I-TROP2 ADC sac-TMT entsha ikhombisa umsebenzi othembisayo wokulwa nomdlavuza kuma-Tumors aqinile athuthukile

Ngomhlaka-6 Juni, ijenali yezokwelapha yamazwe ngamazwe i-Journal of Hematology & Oncology yashicilela imiphumela yocwaningo lwesigaba I/II (KL264-01/MK-2870-001) lwe-TROP2 ADC sacituzumab tirumotecan (sac-TMT) entsha njengokwelashwa okukodwa kwamathumba aqinile angasuswa endaweni noma asakazeke kalula angahambisani nokwelashwa okujwayelekile.

I-Sacituzumab tirumotecan (sac-TMT) iyi-antibody-drug conjugate eyakhiwe yi-antibody ye-anti-TROP2 monoclonal ehlanganiswe ne-cytotoxic belotecan-derived topoisomerase I inhibitor (I-KL610023) ngesixhumanisi esisha.

Izindlela

Iziguli zazinezimila eziqinile ezithuthukisiwe/ezinama-metastatic ezingasuswanga endaweni ethile ezingasuswanga ezingasuswanga ekwelashweni okujwayelekile. Kumaqoqo okukhula komthamo wesigaba 1, iziguli zazinezimila eziqinile ezithuthukisiwe/ezinama-metastatic ezingasuswanga endaweni ethile ezingasuswanga ezisuswanga ekwelashweni okujwayelekile. I-Sac-TMT yayinikezwa ngokufakwa ngemithambo njalo emavikini ama-2 ku-2 kuya ku-12 mg/kg. Esigabeni sesi-2, iziguli ezine-TNBC kanye nomdlavuza webele we-HR+/HER2− zathola i-sac-TMT ngamadosi anconyiwe okwandisa (ama-RDE) atholakale esigabeni soku-1. Izinhloso eziyinhloko kwakuwukunquma umthamo obekezelelwe ophezulu (MTD) we-sac-TMT kanye nokusungula ama-RDE (isigaba soku-1) kanye nokunquma i-ORR nge-RECIST v1.1 ngokuhlolwa komphenyi (isigaba sesi-2). Izehlakalo ezimbi zahlolwa ngokwe-NCI-CTCAE version 5.0.

Imiphumela

Iziguli ezingamashumi amathathu zabhaliswa esigabeni soku-1 futhi zathola i-sac-TMT 2 mg/kg (n = 4), 4 mg/kg (n = 7), 5 mg/kg (n = 7), 5.5 mg/kg (n = 5), kanye no-6 mg/kg (n = 7). Iziguli ezinhlanu zazinobuthi obukhawulela umthamo: i-stomatitis yebanga lesi-3 ku-4, 5.5, kanye no-6 mg/kg; ukuqubuka kwebanga lesi-3 ku-5 mg/kg; kanye ne-urticaria yebanga lesi-3 ku-6 mg/kg. I-MTD yayingu-5.5 mg/kg kanti ama-RDE ayengu-4 no-5 mg/kg. Ekukhulisweni komthamo wesigaba sesi-2, i-ORR (95% CI) yayingu-34.8% (16.4%, 57.3%) eqenjini le-4-mg/kg (n = 23) kanye no-38.9% (23.1%, 56.5%) eqenjini le-5-mg/kg (n = 36) le-TNBC. I-ORR (95% CI) yayingu-31.7% (18.1%, 48.1%) yomdlavuza webele we-HR+/HER2− (n = 41).

Iziphetho

I-Sac-TMT ibonise iphrofayili yokuphepha elawulekayo ezigulini ezinezimila eziqinile ezingasuswa endaweni/ezinama-metastatic kanye nomsebenzi othembisayo wokulwa nesimila kumdlavuza webele we-metastatic TNBC kanye ne-HR+/HER2 −. I-Sac-TMT iyaphenywa ezifundweni zesigaba sesi-3.

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.

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