Rapid and sustained testosterone suppression and improved PSA control may delay time to second-line therapy
Saint-Prex, Switzerland, 31 August 2011 - New data, published in the September issue of The Journal of Urology, showed that long-term use of FIRMAGON® (degarelix) a gonadotropin-releasing hormone therapy (GnRH) approved for the treatment of advanced prostate cancer in both the EU and US, continued to be effective and well tolerated beyond three years. 1 The new study (CS21A) extends the conclusions of the pivotal Phase III study (CS21) in which the risk of prostate specific antigen (PSA) failure or death was significantly lower in patients on FIRMAGON® compared to leuprolide (an LHRH agonist) up to one year. 1 The extension study has now shown that for patients who remained on FIRMAGON®, PSA suppression and the effects on PSA progression free survival (PFS) remained consistent over the long term (42 months). 1
In addition, the study looked at patients who crossed over from leuprolide to FIRMAGON® after one year. At a median follow up of 27.5 months the data showed that the risk of PSA PFS had decreased (p=0.003). 1
Longer PSA PFS is desirable as it is indicative of time to castration-resistant prostate cancer (CRPC) and may delay initiation of second-line therapy, which includes chemotherapy. 2 Time to castration resistance is also an important predictor of survival. 3 These findings support using FIRMAGON® as first-line androgen deprivation therapy. 1
CS21A was designed to collect extended safety and tolerability data on FIRMAGON®. Following the close of the Phase III trial, all patients were offered the option to receive FIRMAGON® as part of the extension study. All patients who had received FIRMAGON® continued with their treatment and those who had previously been treated with leuprorelin were re-randomised to receive FIRMAGON®.
"Being able to delay castration resistance for as long as possible is an important outcome for any first-line therapy," said E. David Crawford, MD, Head, Section of Urologic Oncology and Professor of Urologic and Radiation Oncology, University of Colorado Denver, US. "The data from the Phase III extension study demonstrate that FIRMAGON® provided prostate cancer patients with fast and effective testosterone and PSA control over the long term, which may in turn delay castration resistance."
Prostate cancer is the second leading cause of cancer death amongst men in the Western world. 4 Up to 40% of men diagnosed with prostate cancer will eventually develop advanced disease, and although most respond to initial medical or surgical castration, progression to CRPC is inevitable. 5 The average survival for patients with CRPC is two to three years. 5
FIRMAGON® works by immediately inhibiting the GnRH receptors in the pituitary gland and suppressing the luteinising hormone, which decreases production of testosterone by the testicles with no initial surge. Prostate cancer is dependent on testosterone for its growth, so the goal of therapy is to rapidly reduce testosterone levels to slow the growth of cancer cells. Avoiding flare in testosterone prevents initial worsening of clinical status, allows for faster relief of symptoms such as bone pain, ureteral obstruction, and spinal cord compression and removes the need for adjuvant treatment with anti-androgens. 6, 7, 8
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The extension study of the pivotal FIRMAGON® vs leuprorelin trial (CS21) was designed to collect extended safety and tolerability data on FIRMAGON®. Following the close of the Phase III trial, all patients were offered the option to receive FIRMAGON® as part of the extension study. All patients who had received FIRMAGON® continued with their treatment and those who had previously been treated with leuprorelin were re-randomised to receive FIRMAGON® 240/80mg or 240/160mg.
The primary end point was safety and tolerability and the secondary endpoints were testosterone, PSA, luteinizing hormone and follicle-stimulating hormone responses, and PSA failure and PFS.
CS21A was initiated in March 2007 and an analysis conducted in March 2010 at a median follow up of 27.5 months. CS21A is ongoing and will run for five years.
FIRMAGON® has unique chemical characteristics and a novel mechanism of action, different from traditionally used hormonal therapies. Administered as a subcutaneous injection, FIRMAGON® rapidly reduces levels of PSA within two weeks by immediately blocking the GnRH receptors in the pituitary gland. Blocking the receptors suppresses the release of the luteinising hormone and follicle-stimulating hormone, resulting in a decrease in production of testosterone by the testicles to castration levels within three days. Prostate cancer is dependent on testosterone for its growth, and reducing testosterone levels slows the growth of cancer cells.
In clinical studies, FIRMAGON® suppressed testosterone and PSA faster than leuprolide, an existing treatment for advanced prostate cancer. 9
In clinical trials FIRMAGON® was generally well tolerated. Common side effects are hot flushes, injection site pain and erythema, increased weight, nasopharyngitis, fatigue and back pain. 9, 10
About Prostate Cancer
Prostate cancer is the most common form of male cancer in the western world, 11 and the second leading cause of cancer death in men in some countries. 4 Around 300,000 new cases of prostate cancer are diagnosed in Europe each year. 12 Worldwide this figure rises to 670,000 new cases. 12 For further media information and news alerts on prostate cancer please visit Ferring's information website www.ProstateCancerLiving.com.
Headquartered in Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology and endocrinology. Ferring has its own operating subsidiaries in 50 countries and markets its products in more than 70 countries. To learn more about Ferring or its products please visit www.ferring.com.
 Crawford, ED et al. The Journal of Urology September 2011;186(3):889-897
 Mahon KL, et al. Endocr Relat Cancer 2011;18:R103-R123
 Bournakis E, et al. Icancer Res 2011: Apr;31(4):1475-82 http://www.ncbi.nlm.nih.gov/pubmed/21508406
 American Cancer Society. Available at: http://www.cancer.org/docroot/cri/content/cri_2_4_1x_what_are_the_key_statistics_for_prostate_cancer_36.asp [Accessed 25 May 2010]
 Beltran, H et al. European Urology 60(2011) 279-290 http://www.europeanurology.com/article/S0302-2838(11)00477-5/pdf/New+Therapies+for+Castration-Resistant+Prostate+Cancer%3A+Efficacy+and+Safety
 Van Poppel, H et al. Urology: June 2009; Volume 71, Issue 6:1001-1006 http://www.goldjournal.net/article/S0090-4295(07)02662-3/abstract
 Persson B-E, et al. Neuroendocrinology 2009;90:235-244
 Boccon-Gibod L, et al. Therap Adv Urol June 2011
 Klotz L, et al. BJU Int. 2008;102(11):1531-1538.
 Van Poppel H et al. Abstract (23.) Euro Urol Suppl 2007;6(2):28
 University of Iowa Hospitals and Clinics. Available at: http://www.uihealthcare.com/topics/medicaldepartments/urology/prostatecancer/index.html [Accessed 25 May 2010]
 Cancer Research UK. Available at: http://info.cancerresearchuk.org/cancerstats/types/prostate/index.html [Accessed 25 May 2010]