Pa 25 February, 2025, bungwe la National Medical Products Administration (NMPA) la ku China lavomereza finotonlimab pamodzi ndi SCT510 kuti igwiritsidwe ntchito pochiza matenda a mtima.chithandizo cha khansa ya chiwindi yosachira kapena yofalikira yomwe sinalandire chithandizo chamankhwala amthupi kale.
Finotonlimab ndi antibody ya IgG4 yopangidwanso kuti ikhale yaumunthu yokhala ndi ufulu wonse wa chidziwitso. Monga mankhwala atsopano opangidwa ndi patent, kapangidwe kake ka mamolekyu ndi kapadera ndipo kali ndi ubwino wa njira. Finotonlimab imalumikizana ndi PD-1 ndi mphamvu yayikulu, ndikutseka njira ya PD-1/PD-L1, kubwezeretsa ndikuwonjezera ntchito yopha chitetezo cha mthupi ya maselo a T, motero kuletsa kukula kwa chotupa.
Pa Msonkhano Wapachaka wa ASCO wa 2024, adalengeza kutimayeso a gawo lachitatu mwachisawawa of SCT-I10A yophatikizidwa ndi bevacizumab biosimilar (SCT510) poyerekeza ndi sorafenib mu chithandizo choyamba cha khansa ya chiwindi yoopsa.
Mu kafukufuku wa gawo lachitatu wotseguka, wa multicenter, (NCT04560894) womwe unachitikira ku China, odwala omwe ali ndi HCC yapamwamba omwe sanalandire chithandizo chamankhwala am'mbuyomu adalembedwa ndipo adapatsidwa mwachisawawa (2:1) kuti alandire SCT-I10A (200 mg milungu itatu iliyonse [Q3W]) kuphatikiza SCT510 (bevacizumab biosimilar, 15 mg/kg Q3W) kapena sorafenib (400 mg pakamwa kawiri patsiku) mpaka palibe phindu lachipatala kapena poizoni wosavomerezeka. Kusasinthika kunagawidwa m'magulu malinga ndi momwe ECOG imagwirira ntchito (0 vs. 1), mulingo wa alpha-fetoprotein woyambira (<400ng/ml vs. ≥400ng/ml), kulowerera kwa macrovascular kapena kufalikira kwa chiwindi (inde vs. ayi). Mapeto oyambira anali opulumuka onse (OS) ndi opulumuka opanda progression (PFS) monga momwe adayesedwera ndi blinded independent central review (BICR) malinga ndi Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 mu seti yonse yowunikira.
Pa nthawi yomaliza ya kusanthula kwakanthawi (Novembala 2, 2023), odwala 346 onse adalembetsa ndipo adalandira mlingo umodzi (gulu la SCT-I10A kuphatikiza SCT510, n=230; gulu la sorafenib, n=116), ndipo zotsatira zapakati zinali miyezi 19.7. Gulu la SCT-I10A kuphatikiza SCT510 linawonetsa nthawi yayitali kwambiri yapakati ya OS kuposa yomwe ili mgulu la sorafenib (miyezi 22.1 motsutsana ndi 14.2, chiŵerengero cha zoopsa [HR] 0.60; 95% nthawi yodzidalira [CI]: 0.44, 0.81; p=0.0008). PFS yapakati idapitilira nthawi yayitali mu gulu la SCT-I10A kuphatikiza SCT510 poyerekeza ndi gulu la sorafenib (miyezi 7.1 motsutsana ndi miyezi 2.9; HR 0.50; 95%CI: 0.38, 0.65; p<0.0001). Chiŵerengero cha mayankho ofunikira (ORR) chinali chokwera mu gulu la SCT-I10A kuphatikiza SCT510 (32.8% [75/229]) kuposa gulu la sorafenib (4.3% [5/116]). Zochitika zoyipa zokhudzana ndi chithandizo (TRAEs) za Giredi ≥3 zidawonedwa mu 42.6% (98/230) ya odwala mu gulu la SCT-I10A kuphatikiza SCT510 ndi 33.6% (39/116) ya odwala mu gulu la sorafenib. Giredi yodziwika kwambiri ya TRAE inali kuthamanga kwa magazi (SCT-I10A kuphatikiza gulu la SCT510 poyerekeza ndi gulu la sorafenib: 7.8% [18/230] poyerekeza ndi 4.3% [5/116]). Imfa zitatu zokhudzana ndi mankhwala (chomwe sichikudziwika chifukwa chake, kutuluka magazi m'mutu, kapena kutuluka magazi m'mimba mwa wodwala m'modzi) zinachitika ndipo zinali zokhudzana ndi SCT510.
Zomaliza: Kuphatikiza kwa SCT-I10A ndi SCT510 kwawonetsa zabwino zazikulu zachipatala komanso chitetezo chovomerezeka mwa odwala omwe ali ndi HCC yapamwamba, motero kumathandizira kuti ikhale njira yoyamba yothandizira HCC.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
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Nthawi yotumizira: Mar-10-2025