Ngomhlaka-22 Januwari 2025, "i-Nature Medicine" yashicilela imiphumela ye-Akeso ngokuzimela yakha i-PD-1/CTLA-4 bispecific antibody cadonilimab ngokuhlanganiswa ne-oxaliplatin kanye ne-capecitabine yokwelapha kokuqala kwe-adenocarcinoma yesisu noma ye-gastroesophageal engasuswanga endaweni ethile noma esakazeke kakhulu esifundweni sezokwelapha seSigaba III (i-COMPASSION-15/AK104-302).Imiphumela yocwaningo lwe-COMPASSION-15 yethulwe ngomlomo ngaphambilini eMhlanganweni Waminyaka Yonke we-American Association for Cancer Research (AACR) ka-2024.
Lolu kwakuwucwaningo lwesigaba sesi-3 olungahleliwe, olungaboni kabili, olulawulwa yi-placebo. Iziguli ezifanelekile kwakungabantu abadala abane-G/GEJ adenocarcinoma engalashwa, engasuswa, ethuthukisiwe endaweni noma esakazeke kakhulu. Iziguli zahlelwa ngo-1:1 ukuze zithole i-cadonilimab (10 mg kg−1 njalo emavikini ama-3) noma i-placebo kanye ne-chemotherapy (njalo emavikini ama-3). Isiphetho esiyinhloko kwakuwukusinda okuphelele (OS) kubantu abahlose ukwelapha (izinga lokubaluleka kohlangothi olulodwa, P = 0.025). Iziphetho zesibili zazihlanganisa i-OS ezigulini ezine-PD-L1 combined positive score ≥5, ukusinda okungenalo inqubekela phambili, izinga lokuphendula okuqondile, isikhathi sokusabela kanye nokuphepha. Kusukela ngomhlaka-18 Agasti 2023, iziguli ezingu-610 ezivela ezikhungweni zocwaningo ezingu-75 zahlelwa ngo-1:1 ukuze zithole i-cadonilimab (n = 305) noma i-placebo (n = 305). Ngokulandela okumaphakathi kwezinyanga ezingu-18.7, iqembu le-cadonilimab lalinohlelo olude kakhulu lwe-OS olumaphakathi (14.1 uma kuqhathaniswa nezinyanga ezingu-11.1; isilinganiso sengozi (HR) 0.66; 95% isikhawu sokuzethemba (CI) 0.54–0.81; P < 0.001) kuneqembu le-placebo. Iphuzu lokugcina eliyinhloko lafinyelelwa. Ukusinda okumaphakathi okungenazo inqubekela phambili kwakuyizinyanga ezingu-7.0 uma kuqhathaniswa nezinyanga ezingu-5.3 (HR 0.53, 95% CI 0.44–0.65). Uhlelo olumaphakathi lwe-OS ezigulini ezine-PD-L1 luhlanganise amaphuzu amahle ≥5 lwaluyizinyanga ezingu-15.3 uma kuqhathaniswa nezinyanga ezingu-10.9 (HR 0.58, 95% CI 0.41–0.82). Izinga lokuphendula eliqondile lalingu-65.2% uma kuqhathaniswa no-48.9% kanye nesikhathi esimaphakathi sokuphendula esiyizinyanga ezingu-8.8 uma kuqhathaniswa nezinyanga ezingu-4.4. Izehlakalo ezimbi ezihlobene nokwelashwa zebanga ≥3 zenzeka ku-65.9% weqembu le-cadonilimab kanye no-53.6% weqembu le-placebo, kanti ezivame kakhulu kwakuwukwehla kwenani lama-platelet, ukwehla kwenani lama-neutrophil kanye ne-anemia. Iningi lezehlakalo ezimbi ezihlobene nokuzivikela komzimba kwakuyibanga 1 noma 2. Azikho izimpawu ezintsha zokuphepha ezibonwe. I-Cadonilimab kanye ne-chemotherapy kuthuthukise kakhulu i-OS ngephrofayili yokuphepha elawulekayo ezigulini ezine-G/GEJ adenocarcinoma ethuthukisiwe.
Umjovo we-Cadonilimab umuthi omusha, wokuqala we-PD-1/CTLA-4 we-immunotherapy okhiqizwe ngaphakathi endlini. Ngomhlaka-29 Juni 2022, i-Cadonilimab inikezwe imvume yokumaketha yi-NMPA yaseShayina yokwelapha iziguli eziphinde zathola umdlavuza wesibeletho (R/M CC) eziqhubekele phambili nge-chemotherapy esekelwe eplatinum noma ngemuva kwayo. NgoSepthemba 2024, inkomba entsha ye-cadonilimab ivunyiwe yokwelashwa kokuqala kweziguli ezine-adenocarcinoma engasuswanga noma esakazekile esiswini noma esiswini (G/GEJ) adenocarcinoma, ehlanganiswe ne-fluoropyrimidine kanye ne-chemotherapy esekelwe eplatinum. Njengamanje, izicelo zemithi ezintsha ze-Cadonilimab ezihlanganiswe ne-chemotherapy esekelwe eplatinum, ene-bevacizumab noma engenayo, yokwelashwa kokuqala komdlavuza wesibeletho oqhubekayo, ophindaphindayo, noma osakazekile sezamukelwe yi-CDE. Ngaphezu kwalokho, uchungechunge lwezifundo zezokwelapha, okuhlanganisa nokuhlolwa kwesigaba sesi-3 sokwelashwa okungeziwe ezigulini ezinengozi enkulu yokuphinda zivele ngemva kokususwa kwe-hepatocellular carcinoma, kwenziwa ngempumelelo.
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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Izinkomba
https://www.nature.com/articles/s41591-024-03450-4
Isikhathi sokuthunyelwe: Feb-21-2025