Phase III SPARTAN study of Erleada shows reduced risk of prostate cancer.- Janssen Pharma.

Janssen Pharmaceutical presented a post-hoc analysis from the Phase III SPARTAN study that showed treatment with Erleada (apalutamide) significantly reduced the risk of prostate specific antigen (PSA) progression in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who had a rapidly rising PSA while receiving continuous androgen deprivation therapy (ADT). According to the data from the SPARTAN study, Erleada significantly decreased the risk of PSA progression by 94 percent, compared with the placebo group (median not reached vs. 3.71 months; HR=0.06; 95% CI, 0.05-0.08; P<0.0001).

Additionally, the median time to PSA response was 29 days in the Erleada plus ADT group. At 12 weeks after randomization, median PSA decreased by 90 percent in the Erleada group and increased by 40 percent in the placebo group. Among patients treated, baseline median PSA doubling time was 4.4 and 4.5 months, and median baseline PSA was 7.78 and 7.96 ng/mL in the Erleada and placebo groups, respectively. An at least 90 percent maximum decline in PSA from baseline at any time on study was observed in 66 percent of patients in the Erleada group and 1 percent of patients in the placebo group. These data were presented during the Prostate Cancer: Advanced (including Drug Therapy) I Oral Podium Session at the 2018 American Urological Association (AUA) Annual Meeting.

The FDA approved Erleada in February 2018 for the treatment of patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). Erleada is the first FDA-approved treatment for these patients. This approval follows an FDA Priority Review designation based upon data from the Phase III SPARTAN study, which demonstrated a 72 percent reduction in risk of distant metastasis or death, and an increase in median metastasis-free survival (MFS) by more than two years (difference of 24.31 months) in patients with NM-CRPC. Comment: The need to delay metastasis is critical to the treatment of prostate cancer. Nearly 90 percent of patients with castration-resistant prostate cancer will eventually develop bone metastases, at which point the prognosis sharply worsens.