NgoJuni 04, 2025, u-Akeso umemezela ukuthi i-National Medical Products Administration (NMPA) ivumile i-PD-1/CTLA-4 bispecific antibody yenkampani yokuqala ekilasini, i-cadonilimab, yokwelashwa kokuqala komdlavuza wesibeletho oqhubekayo, ophindaphindayo, noma osakazekile, kuhlanganiswe ne-chemotherapy esekelwe eplatinum, ene-bevacizumab noma engenayo. Ukuvunyelwa kwe-NMPA kuphawula isibonakaliso sesithathu esivunyelwe se-cadonilimab.
Ukuvunyelwa kokusetshenziswa kwe-cadonilimab kanye ne-chemotherapy (ene-bevacizumab noma engenayo) kumdlavuza womlomo wesibeletho wokuqala kusekelwe kudatha yezokwelapha evela ocwaningweni lweSigaba III se-COMPASSION-16 (AK104-303).
Kulesi sivivinyo sesigaba sesi-3 esilawulwa ngokungahleliwe, esingaboni kabili, esinama-centre amaningi, esilawulwa yi-placebo, abesifazane abaneminyaka engu-18-75 ezindaweni zemitholampilo ezingu-59 eShayina abanomdlavuza womlomo wesibeletho ongapheli, ophindaphindayo, noma osakazeke kakhulu ngaphambili banikezwa ngokungahleliwe (1:1) ukuthola i-cadonilimab (10 mg/kg) noma i-placebo kanye ne-platinum-based chemotherapy ene-bevacizumab noma engenayo njalo emavikini ama-3 imijikelezo eyisithupha, kulandelwe ukwelashwa kokugcina njalo emavikini ama-3 kuze kube yiminyaka emi-2. Ukungahleliwe kwenziwa phakathi nendawo ngohlelo lokuphendula lwewebhu olusebenzisanayo. Izici zokuhlukanisa kwakuwukusetshenziswa kwe-bevacizumab (yebo noma cha) kanye ne-chemoradiotherapy yangaphambilini (yebo noma cha). Imiphumela emibili eyinhloko kwakuwukusinda okungenazo inqubekela phambili njengoba kuhlolwe ukubuyekezwa okuzimele okuzimele kanye nokusinda okuphelele kusethi yokuhlaziya ephelele.
Ku-COMPASSION-16, uhlelo lokuhlanganisa i-cadonilimab lubonise inzuzo ephawulekayo yokusebenza kahle ezigulini ezinezimila ezinokubonakaliswa kwe-PD-L1 okungekuhle (CPS <1), okuhlanganisa u-27.9% wabantu eqenjini lokwelashwa, uma kuqhathaniswa no-24.2% eqenjini lokulawula. Ucwaningo luhlangabezane nokusinda okungenakho ukuqhubeka (PFS) kanye nokusinda okuphelele (OS), okubonisa ukuthuthuka okuphawulekayo kuzo zombili izindawo zokugcina zeziguli ezelashwe ngohlelo lokwelapha i-cadonilimab uma kuqhathaniswa nokwelashwa okujwayelekile endaweni yokuqala yomdlavuza wesibeletho.
Ukuhlaziywa kweqembu elincane okuvela ocwaningweni lwe-COMPASSION-16 kubonise ukuthi kokubili abantu abane-PD-L1 kanye nabangenayo i-PD-L1, kungakhathaliseki ukufakwa kwe-bevacizumab, bazuze ekwelashweni. Imiphumela yesilingo se-COMPASSION-16 yethulwe njengesifinyezo se-Late-Breaking Abstract (LBA) eMhlanganweni Womhlaba Wonke we-International Gynecologic Cancer Society (IGCS) ka-2024, futhi kamuva yanyatheliswa ku-The Lancet futhi kamuva yabikwa futhi ku-Nature Reviews Clinical Oncology.
Ukuhumusha
Ukwengezwa kwe-cadonilimab ku-chemotherapy ejwayelekile yomugqa wokuqala kuthuthukise kakhulu ukusinda okungenakho ukuqhubekela phambili kanye nokusinda okuphelele ngephrofayili yokuphepha elawulekayo kubahlanganyeli abanomdlavuza womlomo wesibeletho oqhubekayo, ophindaphindayo, noma osakazekile. Imininingwane isekela ukusetshenziswa kwe-cadonilimab kanye ne-chemotherapy njengokwelashwa komugqa wokuqala okuphumelelayo kumdlavuza womlomo wesibeletho oqhubekayo, ophindaphindayo, noma osakazekile.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
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Isikhathi sokuthunyelwe: Juni-06-2025