Ua hoʻokomo ʻia ʻo IBI343 (CLDN 18.2 ADC) ma ke ʻano he lāʻau lapaʻau holomua e ka National Medical Products Administration no ka mālama ʻana i nā maʻi adenocarcinoma ductal pancreatic holomua.

Ma Ianuali 8, ua hāʻawi ke Center for Drug Evaluation (CDE) o ka National Medical Products Administration (NMPA) o Kina i ka Breakthrough Therapy Designation (BTD) no IBI343, kahi TOPO1i anti-CLDN18.2 ADC maikaʻi loa ma ka papa, ma ke ʻano he monotherapy no ka mālama ʻana i nā maʻi CLDN18.2-positive advanced pancreatic ductal adenocarcinoma (PDAC) i holomua ma hope o hoʻokahi laina o ka mālama ʻōnaehana mua.

Ua hāʻawi ʻia ka BTD no IBI343 ma muli o ka ʻikepili mai kahi noiʻi Phase 1 e hana nei ma Kina, Australia a me US (NCT05458219), nāna i hōʻike i ka palekana maikaʻi a me ka hiki ke hoʻomanawanui, a me ka hana antitumor hoʻohiki o ka IBI343 monotherapy i nā poʻe maʻi PDAC holomua. Ua hōʻike waha ʻia nā ʻikepili mai ka hui hoʻonui dosis o ke aʻo ʻana ma ka 2024 ESMO Asia Congress:

Ma ka lā 6 o Kepakemapa, 2024, ua loaʻa i ka huina o 43 mau maʻi me CLDN18.2-positive (≥60% mau pūnaewele tumor me ka ikaika o ka membranous staining ≥1+ e IHC) PDAC holomua ka IBI343 6 mg/kg Q3W monotherapy. Ua loaʻa mua i nā mea komo āpau ma ka liʻiliʻi he 1 laina o ka therapy mua, a ua loaʻa iā 60.5% he 2 a ʻoi aku paha laina o ka lāʻau anticancer.

Ua hiki ke loiloi ʻia ka pono o 43 mau maʻi me ka helu pane holoʻokoʻa (ORR) o 32.6%, ka helu pane i hōʻoia ʻia (cORR) o 23.3%, a me ka helu kaohi maʻi i hōʻoia ʻia (cDCR) o 81.4%.

Ma ke ʻano he lā palena ʻikepili, ua holomua ka 4 o 10 mau maʻi cORR, ʻo ka lōʻihi waena o ka pane (mDoR) he 7.0 (4.0-NC) mau mahina, a ʻo ka helu DoR 6 mahina he 63%. Ua loaʻa i 26 mau maʻi nā hanana PFS, me ka awelika o ke ola ʻole o ka holomua (mPFS) he 5.3 (4.1-7.4) mau mahina, a ʻaʻole i oʻo ka ʻikepili OS.

Ua hōʻike nā hopena palekana hou i ka ʻaoʻao palekana maikaʻi o IBI343 me ka haʻahaʻa mau o ka ʻawahia o ka ʻōpū a ʻaʻohe hōʻailona palekana hou. 97.7% o nā mea komo i loaʻa nā hanana ʻino e kū mai ana i ka lāʻau lapaʻau (TEAEs), me nā TEAE maʻamau ka anemia, ka emi ʻana o ka helu neutrophil, ka emi ʻana o ka makemake, ka nausea, a me ka emi ʻana o ka helu o nā cell koko keʻokeʻo. 51.2% o nā mea komo i loaʻa i ka ≥ grade 3 TEAEs, a ʻaʻohe ≥ grade 3 nausea a me ka luaʻi i loaʻa. ʻAʻohe TEAE i alakaʻi i ka make.

E pili ana iā IBI343（Anti-CLDN18.2 ADC）

ʻO IBI343 kahi recombinant human anti-CLDN18.2 monoclonal antibody-drug conjugate (ADC) i hoʻomohala ʻia e Innovent Biologics. Hoʻopaʻa ʻo IBI343 i nā cell tumor e hōʻike ana i ka CLDN18.2, e hana ʻia ka internalization ADC hilinaʻi CLDN18.2 a hoʻokuʻu ʻia ka lāʻau lapaʻau e hopena ana i ka hōʻino ʻana o ka DNA a me ka apoptosis hope loa o nā cell tumor. Hiki i ka lāʻau lapaʻau i hoʻokuʻu ʻia ke hoʻolaha ma waena o ka membrane plasma e hiki a pepehi i nā cell e pili ana, e hopena ana i ka "hopena pepehi kanaka".

Ma ke ʻano he TOPO1i ADC hou, ua hōʻike ʻo IBI343 i ka palekana hiki ke hoʻomanawanui a me ka hoʻoikaika ʻana i nā hōʻailona pono i nā haʻawina lapaʻau Phase 1. Ke noiʻi ʻia nei ka hiki ke hoʻōla o IBI343 i nā ʻano puʻupuʻu e like me ke kanesa ʻōpū a me ka pancreatic.

I Mei 2024, ua hāʻawi ka National Medical Products Administration (NMPA) o Kina i ka breakthrough therapy designation (BTD) iā IBI343 no ka hoʻohana ʻana ma ke ʻano he mea hoʻokahi i nā poʻe maʻi me ka CLDN18.2–positive gastric a i ʻole gastroesophageal junction (GEJ) adenocarcinoma i ʻike i ka holomua o ka maʻi ma hope o ʻelua mau laina mua o ka lāʻau lapaʻau systemic. Ke hoʻomau nei ka hoʻokolohua Phase 3 (NCT06238843) o IBI343 no kēia hōʻailona.

I Iune 2024, ua loaʻa iā IBI343 ka Fast Track Designation e ka US Food and Drug Administration (FDA) no ka mālama ʻana i ka ʻoki ʻana o ka pancreatic ductal adenocarcinoma (PDAC) i hiki ʻole ke hoʻopau ʻia a i ʻole ka metastatic i hoʻi hou mai a/a i ʻole he mea kūʻē i hoʻokahi laina lapaʻau ma mua. Ke hoʻomau nei ka hoʻokolohua multi-regional Phase 1 (NCT05458219) o IBI343 no ka PDAC i mālama mua ʻia.

I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.

Helu Kelepona：4008803716

Email：myimmnet@163.com

Nā Kuhikuhi

1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

2.https://cn.innoventbio.com/#/

3.132MO Anti-claudin18.2 (CLDN18.2) antibody-drug conjugate (ADC) IBI343 i nā maʻi (pts) me ka adenocarcinoma ductal pancreatic holomua (PDAC): Nā hopena i hōʻano hou ʻia mai kahi noiʻi pae I - Annals of Oncology