Ngomhlaka-30 Juni, iwebhusayithi esemthethweni ye-National Medical Products Administration (NMPA) yamemezela ukuthi i-Anlotinib, umuthi omusha we-Class 1 owakhiwe yi-Chia Tai Tianqing, uthole imvume yesibonakaliso esisha eShayina: ukwelashwa okuhlanganisiwe ne-chemotherapy yokwelashwa kokuqala kweziguli ezine-sarcoma (STS) engasuswa endaweni noma esakazekile ezingakaze zithole ukwelashwa komzimba ngaphambilini. Lokhu kuphawula isibonakaliso sesishiyagalolunye esivunyelwe i-Anlotinib eShayina futhi kusho imvume esemthethweni yokwelashwa kokuqala kwe-chemotherapy emhlabeni kokwelashwa kokuqala kwe-STS ethuthukisiwe noma esakazekile.
I-Anlotinib (AL3818, i-Anlotinib Hydrochloride) iyi-inhibitor entsha ye-tyrosine kinase (TKI) encane enama-molecule amaningi ahlose ukuvimbela ama-kinase ngempumelelo njenge-VEGFR, i-PDGFR, i-FGFR, kanye ne-c-Kit, enemiphumela yokulwa ne-tumor angiogenesis kanye nokuvimbela ukukhula kwe-tumor.
I-Soft tissue sarcoma (STS) uhlobo lwesimila esibi esivela ezicutshini ezingaphandle kwe-epithelial, ngesilinganiso sokwanda kwaso sonyaka esingaba ngu-2.91 kubantu abayi-100,000 eShayina, okubonisa ukuthambekela okukhuphukayo unyaka nonyaka [1-3]. I-STS ihlanganisa izinhlobo ze-histological ezingu-19 kanye nezinhlobo ezingaphezu kuka-50 ze-pathological ezihlukile. Sekungamashumi eminyaka, i-chemotherapy esekelwe ku-anthracycline isebenze njengesisekelo sokwelashwa kokuqala kwe-STS.
Emhlanganweni Waminyaka Yonke we-American Society of Clinical Oncology (ASCO) ka-2025, inkampani yethule imiphumela emisha evela ocwaningweni lwezokwelapha lweSigaba III lwama-Anlotinib Hydrochloride Capsules ngokuhlanganiswa ne-chemotherapy yokwelashwa kokuqala kwe-STS ethuthukisiwe noma esakazekile engasuswa.
Izindlela: Ama-pts afanelekile ayekade engalashwanga, aqinisekiswe ngokwezifo, angasuswa endaweni noma ama-STS asakazekile. Ama-pts ahlelwa ngokungahleliwe ngesilinganiso esingu-1:1 ukuze athole i-ALTN (12mg) ngomlomo kanye ngosuku (ikhefu lamaviki ama-2/isonto eli-1) kanye ne-EH (90 mg/m2) ngemithambo yegazi kanye njalo emavikini ama-3 kuze kube yimijikelezo eyi-6, kulandelwe i-ALTN yokunakekela (12mg) ngomlomo kanye ngosuku (ikhefu lamaviki ama-2/isonto eli-1) noma i-PBO (0mg) ngomlomo kanye ngosuku (ikhefu lamaviki ama-2/isonto eli-1) kanye ne-EH (90 mg/m2) ngemithambo yegazi kanye emavikini ama-3 kuze kube yimijikelezo eyi-6, kulandelwe i-PBO yokunakekela (0mg) ngomlomo kanye ngosuku (ikhefu lamaviki ama-2/isonto eli-1). Iphuzu eliyinhloko kwaba yi-PFS ehlolwe yikomidi lokubuyekeza elizimele elingaboniwe ngokusho kwe-RECIST 1.1. Iphuzu lesibili lalihlanganisa i-OS, Izinga Lokuphendula Lenhloso (ORR), Izinga Lokulawula Izifo (DCR) kanye nokuphepha.
Imiphumela: Ingqikithi yamaphoyinti angu-272 yenziwe ngokungahleliwe: 135 kuya ku-ALTN + EH arm, 137 kuya ku-PBO + EH arm. Kusukela ngomhlaka-15 kuNhlolanja 2024, ngemuva kokulandelwa okumaphakathi kwezinyanga ezingu-7.16, i-ALTN + EH arm yathuthukisa kakhulu i-PFS (HR 0.30 [95% CI 0.21-0.44]; P < 0.001; imaphakathi 8.57 vs 3.02 mo), kanye ne-ORR (17.8% vs 2.90%; P < 0.001), i-DCR (79.3% vs 54.7%; P < 0.001) uma kuqhathaniswa ne-PBO + EH arm. I-OS emaphakathi ayifinyelelwanga kunoma iyiphi ingalo (HR = 0.78 [95% CI: 0.49-1.25]). Inzuzo yengalo ye-ALTN + EH ibonwe emaqenjini amaningi ahlolwe, okuhlanganisa i-leiomyosarcoma, i-synovial sarcoma kanye nezinye izinhlobo zezifo. Ukusabalala kwezehlakalo ezimbi zebanga ≥3 (ama-AE) (69.6% vs 59.1%), ama-AE aholela ekuyekeni ukwelashwa (3.7% vs 4.4%), ama-AE abulalayo (3.7% vs 3.6%) ayefana phakathi kwezingalo ezimbili.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
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Isikhathi sokuthunyelwe: Julayi-01-2025