Tagitanlimab yakatenderwa kurapwa kwekutanga pamwe chete ne cisplatin ne gemcitabine kune varwere vane chirwere chekenza chemuno chinodzoka kana kuti chinopararira mumhino.

Musi wa20 Ndira, National Medical Products Administration (NMPA) yakabvumidza mushonga mutsva we antibody we monoclonal tagitanlimab.(yaimbova KL-A167) Kurapa kwakasanganiswa kwe cisplatin ne gemcitabine pakurapa varwere vane chirwere chekenza chemudumbu (NPC) chinodzoka kana kuti chinopararira.

Ichi ndicho chiratidzo chechipiri chakatenderwa kushandisa Tagolizumab. Kare, NMPA yakabvumidza kutengeswa muChina kwetagitanlimab monotherapy yekurapa varwere vane recurrent kana metastatic NPC vakakundikana mushure me2L+ chemotherapy yapfuura.

Kubvumidzwa uku kwakavakirwa paongororo yekiriniki yechikamu chechitatu yakarongwa, yakapofumadzwa kaviri, inodzorwa ne placebo, ine nzvimbo dzakawanda, inoongorora kushanda uye kuchengetedzeka kwemhedzisiro ye tagitanlimab pamwe chete ne cisplatin ne gemcitabine versus placebo pamwe chete ne cisplatin ne gemcitabine yekurapa recurrent kana metastatic NPC, iyo yakatungamirwa naProfessor Shi Yuankai weCancer Hospital Chinese Academy of Medical Sciences semuongorori mukuru.

Zvichienderana nemhedzisiro yechidzidzo ichi, tagitanlimab inoshandiswa pamwe chete ne cisplatin ne gemcitabine pakurapa kwekutanga kwe recurrencing kana metastatic NPC inogona kuva ne progression-free survival better (PFS), higher objective response rate (ORR) uye extended duration of response (DoR) zvichienzaniswa ne chemotherapy, uko varwere vese vanogona kubatsirwa pasinei ne PD-L1 expression. Average PFS ye tagitanlimab pamwe chete ne chemotherapy haisvikiki zvichienzaniswa nemwedzi 7.9 ye placebo pamwe chete ne chemotherapy, uye njodzi yekufambira mberi kwechirwere nerufu inoderedzwa ne53%; ORR i81.7% vs 74.5%; average DoR i11.7 vs 5.8 mwedzi, iyo yakapetwa kaviri zvichienzaniswa ne placebo arm; parizvino average overalvage survival (OS) haisati yakura, zvisinei maitiro anobatsira e OS ye tagitanlimab pamwe chete ne chemotherapy atoonekwa, uye njodzi yayo yekufa inoderedzwa ne38%. Tagitanlimab yakaratidzawo kuchengetedzeka kunogoneka.

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.国家药品监督管理局 (nmpa.gov.cn)

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