Ma Pepeluali 25, 2025, ua ʻāpono ka ʻĀina Hoʻokele Huahana Lapaʻau Lahui o Kina (NMPA) i ka finotonlimab i hui pū ʻia me SCT510 noka mālama ʻana i ka carcinoma hepatocellular hiki ʻole ke hoʻopau ʻia a metastatic paha i loaʻa ʻole i ka lāʻau lapaʻau systemic ma mua.
ʻO Finotonlimab kahi antibody monoclonal IgG4 subtype anti-PD-1 recombinant humanized me nā kuleana waiwai noʻonoʻo piha. Ma ke ʻano he lāʻau lapaʻau hou i hoʻopaʻa ʻia, he kū hoʻokahi kona ʻano molekala a he mau pono hana. Hoʻopaʻa ʻo Finotonlimab iā PD-1 me ka pilina kiʻekiʻe, e pale pono ana i ke ala PD-1/PD-L1, e hoʻihoʻi a hoʻoikaika i ka hana pepehi ʻana o nā pūnaewele T, a no laila e pale ana i ka ulu ʻana o ka puʻupuʻu.
Ma ka Hālāwai Makahiki ASCO 2024, ua hōʻike ʻia hehoʻokolohua pae 3 i hoʻonohonoho ʻia of Ua hui pū ʻia ʻo SCT-I10A me kahi bevacizumab biosimilar (SCT510) e kūʻē i ka sorafenib i ka lāʻau lapaʻau laina mua o ka carcinoma hepatocellular holomua.
Ma kēia hoʻokolohua hāmama, multicenter, phase 3 (NCT04560894) i mālama ʻia ma Kina, ua kākau inoa ʻia nā maʻi me ka HCC holomua i loaʻa ʻole i ka lāʻau lapaʻau ʻōnaehana mua a ua hoʻonohonoho hewa ʻia (2:1) e loaʻa iā SCT-I10A (200 mg i kēlā me kēia ʻekolu pule [Q3W]) me SCT510 (he bevacizumab biosimilar, 15 mg/kg Q3W) a i ʻole sorafenib (400 mg waha ʻelua manawa i ka lā) a hiki i ka loaʻa ʻole o ka pōmaikaʻi lapaʻau a i ʻole ka ʻawaʻawa ʻae ʻole ʻia. Ua hoʻokaʻawale ʻia ka Randomization e ke kūlana hana ECOG (0 vs. 1), ka pae alpha-fetoprotein baseline (<400ng/ml vs. ≥400ng/ml), ka hoʻouka kaua macrovascular a i ʻole ka metastasis extrahepatic (ʻae vs. ʻaʻole). ʻO nā hopena mua like ʻole he ola holoʻokoʻa (OS) a me ke ola ʻole holomua (PFS) e like me ka loiloi ʻana e ka loiloi kikowaena kūʻokoʻa makapō (BICR) e like me ka Response Evaluation Criteria in Solid Tumors (RECIST) mana 1.1 i ka set loiloi piha.
Ma ka palena ʻikepili no ka loiloi waena (Nowemapa 2, 2023), ua kākau inoa ʻia he 346 mau maʻi a loaʻa i ka liʻiliʻi hoʻokahi mahele lāʻau (SCT-I10A me SCT510 hui, n=230; sorafenib hui, n=116), a ʻo ka awelika o ka hahai ʻana he 19.7 mahina. Ua hōʻike ka hui SCT-I10A me SCT510 i kahi awelika OS lōʻihi loa ma mua o ka hui sorafenib (22.1 vs. 14.2 mahina, lakio pōpilikia [HR] 0.60; 95% waena hilinaʻi [CI]: 0.44, 0.81; p=0.0008). Ua hoʻolōʻihi nui ʻia ka PFS waena ma ka hui SCT-I10A me SCT510 i hoʻohālikelike ʻia me ka hui sorafenib (7.1 vs. 2.9 mahina; HR 0.50; 95%CI: 0.38, 0.65; p<0.0001). ʻOi aku ke kiʻekiʻe o ka helu pane pahuhopu (ORR) ma ka hui SCT-I10A me SCT510 (32.8% [75/229]) ma mua o ka hui sorafenib (4.3% [5/116]). Ua ʻike ʻia nā hanana ʻino e pili ana i ka lāʻau lapaʻau (TRAEs) Papa ≥3 ma 42.6% (98/230) o nā maʻi ma ka hui SCT-I10A me SCT510 a me 33.6% (39/116) o nā maʻi ma ka hui sorafenib. ʻO ka papa maʻamau ≥3 TRAE ʻo ia ka hypertension (SCT-I10A me ka hui SCT510 vs. hui sorafenib: 7.8% [18/230] vs. 4.3% [5/116]). ʻEkolu mau make e pili ana i ka lāʻau lapaʻau (kumu i ʻike ʻole ʻia, hemorrhage intracranial, a i ʻole ke kahe koko gastrointestinal kiʻekiʻe i hoʻokahi maʻi i kēlā me kēia) i hana ʻia a ua pili pū me SCT510.
Nā hopena: Ua hōʻike ka hui pū ʻana o SCT-I10A a me SCT510 i nā pono lapaʻau koʻikoʻi a me kahi ʻano palekana i ʻae ʻia i nā poʻe maʻi me HCC holomua, no laila e kākoʻo ana i kona kūpono ma ke ʻano he koho lapaʻau laina mua no HCC.
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
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Ka manawa hoʻouna: Malaki-10-2025