I-US Food and Drug Administration ivuma ukudayiswa kwe-penpulimab

Ngomhlaka-23 kuMbasa, i-penpulimab ka-Akeso yathola imvume ye-Food and Drug Administration nge-cisplatin noma i-carboplatin kanye ne-gemcitabine yokwelashwa kokuqala kwabantu abadala abane-recurrent noma i-metastatic non-keratinizing nasopharyngeal carcinoma (NPC). I-FDA iphinde yavuma i-penpulimab-kcqx njenge-ejenti eyodwa yabantu abadala abane-metastatic non-keratinizing NPC abane-metastatic non-keratinizing NPC abane-progressive yesifo ku-chemotherapy esekelwe ku-platinum noma ngemuva kwayo kanye nolunye uhlobo lokwelashwa lwangaphambilini okungenani.

Ukusebenza kahle kwe-penpulimab-kcqx nge-cisplatin noma i-carboplatin kanye ne-gemcitabine kuhlolwe ku-Study AK105-304 (NCT04974398), ukuhlolwa okungahleliwe, okungaboni kabili, okunezikhungo eziningi ezigulini ezingu-291 ezine-NPC ephindaphindayo noma ephindaphindayo ezazingazange zithole i-chemotherapy yangaphambilini yesifo esiphindaphindayo noma esiphindaphindayo. Iziguli zahlelwa ngokungahleliwe (1:1) ukuze zithole i-penpulimab-kcqx nge-cisplatin noma i-carboplatin kanye ne-gemcitabine, kulandelwe yi-penpulimab-kcqx, noma i-placebo ene-cisplatin noma i-carboplatin kanye ne-gemcitabine, kulandelwe yi-placebo. Izindlela zokwelapha ngamakhemikhali zichazwe olwazini oluphelele lokunikeza umuthi.

Isikali esiyinhloko somphumela wokusebenza kahle kwaba ukusinda okungenazo izinqubo zokukhula (PFS), njengoba kuhlolwe yiKomidi Lokubuyekeza Elizimele Eliyimpumpuli ngokwe-RECIST v1.1. Ukusinda okuphelele (OS) kwakuyiphuzu lesibili elibalulekile. I-PFS ephakathi yayiyizinyanga ezingu-9.6 (95% CI: 7.1, 12.5) engalweni ye-penpulimab-kcqx kanye nezinyanga ezingu-7.0 (95% CI: 6.9, 7.3) engalweni ye-placebo (isilinganiso sengozi [HR] 0.45 [95% CI: 0.33, 0.62], inani le-p elizinhlangothi ezimbili <0.0001), kanye neziguli ezingu-31% kanye no-11% eziphila futhi ezingenazo izinqubo zokukhula ngemva kwezinyanga ezingu-12 zokulandelwa ezingalweni ze-penpulimab-kcqx kanye ne-placebo, ngokulandelana. Ngenkathi imiphumela ye-OS yayingakavuthwa, kanye nokufa okungu-70% okuchazwe kusengaphambili kokuhlaziywa kokugcina okubikiwe, akukho mkhuba omubi obonwe.

Ukusebenza kahle kwe-single-agent penpulimab-kcqx kuhlolwe ku-Study AK105-202 (NCT03866967), ukuhlolwa kwengalo eyodwa okuvulekile, okunezikhungo eziningi, okwenziwe ezweni elilodwa. Ukuhlolwa kwakuhlanganisa iziguli ezingu-125 ezine-NPC engasuswa noma engaguquki esakazekile ezazine-metastatic non-keratinizing ezazine-progression yesifo ngemuva kokwelashwa ngamakhemikhali okusekelwe ku-platinum kanye nolunye uhlobo lokwelashwa okungenani olulodwa. Iziguli zathola i-penpulimab-kcqx kuze kube yilapho isifo siqhubeka noma ubuthi obungamukeleki, isikhathi esingeqi ezinyangeni ezingu-24.

Izindlela ezinkulu zokulinganisa umphumela wokusebenza kahle kwakuyizinga lokuphendula eliqondile (ORR) kanye nobude bempendulo (DOR) ngokusho kwe-RECIST v1.1 njengoba kuhlolwe yiKomidi Elizimele Lokubuyekeza I-Radiology. Ngosuku lokuphela kwedatha (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%) zazisathola ukwelashwa. I-PFS kanye ne-OS ephakathi nendawo zazinezinyanga 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%) zathola ama-irAE ebanga lesi-3 noma ngaphezulu. I-Penpulimab inemisebenzi ethembisayo yokulwa nomdlavuza kanye nobuthi obamukelekayo ezigulini ze-NPC ezitholwe ngaphambilini, isekela ukuthuthukiswa okuqhubekayo kwezokwelapha njengokwelashwa kwe-NPC etholwe ngaphambilini.

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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