Ọgwụgwọ ngwakọta Finotonlimab akwadoro maka ọrịa kansa hepatocellular

Na Febụwarị 25, 2025, Ụlọ Ọrụ Ngwọta Ọgwụ Mba nke China (NMPA) akwadola finotonlimab yana SCT510 maka ọgwụ mgbochi kansa.ọgwụgwọ nke ọrịa kansa hepatocellular nke a na-apụghị iwepụ ma ọ bụ nke metastatic nke a na-enwetabeghị ọgwụgwọ sistemụ mbụ.

Finotonlimab bụ ọgwụ mgbochi PD-1 monoclonal nke a na-akpọ IgG4 nke nwere ụdị ihe mgbochi PD-1 nke nwere ikike ọgụgụ isi zuru oke. Dịka ọgwụ ọhụrụ a na-enweta ikike, nhazi molekul ya pụrụ iche ma nwee uru usoro. Finotonlimab na-ejikọ na PD-1 nke ọma, na-egbochi ụzọ PD-1/PD-L1 nke ọma, na-eweghachi ma na-eme ka ọrụ igbu mkpụrụ ndụ T dịkwuo mma, ma si otú a na-egbochi uto nke etuto ahụ.

Na Nzukọ Kwa Afọ nke ASCO 2024, kọrọ nannwale nkebi nke atọ a na-enweghị usoro of SCT-I10A jikọtara ya na bevacizumab biosimilar (SCT510) na sorafenib n'ọgwụgwọ mbụ nke kansa imeju dị elu.

N'ime nnwale a nke e mere na mba Chaịna, nke a na-akpọ multicenter, nke phase 3 (NCT04560894), e debara aha ndị ọrịa nwere HCC dị elu nke na-enwetabeghị ọgwụgwọ sistemu mbụ ma kenye ha n'ụzọ na-enweghị usoro (2:1) ka ha nata SCT-I10A (200 mg kwa izu atọ [Q3W]) tinyere SCT510 (bevacizumab biosimilar, 15 mg/kg Q3W) ma ọ bụ sorafenib (400 mg ọnụ ugboro abụọ kwa ụbọchị) ruo mgbe ọ nweghị uru ahụike ma ọ bụ nsí a na-anaghị anabata. E kewara usoro site na ọnọdụ arụmọrụ ECOG (0 vs. 1), ọkwa alpha-fetoprotein nke mbụ (<400ng/ml vs. ≥400ng/ml), mwakpo macrovascular ma ọ bụ metastasis nke extrahepatic (ee vs. mba). Isi njedebe ndị ọzọ bụ ndụ zuru oke (OS) na ndụ na-enweghị ọganihu (PFS) dịka nyocha etiti nke onwe onye gbara ìsì (BICR) si dị dịka Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 si dị na nhazi nyocha zuru oke.

Na njedebe data maka nyocha nwa oge (Nọvemba 2, 2023), e debanyere aha ndị ọrịa 346 ma nata opekata mpe otu dose (SCT-I10A gbakwunyere otu SCT510, n=230; otu sorafenib, n=116), na nleba anya etiti bụ ọnwa 19.7. Otu SCT-I10A gbakwunyere SCT510 gosipụtara OS etiti dị ogologo karịa nke dị na otu sorafenib (ọnwa 22.1 vs. ọnwa 14.2, oke ihe egwu [HR] 0.60; oge ntụkwasị obi 95% [CI]: 0.44, 0.81; p=0.0008). E jiri ogologo oge karịa PFS nke etiti mee ihe n'ime otu SCT-I10A tinyere SCT510 ma e jiri ya tụnyere otu sorafenib (7.1 vs. ọnwa 2.9; HR 0.50; 95%CI: 0.38, 0.65; p<0.0001). Ọnụego nzaghachi ebumnuche (ORR) dị elu na otu SCT-I10A tinyere SCT510 (32.8% [75/229]) karịa na otu sorafenib (4.3% [5/116]). A hụrụ ihe omume ọjọọ metụtara ọgwụgwọ (TRAEs) nke ọkwa ≥3 na 42.6% (98/230) nke ndị ọrịa nọ na otu SCT-I10A tinyere SCT510 na 33.6% (39/116) nke ndị ọrịa nọ na otu sorafenib. Ọkwa kachasị ≥3 TRAE bụ ọbara mgbali elu (SCT-I10A tinyere otu SCT510 megide otu sorafenib: 7.8% [18/230] vs. 4.3% [5/116]). Ọnwụ atọ metụtara ọgwụ (ihe kpatara ya, ọbara ọgbụgba n'ime ụbụrụ, ma ọ bụ ọbara ọgbụgba n'ime eriri afọ n'ime otu onye ọrịa ọ bụla) mere ma nwee njikọ na SCT510.

Mmechi: Nchikota nke SCT-I10A na SCT510 gosiri nnukwu uru ahụike yana profaịlụ nchekwa a na-anabata n'ime ndị ọrịa nwere HCC dị elu, si otú a na-akwado ya dị ka nhọrọ ọgwụgwọ mbụ maka HCC.

Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.

Nọmba ekwentị: 4008803716

Email：myimmnet@163.com

Ntụaka

1.国家药品监督管理局 (nmpa.gov.cn)

2.SCT-I10A jikọtara ya na bevacizumab biosimilar (SCT510) na sorafenib na ọgwụgwọ mbụ nke ọrịa kansa hepatocellular dị elu: Nnwale nke usoro nke atọ. | Journal of Clinical Oncology (ascopubs.org)