Thaum Lub Ib Hlis 22, 2025, "Nature Medicine" tau tshaj tawm cov txiaj ntsig ntawm Akeso tus kheej tsim PD-1/CTLA-4 bispecific antibody cadonilimab ua ke nrog oxaliplatin thiab capecitabine rau thawj kab kev kho mob ntawm cov qog nqaij hlav gastric lossis gastroesophageal junction (G/GEJ) adenocarcinoma uas tsis tuaj yeem phais tau hauv zos lossis metastatic hauv kev tshawb fawb theem III (COMPASSION-15/AK104-302).Cov txiaj ntsig ntawm txoj kev tshawb fawb COMPASSION-15 tau raug nthuav tawm hauv kev hais lus ntawm 2024 American Association for Cancer Research (AACR) Lub Rooj Sib Tham Txhua Xyoo.
Qhov no yog kev tshawb fawb theem 3 uas muaj kev xaiv tsa, ob leeg dig muag, thiab tswj los ntawm cov tshuaj placebo. Cov neeg mob uas tsim nyog yog cov neeg laus uas tsis tau kho, tsis tuaj yeem phais tau, mob qog nqaij hlav hauv zos lossis mob qog nqaij hlav kis mus rau lwm qhov. Cov neeg mob tau raug xaiv tsa 1:1 kom tau txais cadonilimab (10 mg kg−1 txhua 3 lub lis piam) lossis placebo ntxiv rau chemotherapy (txhua 3 lub lis piam). Lub hom phiaj tseem ceeb yog kev ciaj sia tag nrho (OS) hauv cov pej xeem uas xav kho (ib sab tseem ceeb, P = 0.025). Lub hom phiaj thib ob suav nrog OS hauv cov neeg mob uas muaj PD-L1 ua ke tau qhab nia zoo ≥5, kev ciaj sia tsis muaj kev nce qib, tus nqi teb tau zoo, lub sijhawm teb thiab kev nyab xeeb. Txij li hnub tim 18 Lub Yim Hli 2023, 610 tus neeg mob los ntawm 75 lub chaw tshawb fawb tau raug xaiv tsa rau cadonilimab (n = 305) lossis placebo (n = 305). Nrog rau qhov nruab nrab ntawm 18.7 lub hlis, pawg cadonilimab muaj lub sijhawm nruab nrab OS ntev dua (14.1 piv rau 11.1 lub hlis; qhov piv txwv txaus ntshai (HR) 0.66; 95% kev ntseeg siab (CI) 0.54–0.81; P < 0.001) dua li pawg placebo. Lub ntsiab lus kawg tau ntsib. Lub sijhawm ciaj sia tsis muaj kev nce qib nruab nrab yog 7.0 lub hlis piv rau 5.3 lub hlis (HR 0.53, 95% CI 0.44–0.65). Lub sijhawm nruab nrab OS hauv cov neeg mob uas muaj PD-L1 ua ke qhov qhab nia zoo ≥5 yog 15.3 lub hlis piv rau 10.9 lub hlis (HR 0.58, 95% CI 0.41–0.82). Tus nqi teb yog 65.2% piv rau 48.9% nrog lub sijhawm teb nruab nrab ntawm 8.8 lub hlis piv rau 4.4 lub hlis. Qib ≥3 cov teeb meem tsis zoo ntsig txog kev kho mob tau tshwm sim hauv 65.9% ntawm pawg cadonilimab thiab 53.6% ntawm pawg placebo, thiab feem ntau yog cov ntshav platelet txo qis, cov neutrophil txo qis thiab ntshav tsis txaus. Feem ntau ntawm cov teeb meem tsis zoo ntsig txog kev tiv thaiv kab mob yog qib 1 lossis 2. Tsis muaj cov cim qhia kev nyab xeeb tshiab tau pom. Cadonilimab ntxiv rau kev kho mob chemotherapy tau txhim kho OS nrog cov ntaub ntawv kev nyab xeeb uas tswj tau hauv cov neeg mob uas muaj G/GEJ adenocarcinoma siab heev.
Kev txhaj tshuaj Cadonilimab yog ib yam tshuaj tshiab, thawj zaug hauv chav kawm PD-1/CTLA-4 bi-specific immunotherapy uas tau tsim hauv tsev. Thaum Lub Rau Hli 29, 2022, Cadonilimab tau txais kev pom zoo los ntawm NMPA ntawm Tuam Tshoj rau kev kho mob ntawm cov neeg mob qog nqaij hlav rov qab los yog metastatic cervical cancer (R/M CC) uas tau nce qib ntawm lossis tom qab platinum-based chemotherapy. Thaum Lub Cuaj Hli 2024, ib qho cim tshiab rau cadonilimab tau pom zoo rau kev kho mob thawj kab ntawm cov neeg mob uas muaj cov kab mob gastric lossis gastroesophageal junction (G/GEJ) adenocarcinoma uas tsis tuaj yeem phais lossis metastatic hauv zos, ua ke nrog fluoropyrimidine thiab platinum-based chemotherapy. Tam sim no, cov ntawv thov tshuaj tshiab rau Cadonilimab ua ke nrog platinum-based chemotherapy, nrog lossis tsis muaj bevacizumab, rau kev kho mob thawj kab ntawm cov qog nqaij hlav rov qab, rov tshwm sim, lossis metastatic tau txais los ntawm CDE. Tsis tas li ntawd xwb, muaj ntau txoj kev tshawb fawb hauv tsev kho mob, suav nrog kev sim theem III rau kev kho mob adjuvant rau cov neeg mob uas muaj kev pheej hmoo siab rov qab mob tom qab phais mob qog nqaij hlav siab, uas tau ua tiav zoo.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
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Cov ntaub ntawv siv los ua piv txwv
https://www.nature.com/articles/s41591-024-03450-4
Lub sijhawm tshaj tawm: Lub Ob Hlis-21-2025