Positive Phase III results for Decapeptyl in Prostate Cancer-Ipsen

Ipsen has announced positive results from the Phase III study of Decapeptyl (triptorelin pamoate 11.25 mg) administered subcutaneously in patients with locally advanced or metastatic Prostate Cancer. The primary objective of the study was to assess the efficacy and safety profile of the sustained-release triptorelin pamoate 11.25 mg formulation when administered by the subcutaneous route in men with locally advanced or metastatic Prostate Cancer. This objective was met with castration levels of testosterone achieved in 97.6% of men at week 4 and castration maintained in 96.6% of these men at week 26. Mean testosterone levels decreased to 18.4 ng/dl and 10.2 ng/dl at week 4 and week 8, respectively, and remained within this range until the end of the study. Median time to achieve castration was 22 days.

For more than 90% of the patients, the level of testosterone was maintained below 20 ng/dl from week 8 up to the end of the trial. Median Prostate Specific Antigen (PSA) levels were reduced by 64.2% and 96.0% at week 4 and week 26, respectively. PSA levels remained within the normal range (0–4 ng/ml) from week 8 until the end of the study. The efficacy results and safety profile of triptorelin pamoate 11.25 mg administered by the subcutaneous route are consistent with the known efficacy and safety profile of triptorelin administered by the intramuscular route. Based on these results, Ipsen has applied for the addition of the subcutaneous route, alongside the intramuscular route, to the label of triptorelin pamoate 11.25 mg. Data were presented at the European Association of Urology (EAU) 14th Central European Meeting.