A ranar 25 ga Fabrairu, 2025, Hukumar Kayayyakin Lafiya ta Kasa (NMPA) ta amince da amfani da finotonlimab tare da SCT510 don magance cutar sankarau.maganin cutar kansar hanta wadda ba a iya cirewa ko kuma wadda ba a taɓa yi wa maganinta ba a baya.
Finotonlimab wani nau'in antibody ne mai kama da IgG4 wanda aka sake haɗa shi da ɗan adam wanda ke da cikakken haƙƙin mallakar fasaha. A matsayinsa na sabon magani mai lasisi, tsarin kwayoyin halittarsa na musamman ne kuma yana da fa'idodin tsarin aiki. Finotonlimab yana ɗaure da PD-1 tare da babban ƙarfi, yana toshe hanyar PD-1/PD-L1 yadda ya kamata, yana maido da kuma haɓaka aikin kashe garkuwar jiki na ƙwayoyin T, kuma hakan yana hana ci gaban ƙari.
A taron shekara-shekara na ASCO na 2024, an ruwaito wanigwajin mataki na 3 bazuwar of SCT-I10A tare da maganin bevacizumab biosimilar (SCT510) idan aka kwatanta da sorafenib a cikin maganin farko na ciwon daji na hanta.
A cikin wannan gwajin da aka yi a kan layi mai buɗewa, mai cibiya da yawa, mataki na 3 (NCT04560894) wanda aka gudanar a China, an yi wa marasa lafiya da ke da ci gaba a fannin HCC waɗanda ba a taɓa ba su maganin tsarin da aka yi a baya rajista kuma an ba su bazuwar (2:1) don su karɓi SCT-I10A (200 MG a kowane mako uku [Q3W]) tare da SCT510 (bevacizumab biosimilar, 15 mg/kg Q3W) ko sorafenib (400 MG a baki sau biyu a rana) har sai babu wani fa'ida ta asibiti ko guba da ba za a yarda da ita ba. An rarraba bazuwar ta hanyar yanayin aikin ECOG (0 vs. 1), matakin alpha-fetoprotein na asali (<400ng/ml vs. ≥400ng/ml), mamayewar jijiyoyin jini ko metastasis na waje na hanta (eh vs. a'a). Maƙasudin farko sune gaba ɗaya na rayuwa (OS) da rayuwa ba tare da ci gaba ba (PFS) kamar yadda aka tantance ta hanyar bita mai zaman kanta mai zaman kanta (BICR) bisa ga Ka'idojin Kimantawa a cikin Tumors Masu ƙarfi (RECIST) sigar 1.1 a cikin cikakken saitin bincike.
A lokacin da aka yanke bayanai don nazarin wucin gadi (2 ga Nuwamba, 2023), an yi wa jimillar marasa lafiya 346 rajista kuma an karɓi aƙalla allurai ɗaya (SCT-I10A da ƙungiyar SCT510, n=230; ƙungiyar sorafenib, n=116), kuma matsakaicin bin diddigin ya kasance watanni 19.7. Ƙungiyar SCT-I10A da SCT510 ta nuna matsakaicin OS mai tsayi fiye da na ƙungiyar sorafenib (22.1 vs. watanni 14.2, rabon haɗari [HR] 0.60; tazara amincewa ta 95% [CI]: 0.44, 0.81; p=0.0008). An tsawaita matsakaicin PFS sosai a cikin ƙungiyar SCT-I10A da SCT510 idan aka kwatanta da ƙungiyar sorafenib (7.1 vs. watanni 2.9; HR 0.50; 95%CI: 0.38, 0.65; p<0.0001). Matsakaicin amsawar da aka samu (ORR) ya fi girma a cikin ƙungiyar SCT-I10A da SCT510 (32.8% [75/229]) fiye da ƙungiyar sorafenib (4.3% [5/116]). An lura da abubuwan da suka faru na rashin lafiya da suka shafi magani (TRAEs) na maki ≥3 a cikin kashi 42.6% (98/230) na marasa lafiya a cikin ƙungiyar SCT-I10A da SCT510 da kashi 33.6% (39/116) na marasa lafiya a cikin ƙungiyar sorafenib. Mafi yawan masu fama da cutar TRAE sune hawan jini (SCT-I10A da ƙungiyar SCT510 idan aka kwatanta da ƙungiyar sorafenib: 7.8% [18/230] idan aka kwatanta da 4.3% [5/116]). Mutuwa uku da suka shafi magunguna (wanda ba a san musabbabinsa ba, zubar jini a cikin kwakwalwa, ko zubar jini a cikin hanji a cikin majiyyaci ɗaya) sun faru kuma suna da alaƙa da SCT510.
Kammalawa: Haɗin SCT-I10A da SCT510 ya nuna fa'idodi masu yawa na asibiti da kuma ingantaccen bayanin aminci ga marasa lafiya da ke da HCC mai ci gaba, wanda hakan ke tallafawa dacewarsa a matsayin zaɓin magani na farko ga HCC.
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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Lokacin Saƙo: Maris-10-2025