TROP2 ADC sac-TMT Yatsopano Ikuwonetsa Ntchito Yothandiza Polimbana ndi Chotupa mu Zotupa Zolimba Zapamwamba

Pa June 6, magazini ya zachipatala yapadziko lonse ya Journal of Hematology & Oncology inafalitsa zotsatira za kafukufuku wa gawo loyamba/lachiwiri (KL264-01/MK-2870-001) wa TROP2 ADC sacituzumab tirumotecan (sac-TMT) watsopano ngati mankhwala amodzi a khansa yoopsa yomwe singachiritsidwe m'deralo kapena yofalikira kwambiri yomwe singathe kuchiritsidwa ndi mankhwala wamba.

Sacituzumab tirumotecan (sac-TMT) ndi mankhwala opangidwa ndi antibody-drug conjugate opangidwa ndi anti-TROP2 monoclonal antibody yolumikizidwa ndi cytotoxic belotecan-derived topoisomerase I inhibitor (KL610023) kudzera mu cholumikizira chatsopano.

Njira

Odwala anali ndi zotupa zolimba zomwe sizinachotsedwe m'deralo zomwe sizinachotsedwe, zomwe sizinachiritsidwe ndi mankhwala wamba. Mu gulu loyamba la mlingo, odwala anali ndi zotupa zolimba zomwe sizinachotsedwe m'deralo zomwe sizinachiritsidwe, zomwe sizinachiritsidwe ndi mankhwala wamba. Sac-TMT inkaperekedwa kudzera m'mitsempha milungu iwiri iliyonse pa 2 mpaka 12 mg/kg. Mu gawo lachiwiri, odwala omwe ali ndi khansa ya m'mawere ya TNBC ndi HR+/HER2− adalandira sac-TMT pa mlingo woyenera wa expansion (RDEs) womwe unapezeka mu gawo loyamba. Zolinga zazikulu zinali kudziwa mlingo waukulu kwambiri wolekerera (MTD) wa sac-TMT ndikukhazikitsa RDEs (gawo loyamba) ndikuzindikira ORR pa RECIST v1.1 ndi kafukufuku wofufuza (gawo lachiwiri). Zochitika zoyipa zidawunikidwa pa NCI-CTCAE version 5.0.

Zotsatira

Odwala makumi atatu adalembetsa mu gawo loyamba ndipo adalandira sac-TMT 2 mg/kg (n = 4), 4 mg/kg (n = 7), 5 mg/kg (n = 7), 5.5 mg/kg (n = 5), ndi 6 mg/kg (n = 7). Odwala asanu anali ndi poizoni wochepetsa mlingo: stomatitis ya giredi 3 pa 4, 5.5, ndi 6 mg/kg; ziphuphu za giredi 3 pa 5 mg/kg; ndi urticaria ya giredi 3 pa 6 mg/kg. MTD inali 5.5 mg/kg ndipo ma RDE anali 4 ndi 5 mg/kg. Mu kukula kwa mlingo wa gawo lachiwiri, ORR (95% CI) inali 34.8% (16.4%, 57.3%) mu gulu la 4-mg/kg (n = 23) ndi 38.9% (23.1%, 56.5%) mu gulu la 5-mg/kg (n = 36) la TNBC. ORR (95% CI) inali 31.7% (18.1%, 48.1%) ya khansa ya m'mawere ya HR+/HER2− (n = 41).

Mapeto

Sac-TMT yawonetsa chitetezo chodalirika mwa odwala omwe ali ndi zotupa zokhazikika zomwe sizingathe kuchiritsidwa m'deralo komanso zomwe zingathandize polimbana ndi chotupa mu khansa ya m'mawere ya TNBC ndi HR+/HER2 −. Sac-TMT ikufufuzidwa mu maphunziro a gawo lachitatu.

Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.

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