Na Jenụwarị nke asatọ, Center for Drug Evaluation (CDE) nke National Medical Products Administration (NMPA) enyela Breakthrough Therapy Nomination (BTD) maka IBI343, otu TOPO1i anti-CLDN18.2 ADC kacha mma, dịka ọgwụgwọ otu maka ọgwụgwọ nke ndị ọrịa CLDN18.2-positive pancreatic ductal adenocarcinoma (PDAC) ndị nwere ọganihu mgbe ha nwetasịrị ọgwụgwọ usoro ma ọ dịkarịa ala otu usoro.
E nyere BTD maka IBI343 dabere na data sitere na nnyocha nke Usoro nke 1 na-aga n'ihu emere na China, Australia na US (NCT05458219), nke gosipụtara nchekwa na ndidi dị mma, yana ọrụ mgbochi etuto nke IBI343 monotherapy na ndị ọrịa PDAC dị elu. E gosipụtara data sitere na otu ndị otu mmụba dose nke ọmụmụ ihe ahụ n'ọnụ na 2024 ESMO Asia Congress:
Ka ọ na-erule Septemba 6, 2024, ngụkọta nke ndị ọrịa 43 nwere CLDN18.2-positive (≥60% mkpụrụ ndụ kansa nwere oke ntụpọ membranous ≥1+ site na IHC) PDAC advanced natara IBI343 6 mg/kg Q3W monotherapy. Ndị niile sonyere natara opekata mpe otu usoro ọgwụgwọ mbụ, 60.5% enwetakwala usoro ọgwụgwọ abụọ ma ọ bụ karịa nke megidere kansa.
A tụlere irè nke ndị ọrịa 43 site na ọnụego nzaghachi ebumnuche (ORR) nke 32.6%, ọnụego nzaghachi ebumnuche (cORR) nke 23.3%, yana ọnụego njikwa ọrịa akwadoro (cDCR) nke 81.4%.
Ka ụbọchị e wepụrụ data ahụ, mmadụ anọ n'ime mmadụ iri nwere cORR agaala n'ihu, oge nzaghachi (mDoR) bụ ọnwa 7.0 (4.0-NC), ọnụego DoR nke ọnwa isii bụkwa 63%. Ndị ọrịa 26 mere ihe omume PFS, yana ndụ nke na-enweghị ọganihu (mPFS) nke ọnwa 5.3 (4.1-7.4), data OS etolitebeghịkwa.
Nsonaazụ nchekwa emelitere gosiri nchekwa dị mma nke IBI343 yana obere oke nsị afọ na enweghị akara nchekwa ọhụrụ. 97.7% nke ndị sonyere nwetara ihe omume ọjọọ na-apụta ìhè nke ọgwụgwọ (TEAEs), ebe TEAE ndị a na-ahụkarị bụ anaemia, ọnụọgụ neutrophil belatara, agụụ belatara, ọgbụgbọ, na ọnụọgụ sel ọbara ọcha belatara. 51.2% nke ndị sonyere nwetara TEAE ≥ klas nke 3, enweghịkwa ọgbụgbọ na agbọ agbọ ≥ klas nke 3 mere. Enweghị TEAE butere ọnwụ.
Banyere IBI343(Anti-CLDN18.2 ADC)
IBI343 bụ ọgwụ mgbochi CLDN18.2 monoclonal antibody-drug conjugate (ADC) nke Innovent Biologics mepụtara. IBI343 na-ejikọ na mkpụrụ ndụ kansa nke na-egosipụta CLDN18.2, ime ihe nke CLDN18.2 dabere na ADC ga-eme, a ga-ewepụtakwa ọgwụ ahụ nke na-ebute mmebi DNA na n'ikpeazụ apoptosis nke mkpụrụ ndụ kansa. Ọgwụ a tọhapụrụ nwekwara ike ịgbasa n'ofe plasma membrane iji ruo ma gbuo mkpụrụ ndụ ndị agbata obi, na-ebute "mmetụta igbu egbu site na mberede".
Dịka TOPO1i ADC ọhụrụ, IBI343 egosila nchekwa a na-anabata ma na-agba ume ka e jiri ya mee ihe n'ọmụmụ ihe gbasara ahụike nke Usoro nke 1. A na-enyocha ike ọgwụgwọ nke IBI343 ugbu a n'ụdị etuto ahụ dịka kansa afọ na nke pancreas.
Na Mee 2024, National Medical Products Administration nke China (NMPA) nyere IBI343 aha ọgwụgwọ breakthrough (BTD) ka e jiri ya mee ihe dị ka otu ọgwụ maka ndị ọrịa nwere CLDN18.2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma ndị nwere ọganihu ọrịa mgbe usoro ọgwụgwọ abụọ gara aga gasịrị. Nnwale nke Usoro nke 3 (NCT06238843) nke IBI343 maka ihe ngosi a ka na-aga n'ihu.
Na June 2024, US Food and Drug Administration (FDA) natara Nhọpụta Ngwa Ngwa IBI343 maka ọgwụgwọ nke ọrịa pancreatic ductal adenocarcinoma (PDAC) nke na-adịghị ewepụ ihe mgbochi ma ọ bụ nke na-adịghị emerụ ahụ nke ukwuu nke na-alaghachi azụ ma ọ bụ na-anaghị anabata otu usoro ọgwụgwọ gara aga. Nnwale nke IBI343 nke usoro 1 (NCT05458219) maka PDAC a gwọrọ na mbụ ka na-aga n'ihu.
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://cn.innoventbio.com/#/
Oge ozi: Jenụwarị-17-2025