I te 23 o Paenga-whāwhā, i whakaaetia te penpulimab a Akeso e te Food and Drug Administration me te cisplatin, carboplatin rānei me te gemcitabine hei rongoā tuatahi mō ngā pakeke e pāngia ana e te mate pukupuku nasopharyngeal non-keratinizing (NPC) e hokihoki mai ana, e horapa mai ana rānei. I whakaaetia hoki e te FDA te penpulimab-kcqx hei rongoā kotahi mō ngā pakeke e pāngia ana e te mate pukupuku non-keratinizing metastatic me te whanaketanga o te mate i runga, i muri rānei i te chemotherapy platinum-based me te iti rawa i tētahi atu rongoā o mua.
I arotakehia te whai huatanga o te penpulimab-kcqx me te cisplatin, te carboplatin me te gemcitabine rānei i roto i te Rangahau AK105-304 (NCT04974398), he whakamātautau matapōkere, matapo-rua, maha-pokapū i roto i te 291 ngā tūroro me te NPC e hokihoki ana, e horapa ana rānei, kāore i whiwhi i te chemotherapy pūnaha o mua mō te mate e hokihoki ana, e horapa ana rānei. I matapōkeretia ngā tūroro (1:1) kia whiwhi i te penpulimab-kcqx me te cisplatin, te carboplatin me te gemcitabine rānei, ā, whai muri ko te penpulimab-kcqx, te placebo rānei me te cisplatin, te carboplatin me te gemcitabine rānei, ā, whai muri ko te placebo. Kei roto i ngā mōhiohio whakahaunga katoa ngā tikanga chemotherapy.
Ko te ine hua matua ko te oranga kore-whakamua (PFS), i aromatawaitia e te Komiti Arotake Motuhake Matapōkere e ai ki te RECIST v1.1. Ko te oranga whānui (OS) te pito tuarua matua. Ko te PFS toharite he 9.6 marama (95% CI: 7.1, 12.5) i roto i te ringa penpulimab-kcqx me te 7.0 marama (95% CI: 6.9, 7.3) i roto i te ringa placebo (ōwehenga mōrearea [HR] 0.45 [95% CI: 0.33, 0.62], uara-p taha-rua <0.0001), me te 31% me te 11% o ngā tūroro e ora ana, ā, kāore he whanaketanga i muri i te 12 marama o te aroturuki i roto i ngā ringa penpulimab-kcqx me te placebo. Ahakoa kāore anō kia tino pakari ngā hua OS, me te 70% o ngā mate kua tohua i mua mō te tātaritanga whakamutunga i pūrongohia, kāore i kitea he ia kino.
I arotakehia te whai huatanga o te penpulimab-kcqx kotahi-kaihoko i roto i te Rangahau AK105-202 (NCT03866967), he whakamātautau tuwhera-tohu, maha-pokapū, kotahi-ringa i whakahaerehia i roto i te whenua kotahi. I whakaurua ki te whakamātautau he 125 ngā tūroro katoa me te NPC kore-keratinizing kāore i taea te tango, i horapa rānei, ā, kua piki haere te mate i muri i te chemotherapy platinum-based me te iti rawa i te kotahi atu raina rongoā. I whiwhi ngā tūroro i te penpulimab-kcqx tae noa ki te piki haere o te mate, te paitini kāore e whakaaetia rānei, mō te 24 marama te roa.
Ko ngā inenga hua whai huatanga matua ko te reiti urupare whāinga (ORR) me te roanga o te urupare (DOR) e ai ki te RECIST v1.1 i aromatawaitia e te Komiti Arotake Irirangi Motuhake. I te rā kati raraunga (Hepetema 28, 2022), kotahi te tūroro i eke ki te urupare katoa, ā, e 34 ngā tūroro i eke ki te urupare hapa. Ko te ORR he 28.0% (95% CI 20.3–36.7%). He roa te urupare, me te 66.8% kei te urupare tonu i te 9 marama. E toru tekau mā toru ngā tūroro (26.4%) kei te rongoatia tonu. Ko te PFS me te OS toharite he 3.6 marama (95% CI = 1.9–7.3 marama) me te 22.8 marama (95% CI = 17.1 marama ki te kore e tae ki te rongoā). Tekau (7.6%) ngā tūroro i pāngia e te irAE taumata 3, teitei ake rānei. He pai ngā mahi ārai-pukupuku a Penpulimab me ngā paitini e whakaaetia ana i roto i ngā tūroro NPC metastatic i mua i te rongoatia, e tautoko ana i te whanaketanga haumanu tonu hei maimoatanga raina tuatoru o te NPC metastatic.
I tēnei wā, he maha tonu ngā whakamātautau haumanu o ngā hangarau hou hei ārai i te matepukupuku i Haina e rapu ana i ngā tūroro. Mēnā kei te hiahia koe ki te kōrero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.
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Wā tuku: Paenga-whāwhā-25-2025