Bayanan Cadonilimab (PD-1/CTLA-4) na Mataki na III don Maganin Ciwon Ciki Mai Cike da Ciwo An buga a cikin Magungunan Yanayi

A ranar 22 ga Janairu, 2025, "Nature Medicine" ta buga sakamakon Akeso da kanta ta samar da maganin rigakafi na PD-1/CTLA-4 mai suna cadonilimab tare da haɗin gwiwa da oxaliplatin da capecitabine don maganin cutar kansar da ba a iya cirewa ba a cikin gida ko kuma ta hanyar metastatic gastric or gastroesophageal junction (G/GEJ) a cikin wani binciken asibiti na Mataki na III (COMPASION-15/AK104-302).Sakamakon binciken COMPASION-15 an gabatar da shi a baki a taron shekara-shekara na Ƙungiyar Binciken Ciwon Daji ta Amurka (AACR) na 2024.

Wannan wani bincike ne da aka gudanar a mataki na 3 wanda aka gudanar a matsayin bazuwar, makafi biyu, wanda aka sarrafa shi ta hanyar placebo. Marasa lafiya da suka cancanta manya ne da ke fama da cutar G/GEJ adenocarcinoma da ba a yi musu magani ba, waɗanda ba a iya cire su ba, waɗanda suka ci gaba a gida ko kuma waɗanda suka kamu da cutar. An yi wa marasa lafiya allurar 1:1 don karɓar cadonilimab (10 mg kg−1 a kowane mako 3) ko placebo tare da chemotherapy (kowane mako 3). Babban abin da aka yi la'akari da shi shine cikakken rayuwa (OS) a cikin mutanen da aka yi niyya don yi musu magani (matakin mahimmanci na gefe ɗaya, P = 0.025). Maƙallan ƙarshe na biyu sun haɗa da OS a cikin marasa lafiya da aka haɗa maki mai kyau na PD-L1 ≥5, rayuwa ba tare da ci gaba ba, ƙimar amsawa ta zahiri, tsawon lokacin amsawa da aminci. Ya zuwa ranar 18 ga Agusta 2023, an bazu ga marasa lafiya 610 daga cibiyoyin bincike 75 zuwa cadonilimab (n = 305) ko placebo (n = 305). Tare da matsakaicin bin diddigin watanni 18.7, ƙungiyar cadonilimab tana da matsakaicin OS mai tsayi sosai (14.1 idan aka kwatanta da watanni 11.1; rabon haɗari (HR) 0.66; tazara amincewa da kashi 95% (CI) 0.54–0.81; P < 0.001) fiye da ƙungiyar placebo. An cimma babban maƙasudin ƙarshe. Matsakaicin rayuwa ba tare da ci gaba ba shine watanni 7.0 idan aka kwatanta da watanni 5.3 (HR 0.53, 95% CI 0.44–0.65). Matsakaicin OS a cikin marasa lafiya da aka haɗa maki mai kyau na PD-L1 ≥5 shine watanni 15.3 idan aka kwatanta da watanni 10.9 (HR 0.58, 95% CI 0.41–0.82). Matsakaicin amsawar manufa shine 65.2% idan aka kwatanta da 48.9% tare da matsakaicin tsawon lokacin amsawa na watanni 8.8 idan aka kwatanta da watanni 4.4. Abubuwan da suka faru na rashin lafiya na aji ≥3 dangane da magani sun faru a cikin kashi 65.9% na ƙungiyar cadonilimab da kuma kashi 53.6% na ƙungiyar placebo, kuma mafi yawansu sune raguwar adadin platelets, raguwar adadin neutrophil da anemia. Yawancin abubuwan da suka faru na rashin lafiya na garkuwar jiki sune aji 1 ko 2. Ba a lura da sabbin siginar tsaro ba. Cadonilimab da chemotherapy sun inganta tsarin aiki na jiki sosai tare da ingantaccen bayanin tsaro ga marasa lafiya da ke fama da cutar G/GEJ mai tsanani.

Allurar Cadonilimab sabuwar magani ce ta farko, wacce aka samar a cikin gida, wacce aka samar da ita ta hanyar PD-1/CTLA-4 ta musamman. A ranar 29 ga Yuni, 2022, Hukumar NMPA ta kasar Sin ta amince da tallata Cadonilimab don maganin marasa lafiya da suka sake kamuwa da cutar kansar mahaifa (R/M CC) wadanda suka ci gaba a kan ko bayan maganin chemotherapy na platinum. A watan Satumba na 2024, an amince da wata sabuwar alama ta cadonilimab don maganin farko ga marasa lafiya da suka kamu da cutar kansar mahaifa da ba a iya cirewa ko kuma suka kamu da cutar kansar ciki ta hanyar amfani da maganin kumburin ciki ko na gastroesophageal junction (G/GEJ), tare da fluoropyrimidine da maganin chemotherapy na tushen platinum. A halin yanzu, CDE ta amince da sabbin magungunan da ake amfani da su don maganin cutar kansar mahaifa da ta ci gaba, maimaituwa, ko kuma ta hanyar amfani da maganin. Bugu da ƙari, ana gudanar da jerin nazarin asibiti, gami da gwajin mataki na uku don maganin adjuvant ga marasa lafiya da ke da babban haɗarin sake dawowa bayan an cire maganin cutar kansar hanta, yadda ya kamata.

A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.

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https://www.nature.com/articles/s41591-024-03450-4

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Lokacin Saƙo: Fabrairu-21-2025