Ma Pepeluali 17, 2025, ua hoʻolaha ʻo Innovent Biologics ua loaʻa i kāna protein fusion antibody bispecific PD-1/IL-2α-bias mua loa, ʻo IBI363, kāna Fast Track Designation (FTD) ʻelua mai ka US Food and Drug Administration (FDA). Pili kēia hoʻolālā i ka mālama ʻana i ka maʻi kanesa māmā squamous non-small cell lung cancer (sqNSCLC) hiki ʻole ke hoʻopau ʻia, kūloko holomua, a i ʻole metastatic i holomua ma hope o ka anti-PD-(L)1 immune checkpoint inhibitor therapy a me ka chemotherapy platinum-based. Ua hōʻike ʻo IBI363 i ka pono a me ka palekana hoʻoikaika ma waena o nā ʻano tumor paʻa he nui. I kēia manawa, ke hana nei ʻo Innovent i nā hoʻokolohua lapaʻau Phase 1/2 o IBI363 ma Kina a me US.
ʻO ka Fast Track Designation (FTD) kahi kaʻina hana hoʻoponopono i hoʻolālā ʻia e hoʻolalelale i ka hoʻomohala lapaʻau a me ka loiloi ʻana i nā lāʻau lapaʻau i manaʻo ʻia e mālama i nā kūlana koʻikoʻi a hoʻoponopono i nā pono olakino i hoʻokō ʻole ʻia. Loaʻa i nā moho lāʻau lapaʻau i hāʻawi ʻia i ka FTD ka pōmaikaʻi mai ka hoʻonui ʻana i ke kamaʻilio ʻana me ka FDA ma o ka hoʻomohala ʻana i nā lāʻau lapaʻau ma hope, e hoʻolalelale paha i kā lākou hoʻomohala lapaʻau a me ke kaʻina ʻae.
E pili ana iā IBI363 (ʻO ka protein fusion antibody bispecific PD-1/IL-2α-bias mua loa o ka papa))
ʻO IBI363 kahi moho lāʻau lapaʻau mua loa i hoʻomohala kūʻokoʻa ʻia e Innovent Biologics. He protein fusion antibody bispecific PD-1/IL-2 i hoʻolālā ʻia e hoʻonui i ka pono me ka hoʻēmi ʻana i ka ʻawahia. Ua hana ʻia ka lima IL-2 o IBI363 e hoʻomaikaʻi i nā hopena therapeutic me nā hopena ʻaoʻao i hoʻemi ʻia, ʻoiai ʻo ka lima hoʻopaʻa PD-1 e hiki ai i ka PD-1 blockade a me ka lawe ʻana o IL-2 koho. Ma ka pale ʻana i ke ala PD-1/PD-L1 a me ka hoʻoulu ʻana i ke ala IL-2, hoʻomaʻamaʻa ʻo IBI363 i ka hoʻopaʻa pololei a me ka maikaʻi a me ka hoʻoulu ʻana o nā cell T kikoʻī tumor. Ua hōʻike nā haʻawina preclinical e hōʻike ana ʻo IBI363 i ka hana anti-tumor ikaika ma waena o nā hiʻohiʻona pharmacological tumor-bearing he nui, me nā mea kūʻē i nā mea hoʻopaʻa PD-1 a me nā hiʻohiʻona metastatic. Eia kekahi, ua hōʻike ʻo ia i kahi ʻano palekana maikaʻi i nā hiʻohiʻona preclinical. Ke hana nei nā hoʻokolohua lapaʻau i kēia manawa ma Kina, ʻAmelika Hui Pū ʻIa, a me Australia e loiloi i kona palekana, ka hoʻomanawanui a me ka pono mua i nā kumuhana me nā maʻi ʻino holomua.
Ma ka ʻAha Kūkākūkā o ke Ao no ka Maʻi ʻAʻai Mama (WCLC) i Kepakemapa 2024, ua hōʻike ʻo IBI363 i nā hōʻailona pono e hoʻohiki ana i nā poʻe maʻi me sqNSCLC i loaʻa mua i ka immunotherapy:
I loko o ka hui mahele lāʻau 3 mg/kg, i waena o nā maʻi me ka liʻiliʻi he 12 mau pule o ka nānā ʻana a i ʻole ka hoʻopau ʻana i ke aʻo ʻana (n=18), ʻo ka helu pane pahuhopu (ORR) he 50.0%, a ʻo ka helu kaohi maʻi (DCR) he 88.9%. ʻAʻole i hiki i ka awelika o ke ola ʻole o ka holomua (PFS) a ke hoʻomau nei ma lalo o ka nānā ʻana.
I loko o ka hui mahele lāʻau 1/1.5 mg/kg, ʻo ka PFS waena he 5.5 mau mahina (95% CI: 1.5, 8.3), me ka helu PFS 12 mahina o 30.7%, e hōʻike ana i nā pono lōʻihi o ka immunotherapy.
Ma waena o nā hui mahele lāʻau 1/1.5/3 mg/kg, ua loaʻa i nā maʻi me PD-L1 TPS<1% (n=22) a me ka poʻe me PD-L1 TPS≥1% (n=22) nā ORR hoʻoikaika o 36.4% a me 31.8%, kēlā me kēia, e hōʻike ana i ka pono kūpono o IBI363 i nā heluna kanaka haʻahaʻa PD-L1.
E pili ana i ka maʻi ʻaʻai māmā ʻaʻole liʻiliʻi o ke kelepona Squamous (sqNSCLC)
ʻO ke kanesa māmā ka maʻi ʻino maʻamau a make loa ma ka honua holoʻokoʻa, me Kina hoʻi[1], e hoʻokū ana i kahi pilikia nui i ke olakino lehulehu. ʻOi aku ma mua o 80% o nā hihia kanesa māmā āpau ka maʻi kanesa cell liʻiliʻi (NSCLC), me ka squamous cell carcinoma kekahi o kāna mau ʻano nui ʻelua[2]. I nā makahiki i hala iho nei, ua hoʻololi nā mea hoʻopaʻa i ka pale ʻana i ka pale ʻana i ke ʻano lapaʻau no NSCLC. Eia nō naʻe, no nā poʻe maʻi me NSCLC i hāʻule i ka immunotherapy a nele i nā mutations gene driver, aia nō kahi pono koʻikoʻi a wikiwiki hoʻi no nā koho lapaʻau kūpono. ʻO ka lāʻau lapaʻau maʻamau ʻelua a ʻekolu paha, ʻo docetaxel, hāʻawi i ka hopena palena, me ka median progression-free survival (PFS) ma lalo o ʻehā mahina[3],[4]. ʻOiai ua hōʻike nā antibody-drug conjugates (ADCs) i ka hoʻohiki, ʻelua mau haʻawina nui Phase 3 i ka squamous NSCLC ʻaʻole i hōʻike i ka hopena kūpono.
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.ʻO Innovent (innoventbio.com)
Ka manawa hoʻouna: Pepeluali-20-2025