Ma ʻAukake 13, 2025, ua hoʻokuʻu ka Pacific Time, ka pūnaewele kūhelu o ka 2025 World Conference on Lung Cancer (WCLC) i nā ʻōlelo hōʻuluʻulu noiʻi i koho ʻia no ka ʻaha kūkā o kēia makahiki, ʻO kekahi o nā mea koʻikoʻi ka ʻōlelo hōʻuluʻulu i hōʻano hou ʻia no ka hoʻokolohua lapaʻau mua ma ke kanaka o HLX43, ʻo Henlius' PD-L1 ADC.
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
ʻO HLX43 kahi moho ADC anti-tumor ākea e kuhikuhi ana iā PD-L1, kahi e hōʻike ana i nā ʻano hana pālua e hoʻohui ana i ka pale ʻana i ka pale ʻana i ka nānā ʻana o ka pale ʻana a me ka cytotoxicity i hoʻopili ʻia e ka payload. Ua hōʻike ʻia nā ʻikepili preclinical he hopena anti-tumor maikaʻi ko HLX43 a me kahi ʻano tolerability maikaʻi i ka maʻi kanesa māmā ʻaʻole liʻiliʻi (NSCLC), ka maʻi kanesa cervical (CC), ka esophageal squamous cell carcinoma (ESCC), a me nā ʻano tumor ʻē aʻe i kūʻē i ka PD-1/L1 mAb.
Wahi a ka hōʻuluʻulu manaʻo hou, ke hoʻomau nei ʻo HLX43 i ka hōʻike ʻana i kahi pane kiʻekiʻe i nā poʻe maʻi me nā ʻōpū paʻa holomua, ʻoi aku hoʻi i nā poʻe maʻi NSCLC i mālama mua ʻia i hāʻule i ka lāʻau lapaʻau checkpoint inhibitor. Hōʻike ʻo HLX43 i ka pono maikaʻi loa i nā hui liʻiliʻi kikoʻī, me ka helu pane pahuhopu (ORR) o 47.4% ma EGFR wild-type non-squamous NSCLC, me ka mālama ʻana i kahi ʻano palekana maikaʻi. ʻIke ʻia, hōʻike ʻo HLX43 i ka pono ikaika me ka nānā ʻole i ka hōʻike ʻana o PD-L1, e hōʻike ana i kona hiki ke antitumor biomarker-independent.
Loaʻa ka hopena maikaʻi i ka mālama ʻana i ka NSCLC kūʻē i ka CPI ma hope o ka lā: Ma ka lā 28 o Pepeluali, 2025, ua loaʻa i ka huina o 85 mau maʻi ka HLX43. I ka Phase Ia (dose-piscalation), ua kākau inoa ʻia he 21 mau maʻi me nā ʻōpū paʻa paʻa kiʻekiʻe, ʻoiai ma ka Phase Ib (dose-expansion), ua hoʻopaʻa inoa ʻia he 64 mau maʻi NSCLC ma ʻekolu mau cohorts (2, 2.5, a me 3 mg/kg). ʻIke ʻia, ua hāʻule ka 88.2% (75/85) o nā maʻi i ka lāʻau lapaʻau checkpoint inhibitor (CPI) ma mua.
Ka Pono Hoʻohiki ma NSCLC me nā Hopena Koʻikoʻi ma nā Hui Pūʻulu Kūikawā: Ma waena o nā maʻi NSCLC 76 (69 hiki ke loiloi ʻia ka pono), ʻo ORR he 31.9% (22/69), me ka helu kaohi maʻi (DCR) o 87.0% (60/69). Ua hōʻike nā loiloi hui pūʻulu i ka pono hoʻohiki o HLX43 i nā heluna kanaka kikoʻī: ua loaʻa i nā hui 2 mg/kg a me 2.5 mg/kg ma Phase Ib nā ORR o 38.1% (8/21) a me 33.3% (7/21), kēlā me kēia; Ua hōʻike nā maʻi NSCLC CPI-refractory (n=61) i kahi ORR o 32.8% (20/61); ʻO nā maʻi NSCLC non-squamous EGFR wild-type (n=19) he 47.4% (9/19).
ʻIke Palekana Kūpono, Kūlana Kiʻekiʻe me ka ʻAkika Haʻahaʻa: I ka Pae Ia, ua ʻike ʻia kekahi hanana DLT e pili ana i ka neutropenia febrile i ka hui 4 mg/kg. Ua hōʻike ʻia nā hanana ʻino e pili ana i ka lāʻau lapaʻau (TRAEs) ma 95.2% o nā maʻi, ʻo ka hapa nui he Papa 1-2. Ua loaʻa nā TRAE Papa ≥3 i 5 mau maʻi (23.8%), mai nā hui 3 a me 4 mg/kg, ʻo ka hapa nui i emi pinepine ka helu neutrophil (19%), ua emi ka helu o nā cell koko keʻokeʻo (19.0%) a me ka anemia (14.3%). ʻO nā hanana ʻino e pili ana i ka pale ʻana (irAEs) i hōʻike ʻia ma kēia haʻawina e hōʻike ana he hiki iā HLX43 ke hoʻoulu i nā hopena immunotherapeutic. ʻO ka mea nui, ua hōʻike nā maʻi i hōʻike i nā irAE i kahi helu pane kiʻekiʻe (ORR).
Loaʻa ka hopena i nā kūlana biomarker like ʻole: Ua hōʻike nā mea maʻi NSCLC PD-L1-positive (n=50) i kahi ORR o 32.0% (16/50) ʻoiai ua loaʻa i nā mea maʻi PD-L1-negative/ʻike ʻole ʻia (n=19) kahi ORR o 31.6% (6/19), me ka ʻike ʻole ʻia o ka ʻokoʻa koʻikoʻi.
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: Aug-15-2025