IBI343 (CLDN 18.2 ADC) yaphatikizidwa ngati mankhwala ochizira opambana ndi National Medical Products Administration pochiza odwala a pancreatic ductal adenocarcinoma.

Pa Januwale 8, Center for Drug Evaluation (CDE) ya China's National Medical Products Administration (NMPA) yapereka Breakthrough Therapy Designation (BTD) ya IBI343, mankhwala abwino kwambiri oletsa CLDN18.2 ADC, ngati mankhwala amodzi ochizira odwala a CLDN18.2-positive advanced pancreatic ductal adenocarcinoma (PDAC) omwe apita patsogolo atatha kulandira chithandizo chimodzi mwa njira zomwe adapatsidwa kale.

BTD ya IBI343 idaperekedwa kutengera deta yochokera ku kafukufuku wa Gawo 1 womwe ukuchitika ku China, Australia ndi US (NCT05458219), womwe udawonetsa chitetezo chabwino komanso kulekerera, komanso ntchito yabwino yolimbana ndi chotupa cha IBI343 monotherapy mwa odwala apamwamba a PDAC. Deta yochokera ku gulu lokulitsa mlingo wa kafukufukuyu idaperekedwa pakamwa pa 2024 ESMO Asia Congress:

Pofika pa Seputembala 6, 2024, odwala 43 omwe anali ndi CLDN18.2-positive (≥60% maselo otupa omwe ali ndi mphamvu yopaka utoto wa membranous ≥1+ ndi IHC) advanced PDAC adalandira IBI343 6 mg/kg Q3W monotherapy. Onse omwe adatenga nawo mbali adalandira kale mzere umodzi wa chithandizo chakale, ndipo 60.5% adalandira mizere iwiri kapena kuposerapo ya chithandizo choletsa khansa.

Odwala 43 adayesedwa bwino ndi kuchuluka kwa mayankho olunjika (ORR) kwa 32.6%, kuchuluka kwa mayankho otsimikizika (cORR) kwa 23.3%, ndi kuchuluka kwa matenda otsimikizika (cDCR) kwa 81.4%.

Pamene tsiku lomaliza la deta linafika, odwala anayi mwa khumi a cORR anali atapita patsogolo, nthawi yapakati yoyankhira (mDoR) inali miyezi 7.0 (4.0-NC), ndipo chiŵerengero cha DoR cha miyezi 6 chinali 63%. Odwala 26 adakumana ndi zochitika za PFS, ndi kupulumuka kwapakati kopanda kupita patsogolo (mPFS) kwa miyezi 5.3 (4.1-7.4), ndipo deta ya OS sinakule.

Zotsatira zatsopano za chitetezo zinawonetsa mbiri yabwino ya chitetezo cha IBI343 ndi chiŵerengero chotsika cha poizoni m'mimba komanso palibe zizindikiro zatsopano zachitetezo. 97.7% ya omwe adatenga nawo mbali adakumana ndi zochitika zoyipa zomwe zimachitika mwadzidzidzi (TEAEs), pomwe ma TEAE ofala kwambiri anali kuchepa kwa magazi m'thupi, kuchuluka kwa ma neutrophil kunachepa, kuchepa kwa chilakolako cha chakudya, nseru, ndi kuchuluka kwa maselo oyera m'magazi kunachepa. 51.2% ya omwe adatenga nawo mbali adakumana ndi ma TEAE a giredi 3, ndipo palibe nseru ndi kusanza kwa giredi 3 komwe kudachitika. Palibe TEAE yomwe idapangitsa kuti afe.

Zokhudza IBI343 (Anti-CLDN18.2 ADC)

IBI343 ndi mankhwala opangidwa ndi anthu omwe amalimbana ndi CLDN18.2 monoclonal antibody-drug conjugate (ADC) omwe amapangidwa ndi Innovent Biologics. IBI343 imagwirizana ndi maselo otupa omwe amawonetsa CLDN18.2, CLDN18.2 dependent ADC internalization imachitika ndipo mankhwalawa amatulutsidwa zomwe zimapangitsa kuti DNA iwonongeke komanso kuti maselo otupa awonongeke. Mankhwala omasulidwawo amathanso kufalikira kudzera mu plasma nembanemba kuti afikire ndikupha maselo oyandikana nawo, zomwe zimapangitsa kuti "kupha anthu omwe akuyang'ana".

Monga TOPO1i ADC yatsopano, IBI343 yawonetsa chitetezo chovomerezeka komanso yolimbikitsa zizindikiro zogwira ntchito bwino mu maphunziro azachipatala a Gawo 1. Mphamvu yochiritsira ya IBI343 ikufufuzidwa pakali pano m'mitundu ya zotupa monga khansa ya m'mimba ndi ya kapamba.

Mu Meyi 2024, bungwe la National Medical Products Administration (NMPA) la ku China linapereka chizindikiro cha breakthrough therapy (BTD) ku IBI343 kuti igwiritsidwe ntchito ngati mankhwala amodzi mwa odwala omwe ali ndi CLDN18.2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma omwe adakumana ndi matenda pambuyo pa njira ziwiri zochiritsira za systemic. Kuyesa kwa Gawo 3 (NCT06238843) kwa IBI343 pazizindikirozi kukupitilira.

Mu June 2024, IBI343 idalandira Fast Track Designation ndi US Food and Drug Administration (FDA) kuti ichite chithandizo cha advanced unrecoctable or metastatic pancreatic ductal adenocarcinoma (PDAC) yomwe yabwereranso ndipo/kapena ikukana chithandizo chimodzi cham'mbuyomu. Kuyesa kwa Multi-Regional Phase 1 (NCT05458219) kwa IBI343 kwa PDAC yomwe idachiritsidwa kale kukupitilira.

Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.

Nambala ya Foni: 4008803716

Email：myimmnet@163.com

Zolemba

1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

2.https://cn.innoventbio.com/#/

3.132MO Anti-claudin18.2 (CLDN18.2) antibody-drug conjugate (ADC) IBI343 mwa odwala (pts) omwe ali ndi pancreatic ductal adenocarcinoma yapamwamba (PDAC): Zotsatira zatsopano kuchokera ku kafukufuku wa gawo loyamba - Annals of Oncology