Pa Epulo 23, penpulimab ya Akeso idavomerezedwa ndi Food and Drug Administration ndi cisplatin kapena carboplatin ndi gemcitabine kuti igwiritsidwe ntchito pochiza akuluakulu omwe ali ndi khansa ya m'mimba yopanda keratinizing (NPC) yobwerezabwereza kapena yofalikira. FDA idavomerezanso penpulimab-kcqx ngati mankhwala amodzi kwa akuluakulu omwe ali ndi khansa yopanda keratinizing ya m'mimba yokhala ndi matenda omwe akupita patsogolo pa chemotherapy yochokera ku platinum kapena pambuyo pake komanso njira ina yothandizira kale.
Kugwira ntchito kwa penpulimab-kcqx ndi cisplatin kapena carboplatin ndi gemcitabine kunayesedwa mu Study AK105-304 (NCT04974398), kafukufuku wosankha odwala 291 omwe adachira kapena kufalikira kwa NPC omwe sanalandirepo mankhwala a chemotherapy m'mbuyomu chifukwa cha matenda obwerezabwereza kapena kufalikira kwa matendawa. Odwala adapatsidwa mankhwala mwachisawawa (1:1) kuti alandire penpulimab-kcqx ndi cisplatin kapena carboplatin ndi gemcitabine, kutsatiridwa ndi penpulimab-kcqx, kapena placebo ndi cisplatin kapena carboplatin ndi gemcitabine, kutsatiridwa ndi placebo. Njira zochizira matenda a chemotherapy zafotokozedwa mwatsatanetsatane wa malangizo.
Muyeso woyamba wa zotsatira za mphamvu unali kupulumuka popanda kupita patsogolo (PFS), monga momwe adawunikira ndi Komiti Yowunikira Yodziyimira Payokha Yopanda Blinded malinga ndi RECIST v1.1. Kupulumuka konse (OS) kunali kofunikira kwambiri. PFS yapakati inali miyezi 9.6 (95% CI: 7.1, 12.5) mu mkono wa penpulimab-kcqx ndi miyezi 7.0 (95% CI: 6.9, 7.3) mu mkono wa placebo (hazard ratio [HR] 0.45 [95% CI: 0.33, 0.62], two-sided p-value <0.0001), ndi 31% ndi 11% ya odwala amoyo komanso opanda kupita patsogolo pambuyo pa miyezi 12 yotsatiridwa mu mikono ya penpulimab-kcqx ndi placebo, motsatana. Ngakhale zotsatira za OS sizinali zachikale, ndi 70% ya imfa zomwe zidanenedwa kale pakuwunika komaliza zomwe zidanenedwa, palibe kusintha koipa komwe kudawonedwa.
Kugwira ntchito kwa penpulimab-kcqx yokhala ndi mankhwala amodzi kunayesedwa mu Kafukufuku wa AK105-202 (NCT03866967), kafukufuku wotseguka, wa malo ambiri, wa mkono umodzi womwe unachitikira kudziko limodzi. Kafukufukuyu anaphatikizapo odwala 125 omwe anali ndi NPC yosachira kapena yofalikira yomwe sinali keratinizing omwe anali ndi matenda atalandira chithandizo cha chemotherapy chochokera ku platinum komanso njira ina yothandizira. Odwala adalandira penpulimab-kcqx mpaka matendawo atakula kapena atadwala kwambiri, kwa miyezi 24.
Njira zazikulu zoyezera zotsatira zake zinali kuchuluka kwa mayankho olondola (ORR) ndi nthawi yoyankha (DOR) malinga ndi RECIST v1.1 monga momwe adawunikira ndi Komiti Yodziyimira Payokha Yowunikira Ma Radiology. Pa tsiku lomaliza la deta (Seputembala 28, 2022), wodwala m'modzi adayankha mokwanira ndipo odwala 34 adayankha pang'ono. ORR inali 28.0% (95% CI 20.3–36.7%). Yankho linali lolimba, ndipo 66.8% adayankhabe pa miyezi 9. Odwala makumi atatu ndi atatu (26.4%) anali akadali pa chithandizo. Apakati a PFS ndi OS anali miyezi 3.6 (95% CI = miyezi 1.9–7.3) ndi miyezi 22.8 (95% CI = miyezi 17.1 kuti asafike), motsatana. Odwala khumi (7.6%) adakumana ndi irAEs ya giredi 3 kapena kupitirira apo. Penpulimab ili ndi ntchito zabwino zotsutsana ndi chotupa komanso poizoni wovomerezeka mwa odwala a NPC omwe adachiritsidwa kale, zomwe zimathandiza chitukuko chachipatala chachitatu ngati chithandizo cha NPC yofalikira.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
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Nthawi yotumizira: Epulo-25-2025