Ngomhla wama-23 ku-Epreli, i-penpulimab ka-Akeso yafumana imvume kwi-Food and Drug Administration ene-cisplatin okanye i-carboplatin kunye ne-gemcitabine kunyango lokuqala lwabantu abadala abane-recurrent okanye i-metastatic non-keratinizing nasopharyngeal carcinoma (NPC). I-FDA ikwavumile i-penpulimab-kcqx njengeyeza elinye kubantu abadala abane-metastatic non-keratinizing NPC abane-metastatic non-keratinizing nesifo esiqhubekela phambili kwi-chemotherapy esekelwe kwi-platinum okanye emva kwayo kunye nolunye unyango lwangaphambili.
Ukusebenza kakuhle kwe-penpulimab-kcqx nge-cisplatin okanye i-carboplatin kunye ne-gemcitabine kuhlolwe kwiSifundo i-AK105-304 (NCT04974398), uvavanyo olucwangcisiweyo, olungaboni kabini, oluneziko ezininzi kwizigulane ezingama-291 ezine-NPC ephindaphindayo okanye ephindaphindayo ezingazange zifumane i-chemotherapy yangaphambili yesifo esiphindaphindayo okanye esiphindaphindayo. Izigulane zenziwe ngokungacwangciswanga (1:1) ukuze zifumane i-penpulimab-kcqx nge-cisplatin okanye i-carboplatin kunye ne-gemcitabine, kulandele i-penpulimab-kcqx, okanye i-placebo ene-cisplatin okanye i-carboplatin kunye ne-gemcitabine, kulandele i-placebo. Iindlela zonyango lwe-chemotherapy zichazwe kulwazi olupheleleyo lokunika amayeza.
Umlinganiselo oyintloko wesiphumo sokusebenza kakuhle yayikukusinda okungenazo iiprogression-free survival (PFS), njengoko kuhlolwe yiKomiti yoHlolo oluZimeleyo oluyiBlinded ngokwe-RECIST v1.1. Ukusinda ngokubanzi (OS) yayiyeyona nto iphambili yesibini. I-Median PFS yayiziinyanga eziyi-9.6 (95% CI: 7.1, 12.5) kwingalo ye-penpulimab-kcqx kunye neenyanga eziyi-7.0 (95% CI: 6.9, 7.3) kwingalo ye-placebo (umlinganiselo wengozi [HR] 0.45 [95% CI: 0.33, 0.62], ixabiso le-p elimacala mabini <0.0001), kunye ne-31% kunye ne-11% yezigulane eziphila kwaye ezingenazo iiprogression emva kweenyanga ezili-12 zokulandelela kwingalo ye-penpulimab-kcqx kunye ne-placebo, ngokwahlukeneyo. Nangona iziphumo ze-OS zazingekavuthwa, kunye ne-70% yokufa okuchazwe kwangaphambili kuhlalutyo lokugqibela olubikiweyo, akukho mkhwa unobungozi obonwe.
Ukusebenza kakuhle kwe-single-agent penpulimab-kcqx kuhlolwe kwiSifundo i-AK105-202 (NCT03866967), uvavanyo oluvulelekileyo, oluneziko ezininzi, nolwengalo enye oluqhutywe kwilizwe elinye. Olu vavanyo luquke izigulane ezili-125 ezine-NPC engasuswayo okanye engaguqukiyo enesifo emva kwe-chemotherapy esekelwe kwi-platinum kunye nolunye unyango ubuncinane olunye. Izigulane zafumana i-penpulimab-kcqx de kube kuqhubeke isifo okanye ubuthi obungamkelekanga, ubuninzi beenyanga ezingama-24.
Iindlela eziphambili zokulinganisa iziphumo zokusebenza kakuhle yayilizinga lokuphendula ngendlela echanekileyo (ORR) kunye nobude bempendulo (DOR) ngokwe-RECIST v1.1 njengoko ihlolwe yiKomiti yoHlolo lweRadiology eZimeleyo. Ngomhla wokugqibela wedatha (nge-28 kaSeptemba, 2022), isigulane esinye sifumene 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 ezingama-33 (26.4%) zazisafumana unyango. I-PFS kunye ne-OS ephakathi zazineenyanga 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%) zafumana i-irAEs yebanga lesi-3 okanye ngaphezulu. I-Penpulimab inemisebenzi ethembisayo yokulwa nethumba kunye nobuthi obamkelekileyo kwizigulane ze-NPC ezisandul’ ukunyangwa kakhulu, ixhasa uphuhliso olongezelelekileyo lwezonyango njengonyango lwesithathu lwe-NPC esasazekileyo.
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.
Inombolo yefowuni: 4008803716
Email：myimmnet@163.com
Ixesha leposi: Epreli-25-2025