Kua whakaurua a IBI343 (CLDN 18.2 ADC) hei rongoā whakaora hou e te National Medical Products Administration mō te rongoā i ngā tūroro adenocarcinoma ductal pancreatic matatau.

I te 8 o Hānuere, i whakawhiwhia e te Center for Drug Assessment (CDE) o te National Medical Products Administration (NMPA) te Breakthrough Therapy Designation (BTD) mō te IBI343, he TOPO1i anti-CLDN18.2 ADC pea te mea pai rawa atu i roto i te karaehe, hei monotherapy mō te maimoatanga o ngā tūroro CLDN18.2-positive advanced pancreatic ductal adenocarcinoma (PDAC) kua whanake haere i muri i te iti rawa i te kotahi raina o te maimoatanga pūnaha o mua.

I whakaaetia te BTD mō IBI343 i runga i ngā raraunga mai i tētahi rangahau Wāhanga 1 e haere tonu ana i Haina, Ahitereiria me te US (NCT05458219), i whakaatu i te haumaru me te manawanui pai, me te kaha ārai pukupuku o te IBI343 monotherapy i roto i ngā tūroro PDAC matatau. I tukuna ā-waha ngā raraunga mai i te rōpū whakawhānui horopeta o te rangahau i te Huihuinga Āhia o te ESMO 2024:

I te 6 o Hepetema, 2024, e 43 ngā tūroro katoa he CLDN18.2-pai (≥60% ngā pūtau pukupuku me te kaha o te tae membranous ≥1+ e IHC) PDAC matatau i whiwhi IBI343 6 mg/kg Q3W monotherapy. Kua whiwhi ngā kaiuru katoa i te iti rawa 1 raina o te maimoatanga o mua, ā, 60.5% i whiwhi 2, neke atu rānei raina o te maimoatanga anticancer.

E 43 ngā tūroro i taea te arotake i te whai huatanga me te reiti urupare whāinga whānui (ORR) o te 32.6%, te reiti urupare whāinga kua whakaūtia (cORR) o te 23.3%, me te reiti whakahaere mate kua whakaūtia (cDCR) o te 81.4%.

I te rā kati raraunga, e 4 o te 10 ngā tūroro cORR kua ahu whakamua, ko te roanga tauhohenga toharite (mDoR) he 7.0 (4.0-NC) marama, ā, ko te reiti DoR 6-marama he 63%. E 26 ngā tūroro i pāngia e ngā kaupapa PFS, me te oranga kore ahu whakamua toharite (mPFS) he 5.3 (4.1-7.4) marama, ā, kāore anō kia pakari ngā raraunga OS.

I whakaatuhia e ngā hua haumaru hou te āhua haumaru pai o IBI343 me te iti tonu o te paitini o te puku, ā, kāore he tohu haumaru hou. 97.7% o ngā kaiuru i pāngia e ngā pānga kino ohorere (TEAE), ko ngā TEAE tino kitea ko te anemia, te hekenga o te maha o ngā neutrophil, te hekenga o te hiahia kai, te whakapairuaki, me te hekenga o te maha o ngā pūtau toto mā. 51.2% o ngā kaiuru i pāngia e ngā TEAE ≥ taumata 3, ā, kāore he whakapairuaki me te ruaki ≥ taumata 3 i puta. Kāore he TEAE i mate ai.

Mō IBI343（Anti-CLDN18.2 ADC）

Ko te IBI343 he hononga rongoā monoclonal anti-CLDN18.2 tangata (ADC) i hangaia e Innovent Biologics. Ka herea te IBI343 ki ngā pūtau pukupuku e whakaatu ana i te CLDN18.2, ka puta te whakaurunga o te ADC e whakawhirinaki ana ki te CLDN18.2, ā, ka tukuna te rongoā ka hua ake te kino o te DNA, ā, i te mutunga ka mate ngā pūtau pukupuku. Ka taea hoki e te rongoā kua wetekina te horapa puta noa i te kiriuhi plasma kia tae atu ai, kia patu ai hoki i ngā pūtau tata, ka hua ake te "pānga patu tangata tū tata".

Hei TOPO1i ADC auaha, kua whakaatuhia e IBI343 te haumaru e taea ana te whakamanawanui me ngā tohu whai hua whakatenatena i roto i ngā rangahau haumanu Wāhanga 1. Kei te tūhuratia te pūmanawa rongoā o IBI343 i tēnei wā i roto i ngā momo pukupuku pēnei i te mate pukupuku puku me te mate pukupuku repeure.

I te marama o Mei 2024, i tukuna e te Whakahaere Hua Hauora ā-Motu o Haina (NMPA) te tohu whakaora pakarukaru (BTD) ki a IBI343 hei whakamahi mā te hunga whai adenocarcinoma CLDN18.2–pai o te hononga puku, te hononga gastroesophageal rānei (GEJ) i pāngia e te whanaketanga o te mate whai muri i ngā raina maimoatanga pūnaha e rua o mua. Kei te haere tonu te whakamātautau Wāhanga 3 (NCT06238843) o IBI343 mō tēnei tohu.

I te marama o Hune 2024, i whakawhiwhia a IBI343 ki te Tohu Tere mai i te US Food and Drug Administration (FDA) mō te maimoatanga o te mate pukupuku adenocarcinoma pancreatic (PDAC) kua horapa, kua hoki mai rānei, ā, kua kore e taea te rongoā i mua. Kei te haere tonu te whakamātautau Wāhanga 1 maha-rohe (NCT05458219) o IBI343 mō te PDAC i rongoatia i mua.

I tēnei wā, he maha tonu ngā whakamātautau haumanu o ngā hangarau hou hei ārai i te matepukupuku i Haina e rapu ana i ngā tūroro. Mēnā kei te hiahia koe ki te kōrero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.

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Ngā Tohutoro

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 i roto i ngā tūroro (pts) me te pancreatic ductal adenocarcinoma matatau (PDAC): Ngā hua kua whakahoutia mai i tētahi rangahau wāhanga I – Annals of Oncology