2021
DOI: 10.1016/j.annonc.2021.03.005
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Sacituzumab govitecan, a Trop-2-directed antibody-drug conjugate, for patients with epithelial cancer: final safety and efficacy results from the phase I/II IMMU-132-01 basket trial

Abstract: Background: Sacituzumab govitecan (SG), a trophoblast cell surface antigen-2 (Trop-2)-directed antibody-drug conjugate, has demonstrated antitumor efficacy and acceptable tolerability in a phase I/II multicenter trial (NCT01631552) in patients with advanced epithelial cancers. This report summarizes the safety data from the overall safety population (OSP) and efficacy data, including additional disease cohorts not published previously. Patients and methods: Patients with refractory metastatic epithelial cancer… Show more

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Cited by 207 publications
(181 citation statements)
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“…Our immunohistochemical results revealed strong Trop2 expression in EMPD, suggesting EMPD is a good candidate for sacituzumab govitecan. Furthermore, strong Trop2 expression in hair follicles accords well with the fact that alopecia was a common (occurred in 40.4% of patients) treatmentrelated adverse event in the basket trial [36].…”
Section: Discussionsupporting
confidence: 72%
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“…Our immunohistochemical results revealed strong Trop2 expression in EMPD, suggesting EMPD is a good candidate for sacituzumab govitecan. Furthermore, strong Trop2 expression in hair follicles accords well with the fact that alopecia was a common (occurred in 40.4% of patients) treatmentrelated adverse event in the basket trial [36].…”
Section: Discussionsupporting
confidence: 72%
“…As a Trop2-targeted therapy, sacituzumab govitecan has recently entered clinical use [ 35 , 36 ]. Sacituzumab govitecan is an ADC consisting of a fully humanized IgG1 anti-Trop2 antibody and the active metabolite of irinotecan (SN-38), a topoisomerase I inhibitor.…”
Section: Discussionmentioning
confidence: 99%
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“…Ideally, the linker that connects the antibody to the drug should be stable in circulation and cleaved enzymatically (by a protease such as cathepsin B) or chemically (by reducing agents such as cysteine and GSH) inside the cell to release the attached payload to act on the intended target ( Zhang et al, 2016a ; Zhang et al, 2016b ; Ponziani et al, 2020 ; Poreba, 2020 ) In the absence of linker stability in serum, premature release of the payload can result in systemic toxicity. Whereas the low stability of Trodelvy ® bearing an unstable linker seems to avoid this effect with manageable safety likely due to the selected toxicity profile of its topisomerase I inhibitor payload ( Bardia et al, 2017 ; Sahota and Vahdat, 2017 ; Bardia et al, 2021 ). On the other hand, inefficient cleavage of the linker inside the cell may not produce the intended antitumor activity ( Zhang et al, 2016a ; Zhang et al, 2016b ; Ma et al, 2016 ; Poreba, 2020 ).…”
Section: Modulating Antibody-drug Conjugate Stability Via Conjugation Site Linker Length and Linker Steric Hindrancementioning
confidence: 99%