Loaʻa iā Anti-PD-L1 (Tagitanlima) ka ʻae ʻia ʻana o NMPA no ke kūʻai aku ʻana

Kekemapa 31, 2024, ua loaʻa iā Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Hui") ka ʻae kūʻai aku ma Kina mai ka National Medical Products Administration (NMPA) no ka programmed cell death ligand1(PD-L1)-directed innovative humanized monoclonal antibody ("mAb") tagitanlimab (ma mua ʻo KL-A167) (科泰莱®) no ka mālama ʻana i nā maʻi me ka maʻi ʻaʻai nasopharyngeal recurrent a metastatic paha (NPC) i hāʻule ma hope o ka chemotherapy 2L+ ma mua. ʻO kēia ka PD-L1 monoclonal antibody mua loa o ka honua i ʻae ʻia no ka mālama ʻana i ka NPC.

Hoʻokumu ʻia ka ʻae ʻia ma kahi noiʻi lapaʻau hoʻokahi lima, multi-center, phase II i nā poʻe maʻi me ka NPC recurrent a metastatic paha i hāʻule ma hope o nā therapies ʻōnaehana 2L+ ma mua, i alakaʻi ʻia e Polofesa Shi Yuankai o ka Cancer Hospital Chinese Academy of Medical Sciences ma ke ʻano he mea noiʻi nui, e loiloi i ka pono a me ka palekana o ka monotherapy tagitanlimab.

Ma waena o Pepeluali 26, 2019 a me Ianuali 13, 2021, ua mālama ʻia he 153 mau maʻi. ʻO ka huina, ua komo he 132 mau maʻi i ka hoʻonohonoho loiloi piha (FAS) a ua loiloi ʻia no ka pono. E like me ka lā palena ʻikepili ma Iulai 13, 2021, ʻo ka manawa hahai waena he 21.7 mau mahina (95%CI 19.8–22.5). No ka heluna kanaka FAS, ʻo ka ORR i loiloi ʻia e IRC he 26.5% (95%CI 19.2–34.9%), a ʻo ka helu kaohi maʻi (DCR) he 56.8% (95%CI 47.9–65.4%). ʻO ke ola ʻole o ka holomua waena (PFS) he 2.8 mau mahina (95%CI 1.5–4.1). ʻO ka lōʻihi waena o ka pane ʻana he 12.4 mau mahina (95%CI 6.8–16.5), a ʻo ka awelika holoʻokoʻa ola (OS) he 16.2 mau mahina (95%CI 13.4–21.3).

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.ʻO ka ʻenehana a me ka paipa huahana - 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.Ka pono a me ka palekana o KL-A167 i ka carcinoma nasopharyngeal recurrent a metastatic paha i mālama mua ʻia: kahi noiʻi multicenter, single-arm, phase 2 - The Lancet Regional Health - Western Pacific

4.Chen YP, Chan ATC, Le QT, Blanchard P, Sun Y, Ma J. ʻO ka maʻi ʻaʻai nasopharyngeal. Lancet (Ladana, ʻEnelani) 2019;394(10192):64–80. doi: 10.1016/S0140-6736(19)30956-0.