Maarso 13, 2025, joornaalka caalamiga ah ee ugu sarreeya Nature Medicine wuxuu daabacay tijaabada MediLink ee B7-H3 oo bartilmaameedsanaya isku-darka daawada antibody-ga (ADC) ee marxaladda 1/1b ee YL201.
Tijaabada waxaa ku jiray qayb qiyaasta kor u kaca ah (wajiga 1) iyo qayb qiyaasta-ballaarinta ah (wajiga 1b). Wadarta 312 bukaan ayaa lagu diiwaangeliyey noocyo badan oo burooyinka ah, oo ay ku jiraan kansarka sambabka unugyada yaryar ee heerka ballaaran (ES-SCLC), kansarka nasopharyngeal (NPC), kansarka sambabka unugyada aan yar ahayn, kansarka unugyada squamous ee esophageal iyo burooyinka kale ee adag.
287 bukaan oo lagu qiimeeyay waxtarka, heerka jawaab celinta ujeeddada leh (ORR) wuxuu ahaa 40.8%, heerka xakamaynta cudurka (DCR) wuxuu ahaa 83.6%. Badbaadada dhexdhexaadka ah ee aan horumarka lahayn (mPFS) waxay ahayd 5.9 bilood, muddada dhexdhexaadka ah ee jawaab celinta (mDOR) waxay ahayd 6.3 bilood. Badbaadada guud ee dhexdhexaadka ah (OS) ma ahayn mid bisil.
48-kii bukaan ee qabay kansarka maskaxda ee asaasiga ah, 21 ayaa la qiimeyn karaa; ORR-ka intracranial wuxuu ahaa 28.5%; DOR-na wuxuu ahaa 6.2 bilood.
Dhammaan bukaanada qaba ES-SCLC waxay hore u qaateen daaweyn kiimoterabiga ku salaysan platinum, 95.8% bukaanadana waxay sidoo kale hore u qaateen daaweyn dhimasho 1 (PD-1) ama antibody-ga dhimashada ee barnaamijka lagu sameeyay ee ligand 1 (PD-L1). ORR wuxuu ahaa 63.9%; DCR wuxuu ahaa 91.7%; mPFS wuxuu ahaa 6.3 bilood; mDOR-na wuxuu ahaa 5.7 bilood. Daraasadda kor u qaadista qiyaasta, shan bukaan oo qaba SCLC oo hore u helay daaweyn topoisomerase 1 inhibitor (topotecan ama irinotecan) ayaa la diiwaan geliyay, iyadoo hal bukaan oo keliya uu ka jawaabay (ORR, 20%). 70 bukaan oo qaba NPC, dhammaantood waxay hore u qaateen daaweyn kiimoterabiga ku salaysan PD-L1 iyo platinum, 84.3% (59/70) waxay lahaayeen laba ama in ka badan oo daaweyn nidaamsan oo hore. Laba ka mid ah bukaanada qaba NPC waxay gaareen jawaab dhammaystiran (CR), oo leh ORR oo ah 48.6% iyo DCR oo ah 92.9%. MPFS waxay jirtay 7.8 bilood, mDOR-na waxay ahayd 8.4 bilood. Wadarta 64 bukaan oo qaba NSCLC nooca duurjoogta ah ayaa la qiimeeyay, oo ay ku jiraan 28 qaba adenocarcinoma, 12 qaba kansarka unugyada squamous iyo 24 qaba kansarka lymphoepithelioma-like (LELC). Guud ahaan, 90.6% (58/64) bukaannada qaba NSCLC waxay hore u qaateen daaweyn ka hortag ah oo ku salaysan PD-L1 iyo kiimoterabiga platinum. Qiimaha ORR ee bukaanada qaba adenocarcinoma sambabada, kansarka unugyada squamous iyo LELC waxay ahaayeen 28.6%, 8.3% iyo 54.2%, siday u kala horreeyaan, mDOR-na wuxuu ahaa 13.6 bilood, 2.6 bilood iyo 6.7 bilood, siday u kala horreeyaan.
YL201 waxay muujisay muuqaal badbaado oo la aqbali karo iyo waxtar rajo leh oo ku saabsan bukaanada si weyn loo daaweeyay ee leh burooyinka adag ee horumarsan, gaar ahaan kuwa qaba kansarka ES-SCLC, NPC ama lymphoepithelioma-like.
YL201 waa ADC cusub oo ka kooban antibody-ka ka hortagga B7H3 monoclonal ee aadanaha oo lagu daray daawada cusub ee topoisomerase 1 iyada oo loo marayo isku xire protease-la tirtiri karo, oo leh saamiga daawada-ilaa-antibody ee 8. YL201 waxaa lagu sameeyay iyadoo la adeegsanayo madal isku xire-ka firfircoon ee MediLink ee microenvironment microenvironment activated linker-payload (TMALIN), kaas oo lagu garto culeys isku xire-ka-qaadis aad u hydrophilic ah, xasillooni la yaab leh oo ku jirta wareegga dhiigga iyo farsamo sii dayn labanlaab ah oo culays ah oo ay ku jiraan kala-goynta labadaba dibadda ee deegaanka burooyinka iyo gudaha gudaha lysosomes. Daraasad hore oo kiliinikada ah, YL201 waxay muujisay firfircooni ka-hortagga burooyinka oo xooggan oo ku jira noocyo kala duwan oo jiirka CDX/PDX ah oo leh SCLC, NSCLC, kansarka hunguriga iyo kansarka ugxan-sidaha. Xogta waxtarka iyo badbaadada ee daraasaddan kahor kiliinikada ah waxay soo jeedinaysaa dheelitir faa'iido-khatar ah oo wanaagsan, oo taageeraya horumar dheeraad ah oo YL201 ah oo ku yaal kiliinikada.
Waqtigan xaadirka ah, waxaa weli jira tijaabooyin caafimaad oo badan oo ku saabsan teknoolojiyada cusub ee ka hortagga kansarka ee Shiinaha oo raadinaya bukaanno. La-tashi ku saabsan daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing.
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Waqtiga boostada: Abriil-08-2025