TROP2 ADC sac-TMT ọhụrụ na-egosi ọrụ mgbochi etuto ahụ na etuto siri ike dị elu

Na June 6, akwụkwọ akụkọ ahụike mba ụwa bụ Journal of Hematology & Oncology bipụtara nsonaazụ ọmụmụ nkebi nke I/II (KL264-01/MK-2870-001) nke TROP2 ADC sacituzumab tirumotecan (sac-TMT) ọhụrụ dị ka ọgwụgwọ otu maka etuto siri ike nke a na-apụghị ịgbanahụ n'ógbè ma ọ bụ nke na-anaghị anabata ọgwụgwọ ọkọlọtọ.

Sacituzumab tirumotecan (sac-TMT) bụ ọgwụ mgbochi-ọgwụ jikọtara ya na antibody anti-TROP2 monoclonal jikọtara ya na topoisomerase I inhibitor nke sitere na cytotoxic belotecan (nke sitere na cytotoxic belotecan).KL610023) site na njikọ ọhụrụ.

Ụzọ

Ndị ọrịa nwere etuto siri ike nke a na-apụghị iwepụ n'ógbè ha/metastatic nke na-anaghị anabata ọgwụgwọ ọkọlọtọ. N'ime usoro nke mbụ nke usoro nke abụọ nke usoro nke abụọ nke usoro nke abụọ, ndị ọrịa nwere etuto siri ike nke a na-apụghị iwepụ n'ógbè ha/metastatic nke na-anaghị anabata ọgwụgwọ ọkọlọtọ. A na-enye Sac-TMT site na ọgwụ intravenous kwa izu abụọ na 2 ruo 12 mg/kg. Na usoro nke abụọ, ndị ọrịa nwere kansa ara TNBC na HR+/HER2− natara sac-TMT kwa usoro akwadoro maka mgbasa (RDEs) achọpụtara na usoro nke mbụ. Ebumnuche bụ isi bụ ịchọpụta oke dose a na-anabata (MTD) nke sac-TMT na ịmepụta RDEs (usoro nke 1) na ịchọpụta ORR kwa RECIST v1.1 site na nyocha onye nyocha (usoro nke 2). E nyochachara ihe ọjọọ ndị a dịka ụdị NCI-CTCAE 5.0 si dị.

Nsonaazụ

E debara aha ndị ọrịa iri atọ na ngalaba nke mbụ ma nata sac-TMT 2 mg/kg (n = 4), 4 mg/kg (n = 7), 5 mg/kg (n = 7), 5.5 mg/kg (n = 5), na 6 mg/kg (n = 7). Ndị ọrịa ise nwere ihe ndị na-egbochi dose: stomatitis ọkwa nke atọ na 4, 5.5, na 6 mg/kg; ọkụ ọkụ ọkwa nke atọ na 5 mg/kg; na urticaria ọkwa nke atọ na 6 mg/kg. MTD bụ 5.5 mg/kg na RDEs bụ 4 na 5 mg/kg. Na mgbasa nke usoro nke abụọ nke dose, ORR (95% CI) bụ 34.8% (16.4%, 57.3%) na otu 4-mg/kg (n = 23) na 38.9% (23.1%, 56.5%) na otu 5-mg/kg (n = 36) maka TNBC. ORR (95% CI) bụ 31.7% (18.1%, 48.1%) maka ọrịa kansa ara HR+/HER2− (n = 41).

Mmechi

Sac-TMT gosipụtara nchekwa a na-achịkwa nke ọma n'ahụ ndị ọrịa nwere etuto siri ike nke na-adịghị ewepụ ihe ndị dị n'ógbè ahụ/ọrịa kansa ara nke na-adịghị ahụkebe ma na-ekwe nkwa ọrụ mgbochi etuto ahụ na kansa ara nke TNBC na HR+/HER2 − metastatic. A na-enyocha Sac-TMT n'ọmụmụ ihe nkebi nke atọ.

Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.

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