Efficacy of degarelix compared to leuprolide: new data
Posted Sep 28 2008 7:03pm
According to a report yesterday on DocGuide, the investigational LHRH antagonist degarelix is at least as effective as leuprolide acetate in treatment of men requiring hormonal therapy for advanced prostate cancer. Funding for this study was provided by Ferring Pharmaceuticals (the developer of degarelix). Unfortunately, the initial report offers no information on any adverse events associated with the use of degarelix in this 610-patient, randomized, controlled trial. As we have noted earlier, the only other LHRH antagonist to go into advanced clinical trials to date (abarelix/Plenaxis) had significant risks associated with its use, and we need reassurance that degarelix won’t have similar problems.
Data from the Phase 3 study, presented at the 23rd Annual Congress of the European Association of Urology (EAU 2008), also showed that use of degarelix is associated with rapid, profound, and sustained testosterone suppression, accoring to the lead investigator, Prof. Laurent Boccon-Gibod.
The efficacy and safety of degarelix were compared to the effectiveness and safety of leuprolide depot 7.5 mg/day over 12 months in 610 men with histologically confirmed adenocarcinoma of the prostate for whom androgen deprivation was indicated. The trial did not include any patients requiring neoadjuvant hormonal therapy.
Patients received one of three possible dosing regimens:
a subcutaneous starting dose of degarelix of 240 mg (40 mg/mL) for 1 month followed by monthly maintenance doses of 160 mg (40 mg/mL; group A, n=202)
a subcutaneous starting dose of degarelix of 240 mg (40 mg/mL) for 1 month followed by monthly maintenance doses of 80 mg (20 mg/mL; group B, n=207)
Patients in group C could use the antiandrogen bicalutamide (Casodex) for clinical flare protection.
Treatment response was defined as suppression of testosterone levels to no greater than 0.5 ng/mL at all monthly measurements from day 28 to day 364.
Results showed that both maintenance doses of degarelix were at least as effective as leuprolide in terms of response to treatment. Furthermore, degarelix demonstrated a quicker onset of action. Overall, 95.5% and 96% of men in the degarelix 160 and 80 mg groups, respectively, had testosterone levels of 0.5 ng/mL on day 3, compared with none of the patients in the leuprolide group.
The experimental drug showed no sign of causing a testosterone surge or microsurge, and PSA levels decreased more rapidly with degarelix than with leuprolide.
According to a report yesterday on DocGuide, the investigational LHRH antagonist degarelix is at least as effective as leuprolide acetate in treatment of men requiring hormonal therapy for advanced prostate cancer. Funding for this study was provided by Ferring Pharmaceuticals (the developer of degarelix). Unfortunately, the initial report offers no information on any adverse events associated with the use of degarelix in this 610-patient, randomized, controlled trial. As we have noted earlier, the only other LHRH antagonist to go into advanced clinical trials to date (abarelix/Plenaxis) had significant risks associated with its use, and we need reassurance that degarelix won’t have similar problems.
Data from the Phase 3 study, presented at the 23rd Annual Congress of the European Association of Urology (EAU 2008), also showed that use of degarelix is associated with rapid, profound, and sustained testosterone suppression, accoring to the lead investigator, Prof. Laurent Boccon-Gibod.
The efficacy and safety of degarelix were compared to the effectiveness and safety of leuprolide depot 7.5 mg/day over 12 months in 610 men with histologically confirmed adenocarcinoma of the prostate for whom androgen deprivation was indicated. The trial did not include any patients requiring neoadjuvant hormonal therapy.
Patients received one of three possible dosing regimens:
Patients in group C could use the antiandrogen bicalutamide (Casodex) for clinical flare protection.
Treatment response was defined as suppression of testosterone levels to no greater than 0.5 ng/mL at all monthly measurements from day 28 to day 364.
Results showed that both maintenance doses of degarelix were at least as effective as leuprolide in terms of response to treatment. Furthermore, degarelix demonstrated a quicker onset of action. Overall, 95.5% and 96% of men in the degarelix 160 and 80 mg groups, respectively, had testosterone levels of 0.5 ng/mL on day 3, compared with none of the patients in the leuprolide group.
The experimental drug showed no sign of causing a testosterone surge or microsurge, and PSA levels decreased more rapidly with degarelix than with leuprolide.
Filed under: Drugs in development, Management, Treatment | Tagged: delgarelix, LHRH antagonist