Cadonilimab ya Akeso ya PD-1/CTLA-4 Bispecific Antibody Yavomerezedwa Kuti Igwiritsidwe Ntchito Pochiza Khansa ya Pakhosi mwa Anthu Onse—Chizindikiro Chachitatu Chovomerezeka cha Cadonilimab

Pa Juni 04, 2025, Akeso adalengeza kuti National Medical Products Administration (NMPA) yavomereza mankhwala oyamba a PD-1/CTLA-4 bispecific antibody a kampaniyo, cadonilimab, kuti agwiritsidwe ntchito pochiza khansa ya pachibelekero yomwe imachitika nthawi zonse, yobwerezabwereza, kapena yofalikira, pamodzi ndi chemotherapy yochokera ku platinum, yokhala ndi kapena yopanda bevacizumab. Kuvomerezedwa kwa NMPA ndi chizindikiro chachitatu chovomerezeka cha cadonilimab.

Kuvomerezedwa kwa kugwiritsidwa ntchito kwa cadonilimab pamodzi ndi chemotherapy (yokhala ndi kapena yopanda bevacizumab) mu khansa yoyamba ya pachibelekero kumachokera ku deta yachipatala kuchokera ku kafukufuku wa Phase III COMPASSION-16 (AK104-303).

Mu kafukufuku wa gawo lachitatu wochitidwa mwachisawawa, wosawona mbali ziwiri, wokhala ndi malo ambiri, komanso wolamulidwa ndi placebo, akazi azaka zapakati pa 18-75 m'malo 59 azachipatala ku China omwe anali ndi khansa ya pachibelekero yomwe sinachiritsidwepo kale, yobwerezabwereza, kapena yofalikira kale adapatsidwa mwachisawawa (1:1) kuti alandire cadonilimab (10 mg/kg) kapena placebo kuphatikiza platinum-based chemotherapy yokhala ndi kapena yopanda bevacizumab milungu itatu iliyonse kwa nthawi zisanu ndi chimodzi, kutsatiridwa ndi chithandizo chosamalira milungu itatu iliyonse kwa zaka ziwiri. Kusankhidwa mwachisawawa kunachitika pakati pa anthu kudzera mu njira yolumikizirana ya intaneti. Zinthu zogawa magawo zinali kugwiritsa ntchito bevacizumab (inde kapena ayi) ndi mankhwala a chemoradiotherapy am'mbuyomu (inde kapena ayi). Zotsatira ziwiri zazikulu zinali kupulumuka kopanda kupita patsogolo monga momwe zayesedwera ndi ndemanga yodziyimira payokha yapakati komanso kupulumuka konse mu kusanthula kwathunthu.

Mu COMPASSION-16, njira yogwiritsira ntchito cadonilimab inawonetsa phindu lodziwika bwino kwa odwala omwe ali ndi zotupa zomwe zili ndi PD-L1 yoipa (CPS <1), zomwe zili ndi 27.9% ya anthu omwe ali mgulu la chithandizo, poyerekeza ndi 24.2% omwe ali mgulu loyang'anira. Kafukufukuyu adakwaniritsa zonse ziwiri: progression-free survival (PFS) ndi oversuffering (OS), zomwe zikuwonetsa kusintha kwakukulu m'magawo onse awiri a odwala omwe adalandira njira ya cadonilimab poyerekeza ndi njira zochiritsira zomwe zimagwiritsidwa ntchito pa mzere woyamba wa khansa ya pachibelekero.

Kusanthula kwa magulu ang'onoang'ono kuchokera ku kafukufuku wa COMPASSION-16 kunasonyeza kuti magulu onse awiri omwe ali ndi PD-L1 ndi PD-L1 omwe alibe, mosasamala kanthu za kukhalapo kwa bevacizumab, adapindula ndi chithandizochi. Zotsatira za mayeso a COMPASSION-16 zidaperekedwa ngati Chidule cha Kuchedwa Kwambiri (LBA) pa Msonkhano Wapadziko Lonse wa International Gynecologic Cancer Society (IGCS) wa 2024, ndipo pambuyo pake zidasindikizidwa mu The Lancet ndipo pambuyo pake zidanenedwanso mu Nature Reviews Clinical Oncology.

Kutanthauzira

Kuwonjezeredwa kwa cadonilimab ku mankhwala oyamba a chemotherapy kunathandiza kwambiri kuti munthu apulumuke popanda kupita patsogolo komanso kuti apulumuke kwathunthu ndi chitetezo chokwanira mwa odwala omwe ali ndi khansa ya pachibelekero yopitirira, yobwerezabwereza, kapena yofalikira. Detayo ikuthandizira kugwiritsa ntchito cadonilimab kuphatikiza mankhwala a chemotherapy ngati chithandizo choyamba chothandiza pa khansa ya pachibelekero yopitirira, yobwerezabwereza, kapena yofalikira.

Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.

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