Ipsen's Decapeptyl Shows Positive Phase 3 Results For Prostate Cancer
By C. Rajan, contributing writer
French pharmaceutical company Ipsen has announced positive results from the Phase 3 study of its prostate cancer treatment, Decapeptyl (triptorelin pamoate), with subcutaneous administration of the drug. The results were presented at the European Association of Urology conference in Poland last week.
Decapeptyl has been approved in EU and the U.S. as a sustained release six-month intramuscular injectable suspension for advanced prostate cancer. This new formulation offers patients another administration option should they have issues receiving intramuscular injections.
Claude Bertrand, EVP, R&D, and CSO 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.”
The primary goal of the Phase 3 study was to assess the efficacy and safety profile of the sustained-release Decapeptyl formulation when given subcutaneously to prostate cancer patients, as determined by the castration levels of serum testosterone.
The study met the primary end-points, with castration levels of testosterone achieved in 97.6 percent of men at week 4 (exceeding target of 80 percent) and castration maintained in 96.6 percent of these men at week 26 (exceeding target of 85 percent).
The results also demonstrated that the efficacy and safety profile of triptorelin pamoate administered by the subcutaneous route were consistent with the results observed with the intramuscular administration of the drug.
Following the release of these positive the results, the company had applied for a label change for triptorelin pamoate 11.25 mg that would allow it to be administered subcutaneously as well as intramuscularly.
Decapeptyl is a peptide formulation consisting of triptorelin pamoate, a decapeptide analog of GnRH (Gonadotrophin Releasing Hormone). The GnRH hormone is involved in the control of hormonal secretions by the testicles and ovaries, and the decapeptide analog suppresses GnRH activity that plays a key role in hormonal castration in men.
It is currently available as an injectable suspension for treating locally advanced or metastatic prostate cancer, as well as other indications such as uterine fibroids and endometriosis. Ipsen is marketing Decapeptyl as a daily, one-month, three-month and six-month formulation.
Decapeptyl generated revenues of $379.2 million in 2013 in the EU and U.S., representing nearly a quarter of the consolidated Ipsen group sales, reports Pharma Letter.