Ku ya 04 Kamena 2025, Akeso yatangaje ko Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi (NMPA) cyemeje umuti wa mbere w’ikigo witwa PD-1/CTLA-4 bispecific antibody, cadonilimab, wo kuvura kanseri y’inkondo y’umura ihoraho, isubiramo, cyangwa ikwirakwira, hamwe na platine-based chemotherapy, hamwe na bevacizumab cyangwa idafite. Kwemezwa kwa NMPA ni ikimenyetso cya gatatu cyemewe cya cadonilimab.
Kwemererwa gukoresha cadonilimab hamwe na chimiotherapie (harimo cyangwa hatarimo bevacizumab) muri kanseri y'inkondo y'umura ya mbere bishingiye ku makuru y'ubuvuzi yavuye mu bushakashatsi bwa Phase III COMPASSION-16 (AK104-303).
Muri ubu bushakashatsi bwakozwe mu cyiciro cya 3 cyakozwe mu buryo butaziguye, budafite ubumuga bwo kuvura indwara ebyiri, bukorerwa mu bigo byinshi, kandi bugenzurwa na placebo, abagore bari hagati y'imyaka 18-75 mu bitaro 59 mu Bushinwa barwaye kanseri y'inkondo y'umura ikomeza kuvurwa, isubiramo, cyangwa yanduye mbere, bashyizwe mu buryo butaziguye (1:1) kugira ngo bahabwe cadonilimab (10 mg / kg) cyangwa placebo hamwe na platine-based chemotherapy hamwe cyangwa idafite bevacizumab buri byumweru 3 mu gihe cy'ingendo esheshatu, hagakurikiraho ubuvuzi bwo kubungabunga buri byumweru 3 kugeza ku myaka 2. Uburyo butaziguye bwakozwe hagati binyuze muri sisitemu yo gusubiza ku rubuga. Ibintu byashyizwe mu byiciro ni ugukoresha bevacizumab (yego cyangwa oya) na chemotherapy yakoreshejwe mbere (yego cyangwa oya). Ibisubizo bibiri by'ibanze ni ukurokoka kutagira iterambere nk'uko byasuzumwe n'isuzuma ryigenga rya blindless central hamwe no kubaho muri rusange mu isesengura ryuzuye.
Muri COMPASSION-16, uburyo bwo gufata imiti ya cadonilimab bwagaragaje akamaro kanini ku barwayi bafite ibibyimba bifite PD-L1 negative (CPS <1), bigizwe na 27.9% by'abaturage bari mu itsinda ry'ubuvuzi, ugereranije na 24.2% mu itsinda ry'abagenzuwe. Ubushakashatsi bwahuye n'ingaruka zo kubaho nta guhindagurika (PFS) ndetse n'ingaruka zo kubaho muri rusange (OS), bwerekanye iterambere rikomeye mu ngaruka zombi ku barwayi bavuwe na cadonilimab ugereranije n'ubuvuzi busanzwe mu cyiciro cya mbere cy'ubuvuzi bwa kanseri y'inkondo y'umura.
Isesengura ry’amatsinda mato ryavuye mu bushakashatsi bwa COMPASSION-16 ryagaragaje ko abantu banduye PD-L1 na PD-L1, hatitawe ku kuba barashyizwemo bevacizumab, bungukiye muri ubwo buvuzi. Ibisubizo by’igerageza rya COMPASSION-16 byatanzwe nk’incamake y’incamake (LBA) mu nama mpuzamahanga y’umuryango mpuzamahanga wita ku ndwara z’abagore (IGCS) yo mu 2024, hanyuma bitangazwa mu kinyamakuru The Lancet ndetse binatangazwa no muri Nature Reviews Clinical Oncology.
Gusobanura
Kongera cadonilimab ku miti isanzwe ya chimiotherapie yo ku rwego rwa mbere byatumye ubuzima butagira ingaruka ku barwayi ndetse no kubaho muri rusange, bituma habaho umutekano muke ku barwayi ba kanseri y'inkondo y'umura idakira, isubira inyuma, cyangwa isubira inyuma. Amakuru ashyigikira ikoreshwa rya cadonilimab hamwe na chimiotherapie nk'uburyo bwiza bwo kuvura kanseri y'inkondo y'umura idakira, isubira inyuma, cyangwa isubira inyuma.
Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.
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Igihe cyo kohereza: Kamena-06-2025