Positive Ph III results for Ipsen's Decapeptyl in prostate cancer patients

French drugmaker Ipsen (Euronext: IPN) has released positive results from the Phase III study of Decapeptyl (triptorelin pamoate) administered subcutaneously in patients with locally advanced or metastatic prostate cancer at the European Association of Urology (EAU) 14thCentral European Meeting in Cracow, Poland (October 10-12, 2014).

The primary objective of the study was to assess the efficacy and safety profile of the sustained-release triptorelin pamoate 11.25 mg (Decapeptyl3 months) 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% [95% CI: 93.2-99.5] of men at week 4 and castration maintained in 96.6% of these men [95% CI: 91.6-99.1] 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 four and week 26, respectively. PSA levels remained within the normal range (0–4 ng/ml) from week eight until the end of the study.
Efficacy and safety consistent with intramuscular route

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 11.25mg.

Claude Bertrand, executive vice president, R&D, and chief scientific officer of Ipsen stated: “These results provide further evidence to the efficacy and safety of Decapeptyl in the treatment of patients with prostate cancer. The subcutaneous route widens the options for the administration of Decapeptyl and may be offered to patients for whom intramuscular administration is not recommended.”