Ku itariki ya 25 Gashyantare 2025, Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi mu Bushinwa (NMPA) cyemeje imiti ya finotonlimab hamwe na SCT510 yokuvura kanseri y'umwijima idashobora kuvurwa cyangwa yangiritse itaravurwa mbere.
Finotonlimab ni antibody ya IgG4 yahinduwe umuntu ifite uburenganzira bwuzuye mu by’ubwenge. Nk’umuti mushya ufite uburenganzira ku giti cye, imiterere yawo ya molekile ni yihariye kandi ifite ibyiza byawo mu mikorere. Finotonlimab ifatana na PD-1 ifite imbaraga nyinshi, igafunga inzira ya PD-1/PD-L1, ikagarura kandi ikongera imikorere yo kwica ubudahangarwa bw’uturemangingo twa T, bityo ikabuza gukura kwa kanseri.
Mu nama ngarukamwaka ya ASCO ya 2024, hatangajweigerageza ryakozwe ku buryo butaziguye mu cyiciro cya 3 of SCT-I10A ivanze na bevacizumab biosimilar (SCT510) ugereranije na sorafenib mu kuvura kanseri y’umwijima iteye imbere.
Muri iki gikorwa cya gatatu cy’igerageza cyakozwe mu Bushinwa, cyakozwe mu byiciro bitandukanye, cyakozwe mu Bushinwa, abarwayi bafite HCC ihanitse batari barahawe imiti mbere y’uko ikoreshwa mu kuvura indwara, bashyizwe mu byiciro (2: 1) kugira ngo bahabwe SCT-I10A (200 mg buri byumweru bitatu [Q3W]) hamwe na SCT510 (bevacizumab biosimilar, 15 mg/kg Q3W) cyangwa sorafenib (400 mg mu kanwa kabiri ku munsi) kugeza igihe nta nyungu cyangwa uburozi budakwiye. Uburyo bwo kuvura indwara bwashyizwe mu byiciro hakurikijwe uko ECOG ikora (0 vs. 1), urugero rwa alpha-fetoprotein (<400ng/ml vs. ≥400ng/ml), uburyo bwo gutera imitsi cyangwa kwangirika kw’amaraso mu mubiri (yego vs. oya). Ingaruka z’ibanze zari ukurokoka kose (OS) no kubaho nta guhindagurika (PFS) nk’uko byagenzuwe na Blind Independent central review (BICR) hakurikijwe Response Evaluation Criteria in Solid Tumors (RECIST) verisiyo ya 1.1 mu isesengura ryuzuye.
Mu gihe cyo gusesengura by'agateganyo (2 Ugushyingo 2023), abarwayi 346 bose hamwe banditswe kandi bahabwa nibura dose imwe (itsinda rya SCT-I10A hamwe na SCT510, n=230; itsinda rya sorafenib, n=116), kandi ikurikirana ry'igihembwe ryari amezi 19.7. Itsinda rya SCT-I10A hamwe na SCT510 ryagaragaje ko rimaze igihe kirekire cyane hagati y'itsinda rya sorafenib (amezi 22.1 ugereranyije n'amezi 14.2, igipimo cy'ibyago [HR] 0.60; 95% igihe cy'icyizere [CI]: 0.44, 0.81; p=0.0008). Impuzandengo ya PFS yatinze cyane mu itsinda rya SCT-I10A hamwe na SCT510 ugereranije n'itsinda rya sorafenib (amezi 7.1 ugereranyije na 2.9; HR 0.50; 95%CI: 0.38, 0.65; p<0.0001). Igipimo cy'ubutabazi bw'ibanze (ORR) cyari hejuru mu itsinda rya SCT-I10A hamwe na SCT510 (32.8% [75/229]) ugereranyije n'itsinda rya sorafenib (4.3% [5/116]). Ingaruka mbi zijyanye n'ubuvuzi (TRAEs) zo mu cyiciro cya ≥3 zagaragaye muri 42.6% (98/230) by'abarwayi mu itsinda rya SCT-I10A hamwe na SCT510 na 33.6% (39/116) by'abarwayi mu itsinda rya sorafenib. Indwara ya TRAE ikunze kugaragara cyane ni umuvuduko ukabije w'amaraso (SCT-I10A hamwe n'itsinda rya SCT510 ugereranije n'itsinda rya sorafenib: 7.8% [18/230] ugereranije na 4.3% [5/116]). Impfu eshatu zikomoka ku biyobyabwenge (impamvu itazwi, kuva amaraso mu mutwe, cyangwa kuva amaraso mu gifu ku murwayi umwe) zabayeho kandi zifitanye isano na SCT510.
Umwanzuro: Guhuza SCT-I10A na SCT510 byagaragaje ibyiza bikomeye byo kuvura ndetse n'umutekano wemewe ku barwayi bafite HCC iteye imbere, bityo bigashyigikira ko ikwiriye nk'uburyo bwa mbere bwo kuvura HCC.
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 ubutumwa: Werurwe-10-2025