I-Anti-PD-L1 (Tagitanlima) Ithola Imvume ye-NMPA Yokumaketha

Disemba 31, 2024, I-Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Inkampani") ithole imvume yokumaketha eShayina evela ku-National Medical Products Administration (NMPA) ye-programmed cell death ligand1(PD-L1)-directed humanized monoclonal antibody ("mAb") tagitanlimab (eyayikade i-KL-A167) (科泰莱®) yokwelapha iziguli ezinomdlavuza we-nasopharyngeal ophindaphindayo noma osakazekile (NPC) eziye zahluleka ngemuva kwe-chemotherapy ye-2L+ yangaphambili. Lena yi-antibody yokuqala ye-PD-L1 monoclonal emhlabeni evunyelwe ukwelashwa kwe-NPC.

Ukuvunyelwa kusekelwe ocwaningweni lwezokwelapha lwesigaba sesi-2 olungalo olulodwa, olunezikhungo eziningi, ezigulini ezine-NPC ephindaphindayo noma esakazeke kakhulu eziye zehluleka ngemuva kokwelashwa okuhleliwe kwangaphambilini kwe-2L+, okuholwa nguSolwazi Shi Yuankai weCancer Hospital Chinese Academy of Medical Sciences njengomphenyi oyinhloko, ukuhlola ukusebenza kahle kanye nephrofayili yokuphepha kwe-tagitanlimab monotherapy.

Phakathi kukaFebhuwari 26, 2019 kanye noJanuwari 13, 2021, iziguli ezingu-153 zelashwe. Sekukonke, iziguli ezingu-132 zangena kusethi ephelele yokuhlaziya (i-FAS) futhi zahlolwa ukuthi ziyasebenza yini. Kusukela ngosuku lokuphela kwedatha mhla ziyi-13 kuJulayi, 2021, isikhathi esimaphakathi sokulandelela sasiyizinyanga ezingu-21.7 (95%CI 19.8–22.5). Kubantu be-FAS, i-ORR ehlolwe yi-IRC yayingu-26.5% (95%CI 19.2–34.9%), kanti izinga lokulawula izifo (DCR) lalingu-56.8% (95%CI 47.9–65.4%). Ukusinda okungenawo ama-progression (PFS) okumaphakathi kwakuyizinyanga ezingu-2.8 (95%CI 1.5–4.1). Isikhathi esimaphakathi sempendulo sasiyizinyanga eziyi-12.4 (95%CI 6.8–16.5), kanti isilinganiso sokusinda okuphelele (OS) sasiyizinyanga eziyi-16.2 (95%CI 13.4–21.3).

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.Ubuchwepheshe kanye Nombhobho Womkhiqizo – 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 kahle nokuphepha kwe-KL-A167 ku-carcinoma ye-nasopharyngeal ephindaphindayo noma esakazekile ngaphambili: ucwaningo lwesigaba sesi-2 olunezikhungo eziningi, olungalo olulodwa – I-Lancet Regional Health – I-Western Pacific

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