Ma Iune 30, ua hoʻolaha ka pūnaewele kūhelu o ka National Medical Products Administration (NMPA) ua loaʻa iā Anlotinib, kahi lāʻau lapaʻau hou Class 1 i hoʻomohala ʻia e Chia Tai Tianqing, ka ʻae ʻia no kahi hōʻailona hou ma Kina: ka hui pū ʻana me ka chemotherapy no ka mālama mua ʻana o nā maʻi me ka unresectable locally advanced a i ʻole metastatic soft tissue sarcoma (STS) i loaʻa ʻole i ka systemic therapy. ʻO kēia ka hōʻailona ʻeiwa i ʻae ʻia no Anlotinib ma Kina a hōʻike i ka ʻae kūhelu ʻana o ka hui pū ʻana o ka chemotherapy mua o ka honua no ka mālama mua ʻana o ka STS holomua a i ʻole metastatic.
ʻO Anlotinib (AL3818, Anlotinib Hydrochloride) kahi mea hoʻopaʻa tyrosine kinase multi-target liʻiliʻi (TKI) e kāohi pono ana i nā kinases e like me VEGFR, PDGFR, FGFR, a me c-Kit, e hoʻokō ana i ka angiogenesis anti-tumor a me nā hopena kāohi ulu ʻana o ka tumor.
ʻO ka sarcoma ʻiʻo palupalu (STS) kahi ʻano puʻupuʻu ʻino e puka mai ana mai nā ʻiʻo extraskeletal non-epithelial, me ka nui o ka hanana makahiki ma kahi o 2.91 no 100,000 heluna kanaka ma Kina, e hōʻike ana i kahi ʻano piʻi i kēlā me kēia makahiki [1-3]. Hoʻopuni ʻo STS i 19 mau ʻano histological a ʻoi aku ma mua o 50 mau ʻano pathological like ʻole. No nā makahiki he ʻumi, ua lawelawe ka chemotherapy e pili ana i ka anthracycline ma ke ʻano he kihi o ka lāʻau lapaʻau laina mua no STS.
Ma ka Hālāwai Makahiki 2025 o ka American Society of Clinical Oncology (ASCO), ua hōʻike ka ʻoihana i nā hopena holomua mai ka hoʻopaʻa haʻawina lapaʻau Phase III o Anlotinib Hydrochloride Capsules i hui pū ʻia me ka chemotherapy no ka mālama mua ʻana o nā STS holomua a metastatic paha i hiki ʻole ke ʻoki ʻia.
Nā Hana: Loaʻa i nā poʻe kūpono i mālama ʻole ʻia, i hōʻoia ʻia e ka pathology, ʻaʻole hiki ke ʻoki ʻia nā STS holomua kūloko a i ʻole metastatic. Ua koho ʻia nā poʻe kūpono ma ka lakio 1: 1 e loaʻa iā ALTN (12mg) waha i hoʻokahi manawa i ka lā (2-pule ma/1-pule hoʻomaha) me EH (90 mg/m2) intravenously i hoʻokahi manawa i kēlā me kēia 3 pule a hiki i 6 mau pōʻaiapuni, ukali ʻia e ka mālama ʻana iā ALTN (12mg) waha i hoʻokahi manawa i ka lā (2-pule ma/1-pule hoʻomaha) a i ʻole PBO (0mg) waha i hoʻokahi manawa i ka lā (2-pule ma/1-pule hoʻomaha) me EH (90 mg/m2) intravenously i hoʻokahi manawa i kēlā me kēia 3 pule a hiki i 6 mau pōʻaiapuni, ukali ʻia e ka mālama ʻana iā PBO (0mg) waha i hoʻokahi manawa i ka lā (2-pule ma/1-pule hoʻomaha). ʻO ka hopena mua ʻo PFS i loiloi ʻia e ke kōmike loiloi kūʻokoʻa makapō e like me RECIST 1.1. ʻO ka hopena lua i hoʻokomo ʻia ʻo OS, Objective Response Rate (ORR), Disease control rate (DCR) a me ka palekana.
Nā Hualoaʻa: Ua koho wale ʻia he 272 mau pts: 135 i ka lima ALTN + EH, 137 i ka lima PBO + EH. Ma Pepeluali 15, 2024, ma hope o ka hahai ʻana ma waena o 7.16 mahina, ua hoʻomaikaʻi nui ka lima ALTN + EH i ka PFS (HR 0.30 [95% CI 0.21-0.44]; P < 0.001; waena 8.57 vs 3.02 mahina), a me ORR (17.8% vs 2.90%; P < 0.001), DCR (79.3% vs 54.7%; P < 0.001) e kūʻē i ka lima PBO + EH. ʻAʻole i hiki i ka waena OS ma kekahi lima (HR = 0.78 [95% CI: 0.49-1.25]). Ua ʻike ʻia ka pōmaikaʻi o ka lima ALTN + EH ma waena o ka hapa nui o nā hui liʻiliʻi i hoʻāʻo ʻia, me ka leiomyosarcoma, ka synovial sarcoma a me nā ʻano pathological ʻē aʻe. ʻO ka nui o nā hanana ʻino (AE) Grade ≥3 (69.6% vs 59.1%), nā AE e alakaʻi ana i ka hoʻopau ʻana i ka lāʻau (3.7% vs 4.4%), nā AE make (3.7% vs 3.6%) ua like ma waena o nā lima ʻelua.
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: Iulai-01-2025