Ma ʻApelila 23, ua loaʻa i ka penpulimab a Akeso ka ʻae ʻia ʻana e ka Food and Drug Administration me cisplatin a i ʻole carboplatin a me gemcitabine no ka lāʻau lapaʻau mua o nā pākeke me ka recurrent a metastatic non-keratinizing nasopharyngeal carcinoma (NPC). Ua ʻae pū ka FDA i ka penpulimab-kcqx ma ke ʻano he mea hoʻokahi no nā pākeke me ka metastatic non-keratinizing NPC me ka holomua o ka maʻi ma luna a ma hope paha o ka chemotherapy platinum-based a me ka liʻiliʻi o hoʻokahi laina lapaʻau mua.
Ua loiloi ʻia ka pono o ka penpulimab-kcqx me cisplatin a i ʻole carboplatin a me gemcitabine ma ke Aʻo AK105-304 (NCT04974398), kahi hoʻokolohua randomized, double-blind, multi-center i 291 mau maʻi me ka NPC recurrent a metastatic paha i loaʻa ʻole i ka chemotherapy systemic ma mua no ka maʻi recurrent a metastatic paha. Ua randomized ʻia nā maʻi (1:1) e loaʻa iā penpulimab-kcqx me cisplatin a i ʻole carboplatin a me gemcitabine, a ukali ʻia e penpulimab-kcqx, a i ʻole placebo me cisplatin a i ʻole carboplatin a me gemcitabine, a ukali ʻia e placebo. Ua wehewehe ʻia nā regimen chemotherapy ma ka ʻike kuhikuhi piha.
ʻO ke ana hopena hopena mua loa, ʻo ia ka holomua ʻole o ke ola (PFS), e like me ka loiloi ʻana a kahi Komite Loiloi Kūʻokoʻa Blinded e like me RECIST v1.1. ʻO ke ola holoʻokoʻa (OS) kahi hopena lua koʻikoʻi. ʻO ka PFS waena he 9.6 mau mahina (95% CI: 7.1, 12.5) ma ka lima penpulimab-kcqx a me 7.0 mau mahina (95% CI: 6.9, 7.3) ma ka lima placebo (lakio pōpilikia [HR] 0.45 [95% CI: 0.33, 0.62], ʻelua ʻaoʻao p-value <0.0001), me 31% a me 11% o nā maʻi e ola ana a me ka holomua ʻole ma hope o 12 mau mahina o ka hahai ʻana ma nā lima penpulimab-kcqx a me placebo. ʻOiai ʻaʻole i oʻo nā hopena OS, me 70% o nā make i kuhikuhi mua ʻia no ka loiloi hope loa i hōʻike ʻia, ʻaʻohe ʻano maikaʻi ʻole i ʻike ʻia.
Ua loiloi ʻia ka pono o ka penpulimab-kcqx hoʻokahi-agent ma ke aʻo ʻana AK105-202 (NCT03866967), kahi hoʻokolohua open-label, multicenter, single-arm i mālama ʻia ma kahi ʻāina hoʻokahi. Ua komo pū ka hoʻokolohua me ka huina o 125 mau maʻi me ka unresectable a i ʻole metastatic non-keratinizing NPC i loaʻa ka holomua o ka maʻi ma hope o ka chemotherapy platinum-based a me ka liʻiliʻi o hoʻokahi laina ʻē aʻe o ka lāʻau lapaʻau. Ua loaʻa i nā maʻi ka penpulimab-kcqx a hiki i ka holomua o ka maʻi a i ʻole ka ʻawaʻawa hiki ʻole ke ʻae ʻia, no ka lōʻihi o 24 mau mahina.
ʻO nā ana hopena hopena nui, ʻo ia ka helu pane kūʻokoʻa (ORR) a me ka lōʻihi o ka pane (DOR) e like me ka RECIST v1.1 e like me ka loiloi ʻana e kahi Kōmike Loiloi Radiology Kūʻokoʻa. I ka lā palena ʻikepili (Kepakemapa 28, 2022), ua loaʻa i ka mea maʻi 1 ka pane piha a ua loaʻa i ka mea maʻi 34 ka pane hapa. ʻO ka ORR he 28.0% (95% CI 20.3–36.7%). Ua paʻa ka pane, me 66.8% i pane mau i 9 mau mahina. He kanakolukumamākolu mau mea maʻi (26.4%) e mālama ʻia ana. ʻO ka PFS waena a me OS he 3.6 mau mahina (95% CI = 1.9–7.3 mau mahina) a me 22.8 mau mahina (95% CI = 17.1 mau mahina a hiki ʻole i ka hiki ʻana), kēlā me kēia. He ʻumi (7.6%) mau mea maʻi i loaʻa i ka papa 3 a ʻoi aku paha nā irAE. Loaʻa iā Penpulimab nā hana anti-tumor hoʻohiki a me nā mea ʻawaʻawa i ʻae ʻia i nā mea maʻi NPC metastatic i mālama mua ʻia, e kākoʻo ana i ka hoʻomohala lapaʻau hou aʻe ma ke ʻano he lāʻau lapaʻau laina ʻekolu o ka metastatic NPC.
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
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Ka manawa hoʻouna: ʻApelila-25-2025