Na Mee 29, National Medical Products Administration (NMPA) kwadoro ọgwụ mgbochi-ọgwụ conjugate (ADC) trastuzumab rezetecan (SHR-A1811) nke HER2-targeted antibody-drug conjugate (ADC) maka ahịa. A na-egosi ya dị ka ọgwụgwọ naanị maka ọgwụgwọ ndị okenye nwere ọrịa kansa akpa ume nke na-abụghị obere mkpụrụ ndụ (NSCLC) nke na-eme ka mgbanwe HER2 (ERBB2) rụọ ọrụ ma nweta opekata mpe otu ọgwụgwọ sistemu gara aga. Nke a bụ ADC mbụ e mepụtara na China kwadoro maka ndị ọrịa nwere NSCLC nke HER2-muted, na-enye nhọrọ ọgwụgwọ ọhụrụ maka ndị ọrịa a.
Nkwenye a dabere na nnyocha dị mkpa nke HORIZON-Lung, nke Prọfesọ Lu Shun si Shanghai Chest Hospital duziri.
Ọmụmụ ihe HORIZON-Lung bụ nnwale ahụike nke Phase I/II nke otu Prọfesọ Lu Shun na Shanghai Chest Hospital duziri. Akụkụ Phase I bu n'obi ịchọpụta oke dose a na-anabata (MTD) nke trastuzumab rezetecan ma nyochaa irè ya na nchekwa mbụ na ndị ọrịa nwere HER2-muted NSCLC. Nhazi ọmụmụ ihe ahụ gụnyere ma usoro mmụba dose na usoro mmụba dose. Na akụkụ Phase I, trastuzumab rezetecan gosipụtara ọrụ mgbochi etuto mbụ na profaịlụ nchekwa dị mma. Emebere ọmụmụ Phase II iji nyochaa irè na nchekwa nke trastuzumab rezetecan na ndị ọrịa nwere HER2-muted NSCLC.
Ngụkọta ndị ọrịa 94 ka e debanyere aha na nnyocha ahụ. Nsonaazụ ya gosiri na ọnụego nzaghachi ebumnuche (ORR), dịka Kọmitii Nyocha Onwe Onye (IRC) si nyochaa, bụ 74.5%, yana ọnụego njikwa ọrịa (DCR) nke 98.9%. Ogologo oge nzaghachi etiti (DoR) bụ ọnwa 9.8. Nyocha nke obere otu gosiri na irè nke trastuzumab rezetecan kwekọrọ na obere otu ndị ọrịa dị iche iche, n'agbanyeghị ọgwụgwọ anti-HER2 tyrosine kinase inhibitor (TKI) gara aga ma ọ bụ ọnụnọ nke metastases ụbụrụ mmalite.
Nnwale IRC nke enweghị ọganihu (PFS) gosiri na ọ na-adịru ọnwa 11.5, yana ọnụego PFS nke ọnwa 12 bụ 48.6%. Onye nyocha nyocha (INV) bụ ọnwa 12.5, yana ọnụego PFS nke ọnwa 12 bụ 51.4%.
Data zuru oke maka nlanarị (OS) etolitebeghị, ebe usoro sistemụ etiti erutebeghị na ọnụego OS nke ọnwa iri na abụọ nke 88.2%.
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
Oge ozi: Jun-04-2025