Ua ʻae ʻia ʻo Tagitanlimab no ka mālama mua ʻana me ka cisplatin a me gemcitabine no nā poʻe maʻi me ka carcinoma nasopharyngeal recurrent a metastatic paha.

Ma Ianuali 20, ua ʻāpono ka National Medical Products Administration (NMPA) i ka hana hou o ka tagitanlimab antibody monoclonal humanized(KL-A167 ma mua) ʻO ka hui pū ʻana o cisplatin a me gemcitabine no ka mālama mua ʻana i nā maʻi nasopharyngeal carcinoma (NPC) e hana hou ʻia a metastatic paha.

ʻO kēia ka lua o ka hōʻailona i ʻāpono ʻia no Tagolizumab. Ma mua, ua ʻāpono ʻo NMPA i ke kūʻai aku ʻana ma Kina o ka monotherapy tagitanlimab no ka mālama ʻana i nā maʻi me ka NPC recurrent a metastatic paha i hāʻule ma hope o ka chemotherapy 2L+ ma mua.

Ua hoʻokumu ʻia ka ʻāpono ʻana ma kahi noiʻi lapaʻau randomized, double-blinded, placebo controlled, multi-center, phase III i loiloi i ka pono a me nā hopena palekana o tagitanlimab i hui pū ʻia me cisplatin a me gemcitabine versus placebo i hui pū ʻia me cisplatin a me gemcitabine no ka mālama ʻana i ka NPC recurrent a metastatic paha, i alakaʻi ʻia e Polofesa Shi Yuankai o ka Cancer Hospital Chinese Academy of Medical Sciences ma ke ʻano he mea noiʻi nui.

Wahi a nā hopena o ke aʻo ʻana, ʻo ka tagitanlimab i hoʻohana ʻia me ka cisplatin a me ka gemcitabine no ka lāʻau lapaʻau mua no ka NPC recurrent a metastatic paha hiki ke loaʻa ka ola ola ʻole holomua (PFS), ka helu pane kiʻekiʻe (ORR) a me ka lōʻihi o ka pane (DoR) i hoʻohālikelike ʻia me ka chemotherapy, kahi e hiki ai i nā maʻi āpau ke pōmaikaʻi me ka nānā ʻole i ka hōʻike ʻana o PD-L1. ʻAʻole i hiki i ka PFS waena no ka tagitanlimab i hui pū ʻia me ka chemotherapy i hoʻohālikelike ʻia me 7.9 mau mahina no ka placebo i hui pū ʻia me ka chemotherapy, a ua hoʻemi ʻia ka pilikia o ka holomua o ka maʻi a me ka make e 53%; ʻO ORR he 81.7% vs 74.5%; ʻO ka DoR waena he 11.7 vs 5.8 mau mahina, kahi i aneane pālua i hoʻohālikelike ʻia me ka lima placebo; i kēia manawa ʻaʻole i oʻo ka median overall survival (OS), akā naʻe ua ʻike mua ʻia ke ʻano maikaʻi no ka OS o tagitanlimab i hui pū ʻia me ka chemotherapy, a ua hoʻemi ʻia kona pilikia o ka make e 38%. Ua hōʻike pū ʻo Tagitanlimab i kahi ʻano palekana hiki ke hoʻokele ʻia.

E pili ana iā NPC

Ua hōʻike ka ʻikepili GLOBOCAN 2022 he ʻoi aku ma mua o 120,000 mau hihia hou o ke kanesa nasopharyngeal ma ka honua holoʻokoʻa, 51,000 mau hihia hou o ke kanesa nasopharyngeal a me 28,400 mau make ma Kina. Wahi a nā alakaʻi CSCO 2021, ʻo ke ʻano lapaʻau 1L no ke kanesa nasopharyngeal recurrent a metastatic paha i hiki ʻole ke mālama ʻia ma kahi kūloko ua hoʻokumu ʻia ma ka chemotherapy hui pū ʻia me ka platinum, a ua hoʻokumu ʻia ka lāʻau 2L ma ka monotherapy. ʻO ka helu ola 5 makahiki o nā maʻi me ke kanesa nasopharyngeal recurrent a metastatic paha he 18.5%, me ka OS waena o 22.1 mau mahina, a aia nō kahi pono lapaʻau i hoʻokō ʻole ʻia e hoʻomaikaʻi i ka pono lapaʻau o kēia hui o nā maʻi, ʻoi aku ka poʻe e ulu ana i nā metastases ma hope o ka mālama ʻana. I nā makahiki i hala iho nei, ua hāʻawi ka immunotherapy i nā koho therapeutic hou aʻe no nā maʻi tumor a ua lilo ia i ala kūpono e mālama ai i nā maʻi me ka carcinoma nasopharyngeal.

E pili ana iā Tagitanlima

ʻO Tagitanlima, i hana ʻia e Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (Chengdu, Kina), he antibody monoclonal IgG1κ i hoʻololi piha ʻia i ke kanaka e pili ana iā PD-L1 e ālai koho ana i ka pilina o PD-L1 a me PD-1.

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.

Helu Kelepona：4008803716

Leka uila:myimmnet@163.com

Nā Kuhikuhi

1.国家药品监督管理局 (nmpa.gov.cn)

2.ʻO Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.