Musi wa21 Kurume, 2025, Junshi Biosciences yakazivisa kuti National Medical Products Administration ("NMPA") yabvumidza kushandiswa kwemushonga mutsva ("sNDA") wemushonga wekambani, toripalimab, pamwe chete nebevacizumab pakurapa varwere vehepatocellular carcinoma vasina kubatwa kana kuti vane chirwere chemoyo chinonzi metastatic hepatocellular carcinoma ("HCC").
Kubvumidzwa kwekuwedzera kweNDA kwakavakirwa padata kubva muchidzidzo cheHEPATORCH (NCT04723004), chinova chidzidzo chekiriniki chechikamu chechitatu chine nzvimbo dzakawanda, chakasarudzwa, chakavhurika, uye chinotungamirirwa nemabasa. Purofesa Jia FAN, nyanzvi yeChinese Academy of Sciences, kubva kuZhongshan Hospital yakabatana neFudan University, akashanda semuongorori mukuru. HEPATORCH yakatangwa munzvimbo dzekiriniki makumi mashanu nenomwe munyika yeChina, Taiwan neSingapore yeChina, uye varwere vanosvika mazana matatu nemakumi maviri nevatanhatu vakanyoreswa. Chidzidzo ichi chaive nechinangwa chekuongorora kushanda uye kuchengetedzeka kwetoripalimab pamwe chete nebevacizumab pakurapa kwekutanga kweHCC isingabvisike kana kuti inopararira kana ichienzaniswa nekurapa kwakajairika nesorafenib.
MunaGunyana 2024, mhedzisiro yechidzidzo cheHEPATORCH yakatanga kuratidzwa paMusangano weNational Clinical Oncology wechi27 neMusangano wegore negore we2024 weChinese Society of Clinical Oncology (CSCO). Mhedzisiro yechidzidzo yakaratidza kuti magumo ekutanga, kurarama pasina kufambira mberi ("PFS," zvichibva paongororo yakazvimirira yeradiographic) uye OS, zvese zvakawana mhedzisiro yakanaka.
HEPATORCH yakaratidza kuti kana ichienzaniswa nesorafenib, toripalimab pamwe chete nebevacizumab zvinogona kuwedzera PFS neOS yevarwere, nePFS yepakati yemwedzi 5.8 vs. mwedzi 4.0, kuderedza njodzi yekufambira mberi kwechirwere kana kufa ne31% (hazard ratio [HR]=0.69, 95% CI: 0.525-0.913; P=0.0086), neOS yepakati yemwedzi 20.0 vs. mwedzi 14.5, uye kuderedza njodzi yekufa ne24% (HR=0.76, 95% CI: 0.579-0.987; P=0.0394). Mwero wekupindura wakananga ("ORR") weboka retoripalimab nebevacizumab wakakwira zvakanyanya kupfuura weboka resorafenib. ORR yemapoka maviri aya yaive 25.3% uye 6.1%, zvichiteerana. Uyezve, mushonga wekubatanidza une hutano hwakanaka muvarwere vane HCC yepamusoro. Hunhu hwehunhu hwehunhu hunoenderana nehuwandu hunozivikanwa hwehunhu hwehunhu hwe monotherapy, uye hapana chiratidzo chitsva chehunhu hwakawanikwa.
NezveToripalimab
Toripalimab iantibody inorwisa PD-1 monoclonal yakagadzirwa nekuda kwekugona kwayo kudzivirira kusangana kwePD-1 nema ligands ayo, PD-L1 nePD-L2, uye kukurudzira internalization yePD-1 receptor (basa re endocytosis). Kuvhara kusangana kwePD-1 nePD-L1 nePD-L2 kunokurudzira kugona kwemasoja emuviri kurwisa nekuuraya masero egomarara.
Zvidzidzo zvekiriniki zvinodarika makumi mana zvinotsigirwa nekambani zve toripalimab zvine zviratidzo zvinopfuura gumi nezvishanu zvakaitwa pasi rose neJunshi Biosciences, kusanganisira muChina, United States, Europe neSoutheast Asia. Miedzo yekiriniki inoenderera mberi kana yakapedzwa inoongorora kuchengetedzeka uye kushanda kwe toripalimab inovhara mhando dzakasiyana dzemamota, kusanganisira kenza yemapapu, nasopharynx, esophagus, dumbu, dundira, zamu, chiropa, itsvo, uye ganda.
Munyika yeChina, toripalimab ndiyo yaive yekutanga anti-PD-1 monoclonal antibody yakabvumidzwa kutengeswa (yakatenderwa kuChina seTUOYI®). Parizvino, kune zviratidzo gumi nerimwe zvakatenderwa zve toripalimab munyika yeChina:
melanoma isingabvisike kana kuti inopararira mushure mekukundikana kwekurapa kwakajairika;
kansa yemudumbu inodzokororwa kana kuti inopararira mumhino (NPC) mushure mekukundikana kwemishonga miviri yekare yekurapa;
chirwere chekenza chemudumbu chakapararira kana kuti chakapararira munzvimbo iyoyo chakakundikana kurapwa ne platinum-containing chemotherapy kana kuti chakaenderera mberi mukati memwedzi gumi nemiviri mushure mekurapwa ne neoadjuvant kana adjuvant platinum-containing chemotherapy;
pamwe chete ne cisplatin ne gemcitabine senzira yekutanga yekurapa varwere vane NPC inodzoka kana kuti ine chirwere che metastatic munharaunda;
pamwe chete nepaclitaxel necisplatin mukurapa kwekutanga kwevarwere vane chirwere chekenza chesquamous cell carcinoma (ESCC) chisingarapiki kana kuti chisingaperi;
pamwe chete nepemetrexed neplatinum senzira yekutanga yekurapa EGFR mutation-negative uye ALK mutation-negative, isingarapiki, yakakwira munharaunda kana metastatic non-squamous non-small cell lung cancer (NSCLC);
pamwe chete nechemotherapy sekurapa kweperiooperative uye mushure mezvo ne monotherapy sekurapa kwekubatsira pakurapa varwere vakuru vane reseable stage IIIA-IIIB NSCLC;
pamwe chete neaxitinib pakurapa varwere vane chirwere chekenza yemasero emudumbu (RCC) chine njodzi yepakati kusvika yakakwira;
pamwe chete ne etoposide pamwe ne platinum pakurapa kenza yemapapu yemasero madiki (ES-SCLC);
pamwe chete nepaclitaxel yekubaiwa jekiseni (yakasungwa nealbumin) yekurapa kenza yemazamu ine triple-negative (TNBC) inodzokororwa kana kuti inopararira;
pamwe chete nebevacizumab pakurapa varwere veHCC (HCC) vasina kubatwa kana kubatwa nekenza yeropa.
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
Email：myimmnet@163.com
Nguva yekutumira: Kurume-27-2025