Ma Malaki 31, 2025, ua hoʻolaha ʻo Innovent Biologics ua hāʻawi ke Center for Drug Evaluation (CDE) o ka National Medical Products Administration (NMPA) o Kina i ka Breakthrough Therapy Designation (BTD) no IBI363, kahi protein fusion antibody bispecific PD-1/IL-2α-bias mua loa o ka papa, ma ke ʻano he monotherapy no ka mālama ʻana i ka melanoma mucosal a acral paha i hiki ʻole ke hoʻopau ʻia ma kahi kūloko a i ʻole metastatic i loaʻa ʻole ka lāʻau lapaʻau systemic ma mua.
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 pale ʻana o PD-1 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 ʻia 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 ia i kahi ʻano palekana maikaʻi i nā hiʻohiʻona preclinical.
Ke hana ʻia nei nā hoʻokolohua lapaʻau o IBI363 ma Kina, ʻAmelika Hui Pū ʻIa, a me Australia e loiloi i kona palekana, ka hiki ke hoʻomanawanui a me ka pono mua i nā poʻe me nā maʻi ʻino holomua. Ua hoʻomaka ʻia ke aʻo koʻikoʻi mua o IBI363, no ka mālama ʻana i ka IO-naive mucosal a i ʻole acral melanoma.
Eia kekahi, ua loaʻa iā IBI363 ʻelua mau hoʻolālā wikiwiki (FTD) mai ka US FDA, no ka mālama ʻana i ka melanoma a me ka squamous NSCLC. Ua loaʻa pū iā IBI363 ka hoʻolālā lapaʻau holomua mai ka NMPA o Kina no ka mālama ʻana i ka melanoma.
Hōʻike ʻo Innovent i ka ʻIkepili Lapaʻau Pae 1 o ka PD-1/IL-2α Bispecific Antibody Fusion Protein (IBI363) mua loa ma ka papa ma Melanoma ma ka Hālāwai Makahiki ASCO 2024.
Ua kākau inoa ʻia he 67 mau kumuhana me ka melanoma holomua kūloko a metastatic paha i hāʻule a ʻaʻole hoʻi i ʻae ʻole i ka lāʻau maʻamau a loaʻa iā IBI363 intravenously ma nā pae mahele ma waena o 100 μg/kg QW a me 2 mg/kg Q3W. Ua loaʻa iā 89.6% o nā kumuhana ka immunotherapy ma mua, a he 61.2% o nā kumuhana he ≥ 2 laina o ka lāʻau lapaʻau systemic ma mua. He 25.4% o nā kumuhana i loaʻa ka metastasis ate baseline a he 70.1% o nā kumuhana he acral a mucosal paha nā ʻano.
Ma Ianuali 11, 2024, ua loaʻa i nā kumuhana 57 ma ka liʻiliʻi he 1 loiloi puʻupuʻu post-baseline. ʻO ka pane holoʻokoʻa maikaʻi loa ka pane piha (CR) i loko o 1 kumuhana, pane hapa (PR) i loko o 15 mau kumuhana. ʻO ka helu pane holoʻokoʻa (ORR) he 28.1% (95%CI: 17.0-41.5) a ʻo DCR he 71.9% (95%CI: 58.5-83.0). I loko o 25 mau kumuhana i mālama ʻia me ka immunotherapy (IO) i loko o ka hui mahele lāʻau 1mg/kg Q2W (n=25), ʻo ka ORR he 32.0% (95%CI: 14.9-53.5), ʻo DCR he 80.0% (95%CI: 59.3-93.2).
No ka palekana, he 16 (23.9%) mau kumuhana i loaʻa nā hanana ʻino emergency treatment (TEAEs) ma ka papa ≥3. ʻO ka hapa nui o nā TEAE maʻamau he arthralgia (34.3%), hyperthyroidism (29.9%), a me ka anemia (25.4%). Ua loaʻa nā hanana ʻino e pili ana i ka pale ʻana o ka maʻi (irAEs) ma ka papa ≥3 i 8 (11.9%) mau kumuhana. ʻAʻohe TRAE i alakaʻi i ka make.
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.
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Ka manawa hoʻouna: ʻApelila-01-2025