I-TROP2 ADC sac-TMT entsha ibonisa umsebenzi othembisayo wokulwa nethumba kwii-tumor eziqinileyo eziphambili

Ngomhla wesi-6 kweyeSilimela, ijenali yezonyango yehlabathi iJournal of Hematology & Oncology yapapasha iziphumo zophando lwesigaba soku-1/sesibini (KL264-01/MK-2870-001) lwe-TROP2 ADC sacituzumab tirumotecan (sac-TMT) entsha njengonyango olulodwa lwe-tumor eqinileyo engenakucocwa ekwindawo okanye eguqukileyo echasene nonyango oluqhelekileyo.

I-Sacituzumab tirumotecan (sac-TMT) yi-antibody-drug conjugate eyenziwe yi-antibody ye-anti-TROP2 monoclonal edityaniswe ne-cytotoxic belotecan-derived topoisomerase I inhibitor (KL610023) ngesixhobo esitsha sokudibanisa.

Iindlela

Izigulana zazinezimila eziqinileyo eziphucukileyo/ezisasazekayo ezinganyangekiyo ezinganyangekiyo kunyango oluqhelekileyo. Kwiqela le-dose-escalation cohorts yesigaba soku-1, izigulana zazinezimila eziqinileyo eziphucukileyo/ezisasazekayo ezinganyangekiyo kunyango oluqhelekileyo. I-Sac-TMT yayinikwa ngokufakwa ngemithambo rhoqo kwiiveki ezi-2 kwi-2 ukuya kwi-12 mg/kg. Kwisigaba sesi-2, izigulana ezine-TNBC kunye nomhlaza webele we-HR+/HER2− zafumana i-sac-TMT ngeedosi ezicetyiswayo zokwandiswa (ii-RDE) ezichongiweyo kwisigaba soku-1. Iinjongo eziphambili yayikukumisela idosi ephezulu enyanyekelwayo (i-MTD) ye-sac-TMT kunye nokumisela ii-RDE (isigaba soku-1) kunye nokumisela i-ORR nge-RECIST v1.1 ngovavanyo lophando (isigaba sesi-2). Iziganeko ezimbi zavavanywa ngokwe-NCI-CTCAE version 5.0.

Iziphumo

Izigulana ezingamashumi amathathu zibhaliswe kwisigaba soku-1 kwaye zafumana i-sac-TMT 2 mg/kg (n = 4), 4 mg/kg (n = 7), 5 mg/kg (n = 7), 5.5 mg/kg (n = 5), kunye ne-6 mg/kg (n = 7). Izigulana ezihlanu zazinetyhefu ethintela idosi: i-stomatitis yebanga lesi-3 kwi-4, 5.5, kunye ne-6 mg/kg; i-rash yebanga lesi-3 kwi-5 mg/kg; kunye ne-urticaria yebanga lesi-3 kwi-6 mg/kg. I-MTD yayiyi-5.5 mg/kg kwaye ii-RDE zaziyi-4 kunye ne-5 mg/kg. Kwinqanaba lesi-2 lokwandiswa kwedosi, i-ORR (95% CI) yayiyi-34.8% (16.4%, 57.3%) kwiqela le-4-mg/kg (n = 23) kunye ne-38.9% (23.1%, 56.5%) kwiqela le-5-mg/kg (n = 36) le-TNBC. I-ORR (95% CI) yayiyi-31.7% (18.1%, 48.1%) yomhlaza webele we-HR+/HER2− (n = 41).

Izigqibo

I-Sac-TMT ibonakalise iprofayili yokhuseleko elawulekayo kwizigulane ezineethumba eziqinileyo ezingenakucocwa kwindawo yazo/ezinomhlaza oqinileyo kunye nomsebenzi othembisayo wokulwa nethumba kwi-metastatic TNBC kunye nomhlaza webele we-HR+/HER2 −. I-Sac-TMT iphandwa kwizifundo zesigaba sesi-3.

Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.

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