I te 4 o Hune, 2025, ka panuitia e Akeso kua whakaaetia e te National Medical Products Administration (NMPA) te cadonilimab, te paturopi PD-1/CTLA-4 bispecific tuatahi o te kamupene, hei rongoā tuatahi mō te mate pukupuku waha kōpū pumau, pūmau, horapa rānei, me te chemotherapy platinum, me te bevacizumab, me te kore rānei. Ko te whakaaetanga NMPA te tuatoru o ngā tohu kua whakaaetia mō te cadonilimab.
Ko te whakaaetanga mō te whakamahinga o te cadonilimab me te chemotherapy (me te bevacizumab, kāore rānei) i roto i te mate pukupuku waha kōpū e ahu mai ana i ngā raraunga haumanu mai i te rangahau Phase III COMPASSION-16 (AK104-303).
I roto i tēnei whakamātautau matapōkere, matapo-rua, pokapū maha, whakahaere-placebo, i whakaritea matapōkeretia ngā wāhine 18–75 tau te pakeke puta noa i te 59 ngā wāhi haumanu i Haina me te mate pukupuku waha pūmau, pūmau, horapa rānei kāore anō kia rongoatia i mua (1:1) ki te whiwhi cadonilimab (10 mg/kg) placebo rānei me te chemotherapy e hangai ana ki te platinum me te bevacizumab, kāore rānei i ia 3 wiki mō ngā huringa e ono, ā, whai muri ko te whakaora tiaki ia 3 wiki mō te 2 tau. I whakahaerehia te matapōkere i waenganui mā te pūnaha urupare tukutuku tauwhitiwhiti. Ko ngā āhuatanga wehewehe ko te whakamahinga o te bevacizumab (āe, kāo rānei) me te chemoradiotherapy o mua (āe, kāo rānei). Ko ngā putanga tuatahi e rua ko te oranga kore-haere whakamua i aromatawaitia e te arotake pokapū motuhake matapo me te oranga whānui i roto i te huinga tātari katoa.
I roto i te COMPASSION-16, i whakaatuhia e te huinga maimoatanga cadonilimab he painga whai hua nui i roto i ngā tūroro he pukupuku kei a rātou he whakaaturanga PD-L1 kino (CPS <1), e 27.9% o te taupori i roto i te rōpū maimoatanga, ki te whakaritea ki te 24.2% i roto i te rōpū whakahaere. I tutuki i te rangahau ngā pito mutunga o te oranga kore-haere whakamua (PFS) me te oranga whānui (OS), e whakaatu ana i ngā whakapainga nui i roto i ngā pito mutunga e rua mō ngā tūroro i rongoatia ki te maimoatanga cadonilimab ki te whakataurite ki ngā maimoatanga paerewa i roto i te tautuhinga raina tuatahi mō te mate pukupuku waha kōpū.
I whakaatuhia e ngā tātaritanga rōpū iti mai i te rangahau COMPASSION-16 i whai hua ngā taupori PD-L1-pai me te PD-L1-kino, ahakoa te whakaurunga o te bevacizumab. I whakaatuhia ngā hua o te whakamātautau COMPASSION-16 hei Whakarāpopototanga Whakamutunga (LBA) i te Hui-ā-Ao o te International Gynecologic Cancer Society (IGCS) o te tau 2024, ā, i whakaputaina i muri mai ki roto i te The Lancet, ā, i muri mai ka pūrongohia anō ki roto i te Nature Reviews Clinical Oncology.
Whakamārama
Nā te tāpiritanga o te cadonilimab ki te chemotherapy paerewa raina tuatahi i tino whakapai ake i te oranga kore-whakahaere me te oranga whānui me te kōtaha haumaru e taea te whakahaere i roto i ngā kaiuru e pāngia ana e te mate pukupuku waha kaki pumau, e hokihoki ana, e horapa ana rānei. E tautoko ana ngā raraunga i te whakamahinga o te cadonilimab me te chemotherapy hei rongoā raina tuatahi whai hua i roto i te mate pukupuku waha kaki pumau, e hokihoki ana, e horapa ana rānei.
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: Pipiri-06-2025