Anti-PD-L1 (Tagitanlima) Yagamuchira Mvumo yeNMPA yeKushambadzira

Zvita 31, 2024, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kambani") yakagamuchira mvumo yekushambadzira muChina kubva kuNational Medical Products Administration (NMPA) ye programmed cell death ligand1(PD-L1)-directed humanized monoclonal antibody ("mAb") tagitanlimab (yaimbonzi KL-A167) (科泰莱®) yekurapa varwere vane recurrent kana metastatic nasopharyngeal cancer (NPC) avo vakakundikana mushure me2L+ chemotherapy yapfuura. Iyi ndiyo yekutanga pasi rose PD-L1 monoclonal antibody yakatenderwa kurapa NPC.

Kubvumidzwa uku kwakavakirwa pakudzidza kwekiriniki kwechikamu chechipiri chechikamu chimwe chete, chepakati nepakati, muvarwere vane NPC inodzokororwa kana kuti yakapararira vakakundikana mushure mekurapwa kwakapfuura kwe2L+, vachitungamirwa naProfessor Shi Yuankai weCancer Hospital Chinese Academy of Medical Sciences semuongorori mukuru, kuti vaongorore kushanda uye kuchengetedzeka kwetagitanlimab monotherapy.

Pakati pa26 Kukadzi, 2019 na13 Ndira, 2021, varwere 153 vakarapwa. Varwere vese 132 vakapinda muongororo yakazara (FAS) uye vakaongororwa kuti vaone kushanda kwayo. Pakazosvika zuva rekupedzisira redata musi wa13 Chikunguru, 2021, nguva yekutevera yaive mwedzi 21.7 (95%CI 19.8–22.5). Kune vanhu veFAS, ORR yakaongororwa neIRC yaive 26.5% (95%CI 19.2–34.9%), uye mwero wekutonga chirwere (DCR) waive 56.8% (95%CI 47.9–65.4%). Kurarama kwepakati pasina kufambira mberi (PFS) kwaive kwemwedzi 2.8 (95%CI 1.5–4.1). Nguva yepakati yemhinduro yaive mwedzi 12.4 (95%CI 6.8–16.5), uye avhareji yekurarama kwese (OS) yaive mwedzi 16.2 (95%CI 13.4–21.3).

Nezve NPC

Data reGLOBOCAN ra2022 rakaratidza kuti kwaive nevanhu vanopfuura 120,000 vatsva vegomarara remuno pasi rose, vanhu 51,000 vatsva vegomarara remuno uye vanhu 28,400 vakafa muChina. Sekureva kwenhungamiro dzeCSCO dza2021, nzira yekurapa ye1L yegomarara remuno risingarapike kana kuti rinopararira munzvimbo imwe chete yakavakirwa pamishonga yekurapa ine platinum, uye kurapwa kwe2L kwakavakirwa pakurapa kwega kwega. Huwandu hwekurarama kwemakore mashanu hwevarwere vane gomarara remuno rinoramba richidzoka kana rinopararira muno i18.5%, neavhareji yeOS yemwedzi 22.1, uye kuchine chinodiwa chekiriniki chekuvandudza mabhenefiti ekiriniki eboka iri revarwere, kunyanya avo vanowana metastases mushure mekurapwa. Mumakore achangopfuura, immunotherapy yakapa nzira dzakawanda dzekurapa kune varwere vane gomarara uye yave nzira inoshanda yekurapa varwere vane gomarara remuno.

Nezve Tagitanlima

Tagitanlima, yakagadzirwa neSichuan Kelun-Biotech Biopharmaceutical Co., Ltd (Chengdu, China), iIgG1κ monoclonal antibody yakagadzirwa nevanhu yakazara inotarisa PD-L1 iyo inodzivisa kudyidzana kwePD-L1 nePD-1.

Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.

Nhamba yefoni: 4008803716

Imeyili：myimmnet@163.com

Mareferensi

1.Tekinoroji & Mapaipi Ezvigadzirwa – 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.Kushanda zvakanaka uye kuchengetedzeka kweKL-A167 mune yakamborapwa chirwere chekenza chemudumbu chakadzoka kana kuti chakapararira: chidzidzo chechikamu chechipiri che multicenter, single-arm, - The Lancet Regional Health - Western Pacific

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