Musi wa25 Kukadzi, 2025, National Medical Products Administration (NMPA) yeChina yakabvumidza mushonga wefinotonlimab pamwe chete neSCT510 wekurapa.kurapwa kwekenza yeropa isingabvisike kana kuti yakapararira iyo isina kurapwa mumuviri.
Finotonlimab iantibody yerudzi rweIgG4 ine simba rehumanized anti-PD-1 monoclonal ine kodzero dzakakwana dzepfungwa. Semushonga mutsva une patent, chimiro chayo chemamorekuru chakasiyana uye chine zvakanakira mashandiro ayo. Finotonlimab inobatanidza PD-1 nehukama hwakasimba, ichinyatsovhara nzira yePD-1/PD-L1, ichidzorera nekusimudzira mashandiro ekuuraya masero eT, uye nokudaro ichidzivisa kukura kwebundu.
Pamusangano wegore negore weASCO wa2024, vakashuma kutibvunzo yechikamu chechitatu isina kurongeka of SCT-I10A yakabatanidzwa nebevacizumab biosimilar (SCT510) zvichienzaniswa nesorafenib mukurapa kwekutanga kwekenza yeropa yakapararira.
Muongororo iyi yechikamu chechitatu che open-label, multicenter, phase 3 (NCT04560894) yakaitwa muChina, varwere vane HCC yepamusoro vasina kugamuchira system therapy kare vakanyoreswa uye vakagoverwa zvisina kurongeka (2:1) kuti vagamuchire SCT-I10A (200 mg mavhiki matatu ega ega [Q3W]) pamwe neSCT510 (bevacizumab biosimilar, 15 mg/kg Q3W) kana sorafenib (400 mg nemuromo kaviri pazuva) kusvika pasina rubatsiro rwekiriniki kana chepfu isingagamuchirwi. Kusarongeka kwakarongwa zvichienderana nemamiriro ekushanda kweECOG (0 vs. 1), baseline alpha-fetoprotein level (<400ng/ml vs. ≥400ng/ml), macrovascular invasion kana extrahepatic metastasis (hongu vs. kwete). Magumo ekupedzisira ekuwedzera aiva ekurarama kwese (OS) uye ekurarama kwekusafambira mberi (PFS) sezvakaongororwa neBlind Independent central review (BICR) zvichienderana neResponse Evaluation Criteria in Solid Tumors (RECIST) version 1.1 muongororo yakazara.
Pakachekwa data rekuongorora kwenguva pfupi (Mbudzi 2, 2023), varwere vanosvika 346 vakanyoreswa uye vakapihwa kanenge dose imwe chete (SCT-I10A pamwe neboka reSCT510, n=230; boka resorafenib, n=116), uye avhareji yekutevera yaive mwedzi 19.7. Boka reSCT-I10A pamwe neSCT510 rakaratidza avhareji yekushanda kwenguva refu kupfuura iri muboka resorafenib (mwedzi 22.1 vs. 14.2, hazard ratio [HR] 0.60; 95% confidence interval [CI]: 0.44, 0.81; p=0.0008). PFS yepakati yakaramba ichiwedzerwa zvakanyanya muboka reSCT-I10A pamwe neSCT510 zvichienzaniswa neboka resorafenib (7.1 vs. mwedzi 2.9; HR 0.50; 95%CI: 0.38, 0.65; p<0.0001). Muyero wemhinduro chaiyo (ORR) wakakwira muboka reSCT-I10A pamwe neSCT510 (32.8% [75/229]) pane muboka resorafenib (4.3% [5/116]). Zviitiko zvakaipa zvine chekuita nekurapwa (TRAEs) zveGiredhi ≥3 zvakaonekwa mu42.6% (98/230) yevarwere muboka reSCT-I10A pamwe neSCT510 uye 33.6% (39/116) yevarwere muboka resorafenib. Giredhi rakajairika ≥3 TRAE raive BP (SCT-I10A pamwe neboka reSCT510 zvichienzaniswa neboka resorafenib: 7.8% [18/230] zvichienzaniswa ne4.3% [5/116]). Rufu rutatu rwakakonzerwa nemishonga (chisingazivikanwe chikonzero, kubuda ropa mumusoro, kana kubuda ropa mudumbu repamusoro mumurwere mumwe chete) rwakaitika uye rwaive rwakabatana neSCT510.
Mhedziso: Kusanganiswa kweSCT-I10A neSCT510 kwakaratidza mabhenefiti makuru ekurapa uye kuchengetedzeka kunogamuchirika muvarwere vane HCC yepamusoro, nokudaro zvichitsigira kukodzera kwayo senzira yekutanga yekurapa HCC.
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.
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Nguva yekutumira: Kurume-10-2025