Musi wa4 Chikumi, 2025, Akeso akazivisa kuti National Medical Products Administration (NMPA) yabvumidza mushonga wekutanga wePD-1/CTLA-4 bispecific antibody wekambani, cadonilimab, wekurapa gomarara remuromo wechibereko rinogara riripo, rinodzokororwa, kana kuti rakapararira, pamwe chete ne platinum-based chemotherapy, ine kana isina bevacizumab. Kubvumidzwa kweNMPA kunoratidza chiratidzo chechitatu chakabvumidzwa checadonilimab.
Kubvumidzwa kwekushandiswa kwecadonilimab pamwe chete nechemotherapy (ine kana isina bevacizumab) mukenza yemuromo wechibereko yekutanga kwakavakirwa padata rekiriniki kubva muchidzidzo chePhase III COMPASSION-16 (AK104-303).
Muongororo iyi yechikamu chechitatu chekurapa, ine mapofu maviri, ine nzvimbo dzakawanda, uye inodzorwa ne placebo, vakadzi vane makore 18-75 munzvimbo 59 dzekiriniki muChina vane kenza yemumuromo yemuromo yakamborapwa, inodzokororwa, kana kuti yakapararira kare vakagoverwa zvisina kurongeka (1:1) kuti vagamuchire cadonilimab (10 mg/kg) kana placebo pamwe ne platinum-based chemotherapy ine kana isina bevacizumab mavhiki matatu ega ega kwematanho matanhatu, zvichiteverwa nekurapwa kwekuchengetedza mavhiki matatu ega ega kweanosvika makore maviri. Kurambwa kwakaitwa pakati peboka kuburikidza neinteractive web-response system. Zvinhu zvakapatsanurwa kwaive kushandiswa kwebevacizumab (hongu kana kwete) uye chemoradiotherapy yapfuura (hongu kana kwete). Mhedzisiro miviri mikuru yaive kupona kusina kufambira mberi sezvakaongororwa neblind independent central review uye kupona kwese muongororo yakazara.
MuCHIVA-16, mushonga we cadonilimab wakaratidza kubatsira kukuru muvarwere vane bundu rine PD-L1 expression isina kunaka (CPS <1), ine 27.9% yevanhu vari muboka rekurapwa, zvichienzaniswa ne24.2% muboka rekutonga. Chidzidzo ichi chakawana zvese progression-free survival (PFS) uye overal survival (OS), zvichiratidza kuvandudzika kukuru mu endpoints dzese dzevarwere vakarapwa ne cadonilimab regimen zvichienzaniswa nekurapa kwakajairika mu first-line setting ye cancer yemuromo wechibereko.
Ongororo dzeboka diki kubva kuongororo yeCOMPASSION-16 dzakaratidza kuti vanhu vane PD-L1-positive nePD-L1-negative, pasinei nekuiswa kwebevacizumab, vakabatsirwa nekurapwa. Mhedzisiro yekuyedzwa kweCOMPASSION-16 yakapihwa seLate-Breaking Abstract (LBA) pa2024 International Gynecologic Cancer Society (IGCS) Global Meeting, uye yakazoburitswa muThe Lancet uye yakazoburitswa zvakare muNature Reviews Clinical Oncology.
Dudziro
Kuwedzerwa kwe cadonilimab kune chemotherapy yekutanga kwakavandudza zvakanyanya kupona pasina kufambira mberi uye kurarama kwese nekuchengetedza kwakarongeka kune varwere vane kenza yemuromo wechibereko inogara kwenguva refu, inodzokororwa, kana yakapararira. Ruzivo rwunotsigira kushandiswa kwe cadonilimab pamwe nechemotherapy senzira yekutanga inoshanda yekurapa kenza yemuromo wechibereko inogara kwenguva refu, inodzokororwa, kana yakapararira.
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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Email：myimmnet@163.com
Nguva yekutumira: Chikumi-06-2025