Kua whakaaetia te Tagitanlimab hei rongoā tuatahi me te cisplatin me te gemcitabine mō ngā tūroro e pāngia ana e te mate pukupuku nasopharyngeal e hokihoki mai ana, e horapa mai ana rānei.

I te 20 o Hānuere, i whakaaetia e te National Medical Products Administration (NMPA) te paturopi monoclonal humanized tagitanlimab auaha.(i mua ko KL-A167) He rongoā whakakotahi o te cisplatin me te gemcitabine hei rongoā tuatahi mō ngā tūroro carcinoma nasopharyngeal (NPC) e hokihoki mai ana, e horapa mai ana rānei.

Koinei te tohu tuarua kua whakaaetia mō Tagolizumab. I mua, kua whakaaetia e te NMPA te hokohoko i Haina o te tagitanlimab monotherapy mō te maimoatanga o ngā tūroro he NPC recurrent, he metastatic rānei kua rahua i muri i te chemotherapy 2L+ o mua.

Ko te whakaaetanga i ahu mai i tētahi rangahau haumanu matapōkere, matapō-rua, whakahaere-placebo, maha-pokapū, wāhanga III e aromatawai ana i te whai huatanga me ngā hua haumaru o te tagitanlimab me te cisplatin me te gemcitabine, me te placebo me te cisplatin me te gemcitabine mō te rongoā i te NPC e hokihoki mai ana, e horapa ana rānei, i arahina e te Ahorangi Shi Yuankai o te Cancer Hospital Chinese Academy of Medical Sciences hei kairangahau matua.

E ai ki ngā hua o te rangahau, ko te whakamahi tahi i te tagitanlimab me te cisplatin me te gemcitabine hei rongoā tuatahi mō te NPC e hokihoki mai ana, e horapa ana rānei, tera pea he oranga kore-haere whakamua (PFS) pai ake, he tere urupare whāinga teitei ake (ORR) me te roa o te urupare (DoR) ki te whakataurite ki te chemotherapy, ka taea e ngā tūroro katoa te whai hua ahakoa te whakaaturanga PD-L1. Kāore i eke te PFS toharite mō te tagitanlimab me te chemotherapy ki te whakataurite ki te 7.9 marama mō te placebo me te chemotherapy, ā, kua heke te mōrearea o te haere whakamua me te mate mā te 53%; Ko te ORR he 81.7% vs 74.5%; ko te DoR toharite he 11.7 vs 5.8 marama, kua tata rua te pikinga ki te whakataurite ki te ringa placebo; i tēnei wā, kāore anō kia pakari te oranga whānui toharite (OS), heoi, kua kitea kētia te ia o ngā painga mō te OS o te tagitanlimab me te chemotherapy, ā, kua heke te mōrearea o te mate mā te 38%. I whakaatu hoki a Tagitanlimab i tētahi kōtaha haumaru e taea te whakahaere.

Mō te NPC

I whakaatuhia e ngā raraunga GLOBOCAN o te tau 2022 neke atu i te 120,000 ngā kēhi hou o te mate pukupuku ihu puta noa i te ao, 51,000 ngā kēhi hou o te mate pukupuku ihu, me te 28,400 ngā mate i Haina. E ai ki ngā aratohu CSCO o te tau 2021, ko te tikanga maimoatanga 1L mō te mate pukupuku ihu e hoki mai ana, e horapa ana rānei, kāore e taea te rongoā ā-rohe, e ahu mai ana i te chemotherapy whakakotahi kei roto ko te konukawata, ā, ko te maimoatanga 2L e ahu mai ana i te monotherapy. Ko te reiti oranga 5-tau o ngā tūroro e mate pukupuku ihu e hoki mai ana, e horapa ana rānei, he 18.5%, me te OS toharite o te 22.1 marama, ā, kei te noho tonu he hiahia haumanu kāore anō kia tutukihia hei whakapai ake i te painga haumanu o tēnei rōpū tūroro, inā koa ko te hunga e horapa ana i muri i te maimoatanga. I ngā tau tata nei, kua nui ake ngā kōwhiringa rongoā kua whakaratohia e te immunotherapy mō ngā tūroro pukupuku, ā, kua waiho hei huarahi whai hua ki te rongoā i ngā tūroro e mate pukupuku ihu.

Mō Tagitanlima

Ko Tagitanlima, i hangaia e Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (Chengdu, Haina), he paturopi monoclonal IgG1κ kua whakatangatatia katoatia e aro ana ki te PD-L1 e aukati ana i te taunekeneke o te PD-L1 me te PD-1.

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.

Tau Waea：4008803716

Īmēra：myimmnet@163.com

Ngā Tohutoro

1.国家药品监督管理局 (nmpa.gov.cn)

2.Te Kamupene Rongoā Koiora-Biotech o Sichuan Kelun-Biotech.