Ngomhlaka-29 Meyi, i-National Medical Products Administration (NMPA) yavuma ukudayiswa kwe-Zanidatamab, ethunyelwe yi-BeiGene, yokwelapha iziguli ezinomdlavuza we-biliary tract (BTC) ongasakwazi ukulashwa endaweni noma osakazeke kakhulu, abake bathola ukwelashwa kwesistimu ngaphambilini futhi babonisa ukuvezwa okuphezulu kwe-HER2 (IHC 3+).
I-Zanidatamab iyi-antibody ehlosiwe ye-HER2 ehlosiwe engakwazi ukubopha ngasikhathi sinye ama-epitopes amabili angahlangani we-HER2 receptor, aziwa ngokuthi ukubopha kwe-biparatopic. Lo mklamo oyingqayizivele kanye nokwanda kokubopha kuphumela ezindleleni eziningi zokusebenza, okuhlanganisa ukuvimba kwesignali ye-HER2 kabili, ukususwa kwephrotheni ye-HER2 ebusweni beseli, kanye ne-cytotoxicity ebangelwa amasosha omzimba eholela ekukhuthazeni umsebenzi wokulwa nomdlavuza ezigulini.
I-Receptor tyrosine-protein kinase, eyaziwa kakhulu ngokuthi i-Human Epidermal Growth Factor Receptor 2 (HER2) noma i-CD340, itholakala ebusweni bamaseli. Le phrotheni iyilungu lomndeni we-Epidermal Growth Factor Receptor (EGFR) futhi ibhalwe yi-Erythroblastic oncogene B (ERBB2) gene. I-ERBB2 gene ibalulekile ezinqubweni ezijwayelekile njengokuhlukaniswa kwamaseli, ukuhlukanisa, kanye nokusinda. Ngezindlela ezahlukahlukene zokubonisana, ama-HER2 receptors akhuthaza ukwanda kwamaseli futhi avimbele i-apoptosis (ukufa kwamaseli okuhleliwe). Kubalulekile ukulawula la ma-receptor ukuvimbela ukukhula kwamaseli okungalawulwa. Umdlavuza oveza noma okhulisa i-HER2 gene ubizwa ngokuthi yi-HER2-positive malignancies. Le gene isebenza njenge-biomarker ebalulekile futhi iyisisulu esiyinhloko sokwelashwa ngemithi.
Kodwa-ke, uma i-HER2 ikhuliswa noma ikhiqizwa ngokweqile, ukwanda kwamaseli okungalawulwa kanye nokuhlukana kusheshisa ukuqhubeka komdlavuza. Lokhu kukhula noma ukuvezwa ngokweqile kuvame ukutholakala ezinhlotsheni ezahlukene zamathumba futhi kungaba nokubaluleka okubalulekile kokwelapha izifo zomdlavuza ezingavamile ukusabela kahle ekwelashweni kwe-anti-HER2.
I-HER2-positivity itholakala ezinhlotsheni ezahlukene zomdlavuza ofana nomdlavuza wesisu, we-biliary tract, webele, womphimbo, we-ovarian, kanye nowesibeletho. Ukwanda, incazelo, kanye nemikhuba yokwelashwa kwezimila ezine-HER2-positive ngayinye ikhona kuThebula. Muva nje, kutholakale ubudlelwano nomdlavuza we-pancreatic kanye ne-biliary tract (BTC). Iziguli ezine-HER2-positive zivame ukuba ne-prognosis embi uma kuqhathaniswa nalabo abane-HER2-negative cancer, njengoba lezi zimila zinolaka kakhulu. Kodwa-ke, amasu amasha okwelapha abonise imiphumela ethembisayo.
Lokhu kuvunywa kusekelwe emiphumeleni yocwaningo olubalulekile lwezokwelapha i-HERIZIN-BTC-01 (NCT04466891). Lolu kwakuwucwaningo lweSigaba 2b lomhlaba wonke, olunezikhungo eziningi, oluvulekile, olunengalo eyodwa, olwenzelwe ukuhlola ukusebenza kahle nokuphepha kwe-zanidatamab ezigulini ezine-BTC ethuthukisiwe noma eguquliwe ngaphambilini.
Ucwaningo lubhalise iziguli ezingu-87 ze-BTC, okuhlanganisa nezingu-62 ezine-HER2 expression ephezulu. Imiphumela ibonise ukuthi i-Zanidatamab monotherapy ibonise ukusebenza kahle okubalulekile emtholampilo ezigulini ezelashwe ngaphambilini ezine-HER2-high BTC. Izinga lokuphendula eliqinisekisiwe eliqinisekisiwe (ORR) elibuyekezwe ngokuzimela lalingu-51.6%, kanye nesikhathi esimaphakathi sokuphendula (mDoR) sezinyanga ezingu-14.9, ukusinda okumaphakathi okungenalo ukuqhubekela phambili (mPFS) kwezinyanga ezingu-7.2, kanye nokusinda okumaphakathi okuvamile (mOS) kwezinyanga ezingu-18.1.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
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Isikhathi sokuthunyelwe: Juni-06-2025