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Extension Study With FIRMAGON® (degarelix) Showed Continued Benefits for Prostate Cancer Patients Beyond One Year
Date:6/1/2010

SAN FRANCISCO, June 1 /PRNewswire/ -- Prostate cancer patients on leuprolide who were offered to continue on FIRMAGON® (degarelix for injection) after one year of treatment reduced prostate specific antigen (PSA) recurrence, according to results of a Phase III extension study(1) presented here at the American Urological Association 2010 meeting. PSA is commonly used in monitoring prostate cancer patients' treatment response, and a high PSA number may indicate prostate cancer presence or recurrence.  

Patients with all stages of prostate cancer were randomized to a FIRMAGON® starting dose of 240 mg, then monthly maintenance doses of 80 mg (n = 207) or 160 mg (n =202) or leuprolide 7.5 mg/month (n = 201). Bicalutamide could be given as flare protection to those being treated with leuprolide. After one year, all patients taking leuprolide were re-randomized to FIRMAGON® 240/80 mg or 240/160 mg treatment. PSA progression-free survival (PFS) was defined in this study as time to first PSA recurrence (two consecutive increases in PSA of 50% and greater than or equal to 5 ng/mL on two consecutive measurements at least two weeks apart compared with nadir).

Up to one year, patients receiving FIRMAGON®   had a statistically lower risk of PSA recurrence compared with leuprolide (p = 0.05; log-rank). Adjusting for baseline disease state and PSA resulted in a hazard ratio (HR) of 0.664 (95% CI, 0.385 – 1.146). Beyond 1 year, the PSA recurrence rate decreased in patients previously on leuprolide. As of October 2009, there was a significant PSA PFS hazard change, from 0.20 events/year in the first year to 0.09 in the same group of patients (p=0.006); the corresponding hazards for  FIRMAGON®  were 0.11 and 0.14. The same pattern of hazard change occurred in pa
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SOURCE Ferring Pharmaceuticals Inc.
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