Ngomhla wama-25 kuFebruwari, ngo-2025, i-National Medical Products Administration (NMPA) yaseTshayina ivumile i-finotonlimab kunye ne-SCT510 ukuzeunyango lwe-carcinoma yesibindi engasuswayo okanye esasazekayo engakhange ifumane unyango lwangaphambili lwenkqubo yomzimba.
I-Finotonlimab yi-antibody ye-monoclonal ye-IgG4 ephinda-phindwe ibe ngumntu ene-anti-PD-1 monoclonal enelungelo elipheleleyo lepropathi yobuchopho. Njengeyeza elitsha elinelungelo lobunikazi, ulwakhiwo lwayo lweemolekyuli luhlukile kwaye luneengenelo zendlela yokusebenza. I-Finotonlimab ibopha kwi-PD-1 nge-affinity ephezulu, ivala ngempumelelo indlela ye-PD-1/PD-L1, ibuyisela kwaye iphucula umsebenzi wokubulala amajoni omzimba weeseli ze-T, kwaye ngaloo ndlela ithintela ukukhula kwethumba.
KwiNtlanganiso yoNyaka ye-ASCO ka-2024, kuxelwe ingxelouvavanyo lwesigaba sesi-3 olungacwangciswanga of I-SCT-I10A idityaniswe ne-bevacizumab biosimilar (SCT510) xa ithelekiswa ne-sorafenib kunyango lokuqala lwe-hepatocellular carcinoma ephucukileyo.
Kolu vavanyo lwesigaba sesi-3 oluvulekileyo, oluneziko ezininzi, (i-NCT04560894) olwenziwe eTshayina, izigulane ezine-HCC ephucukileyo ezazingazange zifumane unyango lwenkqubo yangaphambili zabhaliswa kwaye zabelwa ngokungacwangciswanga (2:1) ukuze zifumane i-SCT-I10A (200 mg qho kwiiveki ezintathu [Q3W]) kunye ne-SCT510 (i-bevacizumab biosimilar, 15 mg/kg Q3W) okanye i-sorafenib (400 mg ngomlomo kabini ngemini) de kungabikho nzuzo yeklinikhi okanye ubuthi obungamkelekanga. Ukungalingani kwahlulwa ngokwesimo sokusebenza kwe-ECOG (0 vs. 1), inqanaba le-alpha-fetoprotein elisisiseko (<400ng/ml vs. ≥400ng/ml), ukuhlaselwa kwe-macrovascular okanye i-extrahepatic metastasis (ewe vs. hayi). Ii-endpoints eziphambili zazikukusinda ngokupheleleyo (OS) kunye nokusinda okungenankqubela phambili (PFS) njengoko kuhlolwe yi-blindless independent central review (BICR) ngokweResponse Evaluation Criteria in Solid Tumors (RECIST) version 1.1 kwiseti epheleleyo yohlalutyo.
Kwisiphelo sedatha sohlalutyo lwexeshana (nge-2 kaNovemba 2023), izigulane ezingama-346 zizonke zabhaliswa kwaye zafumana ubuncinci idosi enye (iqela le-SCT-I10A kunye ne-SCT510, n=230; iqela le-sorafenib, n=116), kwaye ukulandelelana okuphakathi bekuziinyanga ezili-19.7. Iqela le-SCT-I10A kunye ne-SCT510 libonise i-OS ephakathi ende kakhulu kunaleyo ikwiqela le-sorafenib (iinyanga ezingama-22.1 vs. ezili-14.2, umlinganiselo wengozi [HR] 0.60; i-95% isithuba sokuzithemba [CI]: 0.44, 0.81; p=0.0008). I-Median PFS yathatha ixesha elide kakhulu kwiqela le-SCT-I10A kunye ne-SCT510 xa ithelekiswa neqela le-sorafenib (iinyanga eziyi-7.1 xa kuthelekiswa ne-2.9; HR 0.50; 95%CI: 0.38, 0.65; p<0.0001). Izinga lokuphendula elijolise ngqo (ORR) laliphezulu kwiqela le-SCT-I10A kunye ne-SCT510 (32.8% [75/229]) kunakwiqela le-sorafenib (4.3% [5/116]). Iziganeko ezimbi ezinxulumene nonyango (ii-TRAE) zebanga ≥3 zibonwe kwi-42.6% (98/230) yezigulane kwiqela le-SCT-I10A kunye ne-SCT510 kunye ne-33.6% (39/116) yezigulane kwiqela le-sorafenib. Ibanga eliqhelekileyo le-≥3 TRAE yayili-hypertension (iqela le-SCT-I10A kunye neqela le-SCT510 xa kuthelekiswa neqela le-sorafenib: 7.8% [18/230] xa kuthelekiswa ne-4.3% [5/116]). Ukufa okuthathu okunxulumene neziyobisi (imbangela engaziwayo, ukopha ngaphakathi kwentloko, okanye ukopha okuphezulu kwesisu kwisigulana esinye ngasinye) kwenzeke kwaye kwakunxulumene ne-SCT510.
Izigqibo: Ukudibana kwe-SCT-I10A kunye ne-SCT510 kubonise iingenelo ezinkulu zeklinikhi kunye neprofayili yokhuseleko eyamkelekileyo kwizigulane ezine-HCC ephucukileyo, ngaloo ndlela ixhasa ukufaneleka kwayo njengokhetho lonyango lokuqala lwe-HCC.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
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Ixesha leposi: Matshi-10-2025