Kua Whiwhi Whakaaetanga NMPA mō te Hokohoko i te Anti-PD-L1 (Tagitanlima)

31 Hakihea 2024, kua whiwhi a Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kamupene") i te whakaaetanga hokohoko i Haina mai i te National Medical Products Administration (NMPA) mō te tagitanlimab (i mua ko KL-A167) (科泰莱®) te antibody monoclonal tangata auaha i whakahaerehia e te ligand1 mate pūtau kua whakaritea (PD-L1) (PD-L1) hei rongoā mō ngā tūroro e pāngia ana e te mate pukupuku nasopharyngeal (NPC) e hokihoki ana, e horapa ana rānei, kua kore e angitu i muri i te chemotherapy 2L+ o mua. Koinei te antibody monoclonal PD-L1 tuatahi o te ao kua whakaaetia mō te rongoā NPC.

Ko te whakaaetanga i ahu mai i tētahi rangahau haumanu wāhanga II, kotahi-wāhanga, maha-pokapū, i roto i ngā tūroro he NPC e hokihoki mai ana, e horapa ana rānei, kua rahua i muri i ngā maimoatanga pūnaha 2L+ o mua, i arahina e te Ahorangi Shi Yuankai o te Cancer Hospital Chinese Academy of Medical Sciences hei kairangahau matua, ki te aromatawai i te whai huatanga me te haumaru o te tagitanlimab monotherapy.

I waenganui i te 26 o Pēpuere 2019 me te 13 o Hānuere 2021, 153 ngā tūroro i rongoatia. I te katoa, 132 ngā tūroro i uru ki te huinga tātaritanga katoa (FAS) ā, i aromatawaitia te whai huatanga. I te rā kati raraunga i te 13 o Hūrae 2021, ko te wā aroturuki toharite he 21.7 marama (95%CI 19.8–22.5). Mō te taupori FAS, ko te ORR i aromatawaitia e te IRC he 26.5% (95%CI 19.2–34.9%), ā, ko te reiti whakahaere mate (DCR) he 56.8% (95%CI 47.9–65.4%). Ko te oranga kore-haere whakamua toharite (PFS) he 2.8 marama (95%CI 1.5–4.1). Ko te roanga tauhohenga toharite he 12.4 marama (95%CI 6.8–16.5), ā, ko te roanga oranga whānui toharite (OS) he 16.2 marama (95%CI 13.4–21.3).

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.

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Ngā Tohutoro

1.Te Ara Hangarau me te Hua – Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

2.国家药监局批准塔戈利单抗注射液上市 (nmpa.gov.cn)

3.Te whai huatanga me te haumaru o te KL-A167 i roto i te mate pukupuku nasopharyngeal kua rongoatia i mua: he rangahau wāhanga 2, he maha-pokapū, he ringa kotahi – The Lancet Regional Health – Te Moana-nui-a-Kiwa ki te Hauāuru

4.Chen YP, Chan ATC, Le QT, Blanchard P, Sun Y, Ma J. Mate pukupuku ihu. Lancet (Rānana, Ingarangi) 2019;394(10192):64–80. doi: 10.1016/S0140-6736(19)30956-0.