Febhuwari 2024: Ukudla 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.
Ukusebenza kahle kuye kwahlolwa kuqoqo le-multi-cohort (iqembu lokwenyusa umthamo, Iqoqo A, Iqoqo K) locwaningo lwe-EV-103/KEYNOTE-869 (NCT03288545). Iziguli zalashwa nge-enfortumab vedotin-ejfv + pembrolizumab kuqoqo lokukhuphuka komthamo kanye neqoqo A, kanti ku-Cohort K, iziguli zazingahleliwe zibe yinhlanganisela noma i-enfortumab vedotin-ejfv iyodwa. Iziguli bezingafaneleki ukuthola i-chemotherapy equkethe i-cisplatin ngoba bezingakaze zithole ukwelashwa okuhleliwe kokugula okuthuthuke endaweni noma kwe-metastatic. Abantu abangu-121 sebebonke bathole i-pembrolizumab kanye ne-enfortumab vedotin-ejfv.
Izinga lokuphendula lenjongo (ORR) kanye nobude besikhathi sokuphendula (i-DoR), okunqunywe ukubuyekezwa okuzimele okuphuphuthekile kusetshenziswa i-RECIST v1.1, bekuyizinyathelo ezibalulekile zemiphumela yokusebenza ngempumelelo. Ezigulini eziyi-121, i-ORR eqinisekisiwe yayingu-68% (95% CI: 59, 76), ne-12% yeziguli ezithola izimpendulo ezigcwele. Iqembu elikhuphukayo lomthamo kanye neQembu A libe ne-DoR emaphakathi yezinyanga ezingu-22 (ububanzi be-interquartile: 1+ ukuya ku-46+), kuyilapho i-Cohort K ingafinyelelanga ku-DoR emaphakathi (ububanzi be-interquartile: 1 ukuya ku-24+).
Ukwenyuka kwe-glucose, ukwanda kwe-aspartate aminotransferase, ukuqubuka, ukwehla kwe-hemoglobin, ukwanda kwe-creatinine, i-peripheral neuropathy, ukuncipha kwe-lymphocyte, ukukhathala, ukwanda kwe-alanine aminotransferase, ukwehla kwe-sodium, ukwanda kwe-lipase, ukwehla kwe-albumin, i-alopecia, ukwehla kwe-phosphate, ukuncipha kwesisindo, isifo sohudo, ukwehla kwe-pruritus, isicanucanu, i-dysgeusia, ukwehla kwe-potassium, ukwehla kwe-sodium kwakuyizimo ezivame kakhulu zokusabela (>20%),
Lapho kuhlanganiswa ne-pembrolizumab, umthamo onconyiwe we-enfortumab vedotin-ejfv ngu-1.25 mg/kg (kufika ku-125 mg ezigulini ezingaphansi kwe-100 kg), unikezwe ngomthambo imizuzu engama-30 ngezinsuku 1 no-8 zomjikelezo wezinsuku ezingama-21 kuze kuqhubeke isifo noma ubuthi obungabekezeleleki. Ngemuva kokuthola i-enfortumab vedotin ngosuku olufanayo, umthamo we-pembrolizumab uyelulekwa ukuthi ube ngu-200 mg njalo emasontweni amathathu noma ama-400 mg njalo emavikini ayisithupha kuze kuqhubeke isifo, kuba nobuthi obungabekezeleleki, noma kufike ezinyangeni ezingama-24.
Buka imininingwane egcwele yemiyalelo ye UPadcev futhi Keytruda.
