Ngomhla we-16 kweyoKwindla, ngo-2025, uAkeso wabhengeza ukuba i-antibody yayo entsha, ephuhlisiweyo ngokwayo, i-penpulimab, ivunyiwe ngokusesikweni yi-National Medical Products Administration (NMPA) kunyango lokuqala lomhlaza we-nasopharyngeal ophindaphindayo okanye osasazekayo (NPC) kunye ne-chemotherapy.
I-Penpulimab (i-PD-1 Monoclonal Antibody） okwangoku yeyona antibody ye-PD-1 monoclonal eyahlukileyo esebenzisa uhlobo lwe-IgG1 ene-Fc-nulldomain eguquliweyo, enokuphucula ukusebenza kakuhle kwe-immunotherapy kwaye inciphise iimpendulo ezimbi ezinxulumene nomzimba. Isetyenziswa kunyango lwezifo eziphambili ezifana nomhlaza wamaphaphu, i-lymphoma, umhlaza we-nasopharyngeal, umhlaza wesibindi, kunye nomhlaza wesisu, ngokhuseleko oluphuculweyo kunye nokusebenza kakuhle njengoko kubonisiwe kwizifundo zeklinikhi.
Oku kubonisa uphawu lwesine oluvunyiweyo lwe-penpulimab. Ukongeza kwizibonakaliso ezimbini ze-NPC, i-penpulimab ikwavunyiwe kunyango lokuqala lomhlaza wemiphunga we-squamous non-small cell (NSCLC) oqhubekekayo okanye osasazekayo xa udityaniswe ne-chemotherapy, kunye nonyango olulodwa kwizigulane ezine-relapse okanye i-refractory classical Hodgkin lymphoma (cHL) eziye zafumana ubuncinane imigca emibini ye-systemic chemotherapy ngaphambili. Ngaphezu koko, i-New Drug Application (sNDA) eyongezelelweyo ye-penpulimab kunye ne-anlotinib kunyango lokuqala lwe-advanced hepatocellular carcinoma (HCC) ngoku iyahlolwa.
Ngaphambili, i-penpulimab yayivunyiwe ukuba isetyenziswe njengonyango lodidi lwesithathu kwi-NPC ephucukileyo. Ngolu vumo lutsha, i-penpulimab ngoku ibonelela ngonyango olupheleleyo kuzo zonke izigaba ze-NPC, inika izigulane ukhetho oluqhubekayo lwe-immunotherapy ukusuka kunyango lodidi lokuqala ukuya kolwesithathu.
Ngomhla we-19 kweyeSilimela, ngowama-2024, i-“Signal Transduction and Targeted Therapy” yapapasha iziphumo zophando lwesigaba sesiBini malunga nonyango lwe-metastatic nasopharyngeal carcinoma eyayisele inyangiwe ngaphambili nge-pembrolizumab.
Olu vavanyo lwesigaba sesiBini lwe-single-arm, oluqhutywa kumaziko okhathalelo lwe-tertiary angama-20 eTshayina lubhalise izigulane zabantu abadala abane-metastatic nasopharyngeal carcinoma (NPC) abaye bahluleka kwi-systemic chemotherapy yangaphambili. Izigulane zafumana i-penpulimab engama-200 mg nge-intravenous rhoqo kwiiveki ezi-2 (iiveki ezi-4 ngomjikelo ngamnye) de kube kuqhubekeka kwesifo okanye ubuthi obunganyamezelekiyo. Isiphelo esiphambili yayiyi-objective response rate (ORR) nge-RECIST (inguqulelo 1.1), njengoko kuhlolwe yikomiti ezimeleyo yokujonga i-radiological. Isiphelo sesibini sasiquka i-progress-free survival (PFS) kunye ne-overall survival (OS). Izigulane ezilikhulu elinamashumi amathathu zabhaliswa kwaye ezili-125 zavavanywa ukusebenza kwazo. Ngomhla wokugqibela wedatha (nge-28 kaSeptemba, 2022), isigulane esinye safumana impendulo epheleleyo kwaye izigulane ezingama-34 zafumana impendulo engaphelelanga. I-ORR yayiyi-28.0% (95% CI 20.3–36.7%). Impendulo yayihlala ixesha elide, kunye nama-66.8% esaphendula kwiinyanga ezili-9. Izigulane ezingamashumi amathathu anesithathu (26.4%) zazisafumana unyango. I-PFS kunye ne-OS ephakathi beziziinyanga ezi-3.6 (95% CI = 1.9–7.3 iinyanga) kunye neenyanga ezingama-22.8 (95% CI = 17.1 iinyanga ezingafikelelwanga), ngokwahlukeneyo. Izigulane ezilishumi (7.6%) ziye zafumana i-irAEs yebanga lesi-3 okanye ngaphezulu. I-Penpulimab inemisebenzi ethembisayo yokulwa nethumba kunye nobuthi obamkelekileyo kwizigulane ze-NPC ezinyangwe kakhulu ngaphambi kokuba zifumane unyango, ixhasa uphuhliso olongezelelweyo lweklinikhi njengonyango lwesithathu lwe-NPC esasazekayo.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
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Ixesha leposi: Epreli-25-2025