Thaum Lub Peb Hlis 13, 2025, phau ntawv xov xwm thoob ntiaj teb Nature Medicine tau tshaj tawm MediLink's B7-H3 targeting antibody drug conjugate (ADC) YL201 Theem 1/1b kev sim.
Qhov kev sim no suav nrog ib feem ntawm kev nce koob tshuaj (theem 1) thiab ib feem ntawm kev nthuav koob tshuaj (theem 1b). Tag nrho muaj 312 tus neeg mob tau sau npe rau ntau hom qog nqaij hlav, suav nrog mob qog nqaij hlav me me theem dav dav (ES-SCLC), mob qog nqaij hlav nasopharyngeal (NPC), mob qog nqaij hlav tsis yog me me, mob qog nqaij hlav esophageal squamous cell carcinoma thiab lwm yam qog nqaij hlav khov kho.
Ntawm 287 tus neeg mob uas tau ntsuam xyuas seb puas ua tau zoo, tus nqi teb rov qab (ORR) yog 40.8%, thiab tus nqi tswj kab mob (DCR) yog 83.6%. Lub sijhawm muaj sia nyob nruab nrab (mPFS) yog 5.9 lub hlis, thiab lub sijhawm teb nruab nrab (mDOR) yog 6.3 lub hlis. Lub sijhawm muaj sia nyob nruab nrab (OS) tsis tau loj hlob.
Ntawm 48 tus neeg mob uas muaj cov qog nqaij hlav metastases hauv lub hlwb, 21 tus tau raug soj ntsuam; qhov ORR intracranial yog 28.5%; thiab DOR yog 6.2 lub hlis.
Txhua tus neeg mob uas muaj ES-SCLC tau kho mob ua ntej nrog platinum-based chemotherapy, thiab 95.8% ntawm cov neeg mob kuj tau kho mob ua ntej nrog programmed death 1 (PD-1) lossis programmed death ligand 1 (PD-L1) antibody. Lub ORR yog 63.9%; DCR yog 91.7%; mPFS yog 6.3 lub hlis; thiab mDOR yog 5.7 lub hlis. Hauv kev tshawb fawb txog koob tshuaj, tsib tus neeg mob uas muaj SCLC uas tau txais kev kho mob ua ntej nrog topoisomerase 1 inhibitor (topotecan lossis irinotecan) tau sau npe, nrog rau ib tus neeg mob teb (ORR, 20%). Ntawm 70 tus neeg mob uas muaj NPC, txhua tus tau kho mob ua ntej nrog anti-PD-L1 thiab platinum-based chemotherapy, thiab 84.3% (59/70) muaj ob lossis ntau kab ntawm kev kho mob ua ntej. Ob tus neeg mob uas muaj NPC tau ua tiav kev teb tiav (CR), nrog ORR ntawm 48.6% thiab DCR ntawm 92.9%. Lub mPFS yog 7.8 lub hlis, thiab mDOR yog 8.4 lub hlis. Tag nrho ntawm 64 tus neeg mob uas muaj NSCLC hom qus tau raug soj ntsuam, suav nrog 28 tus nrog adenocarcinoma, 12 tus nrog squamous cell carcinoma thiab 24 tus nrog lymphoepithelioma-zoo li carcinoma (LELC). Tag nrho, 90.6% (58/64) ntawm cov neeg mob uas muaj NSCLC tau kho mob ua ntej nrog anti-PD-L1 thiab platinum-based chemotherapy. Cov nqi ORR rau cov neeg mob uas muaj mob ntsws adenocarcinoma, squamous cell carcinoma thiab LELC yog 28.6%, 8.3% thiab 54.2%, raws li, thiab mDOR yog 13.6 lub hlis, 2.6 lub hlis thiab 6.7 lub hlis, raws li.
YL201 tau ua pov thawj txog kev nyab xeeb thiab kev ua tau zoo hauv cov neeg mob uas tau kho mob hnyav nrog cov qog nqaij hlav khov kho, tshwj xeeb tshaj yog rau cov neeg uas muaj ES-SCLC, NPC lossis lymphoepithelioma-zoo li carcinoma.
YL201 yog ib qho ADC tshiab uas muaj cov tshuaj antibody anti-B7H3 monoclonal uas sib txuas nrog cov tshuaj topoisomerase 1 inhibitor tshiab los ntawm cov protease-cleavable linker, nrog rau qhov sib piv ntawm cov tshuaj thiab cov tshuaj tiv thaiv kab mob ntawm 8. YL201 tau tsim los ntawm kev siv MediLink's tumor microenvironment activable linker-payload (TMALIN) platform, uas yog tus cwj pwm los ntawm cov hydrophilic linker-payload, kev ruaj khov zoo kawg nkaus hauv kev ncig thiab ob lub payload tso tawm mechanism uas suav nrog kev txiav ob qho tib si extracellularly hauv tumor microenvironment thiab intracellularly hauv lysosomes. Hauv kev tshawb fawb preclinical, YL201 tau ua pov thawj muaj zog tiv thaiv kab mob qog nqaij hlav hauv ntau yam qauv nas CDX/PDX nrog SCLC, NSCLC, mob qog nqaij hlav esophageal thiab mob qog nqaij hlav ovarian. Cov ntaub ntawv ua tau zoo thiab kev nyab xeeb los ntawm kev tshawb fawb preclinical no qhia txog kev sib npaug zoo ntawm cov txiaj ntsig thiab kev pheej hmoo, txhawb nqa kev txhim kho ntxiv ntawm YL201 hauv chaw kho mob.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
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Lub sijhawm tshaj tawm: Plaub Hlis-08-2025