Ma ka lā 20 ʻAukake 2025, ua hoʻolaha ʻo Abbisko Therapeutics ua ʻae ke Center for Drug Evaluation (CDE) o ka China National Medical Products Administration (NlPA) i ka noi lND no ka mea hoʻopaʻa PD-1 waha noiʻi a Abbisko, ABSK043, i hui pū ʻia me ka mea hoʻopaʻa KRAS G12C a Shanghai Alist Pharmaceuticals, glecirasib, no ka mālama ʻana i nā maʻi NscLc me ka hoʻololi ʻana o KRAS G12C.
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
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E pili ana iā ABSK043
He mea hoʻopaʻa hou ʻo ABSK043 i ka mole liʻiliʻi PD-L1, bioavailable waha, koho nui ʻia nona piha ʻo Abbisko Therapeutics. Hiki i nā cell tumor ke hoʻohana i nā wahi nānā pale e like me PD-1 a me kāna ligand PD-L1 e pale aku i ka ʻike ʻana a me ka hoʻomaʻemaʻe ʻana o ka pale, no laila e kāohi ana a i ʻole e kaupalena ana i nā pane I-cell, hoʻopaʻa koho ʻo ABSK043 i ka mea loaʻa PD-L1 a hoʻoulu i kona internaization mai ka ʻili o ke cell, e hoʻoulu pono ana i ka pilina PD-1/PD-L1 a hoʻomāmā i ka hoʻopau ʻana o ka PD-L1-mediated i ka hoʻāla ʻana o T-cell. i nā hiʻohiʻona preclinical, ua hōʻike ʻo ABSK043 i ka pono anti-tumor e like me nā antibodies PD-L1 i ʻae ʻia. ʻOiai ua ʻae ʻia kekahi mau antibodies monoconal PD-1/PD-L1 ma ka honua holoʻokoʻa, ʻaʻohe maloʻo mole liʻiliʻi PD-1/PD-L1 i ʻae ʻia i kēia manawa, ke noiʻi ʻia nei ʻo ABSK043 i kahi hoʻokolohua lapaʻau Phase L e hoʻomau nei no nā tumors paʻa holomua ma Australia a me Kina.
Ma kahi haʻawina pae I (NCT04964375), ua hōʻike ʻo ABSK043, kahi mea hoʻopaʻa PD-L1 ikaika, waha, a me nā molekole liʻiliʻi, i ka hopena mua.
Nā ʻAno Hana
Ua hoʻokomo ʻia nā Pts me nā ʻōpū paʻa holomua me nā capsules ABSK043 mai 200 mg i hoʻokahi manawa i ka lā (QD) a i 1000 mg ʻelua manawa i ka lā (BID), e loiloi i ka ʻaoʻao palekana a me ka pono mua. Eia kekahi, ua loiloi ʻia nā ʻōkuhi pharmacodynamic (PD), e like me ka hana T-cell a me ka ʻili PD-L1.
Nā Hualoaʻa
Ma ka lā palena (Iune 7, 2024), ua kākau inoa ʻia a mālama ʻia he 77 mau pts. 87.0% o nā pts i loaʻa nā hanana ʻino emergency-treatment (TEAEs), a he 29.9% he ≥ Grade 3. ʻO nā TEAEs ≥15% he anemia (22.1%). ʻAʻohe neuropathy peripheral i hōʻike ʻia. Ma nā pts loiloi pono āpau o nā hui lāʻau lapaʻau ikaika (600 mg BID, 800 mg BID, a me 1000 mg BID), ua ʻike ʻia kahi ORR o 24% (8/34) i nā pts ICI-naïve. I loko o nā pts 10 ICI-naïve me ka maʻi kanesa māmā (9 i mālama mua ʻia a me 1 i mālama ʻole ʻia), ʻo ka ORR he 40% (4/10). ʻIke ʻia, 3 o 6 (50%) EGFR-mutated a me 1 o 2 (50%) KRAS-mutated pts i loaʻa ka pane hapa (PR). ʻO nā mea pane ʻekolu me nā hoʻololi EGFR he PD-L1 TPS ≥ 50% a holomua ma hope o hoʻokahi laina o nā lāʻau lapaʻau EGFR TKI, me ka hanauna 3. Ua loaʻa nā pane ʻē aʻe i ʻelima mau ʻano puʻupuʻu i hui pū ʻia: MSI-H/dMMR gastric cancer, MSI-H/dMMR endometrial adenocarcinoma, vaginal squamous cell carcinoma, breast cancer (Lynch syndrome), a me melanoma. ʻO ka lōʻihi loa o ka pane ʻana i loko o ke aʻo ʻana he 17 mau mahina (endometrial adenocarcinoma) a ke mālama ʻia nei ka pt. Ua ʻike ʻia ka hoʻāla ʻana o nā cell T a me ka emi ʻana o ka dose-dependent i ka hōʻike ʻana o ka PD-L1 ma hope o ka mālama ʻana iā ABSK043 i nā hui dose BID āpau.
E pili ana iā Glecirasib
ʻO Glecirasib (AST-24081) kahi mea hoʻopaʻa KRAS G12C. Ke hana nei kekahi mau hoʻokolohua lapaʻau ma Kina, ʻAmelika Hui Pū ʻIa a me ʻEulopa no nā poʻe maʻi me nā ʻōpū paʻakai holomua e hūnā ana i ka hoʻololi ʻana o KRAS G12C. ʻO kēia mau mea e komo pū ana me nā hoʻokolohua hoʻōla hui pū ʻana me ka mea hoʻopaʻa SHP2 AST-24082 ma NSCLC a me nā hoʻokolohua monotherapy i ka maʻi kanesa pancreatic. Eia kekahi, ua loaʻa i ka hōʻailona maʻi kanesa pancreatic ka hoʻolālā lāʻau makua ʻole ma ʻAmelika Hui Pū ʻIa a me ka hoʻolālā hoʻōla holomua ma Kina. I Mei 2025, ua ʻae ʻia ʻo Glecirasib no ka hoʻomaka ʻana o ka mākeke e ka ChinaNMPA.
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
Email：myimmnet@163.com
Ka manawa hoʻouna: ʻAukake-21-2025