Ngomhla wesi-4 kweyeSilimela, ngo-2025, uAkeso ubhengeze ukuba iNational Medical Products Administration (NMPA) ivumile i-PD-1/CTLA-4 bispecific antibody yenkampani yokuqala kwiklasi, i-cadonilimab, yonyango lokuqala lomhlaza wesibeleko oqhubekayo, ophindaphindayo, okanye osasazekayo, kunye ne-chemotherapy esekelwe kwiplatinum, ene-bevacizumab okanye engenayo. Imvume ye-NMPA ibonisa uphawu lwesithathu oluvunyiweyo lwe-cadonilimab.
Imvume yokusetyenziswa kwe-cadonilimab kunye ne-chemotherapy (ene-bevacizumab okanye engenayo) kumhlaza womlomo wesibeleko wokuqala isekelwe kwidatha yeklinikhi evela kuphononongo lweSigaba sesiThathu se-COMPASSION-16 (AK104-303).
Kolu vavanyo lwesigaba sesi-3 olucwangcisiweyo, olungaboni kabini, oluneendawo ezininzi, olulawulwa yi-placebo, abafazi abaneminyaka eli-18-75 ubudala kwiindawo ezingama-59 zeklinikhi eTshayina abanomhlaza womlomo wesibeleko ongapheliyo, ophinda ubuye, okanye osasazeka ngaphambili banikwa ngokungacwangciswanga (1:1) ukuba bafumane i-cadonilimab (10 mg/kg) okanye i-placebo kunye ne-platinum-based chemotherapy ene-bevacizumab okanye engenayo rhoqo kwiiveki ezi-3 kwimijikelo emithandathu, kulandele unyango lokugcina rhoqo kwiiveki ezi-3 ukuya kuthi ga kwiminyaka emi-2. Ukhetho lwenziwa phakathi ngenkqubo ye-interactive web-response. Izinto ezibangela ukuhlukaniswa kwamanqanaba yayikukusetyenziswa kwe-bevacizumab (ewe okanye hayi) kunye ne-chemoradiotherapy yangaphambili (ewe okanye hayi). Iziphumo eziphambili ezimbini yayikukusinda okungenankqubela phambili njengoko kuhlolwe luphononongo oluzimeleyo oluyi-blindless kunye nokusinda ngokubanzi kwiseti epheleleyo yohlalutyo.
Kwi-COMPASSION-16, irejimeni yokudibanisa i-cadonilimab ibonise inzuzo ephawulekayo yokusebenza kakuhle kwizigulane ezineethumba ezine-PD-L1 expression engentle (CPS <1), equka i-27.9% yabantu kwiqela lonyango, xa kuthelekiswa ne-24.2% kwiqela lolawulo. Olu phononongo luhlangabezane ne-progression-free survival (PFS) kunye ne-overall survival (OS) endpoints, nto leyo ebonisa ukuphucuka okukhulu kuzo zombini ii-endpoints kwizigulane ezinyangwe ngerejimeni ye-cadonilimab xa kuthelekiswa nonyango oluqhelekileyo kwindawo yokuqala yomhlaza womlomo wesibeleko.
Uhlalutyo lwamaqela amancinci oluvela kuphando lwe-COMPASSION-16 lubonise ukuba zombini iindidi ze-PD-L1-positive kunye ne-PD-L1-negative, nokuba zifakwe kwi-bevacizumab, zizuze kunyango. Iziphumo zovavanyo lwe-COMPASSION-16 ziboniswe njenge-Late-Breaking Abstract (LBA) kwi-2024 International Gynecologic Cancer Society (IGCS) Global Meeting, kwaye kamva zapapashwa kwi-The Lancet kwaye kamva zaxelwa kwakhona kwi-Nature Reviews Clinical Oncology.
Ukutolikwa
Ukongezwa kwe-cadonilimab kwi-chemotherapy yomgca wokuqala kuphucule kakhulu ukusinda okungenankqubela phambili kunye nokusinda ngokubanzi ngeprofayili yokhuseleko elawulekayo kubathathi-nxaxheba abanomhlaza womlomo wesibeleko oqhubekayo, ophindaphindayo, okanye osasazekayo. Idatha ixhasa ukusetyenziswa kwe-cadonilimab kunye ne-chemotherapy njengonyango olusebenzayo lomgca wokuqala kumhlaza womlomo wesibeleko oqhubekayo, ophindaphindayo, okanye osasazekayo.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
Email：myimmnet@163.com
Ixesha leposi: Juni-06-2025