Asco-GU 2019 – Arches confirms Erleada’s difficult task

Xtandi’s performance in the Arches study of 1,150 hormone-sensitive prostate cancer patients has confirmed that Johnson & Johnson faces a tall order in maintaining its prostate cancer franchise with the Zytiga follow-on Erleada. Arches was in December reported to have met its primary endpoint, significantly improving radiographic progression-free survival, and the Asco-Genitourinary Cancers symposium abstract unveiled yesterday revealed that this reduction amounted to 61% versus control. This puts the Pfizer/Astellas drug on a par with J&J’s Zytiga, which is already approved in this new use, but which will soon face generic competition. Erleada’s own trial in hormone-sensitive disease, Titan, has yielded positive topline data, but full results have not yet been disclosed (Titan could give Erleada a fighting chance, January 31, 2019). Xtandi’s second trial in this setting, Embark, is still ongoing, and for now its battle against Erleada is limited to the two drugs’ approved use, non-metastatic, castration-resistant disease (a setting where Zytiga does not feature), on the back of the respective Prosper and Spartan trials.

Selected results in hormone-sensitive prostate cancer
Study OS rPFS/FFS
Zytiga plus androgen deprivation
Latitude (NCT01715285) HR=0.62 HR=0.47
Stampede (NCT00268476) HR=0.63 HR=0.29
Xtandi plus androgen deprivation
Arches (NCT02677896) Data immature HR=0.39

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