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J&J's apalutamide shows strength in non-metastatic prostate cancer

Published on 07/02/18 at 10:40am

Johnson & Johnson unveiled new data at the ASCO Genitourinary Cancer symposium which demonstrated that its androgen receptor antagonist apalutamide significantly improved median metastasis-free survival (MFS) by two years compared to placebo in patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

The 1,207-strong study also revealed that the drug decreased the risk of distant metastasis or death by 72 percent, with a median MFS of 40.5 months compared to 16.2 months for placebo. While the primary endpoint was MFS, secondary endpoints of the study included progression-free survival, overall survival, time to metastasis, and time to symptomatic progression – the drug provided significant improvement in all of these parameters except OS, where an interim analysis reveals a positive trend.  

“Metastatic castration-resistant prostate cancer is a uniformly fatal disease, with a median survival of around 2.5 years,” commented lead study author Dr Eric J Small, Professor of Medicine at the University of California, San Francisco. “The aim of this study was to see if the development of metastases in the transition from nonmetastatic to metastatic castration-resistant prostate cancer could be slowed.”

J&J originally acquired apalutamide with its $1 billion buyout of Argon Pharmaceuticals in 2013. The drug is currently undergoing priority review by the FDA, with a decision due in April this year.

Matt Fellows

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