Iulai 17, 2025 – Ua hoʻolaha ʻo Innovent Biologics ua paʻi ʻo Nature Medicine i nā hopena o ke aʻo ʻana o ka Phase 1 o IBI343, kahi anti-CLDN18.2 ADC hou, no ka mālama ʻana i ka adenocarcinoma gastric/gastroesophageal junction (G/GEJ) holomua. ʻO ka paʻi ʻia ʻana ma kēia puke pai hoʻonaʻauao honua koʻikoʻi e hōʻike ana i ka ʻike ikaika o ka hiki ke lapaʻau o ka lāʻau lapaʻau a hōʻailona i kahi hanana koʻikoʻi ʻē aʻe i ka holomua o Kina i ka hoʻomohala ʻana i nā lāʻau anti-tumor hou. Ma muli o nā ʻike o ke aʻo ʻana, ua hoʻomaka ʻia kahi hoʻokolohua lapaʻau Phase 3 multi-regional (G-HOPE-001, NCT06238843) i ka makahiki 2024 e loiloi hou aku iā IBI343 ma ke ʻano he koho lapaʻau palekana a maikaʻi hoʻi no nā poʻe maʻi me ka G/GEJ AC holomua.
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
ʻIkepili WeChat: 17801183037
Leka uila:myimmnet@163.com
ʻO ke kanesa ʻōpū kekahi o nā puʻupuʻu ʻino maʻamau loa ma ka honua. Wahi a nā helu helu GLOBOCAN 2022, ʻo ia ka puʻupuʻu ʻino maʻamau ʻelima a ʻo ke kumu nui ʻelima o ka make e pili ana i ka maʻi kanesa ma ka honua holoʻokoʻa, me kahi manaʻo he 970,000 mau hihia hou a me 660,000 mau make i kēlā me kēia makahiki. I kēlā me kēia makahiki, hōʻike ʻo Kina i 359,000 mau hihia hou a me 260,000 mau make mai ke kanesa ʻōpū, e hōʻike ana i 37.0% a me 39.4% o nā huina honua, kēlā me kēia, e hōʻike ana i kahi pono lapaʻau koʻikoʻi i hoʻokō ʻole ʻia.
ʻO CLDN 18.2 kahi protein tight junction i hōʻike ʻia i loko o nā cell epithelial i hoʻokaʻawale ʻia ma ka mucosa gastric ma lalo o nā kūlana physiological maʻamau. Ua hōʻike nā haʻawina mua ua hōʻike nui ʻia ʻo Claudin18.2 i nā ʻano maʻi kanesa he nui, me ke kanesa gastric (60-80%), ke kanesa pancreatic (50%), ka carcinoma esophageal (30-50%), a me ke kanesa māmā (40-60%). ʻO ka hoʻopaʻa ʻana iā CLDN18.2 me nā monoclonal antibodies (mAbs) a me nā ADCs he ala hou ia e hoʻohiki ai no ka mālama ʻana i ke kanesa gastric.
He hoʻokolohua lapaʻau honua kēia i paʻi ʻia, he multicenter Phase 1 (ClinicalTrial.gov identifier: NCT05458219) i hoʻolālā ʻia e loiloi i ka palekana, ka hiki ke hoʻomanawanui a me ka pono mua o IBI343 i nā poʻe maʻi me nā ʻōpū paʻa holomua. Ma waena o ʻOkakopa 26, 2022, a me Iune 30, 2024, ua kākau inoa ʻia he 116 mau kumuhana me ka adenocarcinoma G/GEJ holomua e loaʻa iā IBI343 monotherapy (8 i ka piʻi ʻana a me 108 i ka hoʻonui ʻana).
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 pono ia i nā cell tumor e hōʻike ana i ka CLDN18.2, e hoʻoulu ana i ka internalization CLDN18.2-dependent o ka ADC. Ke komo i loko o ke cell, hoʻokuʻu ʻia ka ukana cytotoxic, e hopena ana i ka hōʻino ʻana o ka DNA a me ka apoptosis hope loa o nā cell tumor. Hiki i ka lāʻau i hoʻokuʻu ʻia ke hoʻolaha ma waena o ka membrane plasma e hiki a pepehi i nā cell kokoke, 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 kēia mau 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 ke kanesa pancreatic.
Ke hoʻopaʻa inoa nei ka hoʻokolohua lapaʻau multi-regional Phase 3 o IBI343 no ka adenocarcinoma gastric / gastroesophageal junction holomua i nā maʻi (G-HOPE-001, NCT06238843). Ua hāʻawi ʻia ka hōʻailona pili i ka Breakthrough Therapy Designation (BTD) e ka NMPA o Kina.
