Na Machị 18, 2025, Alphamab Oncology kwupụtara na e nyela ọgwụ mgbochi HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 Breakthrough Therapy Organization site na Center for Drug Evaluation (CDE) nke National Medical Products Administration (NMPA). Aha a bụ maka ọgwụgwọ nke kansa epithelial ovarian nke na-eguzogide platinum (PROC), kansa peritoneal primary, ma ọ bụ kansa fallopian tube, nke anaghị ejedebe na ọkwa ngosipụta HER2.
Onyinye nke Breakthrough Therapy Nhọpụta dabere na nyocha nke ọmụmụ ihe abụọ a haziri nke ọma, JSKN003-101 na JSKN003-102. JSKN003-101 (NCT05494918) bụ ọmụmụ ihe gbasara Phase I nke e mere na Australia, nke e ji akara mepere emepe, nke nwere ọtụtụ etiti, na-amụba ọnụọgụgụ nke ndị ọrịa nwere etuto siri ike dị elu nke na-egosipụta HER2 (IHC≥1+) ma ọ bụ nwere mgbanwe HER2. JSKN003-102 (NCT05744427) bụ ọmụmụ ihe gbasara Phase I/II nke e mere na China. Akụkụ Phase I debara aha ndị ọrịa nwere mgbanwe HER2 (IHC≥1+) ma ọ bụ mgbanwe HER2 nke e mere na histologically. Akụkụ Phase II debara aha ndị ọrịa nwere etuto siri ike dị elu n'agbanyeghị ngosipụta HER2 ma ọ bụ ọnọdụ mgbanwe.
E gosipụtara data mbụ sitere na nyocha nke ọmụmụ abụọ a na 2024 European Society for Medical Oncology (ESMO) Congress.
Ruo Julaị 15, 2024, ndị ọrịa iri ise nwere PROC natara JSKN003 n'ogo dose ise, n'ime ha bụ ndị ọrịa abụọ na dose 4.2mg/kg, ndị ọrịa abụọ na dose 5.2mg/kg, ndị ọrịa 44 na dose 6.3mg/kg, otu onye ọrịa na dose 7.3mg/kg, na otu onye ọrịa na dose 8.4mg/kg. N'ime ndị ọrịa iri ise e debanyere aha dabere na nnwale ụlọ nyocha etiti, e nwere ndị ọrịa iri na asaa nwere ngosipụta HER2 (IHC 1+, 2+ na 3+) (naanị ndị ọrịa abụọ nwere HER2 IHC 3+), ndị ọrịa iri na asaa nwere IHC 0, na ndị ọrịa iri na isii enweghị nsonaazụ HER2 n'ihi na a nwalebeghị ha tupu Julaị 15. Ndị ọrịa iri abụọ na asatọ (56.0%) nwere opekata mpe usoro ọgwụgwọ sistemu atọ gara aga, ndị ọrịa iri atọ na asaa (74.0%) natara ọgwụgwọ bevacizumab, na ndị ọrịa iri abụọ na asatọ (56.0%) natara ọgwụgwọ PARP inhibitors.
Oge ọgwụgwọ ahụ dị n'etiti izu iri na abụọ na anọ (oge: izu 0.7 – 51.0), ebe ndị ọrịa 32 (64.0%) nọgidere na ọgwụgwọ ahụ ruo ụbọchị njedebe data ahụ.
Nchekwa: N'ime ndị ọrịa iri ise niile debanyere aha, ndị ọrịa atọ nwetara ọrịa akpa ume n'etiti (ILD)/pneumonia. Ndị ọrịa ise (10.0%) nwetara ihe egwu dị iche iche metụtara ọgwụgwọ (TRAEs) nke ọkwa nke atọ, nke kachasị bụ afọ ọsịsa (2.0%) na ọbara ọgbụgba (2.0%). Enweghị TRAE butere ọnwụ.
Arụmọrụ: N'ime ndị ọrịa 44 a na-enyocha arụmọrụ ha bụ ndị nwere opekata mpe otu nyocha etuto ahụ mgbe ha gasịrị, ọnụego nzaghachi ebumnuche (ORR) bụ 56.8%, ebe ndị ọrịa 39 (88.6%) gosiri mbelata etuto ahụ. ORR n'ime ndị ọrịa nwere HER2 IHC 0 na HER2 a kwadoro n'etiti (IHC 1+, 2+ na 3+) bụ 52.9% na 68.8%, n'otu n'otu. Maka ndị ọrịa 33 natara ọgwụgwọ bevacizumab tupu oge eruo, ORR bụ 54.5%, maka ndị ọrịa 26 natara ọgwụgwọ ihe mgbochi PARP tupu oge eruo, ORR bụ 46.2%.
Nsonaazụ ndị a chịkọtara egosila na ọgwụgwọ JSKN003 nwere ezigbo nnabata na nchekwa, yana ihe ngosi arụmọrụ na-ekwe nkwa na ndị ọrịa nwere PROC dị elu, a hụkwara irè ya n'ahụ ndị ọrịa nwere (IHC 1+/2+3+) ma ọ bụ na-enweghị (IHC 0) HER2, yana ma ọ bụ na-enweghị bevacizumab na PARP mbụ.
Banyere JSKN003
JSKN003 bụ ọgwụ mgbochi-ọgwụ mgbochi-HER2 bispecific (bis-ADC), nke e mepụtara n'ime ụlọ ọrụ Alphamab nke nwere Glycan-specific conjugation. JSKN003 nwere ike ijikọ HER2 n'elu mkpụrụ ndụ tumor ma wepụta topoisomerase I inhibitors (TOPIi) site na endocytosis cellular, si otú a na-enwe mmetụta mgbochi-tumor. Ma e jiri ya tụnyere ndị ogbo ya ADC, JSKN003 gosipụtara nkwụsi ike ka mma na mmetụta siri ike nke onye na-ahụ maka ihe, nke na-eme ka windo ọgwụgwọ dịkwuo elu.
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.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://www.alphamabonc.com/en/
Oge ozi: Maachị-18-2025