Kukadzi 2024: Chikafu and Drug Administration has sped up the approval process for two drugs, enfortumab vedotin-ejfv (Padcev, Astellas Pharma) and pembrolizumab (Keytruda, Merck). These drugs are meant to treat people with locally advanced or metastatic urothelial carcinoma who can not get cisplatin-containing chemotherapy.
Kubudirira kwakaongororwa mu-multi-cohort (dose escalation cohort, Cohort A, Cohort K) tsvakurudzo EV-103/KEYNOTE-869 (NCT03288545). Varwere vakarapwa neenfortumab vedotin-ejfv + pembrolizumab muyero yekuwedzera cohort uye Cohort A, nepo muCohort K, varwere vaingoitwa zvisina mwero kusanganisa kana enfortumab vedotin-ejfv chete. Varwere vaisakodzera chemotherapy yaive necisplatin nekuti vaive vasati vamborapwa systemic yechirwere chaifambira mberi kana metastatic. 121 vanhu pamwe chete vakagamuchira pembrolizumab pamwe chete neenfortumab vedotin-ejfv.
Objective response rate (ORR) uye nguva yekupindura (DoR), iyo yakatemerwa nebofu yakazvimirira yepakati wongororo uchishandisa RECIST v1.1, ndiyo yaive yakakosha mhedzisiro yemhedzisiro. Mune varwere ve121, ORR yakasimbiswa yaiva 68% (95% CI: 59, 76), ne12% yevarwere vanowana mhinduro dzakakwana. Kukwidziridzwa kwedosi cohort neCohort A vaive nepakati DoR yemwedzi makumi maviri nemaviri (interquartile renji: 22+ kusvika 1+), nepo Cohort K isina kusvika yepakati DoR (interquartile renji: 46 kusvika 1+).
Yakawedzera glucose, yakawedzera aspartate aminotransferase, rash, yakaderera hemoglobin, yakawedzera creatinine, peripheral neuropathy, yakaderera lymphocytes, kuneta, yakawedzera alanine aminotransferase, yakaderera sodium, yakawedzera lipase, yakaderera albumin, alopecia, yakaderera phosphate, kuderera uremu, manyoka, kuderera kwe appeturitus, , kuda kurutsa, dysgeusia, kuderera kwe potassium, kuderera kwesodium ndiyo yaiwanzoita maitiro akaipa (> 20%), pamwe chete
Kana yasanganiswa nepembrolizumab, chiyero chinokurudzirwa cheenfortumab vedotin-ejfv i1.25 mg/kg (kusvika 125 mg kune varwere vari pasi pe100 kg), inopihwa nemutsinga inopfuura maminetsi makumi matatu paMazuva 30 ne1 emazuva makumi maviri nerimwe kusvika pakukura kwechirwere kana. toxicity isingashiviriki. Mushure mekugamuchira enfortumab vedotin pazuva rimwe chete, chiyero chepembrolizumab chinorayirwa kuti ive 8 mg mavhiki matatu ega ega kana 21 mg masvondo matanhatu ega ega kusvika chirwere chakura, pane huturu husingagoneki, kana kusvika kumwedzi makumi maviri nemana apfuura.
