Na Febụwarị 17, 2025, Innovent Biologics kwupụtara na protein PD-1/IL-2α-bias nke mbụ ya na ọkwa PD-1/IL-2α-bias, IBI363, enwetala aha Fast Track nke abụọ ya (FTD) site na US Food and Drug Administration (FDA). Aha a metụtara ọgwụgwọ nke ọrịa kansa akpa ume nke a na-apụghị iwepụ, nke dị elu na mpaghara, ma ọ bụ nke metastatic squamous non-small cell (sqNSCLC) nke na-aga n'ihu mgbe ọgwụgwọ mgbochi PD-(L)1 immune checkpoint inhibitor na chemotherapy dabere na platinum. IBI363 egosila na ọ dị irè ma dịkwa mma n'ọtụtụ ụdị etuto siri ike. Ugbu a, Innovent na-eme nnwale ahụike nke IBI363 nke mbụ na China na US karịsịa.
Nhọpụta Ngwa Ngwa (FTD) bụ usoro iwu e mere iji mee ka mmepe ahụike na nyocha nke ọgwụ ndị e zubere iji gwọọ ọrịa dị njọ ma lebara mkpa ahụike na-emezughị anya. Ndị na-achọ ọgwụ enyere FTD uru site na nkwurịta okwu ka ukwuu na FDA n'oge mmepe ọgwụ na-esote, nke nwere ike ime ka mmepe ahụike na nkwenye ha dịkwuo ngwa ngwa.
Banyere IBI363 (Protein ngwakọta nke antibody bispecific PD-1/IL-2α-bias nke mbụ))
IBI363 bụ ọgwụ mbụ a na-ahọrọ n'ọkwa nke Innovent Biologics mepụtara n'onwe ya. Ọ bụ protein PD-1/IL-2 nke nwere ike itinye ọgwụ mgbochi abụọ nke e mere iji mee ka arụmọrụ dịkwuo mma ma belata nsí. E mepụtara ogwe aka IL-2 nke IBI363 iji mee ka mmetụta ọgwụgwọ dịkwuo mma yana mbelata mmetụta ọjọọ, ebe ogwe aka njikọ PD-1 na-enye ohere igbochi PD-1 na nnyefe IL-2 nhọrọ. Site n'igbochi ụzọ PD-1/PD-L1 n'otu oge ma na-eme ka ụzọ IL-2 rụọ ọrụ, IBI363 na-eme ka ebumnuche na ịgbalite mkpụrụ ndụ T kpọmkwem nke etuto ahụ dịkwuo mma ma dị irè. Ọmụmụ ihe tupu oge eruo egosila na IBI363 na-egosipụta ọrụ siri ike nke mgbochi etuto ahụ n'ọtụtụ ụdị ọgwụ na-ebu etuto ahụ, gụnyere ndị na-eguzogide ọgwụ mgbochi PD-1 na ụdị metastatic. Na mgbakwunye, o gosipụtala profaịlụ nchekwa dị mma na ụdị preclinical. A na-eme nnwale ụlọ ọgwụ ugbu a na China, United States, na Australia iji nyochaa nchekwa ya, ndidi na irè mbụ ya na ndị nwere ọrịa kansa dị elu.
Na Nzukọ Ụwa Maka Ọrịa Kansa Nkuume (WCLC) na Septemba 2024, IBI363 gosipụtara ihe mgbaàmà dị mma maka ndị ọrịa nwere sqNSCLC bụ ndị natara ọgwụgwọ mgbochi ọrịa mbụ:
N'ime otu ọgwụ 3 mg/kg, n'etiti ndị ọrịa nwere opekata mpe izu iri na abụọ nke nleba anya ma ọ bụ ọmụmụ ihe (n=18), ọnụego nzaghachi ebumnuche (ORR) bụ 50.0%, ebe ọnụego njikwa ọrịa (DCR) bụ 88.9%. A kabeghị erute ndụ nke etiti na-enweghị ọganihu (PFS) ma ka nọ na nlekọta.
N'ime otu dose nke 1/1.5 mg/kg, PFS nke etiti bụ ọnwa 5.5 (95% CI: 1.5, 8.3), yana ọnụego PFS nke ọnwa 12 nke 30.7%, na-egosi uru dị ogologo oge nke immunotherapy.
N'ime otu ọgwụ 1/1.5/3 mg/kg, ndị ọrịa nwere PD-L1 TPS <1% (n=22) na ndị nwere PD-L1 TPS≥1% (n=22) nwetara ORR ndị na-agba ume nke 36.4% na 31.8%, n'otu n'otu, nke na-egosi uru IBI363 nwere na ndị nwere obere ngosipụta PD-L1.
Banyere Ọrịa Kansa Nkuume Squamous Na-abụghị nke Obere Cell (sqNSCLC)
Ọrịa kansa akpa ume bụ ọrịa kansa kachasị njọ ma kacha egbu egbu n'ụwa niile, gụnyere na China[1], nke na-eweta nnukwu nsogbu ahụike ọha na eze. Ọrịa kansa akpa ume nke na-abụghị obere mkpụrụ ndụ (NSCLC) na-akpata ihe karịrị 80% nke ọrịa kansa akpa ume niile[2], yana ọrịa kansa squamous cell bụ otu n'ime ụdị abụọ ya dị mkpa[2]. N'afọ ndị na-adịbeghị anya, ndị na-egbochi ihe mgbochi ahụ agbanweela ọdịdị ọgwụgwọ maka NSCLC. Agbanyeghị, maka ndị ọrịa nwere NSCLC bụ ndị dara ada na immunotherapy na enweghị mgbanwe mkpụrụ ndụ ihe nketa na-eduzi, enwere mkpa dị mkpa na ngwa ngwa maka nhọrọ ọgwụgwọ dị irè. Ọgwụgwọ nke abụọ ma ọ bụ nke atọ, docetaxel, na-enye obere arụmọrụ, yana ndụ na-enweghị ọganihu (PFS) nke na-erughị ọnwa anọ[3],[4]. Ọ bụ ezie na njikọta ọgwụ mgbochi-ọgwụ (ADCs) egosila nkwa, ọmụmụ ihe abụọ buru ibu nke Usoro 3 na NSCLC squamous egosibeghị irè zuru oke.
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
Oge ozi: Febụwarị-20-2025