I-Tagitanlimab ivunyiwe ukuba ifumane unyango lokuqala kunye ne-cisplatin kunye ne-gemcitabine kwizigulane ezine-carcinoma ye-nasopharyngeal ephindaphindayo okanye esasazekayo.

Ngomhla wama-20 kweyoMqungu, iNational Medical Products Administration (NMPA) ivumile i-tagitanlimab entsha ye-humanized monoclonal antibody(eyayisakuba yi-KL-A167) Unyango oludibeneyo lwe-cisplatin kunye ne-gemcitabine kunyango lokuqala lwezigulane ezine-recurrent okanye i-metastatic nasopharyngeal carcinoma (NPC).

Olu luphawu lwesibini oluvunyiweyo lweTagolizumab. Ngaphambili, i-NMPA ivumile ukuthengiswa eTshayina kwe-tagitanlimab monotherapy kunyango lwezigulane ezine-recurrent okanye i-metastatic NPC eziye zasilela emva kwe-chemotherapy yangaphambili ye-2L+.

Olu vunyiweyo lusekelwe kuphando lweklinikhi lwesigaba sesiThathu olucwangcisiweyo, olune-double-blind, olulawulwa yi-placebo, oluneziko ezininzi, oluvavanya iziphumo zokusebenza kakuhle kunye nokhuseleko lwe-tagitanlimab xa idibene ne-cisplatin kunye ne-gemcitabine xa ithelekiswa ne-placebo xa idibene ne-cisplatin kunye ne-gemcitabine kunyango lwe-recurrent okanye i-metastatic NPC, eyayikhokelwa nguNjingalwazi uShi Yuankai weCancer Hospital Chinese Academy of Medical Sciences njengomphandi oyintloko.

Ngokweziphumo zophando, i-tagitanlimab esetyenziswa kunye ne-cisplatin kunye ne-gemcitabine kunyango lokuqala lwe-recurrent okanye i-metastatic NPC inokuba nokusinda okungcono kwe-progression-free (PFS), izinga eliphezulu lempendulo ejolise ngqo (ORR) kunye nexesha elandisiweyo lempendulo (DoR) xa kuthelekiswa ne-chemotherapy, apho zonke izigulana zinokungenelwa nokuba i-PD-L1 expression injani. I-PFS ephakathi ye-tagitanlimab edityaniswe ne-chemotherapy ayifikelelwanga xa kuthelekiswa neenyanga eziyi-7.9 ze-placebo edityaniswe ne-chemotherapy, kwaye umngcipheko wokuqhubela phambili kwesifo kunye nokufa uncitshiswa ngama-53%; i-ORR yi-81.7% vs 74.5%; i-DoR ephakathi yi-11.7 vs 5.8 iinyanga, ephantse yaphindwa kabini xa kuthelekiswa ne-placebo arm; okwangoku i-median iyonke yokuphila (OS) ayikavuthwa, nangona kunjalo umkhwa oluncedo we-OS we-tagitanlimab edityaniswe ne-chemotherapy sele ubonwe, kwaye umngcipheko wayo wokufa uncitshisiwe ngama-38%. I-Tagitanlimab ikwabonise iprofayili yokhuseleko elawulekayo.

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.国家药品监督管理局 (nmpa.gov.cn)

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