Ke kākau inoa nei hoʻi ka hoʻokolohua lapaʻau multi-regional Phase 1 o IBI343 no ka adenocarcinoma ductal pancreatic holomua i nā maʻi (NCT05458219). Ua loaʻa i kēia hōʻailona ka Fast Track Designation (FTD) mai ka US FDA a ua hāʻawi ʻia iā BTD e ka NMPA o Kina.
Ua hōʻike ʻo IBI343 i ka hoʻoikaika ʻana i ka pane ʻana i ka maʻi puʻupuʻu a me ka pono o ke ola
Ua kālailai ke aʻo ʻana i ka ʻikepili pono o nā kumuhana loiloi me ka hōʻike kiʻekiʻe o CLDN18.2 (≥75% mau pūnaewele tumor me ka ikaika staining membranous ≥2+ e IHC), ma nā hui mahele ʻelua o 6 mg/kg a me 8 mg/kg.
Ma 6 mg/kg (N=31), ua loaʻa i nā maʻi he 15 nā pane hapa (PR) me 9 mau maʻi me nā PR i hōʻoia ʻia a me 1 maʻi e kali ana i ka hōʻoia. ʻO ka ORR i hōʻoia ʻia he 29.0% (95% CI: 14.2-48.0) a ʻo ka helu kaohi maʻi (DCR) he 90.3% (95% CI: 74.2-98.0). I loko o 9 mau maʻi me ka pane i hōʻoia ʻia, ʻo ka lōʻihi waena o ka pane (DoR) he 5.6 mahina (95% CI: 2.8-7.0). ʻO ka hahai waena he 10.6 mahina (95% CI: 9.7-11.5) no PFS a me OS. ʻO ka PFS waena he 5.5 mahina (95% CI: 4.1-7.0). ʻAʻole i oʻo ka ʻikepili OS me ka OS waena o kēia manawa he 10.8 mahina (95% CI: 6.8-NC). Ma hope o ka ʻoki ʻana o ka ʻikepili, ua hōʻoia ʻia ka pane o ke koena o ka mea maʻi 1 ma Iulai 26, 2024 a ua hōʻano hou ʻia ka ORR i hōʻoia ʻia i 32.3% (95% CI: 16.7-51.4).
Ma 8 mg/kg (N=17), hiki ke loiloi ʻia he 17 mau maʻi me ka hōʻike kiʻekiʻe o CLDN 18.2. Ma waena o lākou, he 9 mau maʻi i loaʻa nā PR me 8 mau maʻi i hōʻoia i ka PR. ʻO ka ORR i hōʻoia ʻia he 47.1% (95% CI: 23.0-72.2), a ʻo ka DCR he 88.2% (95% CI: 63.6-98.5). I loko o ʻewalu mau maʻi me ka pane i hōʻoia ʻia, ʻo ka DoR waena he 5.7 mau mahina (95% CI: 2.7-NC). No nā maʻi adenocarcinoma G/GEJ āpau me ka hōʻike kiʻekiʻe o CLDN18.2 i mālama ʻia ma 8 mg/kg (N=19, me 1 mau maʻi mai ka piʻi ʻana o ka lāʻau a me 18 mau maʻi mai ka hoʻonui ʻana o ka lāʻau), ʻo ka hahai waena he 8.1 mau mahina (95% CI: 7.6-8.5) no PFS a me OS. ʻO ka PFS waena he 6.8 mau mahina (95% CI: 2.8-7.5), a ʻaʻole i hiki i ka OS waena me nā hanana i hana ʻia ma 36.8% o nā maʻi.
Ua hōʻike pū ʻo IBI343 i ka palekana kiʻekiʻe
Ma waena o nā maʻi āpau me ka adenocarcinoma G/GEJ (n=116, me 8 mau maʻi me ke kanesa ʻōpū mai ka pae hoʻonui ʻia ʻana o ka lāʻau), 66.4% o nā maʻi (77/116) he ≥3 papa TEAEs. ʻO nā TEAE ≥3 papa maʻamau (≥35%) ka emi ʻana o ka helu neutrophil (28.4%), ka emi ʻana o ka helu o nā cell koko keʻokeʻo (25.9%), a me ka anemia (16.4%). He kakaikahi loa nā hanana ʻino gastrointestinal ≥3 papa, me 1.7% wale nō o ka nausea ≥3 papa. ʻAʻohe maʻi māmā interstitial o kekahi papa i hōʻike ʻia. Ua hoʻomaha ʻia ka ʻawaʻawa e pili ana i ka lāʻau me ka mālama kākoʻo kūpono, a ua hiki ke ʻae ʻia ka palekana holoʻokoʻa.
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
ʻIkepili WeChat: 17801183037
Leka uila:myimmnet@163.com
Ka manawa hoʻouna: Iulai-22-2025