2021: Dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) yakagamuchira kukurumidza kubvumidzwa kubva kuChikafu neDrug Administration kune varwere vakuru vane kukanganisa kugadzirisa kushomeka (dMMR) yakadzokororwa kana yepamberi endometrial cancer, sekutemerwa neFDA-yakatenderwa bvunzo, avo vakafambira mberi kana mushure mekutanga-ine platinum regimen.
MuGARNET Trial (NCT02715284), multicenter, multicohort, open-label kuyedzwa kune varwere vane advanced tumarara yakasimba, kushanda kwakaongororwa zvichienderana neboka (A1). 71 varwere vane dMMR inodzokororwa kana yepamusoro endometrial kenza yakafambira mberi kana kana mushure meplatinum-iine kurapwa kwakabatanidzwa muhunhu hwehuwandu. Varwere vakapihwa 500 mg ye dostarlimab-gxly intravenously mukati memavhiki matatu emadhizai mana, kozo 1,000 mg intravenously mavhiki matanhatu ese.
Yakazara yekupindura mwero (ORR) uye nguva yekupindura (DOR) yaive mhedzisiro yekubudirira, sekumisikidzwa neyakavharwa yakazvimirira yepakati ongororo (BICR) zvinoenderana neRECIST 1.1. Iyo ORR yakasimbiswa kuve 42.3 muzana (95 muzana CI: 30.6 muzana, 54.6 muzana). Mwero wekupindura waive 12.7 muzana yemhinduro dzakakwana uye 29.6 muzana yemhinduro dzisina kukwana. Iine 93.3 muzana yevarwere vane nguva dzisingasviki mwedzi mitanhatu, wepakati DOR haana kusangana (renji: 2.6 kusvika 22.4 mwedzi, ichienderera pakuongorora kwekupedzisira).
Muchikamu che34 muzana chevanhu vakagamuchira dostarlimab-gxly, mhedzisiro yakaipa yakaitika. Sepsis, acute renal kukuvara, urinary tract infection, abdominal kusagadzikana, uye pyrexia zvaiva pakati pemhinduro dzakaipa dzakaipa dzinowanikwa nevanopfuura 2% yevarwere. Kuneta/asthenia, kuda kurutsa, manyoka, kupererwa neropa, uye kusvusvurwa ndiyo yainyanya kuitika (20%). Anemia uye yakakwira transaminases yaive yakajairika giredhi 3 kana 4 zviitiko zvakashata (2%). Pneumonitis, colitis, hepatitis, endocrinopathies, uye nephritis zvose zvinokonzerwa nekudzivirira zvirwere zvinogona kuitika.
Unogona kuda kuverenga: Kenza kurapwa muIndia
Dostarlimab-gxly 500 mg vhiki dzese nhatu ndiyo inokurudzirwa dhizaini uye chirongwa (doses 3 kuburikidza 1). Kutanga vhiki nhatu dzinotevera kuyerwa 4, dosing inowedzerwa kusvika ku4 mg masvondo matanhatu ega ega kusvika pakurwara kuchikura kana kusagadzikana kwehuturu. Dostarlimab-gxly inofanirwa kuendeswa seye 1,000-miniti inopinza infusion.
Referensi: https://www.fda.gov/
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