TROP2 ADC sac-TMT oo cusub ayaa muujinaysa firfircooni rajo leh oo ka dhan ah burooyinka burooyinka ee burooyinka adag ee horumarsan.

Juun 6, joornaalka caafimaadka caalamiga ah ee Joornaalka Hematology & Oncology wuxuu daabacay natiijooyinka daraasadda wejiga I/II (KL264-01/MK-2870-001) ee TROP2 ADC sacituzumab tirumotecan (sac-TMT) oo ah daaweyn hal-abuur leh oo loogu talagalay burooyinka adag ee aan la tirtiri karin ee maxalliga ah ama kuwa aan la daaweyn karin ee ka soo horjeeda daaweynta caadiga ah.

Sacituzumab tirumotecan (sac-TMT) waa isku-darka antibody-dawada oo ka kooban antibody monoclonal anti-TROP2 ah oo ku xiran topoisomerase I inhibitor oo laga soo qaatay cytotoxic belotecan (ama cytotoxic belotecan).KL610023) iyada oo loo marayo xiriiriye cusub.

Hababka

Bukaannada waxay lahaayeen burooyinka adag ee maxalliga ah ee horumarsan/burburka leh oo aan la jari karin oo aan u adkaysan karin daaweynta caadiga ah. Qaybaha qiyaasta ee marxaladda 1aad, bukaannadu waxay lahaayeen burooyinka adag ee maxalliga ah ee horumarsan/burburka leh oo aan la jari karin oo aan u adkaysan karin daaweynta caadiga ah. Sac-TMT waxaa lagu maamuli jiray irbad xididka ah 2dii toddobaadba mar 2 ilaa 12 mg/kg. Marxaladda 2aad, bukaanada qaba kansarka naasaha ee TNBC iyo HR+/HER2− waxay qaadan jireen sac-TMT halkii qiyaasood ee lagu taliyay ee ballaarinta (RDEs) ee lagu aqoonsaday marxaladda 1aad. Ujeeddooyinka aasaasiga ah waxay ahaayeen go'aaminta qiyaasta ugu badan ee la dulqaadan karo (MTD) ee sac-TMT iyo sameynta RDEs (wajiga 1aad) iyo go'aaminta ORR halkii RECIST v1.1 iyadoo la adeegsanayo qiimaynta baaraha (wajiga 2aad). Dhacdooyinka xun waxaa lagu qiimeeyay nooca NCI-CTCAE 5.0.

Natiijooyinka

Soddon bukaan ayaa lagu qoray wejiga 1aad waxaana la siiyay sac-TMT 2 mg/kg (n = 4), 4 mg/kg (n = 7), 5 mg/kg (n = 7), 5.5 mg/kg (n = 5), iyo 6 mg/kg (n = 7). Shan bukaan ayaa qabay sunta xaddidaysa qiyaasta: stomatitis-ka heerka 3aad 4, 5.5, iyo 6 mg/kg; finan heerka 3aad 5 mg/kg; iyo urticaria heerka 3aad 6 mg/kg. MTD wuxuu ahaa 5.5 mg/kg halka RDE-yaduna ay ahaayeen 4 iyo 5 mg/kg. Ballaarinta qiyaasta wejiga 2aad, ORR (95% CI) wuxuu ahaa 34.8% (16.4%, 57.3%) kooxda 4-mg/kg (n = 23) iyo 38.9% (23.1%, 56.5%) kooxda 5-mg/kg (n = 36) ee TNBC. ORR (95% CI) wuxuu ahaa 31.7% (18.1%, 48.1%) kansarka naasaha HR+/HER2− (n = 41).

Gunaanad

Sac-TMT waxay muujisay astaamo badbaado oo la maarayn karo oo ku saabsan bukaanada qaba burooyinka adag ee maxalliga ah ee aan la tirtiri karin/burburka unugyada iyo firfircooni ka-hortagga burooyinka oo rajo leh oo ku jira kansarka naasaha ee TNBC iyo HR+/HER2 −. Sac-TMT waxaa lagu baarayaa daraasadaha wejiga 3aad.

Waqtigan xaadirka ah, waxaa weli jira tijaabooyin caafimaad oo badan oo ku saabsan teknoolojiyada cusub ee ka hortagga kansarka ee Shiinaha oo raadinaya bukaanno. La-tashi ku saabsan daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing.

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