I-IBI343 (CLDN 18.2 ADC) ifakiwe njengomuthi wokwelapha ophumelelayo yi-National Medical Products Administration wokwelapha iziguli ezithuthukile ze-pancreatic ductal adenocarcinoma.

Ngomhlaka-8 Januwari, i-Center for Drug Evaluation (CDE) ye-National Medical Products Administration (NMPA) yaseShayina inikeze i-Breakthrough Therapy Designation (BTD) ye-IBI343, i-TOPO1i anti-CLDN18.2 ADC engcono kakhulu, njengokwelashwa okukodwa kokwelashwa kweziguli ze-CLDN18.2-positive pancreatic ductal adenocarcinoma (PDAC) eziye zathuthuka ngemuva kokwelashwa okungenani okukodwa kwangaphambilini.

I-BTD ye-IBI343 yanikezwa ngokusekelwe kudatha evela ocwaningweni oluqhubekayo lweSigaba 1 olwenziwe eShayina, e-Australia nase-US (NCT05458219), olubonise ukuphepha nokubekezeleleka okuhle, kanye nomsebenzi othembisayo wokulwa nomdlavuza we-IBI343 monotherapy ezigulini ezithuthukile ze-PDAC. Imininingwane evela eqenjini lokwandisa umthamo wocwaningo yethulwe ngomlomo kwi-ESMO Asia Congress ka-2024:

Kusukela ngomhlaka-6 Septhemba 2024, iziguli ezingu-43 ezinamangqamuzana e-CLDN18.2 (≥60% amaseli esimila ane-membrane staining intensity ≥1+ yi-IHC) advanced PDAC zathola i-IBI343 6 mg/kg Q3W monotherapy. Bonke ababambiqhaza babethole okungenani umugqa owodwa wokwelashwa kwangaphambilini, kanti abangu-60.5% babethole imigqa emibili noma ngaphezulu yokwelashwa komdlavuza.

Iziguli ezingu-43 zihlolwe ukusebenza kahle kwazo ngesilinganiso sokuphendula esiphelele (ORR) esingu-32.6%, isilinganiso sokuphendula esiqinisekisiwe (cORR) esingu-23.3%, kanye nesilinganiso sokulawula izifo esiqinisekisiwe (cDCR) esingu-81.4%.

Njengoba usuku lokuphela kwedatha, iziguli ezine kweziyi-10 ze-cORR zase zithuthukile, ubude besikhathi esimaphakathi sokuphendula (mDoR) babuyizinyanga eziyi-7.0 (4.0-NC), kanti izinga le-DoR lezinyanga eziyi-6 lalingu-63%. Iziguli ezingu-26 zenze izenzakalo ze-PFS, kanye nokusinda okumaphakathi okungenakho ukuqhubeka (mPFS) kwezinyanga ezingu-5.3 (4.1-7.4), futhi idatha ye-OS ayikavuthwa.

Imiphumela yokuphepha ebuyekeziwe ibonise iphrofayili yokuphepha enhle ye-IBI343 ngesilinganiso esiphansi njalo sobuthi besisu futhi kungekho zimpawu ezintsha zokuphepha. Ama-97.7% abahlanganyeli babhekane nemicimbi emibi yokwelashwa (ama-TEAE), lapho ama-TEAE avame kakhulu kube yi-anemia, inani lama-neutrophil lehlile, ukwehla kwesifiso sokudla, isicanucanu, kanye nenani lamaseli amhlophe egazi lehlile. Ama-51.2% abahlanganyeli babhekane ne-TEAEs yebanga lesi-3, futhi akukho ≥ isicanucanu nokuhlanza okwenzekayo kwebanga lesi-3. Akukho TEAE okwaholela ekufeni.

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

I-IBI343 iyi-recombinant human anti-CLDN18.2 monoclonal antibody-drug conjugate (ADC) eyakhiwe yi-Innovent Biologics. I-IBI343 ibopha kumaseli esimila aveza i-CLDN18.2, i-CLDN18.2 dependent ADC internalization izokwenzeka futhi umuthi ukhishwe okuholela ekulimaleni kwe-DNA futhi ekugcineni i-apoptosis yamaseli esimila. Umuthi okhululiwe ungasakazeka futhi kulo lonke ulwelwesi lwe-plasma ukuze ufinyelele futhi ubulale amaseli angomakhelwane, okuholela "ekufeni kwabantu ababukele".

Njenge-TOPO1i ADC entsha, i-IBI343 ibonise ukuphepha okubekezelelekayo nokukhuthaza izimpawu zokusebenza kahle ezifundweni zezokwelapha zeSigaba 1. Amandla okwelapha e-IBI343 okwamanje ayahlolwa ezinhlotsheni zezimila ezifana nomdlavuza wesisu kanye ne-pancreatic.

NgoMeyi 2024, i-National Medical Products Administration (NMPA) yaseShayina yanikeza i-IBI343 igama lokwelashwa okuphumelelayo (BTD) ukuze lisetshenziswe njenge-ejenti eyodwa ezigulini ezine-CLDN18.2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma ezabhekana nokuqhubeka kwesifo ngemuva kwemigqa emibili yangaphambilini yokwelashwa okuhlelekile. Isivivinyo seSigaba sesi-3 (NCT06238843) se-IBI343 salesi sibonakaliso siyaqhubeka.

NgoJuni 2024, i-IBI343 yathola i-Fast Track Designation yi-US Food and Drug Administration (FDA) yokwelapha i-advanced unrecoccusable noma i-metastatic pancreatic ductal adenocarcinoma (PDAC) esebuyele emuva futhi/noma engavumelani nomugqa owodwa wokwelashwa wangaphambilini. Ukuhlolwa kweSigaba 1 sezifunda eziningi (NCT05458219) se-IBI343 se-PDAC eyelashwe ngaphambilini kuyaqhubeka.

Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.

Inombolo yocingo: 4008803716

Email：myimmnet@163.com

Izinkomba

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 ezigulini (ama-pts) ezine-pancreatic ductal adenocarcinoma (PDAC) ethuthukisiwe: Imiphumela ebuyekeziwe evela ocwaningweni lwesigaba sokuqala - Ama-Annals of Oncology