E whakaatu ana te TROP2 ADC sac-TMT auaha i te kaha ārai pukupuku whai hua i roto i ngā pukupuku totoka matatau

I te 6 o Hune, i whakaputa te hautaka hauora o te ao, Journal of Hematology & Oncology, i ngā hua o te rangahau wāhanga I/II (KL264-01/MK-2870-001) o te TROP2 ADC sacituzumab tirumotecan (sac-TMT) auaha hei rongoā kotahi mō ngā pukupuku totoka kua horapa ki te rohe, kāore rānei e taea te tango, ā, kāore e pai ki ngā maimoatanga paerewa.

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Ko te Sacituzumab tirumotecan (sac-TMT) he hononga paturopi-rongoā i titoa mai i te paturopi monoclonal anti-TROP2 kua honoa ki te aukati topoisomerase I i ahu mai i te belotecan cytotoxic (KL610023) mā te hononga hou.

Ngā Tikanga

He pukupuku totoka kua horapa/kua horapa ngā tūroro kāore i taea te tango, ā, kāore i te kaha ki ngā maimoatanga paerewa. I roto i ngā rōpū horomanga-pikitanga wāhanga 1, he pukupuku totoka kua horapa/kua horapa ngā tūroro kāore i te kaha ki ngā maimoatanga paerewa. I tukuna a Sac-TMT mā te werohanga ā-uaua i ia 2 wiki i te 2 ki te 12 mg/kg. I te wāhanga 2, i whiwhi ngā tūroro me te mate pukupuku ū TNBC me HR+/HER2− i te sac-TMT mō ia horopeta kua tūtohutia mō te whakawhānui (RDE) i tautuhia i te wāhanga 1. Ko ngā whāinga matua ko te whakatau i te horopeta manawanui mōrahi (MTD) o te sac-TMT me te whakatū i ngā RDE (wāhanga 1) me te whakatau i te ORR mō ia RECIST v1.1 mā te aromatawai a te kairangahau (wāhanga 2). I aromatawaihia ngā pānga kino mō ia NCI-CTCAE putanga 5.0.

Ngā Hua

E toru tekau ngā tūroro i whakaurua ki te wāhanga 1, ā, i whiwhi i te sac-TMT 2 mg/kg (n = 4), 4 mg/kg (n = 7), 5 mg/kg (n = 7), 5.5 mg/kg (n = 5), me te 6 mg/kg (n = 7). E rima ngā tūroro i pāngia e ngā paitini whakawhāiti horopeta: stomatitis taumata 3 i te 4, 5.5, me te 6 mg/kg; ponana taumata 3 i te 5 mg/kg; me te urticaria taumata 3 i te 6 mg/kg. Ko te MTD he 5.5 mg/kg, ā, ko ngā RDE he 4 me te 5 mg/kg. I te whakawhānui horopeta wāhanga 2, ko te ORR (95% CI) he 34.8% (16.4%, 57.3%) i roto i te rōpū 4-mg/kg (n = 23) me te 38.9% (23.1%, 56.5%) i roto i te rōpū 5-mg/kg (n = 36) mō te TNBC. Ko te ORR (95% CI) he 31.7% (18.1%, 48.1%) mō te matepukupuku ū HR+/HER2− (n = 41).

Ngā Whakatau

I whakaatuhia e Sac-TMT he āhua haumaru ka taea te whakahaere i roto i ngā tūroro he pukupuku totoka kua horapa ā-rohe/kua horapa, ā, he pai te mahi ārai pukupuku i roto i te mate pukupuku ū kua horapa, TNBC me te HR+/HER2 −. Kei te tirotirohia a Sac-TMT i roto i ngā rangahau wāhanga 3.

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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Wā tuku: Pipiri-19-2025