Thaum Lub Ib Hlis 8, Lub Chaw Saib Xyuas Tshuaj (CDE) ntawm Tuam Tshoj Lub Chaw Tswj Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau tso cai rau Breakthrough Therapy Designation (BTD) rau IBI343, uas yog TOPO1i anti-CLDN18.2 ADC zoo tshaj plaws, ua kev kho mob monotherapy rau kev kho mob ntawm CLDN18.2-positive advanced pancreatic ductal adenocarcinoma (PDAC) cov neeg mob uas tau nce qib tom qab tsawg kawg ib kab ntawm kev kho mob yav dhau los.
BTD rau IBI343 tau tso cai raws li cov ntaub ntawv los ntawm kev tshawb fawb theem 1 uas tau ua nyob rau hauv Suav teb, Australia thiab Tebchaws Meskas (NCT05458219), uas tau qhia txog kev nyab xeeb thiab kev kam rau siab, nrog rau kev ua haujlwm tiv thaiv qog ntawm IBI343 monotherapy hauv cov neeg mob PDAC siab heev. Cov ntaub ntawv los ntawm kev tshawb fawb cov koob tshuaj-nthuav dav tau nthuav tawm hauv kev hais lus ntawm 2024 ESMO Asia Congress:
Txij li thaum lub Cuaj Hlis 6, 2024, tag nrho muaj 43 tus neeg mob uas muaj CLDN18.2-zoo (≥60% cov hlwb qog nrog cov xim pleev xim membranous ≥1+ los ntawm IHC) PDAC siab heev tau txais IBI343 6 mg / kg Q3W monotherapy. Txhua tus neeg koom nrog tau txais tsawg kawg 1 kab ntawm kev kho mob ua ntej, thiab 60.5% tau txais 2 lossis ntau kab ntawm kev kho mob qog noj ntshav.
Muaj 43 tus neeg mob uas tau txais kev ntsuam xyuas zoo nrog rau qhov feem pua ntawm kev teb rov qab (ORR) ntawm 32.6%, qhov feem pua ntawm kev teb rov qab (cORR) ntawm 23.3%, thiab qhov feem pua ntawm kev tswj kab mob (cDCR) ntawm 81.4%.
Raws li hnub kawg ntawm cov ntaub ntawv, 4 ntawm 10 tus neeg mob cORR tau nce qib, lub sijhawm nruab nrab ntawm kev teb (mDoR) yog 7.0 (4.0-NC) lub hlis, thiab 6-hli DoR tus nqi yog 63%. 26 tus neeg mob tau tshwm sim PFS cov xwm txheej, nrog rau qhov nruab nrab ntawm kev ciaj sia tsis muaj kev nce qib (mPFS) ntawm 5.3 (4.1-7.4) lub hlis, thiab cov ntaub ntawv OS tseem tsis tau paub tab.
Cov txiaj ntsig kev nyab xeeb tshiab tau qhia txog qhov kev nyab xeeb zoo ntawm IBI343 nrog rau tus nqi qis ntawm kev lom hauv plab thiab tsis muaj cov cim qhia kev nyab xeeb tshiab. 97.7% ntawm cov neeg koom nrog tau ntsib cov xwm txheej tsis zoo ntawm kev kho mob (TEAEs), nrog rau TEAEs feem ntau yog ntshav tsis txaus, cov lej neutrophil txo qis, txo qis kev noj mov, xeev siab, thiab cov lej ntshav dawb txo qis. 51.2% ntawm cov neeg koom nrog tau ntsib ≥ qib 3 TEAEs, thiab tsis muaj ≥ qib 3 xeev siab thiab ntuav tshwm sim. Tsis muaj TEAE ua rau tuag.
Txog IBI343 (Anti-CLDN18.2 ADC)
IBI343 yog ib qho tshuaj recombinant human anti-CLDN18.2 monoclonal antibody-drug conjugate (ADC) uas tsim los ntawm Innovent Biologics. IBI343 khi rau cov hlwb qog CLDN18.2, qhov kev sib txuas ntawm CLDN18.2 ADC yuav tshwm sim thiab cov tshuaj raug tso tawm ua rau DNA puas tsuaj thiab thaum kawg apoptosis ntawm cov hlwb qog. Cov tshuaj uas tau tso tawm kuj tuaj yeem kis mus rau hauv cov plasma membrane kom mus txog thiab tua cov hlwb nyob ze, ua rau "bystander killing effect".
Ua ib qho TOPO1i ADC tshiab, IBI343 tau ua pov thawj tias muaj kev nyab xeeb thiab txhawb nqa cov cim qhia txog kev ua haujlwm zoo hauv Kev Tshawb Fawb Txog Kev Kho Mob Theem 1. Lub peev xwm kho mob ntawm IBI343 tam sim no tab tom tshawb nrhiav hauv cov hom qog nqaij hlav xws li mob qog nqaij hlav hauv plab thiab mob qog nqaij hlav pancreatic.
Thaum lub Tsib Hlis 2024, Tuam Tshoj Lub Chaw Saib Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau tso cai rau IBI343 los siv ua ib tus neeg sawv cev rau cov neeg mob uas muaj CLDN18.2-positive gastric lossis gastroesophageal junction (GEJ) adenocarcinoma uas tau muaj kev mob nkeeg tom qab ob txoj kev kho mob ua ntej. Qhov kev sim theem 3 (NCT06238843) ntawm IBI343 rau qhov kev qhia no tseem tab tom ua mus.
Thaum Lub Rau Hli 2024, IBI343 tau txais Fast Track Designation los ntawm US Food and Drug Administration (FDA) rau kev kho mob ntawm cov qog nqaij hlav pancreatic ductal adenocarcinoma (PDAC) uas tsis tuaj yeem phais lossis kis mus rau lwm qhov uas tau rov qab los thiab/lossis tsis kho tau ib txoj kev kho mob ua ntej. Kev sim theem 1 ntawm ntau thaj tsam (NCT05458219) ntawm IBI343 rau PDAC uas tau kho ua ntej tseem tab tom ua mus.
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.
Xov Tooj: 4008803716
Email：myimmnet@163.com
Cov ntaub ntawv siv los ua piv txwv
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://cn.innoventbio.com/#/
Lub sijhawm tshaj tawm: Lub Ib Hlis-17-2025