Ma Iune 04, 2025, hoʻolaha ʻo Akeso ua ʻāpono ka National Medical Products Administration (NMPA) i ka antibody bispecific PD-1/CTLA-4 mua loa o ka hui, ʻo cadonilimab, no ka lāʻau lapaʻau mua o ka maʻi ʻaʻai cervical mau loa, recurrent, a metastatic paha, i hui pū ʻia me ka chemotherapy platinum-based, me a i ʻole bevacizumab ʻole. ʻO ka ʻāpono NMPA ka hōʻailona ʻekolu i ʻāpono ʻia no cadonilimab.
ʻO ka ʻae ʻia no ka hoʻohana ʻana o cadonilimab i hui pū ʻia me ka chemotherapy (me a me ka ʻole o bevacizumab) i ka maʻi ʻaʻai cervical laina mua e hoʻokumu ʻia ma ka ʻikepili lapaʻau mai ka haʻawina Phase III COMPASSION-16 (AK104-303).
Ma kēia hoʻokolohua randomized, double-blind, multicentre, placebo-controlled phase 3, ua hoʻokaʻawale ʻia nā wahine i piha i ka makahiki 18-75 mau makahiki ma 59 mau wahi lapaʻau ma Kina me ka maʻi ʻaʻai cervical mau loa, recurrent, a metastatic paha i mālama ʻole ʻia ma mua (1:1) e loaʻa iā cadonilimab (10 mg/kg) a i ʻole placebo me ka chemotherapy platinum-based me a i ʻole bevacizumab i kēlā me kēia 3 pule no ʻeono mau pōʻaiapuni, ukali ʻia e ka mālama ʻana i kēlā me kēia 3 pule a hiki i 2 mau makahiki. Ua hana ʻia ka randomisation ma waena o kahi ʻōnaehana pane pūnaewele interactive. ʻO nā mea stratification ka hoʻohana ʻana o bevacizumab (ʻae a ʻaʻole paha) a me ka chemoradiotherapy concurrent ma mua (ʻae a ʻaʻole paha). ʻO nā hopena mua ʻelua he ola holomua ʻole e like me ka loiloi ʻia e ka loiloi kikowaena kūʻokoʻa makapō a me ke ola holoʻokoʻa ma ka set loiloi piha.
Ma ka COMPASSION-16, ua hōʻike ka hui pū ʻana o ka cadonilimab i kahi pōmaikaʻi koʻikoʻi i nā poʻe maʻi me nā ʻōpū i loaʻa kahi hōʻike PD-L1 maikaʻi ʻole (CPS <1), nona ka 27.9% o ka heluna kanaka i ka hui mālama ʻia, i hoʻohālikelike ʻia me 24.2% i ka hui kaohi. Ua hālāwai ka haʻawina me nā hopena ola holomua ʻole (PFS) a me ke ola holoʻokoʻa (OS), e hōʻike ana i nā hoʻomaikaʻi koʻikoʻi ma nā hopena ʻelua no nā poʻe maʻi i mālama ʻia me ka regimen cadonilimab i hoʻohālikelike ʻia me nā lāʻau lapaʻau maʻamau i ka hoʻonohonoho laina mua no ka maʻi ʻaʻai cervical.
Ua hōʻike ʻia nā loiloi hui liʻiliʻi mai ke aʻo ʻana COMPASSION-16 ua loaʻa i nā heluna kanaka PD-L1-positive a me PD-L1-negative, me ka nānā ʻole i ka hoʻokomo ʻia ʻana o bevacizumab, ka pōmaikaʻi mai ka lāʻau lapaʻau. Ua hōʻike ʻia nā hopena o ka hoʻokolohua COMPASSION-16 ma ke ʻano he Late-Breaking Abstract (LBA) ma ka 2024 International Gynecologic Cancer Society (IGCS) Global Meeting, a ua paʻi ʻia ma hope ma The Lancet a ma hope ua hōʻike hou ʻia ma Nature Reviews Clinical Oncology.
Wehewehe ʻana
ʻO ka hoʻohui ʻana o ka cadonilimab i ka chemotherapy maʻamau laina mua i hoʻomaikaʻi nui i ke ola ʻana me ka ʻole o ka holomua a me ke ola holoʻokoʻa me kahi ʻano palekana e hiki ke hoʻokele ʻia i nā mea komo me ka maʻi ʻaʻai cervical mau, recurrent, a metastatic paha. Kākoʻo ka ʻikepili i ka hoʻohana ʻana o ka cadonilimab me ka chemotherapy ma ke ʻano he lāʻau lapaʻau laina mua kūpono i ka maʻi ʻaʻai cervical mau, recurrent, a metastatic paha.
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: Iune-06-2025