I-IBI343 (CLDN 18.2 ADC) ifakiwe njengeyeza lonyango eliphambili yi-National Medical Products Administration ukuze kunyangwe izigulane ze-pancreatic ductal adenocarcinoma eziphambili.

Ngomhla wesi-8 kweyoMqungu, iZiko loVavanyo lwaMayeza (i-CDE) le-National Medical Products Administration (i-NMPA) yaseTshayina linike i-Breakthrough Therapy Designation (BTD) kwi-IBI343, i-TOPO1i anti-CLDN18.2 ADC enokuba yeyona ilungileyo kwiklasi, njengonyango olulodwa lokunyanga izigulane ze-CLDN18.2-positive advanced pancreatic ductal adenocarcinoma (PDAC) eziye zaqhubeka emva konyango olunye olucwangcisiweyo ngaphambili.

I-BTD ye-IBI343 inikwe ngokusekelwe kwidatha evela kuphando oluqhubekayo lweSigaba soku-1 olwenziwe eTshayina, e-Australia nase-US (NCT05458219), olubonise ukhuseleko oluhle kunye nokunyamezeleka, kunye nomsebenzi othembisayo wokulwa nomhlaza we-IBI343 monotherapy kwizigulane ze-PDAC eziphambili. Idatha evela kwiqela lophando lokwandisa umthamo iboniswe ngomlomo kwi-ESMO Asia Congress ka-2024:

Ukusukela nge-6 kaSeptemba 2024, izigulane ezingama-43 ezipheleleyo ezine-CLDN18.2-positive (≥60% iiseli zethumba ezine-membrane staining intensity ≥1+ yi-IHC) i-PDAC ephucukileyo ifumene i-IBI343 6 mg/kg Q3W monotherapy. Bonke abathathi-nxaxheba ngaphambili babefumene ubuncinane umgca omnye wonyango lwangaphambili, kwaye ama-60.5% ayefumene imigca emibini nangaphezulu yonyango lomhlaza.

Izigulane ezingama-43 zivavanyiwe ukusebenza kakuhle kwazo, izinga lokuphendula elijolise kuko konke (ORR) eliyi-32.6%, izinga lokuphendula elijolise kuko konke (cORR) eliyi-23.3%, kunye nezinga lokulawula izifo eliqinisekisiweyo (cDCR) eliyi-81.4%.

Njengoko umhla wokugqibela wedatha wawusele udlulile, izigulane ezi-4 kwezili-10 ze-cORR zazisele ziqhubekile, ubude bexesha eliphakathi lokuphendula (mDoR) yayiyiinyanga eziyi-7.0 (4.0-NC), kwaye izinga le-DoR leenyanga ezi-6 lalingama-63%. Izigulane ezingama-26 zenzeka kwiziganeko ze-PFS, kunye nokusinda okuphakathi okungenankqubela phambili (mPFS) kweenyanga eziyi-5.3 (4.1-7.4), kwaye idatha ye-OS ayikavuthwa.

Iziphumo zokhuseleko ezihlaziyiweyo zibonise iprofayili yokhuseleko oluhle lwe-IBI343 ngesantya esiphantsi rhoqo setyhefu yesisu kwaye akukho zimpawu zintsha zokhuseleko. Ama-97.7% abathathi-nxaxheba afumene iziganeko ezingalunganga zonyango-ezivela ngokukhawuleza (ii-TEAE), apho ii-TEAE eziqhelekileyo ziyi-anemia, inani le-neutrophil linciphile, ukuncipha komnqweno wokutya, isicaphucaphu, kunye nenani leeseli ezimhlophe zegazi lehlile. Ama-51.2% abathathi-nxaxheba afumene ii-TEAE zebanga lesi-3, kwaye akukho sicaphucaphu kunye nokuhlanza kwebanga lesi-3. Akukho TEAE eyakhokelela ekufeni.

Malunga ne-IBI343 (Anti-CLDN18.2 ADC)

I-IBI343 yi-recombinant human anti-CLDN18.2 monoclonal antibody-drug conjugate (ADC) eyenziwe yi-Innovent Biologics. I-IBI343 ibopha kwiiseli ze-tumor eziveza i-CLDN18.2, i-CLDN18.2 dependent ADC internalization iya kwenzeka kwaye iyeza liyakhutshwa nto leyo ekhokelela kumonakalo we-DNA kwaye ekugqibeleni i-apoptosis yeeseli ze-tumor. Eli yeza likhululekileyo linokusasaza kwi-plasma membrane ukuze lifikelele kwaye libulale iiseli ezikufutshane, nto leyo ekhokelela "kwimpembelelo yokubulala abantu ababukeleyo".

Njenge-TOPO1i ADC entsha, i-IBI343 ibonakalise ukhuseleko olunyamezelekayo kunye nemiqondiso ekhuthazayo yokusebenza kakuhle kwizifundo zeklinikhi zeSigaba soku-1. Amandla okunyanga e-IBI343 okwangoku ahlolwa kwiintlobo zeethumba ezifana nomhlaza wesisu kunye nomhlaza wepancreatic.

NgoMeyi 2024, i-National Medical Products Administration (NMPA) yaseTshayina yanika i-IBI343 i-throughthrapy notation (BTD) ukuba isetyenziswe njenge-arhente enye kwizigulane ezine-CLDN18.2–positive gastric or gastroesophageal junction (GEJ) adenocarcinoma ezathi zafumana ukuqhubela phambili kwesifo emva kweendlela ezimbini zonyango lwangaphambili. Uvavanyo lweSigaba sesi-3 (NCT06238843) lwe-IBI343 kwesi sibonakaliso luyaqhubeka.

NgoJuni 2024, i-IBI343 yafumana i-Fast Track Designation yi-US Food and Drug Administration (FDA) yokunyanga i-advanced unrecoctable okanye i-metastatic pancreatic ductal adenocarcinoma (PDAC) ebuye yabuyela kwi-previous and/or engayithandiyo indlela yonyango yangaphambili. Uvavanyo lweSigaba soku-1 semimandla emininzi (NCT05458219) se-IBI343 kwi-PDAC eyayinyangiwe ngaphambili luyaqhubeka.

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.

Inombolo yefowuni: 4008803716

Email：myimmnet@163.com

Iireferensi

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

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

3.I-132MO Anti-claudin18.2 (CLDN18.2) i-antibody-drug conjugate (ADC) I-IBI343 kwizigulane (pts) ezine-pancreatic ductal adenocarcinoma (PDAC) ephucukileyo: Iziphumo ezihlaziyiweyo ezivela kwisifundo sesigaba soku-1 - Iingxelo ze-Annals of Oncology