I-Tagitanlimab ivunyelwe ukwelashwa kokuqala ngokuhlanganiswa ne-cisplatin kanye ne-gemcitabine ezigulini ezine-carcinoma ye-nasopharyngeal ephindaphindayo noma esakazeke kakhulu.

Ngomhlaka-20 Januwari, i-National Medical Products Administration (NMPA) ivuma i-antibody entsha ye-monoclonal tagitanlimab.(okwakukade kuyi-KL-A167) Ukwelashwa okuhlanganisiwe kwe-cisplatin kanye ne-gemcitabine ekwelapheni kokuqala kweziguli ezine-carcinoma ye-nasopharyngeal ephindaphindayo noma esakazeke kakhulu (NPC).

Lesi yisibonakaliso sesibili esivunyelwe i-Tagolizumab. Ngaphambilini, i-NMPA ivumile ukumaketha eShayina kwe-tagitanlimab monotherapy yokwelapha iziguli ezine-NPC ephindaphindayo noma esakazekile ezihlulekile ngemuva kwe-chemotherapy ye-2L+ yangaphambili.

Ukuvunyelwa kusekelwe ocwaningweni lwezokwelapha lwesigaba sesi-3 olungahleliwe, olungaboni kahle, olulawulwa yi-placebo, olunezikhungo eziningi, oluhlola imiphumela yokusebenza kahle kanye nokuphepha kwe-tagitanlimab ngokuhlanganiswa ne-cisplatin kanye ne-gemcitabine uma kuqhathaniswa ne-placebo ngokuhlanganiswa ne-cisplatin kanye ne-gemcitabine ekwelapheni i-NPC ephindaphindayo noma esakazekile, olwaluholwa nguSolwazi Shi Yuankai we-Cancer Hospital Chinese Academy of Medical Sciences njengomphenyi oyinhloko.

Ngokusho kwemiphumela yocwaningo, i-tagitanlimab esetshenziswa kanye ne-cisplatin kanye ne-gemcitabine yokwelashwa kokuqala kwe-recurrent noma i-metastatic NPC ingaba nokusinda okungcono okungenakho ukuqhubeka (PFS), izinga eliphezulu lokuphendula okuhlosiwe (ORR) kanye nesikhathi eside sokuphendula (DoR) uma kuqhathaniswa ne-chemotherapy, lapho zonke iziguli zingazuza khona kungakhathaliseki ukuthi i-PD-L1 iveza kanjani. I-PFS ephakathi ye-tagitanlimab ehlanganiswe ne-chemotherapy ayifinyelelwanga uma kuqhathaniswa nezinyanga ezingu-7.9 ze-placebo ehlanganiswe ne-chemotherapy, futhi ingozi yokuqhubeka kwesifo nokufa incishiswa ngo-53%; i-ORR ingu-81.7% uma kuqhathaniswa no-74.5%; i-DoR ephakathi ingu-11.7 uma kuqhathaniswa nezinyanga ezingu-5.8, okucishe kuphindwe kabili uma kuqhathaniswa ne-placebo arm; okwamanje i-median overal survival (OS) ayikavuthwa, nokho ukuthambekela okuzuzisayo kwe-OS ye-tagitanlimab ehlanganiswe ne-chemotherapy sekuvele kubonwe, futhi ingozi yayo yokufa incishisiwe ngo-38%. I-Tagitanlimab iphinde yabonisa iphrofayili yokuphepha elawulekayo.

Mayelana ne-NPC

Idatha ye-GLOBOCAN ka-2022 ibonise ukuthi kunamacala amasha angaphezu kuka-120,000 omdlavuza we-nasopharyngeal emhlabeni jikelele, amacala amasha angu-51,000 omdlavuza we-nasopharyngeal kanye nokufa okungu-28,400 eShayina. Ngokusho kweziqondiso ze-CSCO zika-2021, uhlelo lokwelashwa lwe-1L lomdlavuza we-nasopharyngeal ongaphili endaweni lusekelwe ku-chemotherapy ehlanganisiwe equkethe i-platinum, kanti ukwelashwa kwe-2L kusekelwe ku-monotherapy. Izinga lokusinda kweminyaka emi-5 leziguli ezinomdlavuza we-nasopharyngeal ongaphili noma ophiliziwe lingu-18.5%, kanye ne-OS ephakathi kwezinyanga ezingu-22.1, futhi kusenesidingo somtholampilo esingakahlangatshezwa sokuthuthukisa inzuzo yezokwelapha yaleli qembu leziguli, ikakhulukazi labo abathola ama-metastases ngemuva kokwelashwa. Eminyakeni yamuva nje, ukwelashwa nge-immunotherapy kunikeze izinketho eziningi zokwelapha iziguli ezine-tumor futhi sekuyindlela ephumelelayo yokwelapha iziguli ezine-nasopharyngeal carcinoma.

Mayelana ne-Tagitanlima

I-Tagitanlima, ekhiqizwe yi-Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (eChengdu, eShayina), iyi-antibody ye-IgG1κ monoclonal ephelele eqondisa i-PD-L1 evimbela ngokukhetha ukusebenzisana kwe-PD-L1 kanye ne-PD-1.

Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.

Inombolo yocingo: 4008803716

I-imeyili：myimmnet@163.com

Izinkomba

1.国家药品监督管理局 (nmpa.gov.cn)

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