Na 20 Ọgọst 2025, Abbisko Therapeutics kwupụtara na Center forDrug Evaluation (CDE) nke China National Medical Products Administration (NlPA) enyela akwụkwọ lND maka ọgwụ mgbochi PD-1 nke Abbisko, ABSK043, yana ọgwụ mgbochi Shanghai Alist Pharmaceuticals KRAS G12C, glecirasib, maka ọgwụgwọ nke ndị ọrịa NscLc nwere mgbanwe KRAS G12C.
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
WeChat ID: 17801183037
Email：myimmnet@163.com
Banyere ABSK043
ABSK043 bụ ihe ọhụrụ, nke a na-ahụ n'ọnụ, nke nwere oke nhọrọ nke obere molekul PD-L1 nke Abbisko Therapeutics nwere kpamkpam. Mkpụrụ ndụ tumor nwere ike iji ihe nlele ahụ ji alụso ọrịa ọgụ dịka PD-1 na ligand PD-L1 ya zere nchọpụta na mwepụ nke ahụ ji alụso ọrịa ọgụ, si otú a na-egbochi ma ọ bụ na-egbochi nzaghachi mkpụrụ ndụ I, ABSK043 na-ejikọ aka na onye nnata PD-L1 ma na-akpali njikọ ya na sel, na-egbochi mmekọrịta PD-1/PD-L1 nke ọma ma na-ebelata mgbochi PD-L1 nke na-akwalite ọrụ mkpụrụ ndụ T. Na ụdị preclinical, ABSK043 egosila ike mgbochi etuto ahụ dị ka ọgwụ mgbochi PD-L1 akwadoro. Ọ bụ ezie na ọtụtụ ọgwụ mgbochi monoconal PD-1/PD-L1 nwere nkwenye biya n'ụwa niile, ugbu a enweghị drygs PD-1/PD-L1 nke a na-enweta n'ọnụ, a na-enyocha ABSK043 ugbu a na nnwale ahụike Phase l na-aga n'ihu maka etuto siri ike dị elu na Australia na China.
N'ọmụmụ ihe nke mbụ (NCT04964375), ABSK043, ọgwụ mgbochi PD-L1 nke a na-aṅụ n'ọnụ, nke dị ike, nke nwere obere molekul, gosipụtara irè mbụ.
Ụzọ
E jiri mkpụrụ ọgwụ ABSK043 tee ndị nwere etuto siri ike dị elu ọgwụ, site na 200 mg otu ugboro kwa ụbọchị (QD) ruo 1000 mg ugboro abụọ kwa ụbọchị (BID), iji chọpụta profaịlụ nchekwa na irè mbụ. E nyochakwara ihe ngosi pharmacodynamic (PD), dị ka ọrụ mkpụrụ ndụ T na elu PD-L1.
Nsonaazụ
Dịka ụbọchị njedebe (June 7, 2024), e debanyere aha ma gwọọ mmadụ 77. 87.0% nke ndị ọrịa ahụ nwetara ihe omume ọjọọ (TEAEs) nke na-apụta n'oge ọgwụgwọ, ebe 29.9% bụ ≥ Ọkwa nke 3. Ndị ọrịa ahụ bụ ≥15% bụ anaemia (22.1%). Akọpụtaghị ọrịa neuropathy nke akụkụ ahụ. N'ihe niile a na-enyocha arụmọrụ nke otu ọgwụ na-arụ ọrụ (600 mg BID, 800 mg BID, na 1000 mg BID), a hụrụ ORR nke 24% (8/34) na ndị ọrịa ICI na-anaghị arụ ọrụ. N'ime ndị ọrịa iri na-anaghị arụ ọrụ nke nwere kansa akpa ume (9 a gwọrọ tupu oge eruo na otu a gwọrọ), ORR bụ 40% (4/10). Ihe pụrụ iche bụ na mmadụ atọ n'ime mmadụ isii (50%) nwere mgbanwe EGFR na otu n'ime mmadụ abụọ (50%) nwere mgbanwe KRAS nwetara nzaghachi akụkụ (PR). Ndị zara ajụjụ atọ niile nwere mgbanwe EGFR nwere PD-L1 TPS ≥ 50% ma nwee ọganihu mgbe e mechara otu usoro ọgwụgwọ EGFR TKI, gụnyere ọgbọ nke atọ. Mmeghachi omume ndị ọzọ mere na ụdị etuto ise agwakọta: kansa afọ MSI-H/dMMR, adenocarcinoma endometrial MSI-H/dMMR, kansa squamous cell ikpu, kansa ara (Lynch syndrome), na melanoma. Ogologo oge nzaghachi kachasị ogologo na ọmụmụ ihe ahụ bụ ọnwa 17 (endometrial adenocarcinoma) na ọgwụgwọ ahụ ka nọ na ọgwụgwọ. A hụrụ mmụba mkpụrụ ndụ T na mbelata dabere na dose na ngosipụta PD-L1 elu mgbe ọgwụgwọ ABSK043 gasịrị na otu dose BID niile.
Banyere Glecirasib
Glecirasib (AST-24081) bụ ọgwụ mgbochi KRAS G12C. A na-eme ọtụtụ nnwale cinical na China, United States na Europe maka ndị ọrịa nwere etuto ahụ dị elu nke nwere mgbanwe KRAS G12C. Ndị a gụnyere nnwale ọgwụgwọ njikọta na SHP2 inhibitor AST-24082 na NSCLC na nnwale monotherapy na kansa pancreatic. Ọzọkwa, ihe ngosi kansa pancreatic enwetala aha ọgwụ ụmụ mgbei na United States na aha ọgwụgwọ ọhụrụ na China. Na Mee 2025, ChinaNMPA kwadoro Glecirasib maka mmalite ahịa.
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
WeChat ID: 17801183037
Email：myimmnet@163.com
Oge ozi: Ọgọst-21-2025