Ngomhla wama-22 kuJanuwari 2025, "iNature Medicine" yapapasha iziphumo ze-Akeso ngokuzimeleyo yavelisa i-PD-1/CTLA-4 bispecific antibody cadonilimab ngokudibeneyo ne-oxaliplatin kunye ne-capecitabine kunyango lokuqala lwe-adenocarcinoma yesisu okanye ye-gastroesophageal junction (G/GEJ) engasuswanga kwindawo ethile okanye esasazekayo kwisifundo seklinikhi seSigaba sesiThathu (COMPASSION-15/AK104-302).Iziphumo zophando lwe-COMPASSION-15 zazichazwe ngomlomo ngaphambili kwiNtlanganiso yoNyaka ye-2024 ye-American Association for Cancer Research (AACR).
Olu yayiluphononongo lwesigaba sesi-3 olucwangcisiweyo, olungaboni kabini, olulawulwa yi-placebo. Izigulana ezifanelekileyo yayingabantu abadala abane-G/GEJ adenocarcinoma enganyangwanga, engenakucocwa, ephucukileyo okanye esasazekayo. Izigulana zacwangciswa ngo-1:1 ukuze zifumane i-cadonilimab (10 mg kg−1 qho kwiiveki ezi-3) okanye i-placebo kunye ne-chemotherapy (qho kwiiveki ezi-3). Isiphelo esiphambili yayikukusinda ngokupheleleyo (OS) kubantu abanomdla wokunyanga (inqanaba lokubaluleka kwelinye icala, P = 0.025). Isiphelo sesibini sasiquka i-OS kwizigulane ezine-PD-L1 combined positive score ≥5, ukusinda okungenankqubela phambili, izinga lokuphendula ngendlela echanekileyo, ixesha lokuphendula kunye nokhuseleko. Ukusukela nge-18 ka-Agasti 2023, izigulana ezingama-610 ezivela kumaziko ophando angama-75 zacwangciswa ngo-1:1 kwi-cadonilimab (n = 305) okanye kwi-placebo (n = 305). Ngokulandelelana okuphakathi kweenyanga ezili-18.7, iqela le-cadonilimab lalinomlinganiselo we-OS omde kakhulu (14.1 xa kuthelekiswa neenyanga ezili-11.1; umlinganiselo wengozi (HR) 0.66; 95% isithuba sokuzithemba (CI) 0.54–0.81; P < 0.001) kuneqela le-placebo. Isiphelo sokuqala safezekiswa. Ukusinda okuphakathi okungenankqubela phambili kwakuyiinyanga ezi-7.0 xa kuthelekiswa neenyanga ezi-5.3 (HR 0.53, 95% CI 0.44–0.65). I-OS ephakathi kwizigulane ezine-PD-L1 idibene namanqaku amahle ≥5 yayiziinyanga ezili-15.3 xa kuthelekiswa neenyanga ezili-10.9 (HR 0.58, 95% CI 0.41–0.82). Izinga lokuphendula elichanekileyo yayiyi-65.2% xa kuthelekiswa ne-48.9% kunye nexesha eliphakathi lokuphendula leenyanga ezi-8.8 xa kuthelekiswa neenyanga ezi-4.4. Iziganeko ezimbi ezinxulumene nonyango lweBanga ≥3 zenzeke kwi-65.9% yeqela le-cadonilimab kunye ne-53.6% yeqela le-placebo, kwaye ezona zixhaphakileyo yayikukuncipha kwenani leeplatelet, ukwehla kwenani le-neutrophil kunye ne-anemia. Uninzi lweziganeko ezimbi ezinxulumene nokuzikhusela komzimba yayilibanga loku-1 okanye lesi-2. Akukho zimpawu zintsha zokhuseleko ezibonweyo. I-Cadonilimab kunye ne-chemotherapy ziphucule kakhulu i-OS ngeprofayili yokhuseleko elawulekayo kwizigulane ezine-G/GEJ adenocarcinoma ephucukileyo.
Inaliti yeCadonilimab liyeza elitsha, lokuqala kwiklasi yePD-1/CTLA-4 ye-immunotherapy eliphuhliswe ngaphakathi. Ngomhla wama-29 kuJuni, ngo-2022, iCadonilimab inikwe imvume yokuthengisa yi-NMPA yaseTshayina yokunyanga izigulane zomhlaza wesibeleko ophinde wabuyela kwimo okanye emva kwe-chemotherapy esekelwe kwiplatinum. NgoSeptemba ka-2024, uphawu olutsha lwe-cadonilimab luvunyiwe kunyango lokuqala lwezigulane ezine-adenocarcinoma engasuswayo okanye esasazekayo yesisu okanye ye-gastroesophageal junction (G/GEJ) adenocarcinoma, kunye ne-fluoropyrimidine kunye ne-chemotherapy esekelwe kwiplatinum. Okwangoku, izicelo ezintsha zamayeza eCadonilimab ezidityaniswe ne-chemotherapy esekelwe kwiplatinum, ene-bevacizumab okanye engenayo, kunyango lokuqala lomhlaza wesibeleko oqhubekayo, ophindaphindayo, okanye osasazekayo zamkelwe yi-CDE. Ukongeza, uthotho lwezifundo zonyango, kuquka uvavanyo lwesigaba sesi-3 lonyango oluncedisayo kwizigulana ezisengozini enkulu yokuphinda zibuye emva kokususwa kwe-hepatocellular carcinoma, lwenziwa ngempumelelo.
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
Iireferensi
https://www.nature.com/articles/s41591-024-03450-4
Ixesha leposi: Februwari-21-2025