NgoMashi 16, 2025, u-Akeso wamemezela ukuthi i-antibody yayo entsha, ezenzele ngokwayo, i-penpulimab, ivunyelwe ngokusemthethweni yi-National Medical Products Administration (NMPA) yokwelapha umdlavuza we-nasopharyngeal ophindaphindayo noma osakazeka kalula (NPC) kanye ne-chemotherapy.
I-Penpulimab (i-PD-1 Monoclonal Antibody） okwamanje iyona kuphela i-PD-1 monoclonal antibody ehlukile esebenzisa uhlobo lwe-IgG1 nge-Fc-nulldomain eguquliwe, engathuthukisa ngempumelelo ukusebenza kahle kwe-immunotherapeutic futhi inciphise ukusabela okubi okuhlobene nokuzivikela komzimba. Isetshenziswa ekwelapheni izifo ezinkulu ezifana nomdlavuza wamaphaphu, i-lymphoma, umdlavuza we-nasopharyngeal, umdlavuza wesibindi, kanye nomdlavuza wesisu, ngokuphepha okuthuthukisiwe kanye nokusebenza kahle njengoba kuboniswe ezifundweni zemitholampilo.
Lokhu kuphawula isibonakaliso sesine esivunyiwe se-penpulimab. Ngaphezu kwezinkomba ezimbili ze-NPC, i-penpulimab iphinde ivunyelwe ukwelashwa komugqa wokuqala komdlavuza wamaphaphu we-squamous non-small cell (NSCLC) osezingeni eliphezulu noma osakazeka kalula lapho uhlanganiswa ne-chemotherapy, kanye nokwelashwa okukodwa ezigulini ezine-Hodgkin lymphoma (cHL) ephindaphindayo noma engaphikisiwe ezike zathola okungenani imigqa emibili ye-chemotherapy ehlelekile ngaphambilini. Ngaphezu kwalokho, i-New Drug Application (sNDA) eyengeziwe ye-penpulimab ehlanganiswe ne-anlotinib yokwelashwa komugqa wokuqala we-carcinoma ye-hepatocellular esezingeni eliphezulu (HCC) okwamanje iyabuyekezwa.
Ngaphambilini, i-penpulimab yayivunyelwe ukusetshenziswa njengokwelashwa komugqa wesithathu kwe-NPC ethuthukisiwe. Ngalesi sivumelwano esisha, i-penpulimab manje inikeza ukumbozwa okuphelele kokwelashwa kuzo zonke izigaba ze-NPC, inikeza iziguli inketho eqhubekayo yokwelapha nge-immunotherapy kusukela komugqa wokuqala kuya komugqa wesithathu.
Ngomhlaka-19 Juni 2024, i-“Signal Transduction and Targeted Therapy” yashicilela imiphumela yocwaningo lwesigaba sesi-2 mayelana nokwelashwa kwe-metastatic nasopharyngeal carcinoma eyake yaphathwa ngaphambilini nge-pembrolizumab.
Lolu cwaningo lwesigaba sesibili olulodwa, olwenziwe ngengalo eyodwa, olwenziwe ezikhungweni zokunakekelwa kwezokwelapha eziphakeme ezingu-20 eShayina lwabhalisa iziguli ezindala ezine-metastatic nasopharyngeal carcinoma (NPC) ezazihlulekile emigqeni emibili noma ngaphezulu ye-systemic chemotherapy yangaphambilini. Iziguli zathola i-penpulimab engu-200-mg ngemithambo njalo emavikini ama-2 (amasonto ama-4 ngomjikelezo ngamunye) kuze kube yilapho isifo siqhubeka noma ubuthi obungabekezeleleki. Isiphetho esiyinhloko kwakuyizinga lokuphendula eliqondile (ORR) nge-RECIST (inguqulo 1.1), njengoba kuhlolwe yikomidi elizimele lokubuyekeza ngemisebe. Iziphetho zesibili zazihlanganisa ukusinda okungenakho ukuqhubeka (PFS) kanye nokusinda okuphelele (OS). Iziguli eziyikhulu namashumi amathathu zabhaliswa kanti ezingu-125 zahlolwa ukusebenza kahle. Ngosuku lokugcina idatha (Septhemba 28, 2022), isiguli esisodwa sathola impendulo ephelele kanti iziguli ezingu-34 zathola impendulo engaphelele. I-ORR yayingu-28.0% (95% CI 20.3–36.7%). Impendulo yayihlala isikhathi eside, kanti u-66.8% wayesaphendula ezinyangeni ezingu-9. Iziguli ezingamashumi amathathu nantathu (26.4%) zazisaphathwa. I-PFS kanye ne-OS ephakathi nendawo kwakuyizinyanga ezingu-3.6 (95% CI = izinyanga ezingu-1.9–7.3) kanye nezinyanga ezingu-22.8 (95% CI = izinyanga ezingu-17.1 ezingakafinyelelwa), ngokulandelana. Iziguli eziyishumi (7.6%) zithole ama-irAE ebanga lesi-3 noma ngaphezulu. I-Penpulimab inemisebenzi ethembisayo yokulwa nomdlavuza kanye nobuthi obamukelekayo ezigulini ze-NPC ezitholwe kakhulu ngaphambi kwesikhathi, okusekela ukuthuthukiswa okuqhubekayo kwezokwelapha njengokwelashwa komugqa wesithathu kwe-NPC etholwe kabusha.
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.
Inombolo yocingo: 4008803716
Email：myimmnet@163.com
Isikhathi sokuthunyelwe: Ephreli-25-2025