I-Anti-PD-L1 (Tagitanlima) Ifumana imvume ye-NMPA yoThengiso

Ngomhla wama-31 kuDisemba, ngo-2024, iSichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("iNkampani") ifumene imvume yokuthengisa eTshayina evela kwiNational Medical Products Administration (NMPA) ye-programmed cell death ligand1(PD-L1)-directed humanized monoclonal antibody ("mAb") tagitanlimab (eyayisakuba yi-KL-A167) (科泰莱®) yokunyanga izigulana ezinomhlaza we-nasopharyngeal ophindaphindayo okanye osasazekayo (NPC) eziye zasilela emva kwe-chemotherapy ye-2L+ yangaphambili. Le yi-antibody yokuqala ye-PD-L1 monoclonal evunyiweyo kunyango lwe-NPC.

Olu vunyiweyo lusekelwe kuphando lweklinikhi lwesigaba sesiBini olusebenzisa ingalo enye, oluneziko ezininzi, kwizigulana ezine-NPC ephindaphindayo okanye eguqukileyo eziye zasilela emva konyango olucwangcisiweyo lwe-2L+, olukhokelwa nguNjingalwazi uShi Yuankai weCancer Hospital Chinese Academy of Medical Sciences njengomphandi oyintloko, ukuvavanya ukusebenza kakuhle kunye neprofayili yokhuseleko lwe-tagitanlimab monotherapy.

Phakathi komhla wama-26 kuFebruwari 2019 kunye nomhla we-13 kuJanuwari 2021, izigulane ezili-153 zanyangwa. Zizonke, izigulane ezili-132 zangena kwiseti epheleleyo yohlalutyo (i-FAS) zaza zavavanywa ukuba ziyasebenza na. Ukusukela ngomhla wokugqibela wedatha ngomhla we-13 kuJulayi 2021, ixesha eliphakathi lokulandelela yayiziinyanga ezingama-21.7 (95%CI 19.8–22.5). Kubantu be-FAS, i-ORR evavanyiweyo yi-IRC yayiyi-26.5% (95%CI 19.2–34.9%), kwaye izinga lokulawula izifo (DCR) yayiyi-56.8% (95%CI 47.9–65.4%). Ukusinda okuphakathi okungenankqubela phambili (PFS) yayiziinyanga ezingama-2.8 (95%CI 1.5–4.1). Ubude bexesha eliphakathi lempendulo yayiziinyanga ezili-12.4 (95%CI 6.8–16.5), kwaye ukusinda okuphakathi (OS) yayiziinyanga ezili-16.2 (95%CI 13.4–21.3).

Malunga ne-NPC

Idatha ye-GLOBOCAN ka-2022 ibonise ukuba bekukho amatyala amatsha angaphezu kwe-120,000 omhlaza we-nasopharyngeal kwihlabathi liphela, amatyala amatsha angama-51,000 omhlaza we-nasopharyngeal kunye nokufa kwabantu abangama-28,400 eTshayina. Ngokwezikhokelo ze-CSCO zika-2021, inkqubo yonyango lwe-1L yomhlaza we-nasopharyngeal ongaphiliyo okanye osasazekayo isekelwe kwi-chemotherapy edibeneyo equlethe i-platinum, kwaye unyango lwe-2L lusekelwe kwi-monotherapy. Izinga lokusinda kweminyaka emi-5 kwizigulane ezinomhlaza we-nasopharyngeal ophindayo okanye osasazekayo yi-18.5%, kunye ne-OS ephakathi yeenyanga ezingama-22.1, kwaye kusekho isidingo seklinikhi esingafezekiswanga sokuphucula inzuzo yeklinikhi yale qela lezigulane, ngakumbi abo baphuhlisa i-metastases emva konyango. Kwiminyaka yakutshanje, unyango lwe-immunotherapy lubonelele ngeendlela ezininzi zonyango kwizigulane ezine-tumor kwaye luye lwaba yindlela esebenzayo yokunyanga izigulane ezine-nasopharyngeal carcinoma.

Malunga neTagitanlima

I-Tagitanlima, eyenziwe yiSichuan Kelun-Biotech Biopharmaceutical Co., Ltd (eChengdu, eTshayina), yi-antibody ye-IgG1κ monoclonal eyenziwe yangumntu ngokupheleleyo ejolise kwi-PD-L1 ethintela ngokukhethekileyo ukusebenzisana kwe-PD-L1 kunye ne-PD-1.

Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.

Inombolo yefowuni: 4008803716

I-imeyile：myimmnet@163.com

Iireferensi

1.Ubuchwephesha kunye noMbhobho weMveliso – 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.Ukusebenza kakuhle kunye nokhuseleko lwe-KL-A167 kwi-carcinoma ye-nasopharyngeal ephinde yanyangwa ngaphambili okanye eguquguqukayo: uphando lwe-multicenter, single-arm, phase 2 – The Lancet Regional Health – Western Pacific

4.Chen YP, Chan ATC, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. ILancet (eLondon, eNgilane) 2019;394(10192):64–80. doi: 10.1016/S0140-6736(19)30956-0.