Ngomhla wama-30 kuJuni, iwebhusayithi esemthethweni ye-National Medical Products Administration (NMPA) ibhengeze ukuba i-Anlotinib, iyeza elitsha leKlasi 1 elenziwe yiChia Tai Tianqing, lifumene imvume yesalathiso esitsha eTshayina: unyango oludibeneyo kunye ne-chemotherapy kunyango lokuqala lwezigulane ezine-sarcoma (STS) ezingasuswanga kwindawo yazo okanye ezisandula ukusasazeka ezingakhange zifumane unyango oluqhelekileyo ngaphambili. Oku kubonisa uphawu lwesithoba oluvunyiweyo lwe-Anlotinib eTshayina kwaye kubonisa imvume esemthethweni yonyango lokuqala lwe-chemotherapy oludibeneyo lwe-STS olusandula ukusasazeka okanye olusandula ukusasazeka.
I-Anlotinib (AL3818, Anlotinib Hydrochloride) yi-inhibitor entsha ye-tyrosine kinase (TKI) encinci ene-molecule eninzi ejolise kuyo ethintela ngempumelelo ii-kinase ezifana ne-VEGFR, i-PDGFR, i-FGFR, kunye ne-c-Kit, enefuthe lokulwa ne-tumor angiogenesis kunye ne-tumor growth-inhibiting.
I-Soft tissue sarcoma (STS) luhlobo lwethumba elibi elivela kwizicubu ezingaphandle kwe-epithelial, kunye nezinga lokwenzeka ngonyaka elimalunga ne-2.91 kubantu abayi-100,000 eTshayina, ebonisa ukunyuka konyaka [1-3]. I-STS iquka iintlobo ezili-19 ze-histological kunye neentlobo ezahlukeneyo ze-pathological ezingaphezu kwama-50. Kangangamashumi eminyaka, i-chemotherapy esekelwe kwi-anthracycline isebenze njengesiseko sonyango lokuqala lwe-STS.
KwiNtlanganiso yoNyaka ye-American Society of Clinical Oncology (ASCO) ka-2025, inkampani ibonise iziphumo eziphambili ezivela kwiSigaba sesiThathu sophando lwezonyango lwe-Anlotinib Hydrochloride Capsules kunye ne-chemotherapy kunyango lokuqala lwe-STS engapheliyo okanye eguqukileyo.
Iindlela: Ii-pts ezifanelekileyo zazingazange zinyangwe ngaphambili, ziqinisekiswe ngokwezifo, zingasuswanga kwindawo ethile okanye i-metastatic STS. Ii-pts zathathwa ngokungacwangciswanga kwi-1:1 ratio ukuze zifumane i-ALTN (12mg) ngomlomo kanye ngemini (iveki ezi-2 kwi/iveki e-1 ikhefu) kunye ne-EH (90 mg/m2) ngemithambo rhoqo emva kweeveki ezi-3 ukuya kwimijikelo emi-6, kulandele i-ALTN yolondolozo (12mg) ngomlomo kanye ngemini (iveki ezi-2 kwi/iveki e-1 ikhefu) okanye i-PBO (0mg) ngomlomo kanye ngemini (iveki ezi-2 kwi/iveki e-1 ikhefu) kunye ne-EH (90 mg/m2) ngemithambo rhoqo emva kweeveki ezi-3 ukuya kwimijikelo emi-6, kulandele i-PBO yolondolozo (0mg) ngomlomo kanye ngemini (iveki ezi-2 kwi/iveki e-1 ikhefu). Isiphelo esiphambili savavanywa yikomiti yophononongo ezimeleyo engaboniyo ngokwe-RECIST 1.1. Isiphelo sesibini sasiquka i-OS, i-Objective Response Rate (ORR), i-Disease control rate (DCR) kunye nokhuseleko.
Iziphumo: I-272 pts iyonke yenziwe ngokungacwangciswanga: 135 ukuya kwi-ALTN + EH arm, 137 ukuya kwi-PBO + EH arm. Ukusukela nge-15 kaFebruwari 2024, emva kokulandelela okuphakathi kwe-7.16 mo, i-ALTN + EH arm iphucuke kakhulu kwi-PFS (HR 0.30 [95% CI 0.21-0.44]; P < 0.001; i-median 8.57 vs 3.02 mo), kunye ne-ORR (17.8% vs 2.90%; P < 0.001), i-DCR (79.3% vs 54.7%; P < 0.001) xa kuthelekiswa ne-PBO + EH arm. I-median OS ayifikelelwanga kuyo nayiphi na ingalo (HR = 0.78 [95% CI: 0.49-1.25]). Inzuzo ye-ALTN + EH arm ibonwe kumaqela amaninzi avavanyiweyo, kuquka i-leiomyosarcoma, i-synovial sarcoma kunye nezinye iintlobo ze-pathological. Ukwanda kweziganeko ezimbi zeBakala ≥3 (ii-AE) (69.6% vs 59.1%), ii-AE ezikhokelela ekuyekeni unyango (3.7% vs 4.4%), ii-AE ezibulalayo (3.7% vs 3.6%) zazifana phakathi kweengalo ezimbini.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
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Ixesha leposi: Julayi-01-2025