Kua Whiwhi te ADC Sac-TMT a Kelun-Biotech i te Tohu Whakaora Hou i Haina

I te 11 o Hune, i panuitia e Kelun-Biotech kua whakawhiwhia ki te Tohu Whakaora Pakari (BTD) te rongoā TROP2 ADC (佳泰莱) i whakawhanakehia motuhaketia, me te PD-L1 monoclonal antibody tagitanlimab (科泰莱), e te Center for Drug Evaluation (CDE) o te National Medical Products Administration (NMPA) o Haina mō te maimoatanga tuatahi o ngā tūroro mate pukupuku pūkahukahu kore-pūtau iti (NSCLC) kua whanake ā-rohe, kua metastatic rānei, kāore he whakarerekētanga ira taraiwa.

Ko Sac-TMT, he hua matua o te Kamupene, he TROP2 ADC tangata hou kei roto i te Kamupene ngā mana pupuri hinengaro, e aro ana ki ngā pukupuku totoka matatau pēnei i te NSCLC, te mate pukupuku ū (BC), te mate pukupuku puku (GC), ngā pukupuku wahine, me ētahi atu. Kua whakawhanakehia a Sac-TMT me tētahi hononga hou hei hono i te kawenga, he aukati topoisomerase I belotecan-derivative me te ōwehenga rongoā-ki-te-antibody (DAR) o te 7.4. Ka mōhio motuhake a Sac-TMT ki a TROP2 i runga i te mata o ngā pūtau pukupuku mā roto i ngā paturopi monoclonal anti-TROP2 recombinant, ka endocytosed e ngā pūtau pukupuku ka tukuna a KL610023 ki roto i te pūtau. Ko KL610023, hei aukati topoisomerase I, ka puta te kino o te DNA ki ngā pūtau pukupuku, ka arahi ki te aukati huringa pūtau me te apoptosis. Hei tāpiri, ka tukuna hoki a KL610023 ki roto i te taiao moroiti pukupuku. I te mea he uruhanga ā-kiri te KL610023, ka taea e ia te whakahohe i tētahi pānga tūmatanui, arā, te patu i ngā pūtau pukupuku e tata ana.

Ko tēnei Tohu Whakaora Whanui i ahu mai i ngā raraunga whai huatanga me te haumaru mai i te rōpū kore-squamous o te rangahau OptiTROP-Lung01 Wāhanga II.

I whakaaturia ngā hua o te rangahau OptiTROP-Lung01 Wāhanga II, i arotakehia ai te sac-TMT me te KL-A167 (he paturopi monoclonal anti-PD-L1) hei maimoatanga tuatahi mō ngā tūroro NSCLC matatau kāore i te whai ira taraiwa, ki te Hui-ā-Tau Mātauranga CSCO 2024.

I whakaatuhia e ngā kitenga: Mō te Rōpū 1A, ko te roanga o te aroturukitanga toharite he 14.0 marama, me te reiti urupare whāinga (ORR) o te 48.6% (18/37, 2 ngā kēhi e tatari ana kia whakaūtia), he reiti whakahaere mate (DCR) o te 94.6%, he roanga ora kore-haere whakamua (PFS) o te 15.4 marama (95% CI: 6.7, NE), me te reiti PFS 6-marama o te 69.2%; mō te Rōpū 1B, ko te roanga o te aroturukitanga toharite he 6.9 marama, me te ORR o te 77.6% (45/58, 5 ngā kēhi e tatari ana kia whakaūtia), he DCR o te 100.0%, he PFS toharite kāore anō kia tutuki, me te reiti PFS 6-marama o te 84.6%.

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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