FIRMAGON® (degarelix) demonstrates non-inferiority to goserelin with bicalutamide in reducing prostate volume in prostate cancer patients while providing better relief from lower urinary tract symptoms

New data show that FIRMAGON^® is non-inferior to the combination of goserelin plus bicalutamide at reducing prostate volume in patients with advanced hormone-dependent prostate cancer while offering better relief from lower urinary tract symptoms

Two new studies presented at the 27th Annual European Association of Urology (EAU) Congress reported that FIRMAGON^® (degarelix), a gonadotropin-releasing hormone (GnRH) receptor blocker, was similar to the combination of goserelin (a luteinizing-hormone-releasing hormone (LHRH) agonist) plus bicalutamide at reducing total prostate volume in men with advanced hormone-dependent prostate cancer, and offered better control of lower urinary tract symptoms (LUTS).^1,2 LUTS can include frequency, urgency and hesitancy in urination and have a major negative impact on quality of life^3,4 for men with prostate cancer.

The Phase IIIb CS30 trial assessed the use of FIRMAGON^® as neoadjuvant hormone therapy in men with intermediate to high-risk prostate cancer. A review published recently shows that androgen deprivation therapy (ADT) prior to radiotherapy can improve disease-specific mortality and overall survival compared to radiotherapy alone in men with high-risk localised or locally advanced prostate cancer.⁵ Week 12 results of the CS30 trial showed the non-inferiority of FIRMAGON^® compared with goserelin plus bicalutamide at prostate shrinking (mean percent change in prostate volume: -36.0% for FIRMAGON^® vs. -35.3% for goserelin plus bicalutamide). In addition, FIRMAGON^® demonstrated more pronounced LUTS relief compared to goserelin plus bicalutamide. Overall incidences of adverse events (AEs) were similar in both groups; the most common AEs were the expected consequences of ADT.¹

The Phase IIIb CS31 trial assessed the ability of FIRMAGON^® to decrease prostate volume in a range of prostate cancer patients. Again, Week 12 results showed prostate volume reduction achieved by FIRMAGON^® was similar to the combination of goserelin and bicalutamide. In addition, FIRMAGON^® had a significantly more pronounced positive effect on LUTS in symptomatic patients.²

“These new data show that FIRMAGON^® is non-inferior to the combination of goserelin and bicalutamide at reducing prostate volume, and also offers the added benefit of better LUTS control,” commented Professor Malcolm Mason, Cardiff University, Institute of Cancer & Genetics, Velindre Hospital, Cardiff, UK. “LUTS can have a significant impact on a man’s quality of life, so relief of these symptoms is hugely important to patients suffering from prostate cancer.”

The goal of ADT is to rapidly reduce testosterone levels in a sustained way to slow the growth of cancer cells. The use of LHRH agonists is associated with an initial rapid release of androgens (surge), which delays the onset of ADT and may be source of complications.⁶ To avoid these limitations, LHRH agonists have to be co-administered with an antiandrogen at the initiation of treatment.⁷

In contrast FIRMAGON^® is a GnRH receptor blocker, which, unlike LHRH agonists, promptly blocks testosterone production, avoiding any initial testosterone surge therefore, mitigating the need for concurrent antiandrogens. In the pivotal study showing the non inferiority of FIRMAGON compared to leuprolide, FIRMAGON^® reduced testosterone to an effective level very quickly in more than 97% of patients^8,9 . Additional analysis of the pivotal study showed that it also reduced the risk of prostate specific antigen (PSA) progression or death by 34% (HR =0.664 – 95%CI, 0.385-1.146). Further studies are needed to confirm theses findings.¹⁰ In an extension trial of the pivotal study, FIRMAGON^® continued to control PSA at three years.¹¹ Delaying PSA progression is desirable as it may delay the need for second-line therapies which include chemotherapy.¹² Now, new data suggest that FIRMAGON^® provides prostate cancer patients with better relief from LUTS.

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About FIRMAGON ^®

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 testosterone 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 trials, FIRMAGON^® decreased the production of testosterone very rapidly, profoundly and in a sustained way.^8,10 FIRMAGON^® also maintains the PSA control over the long term and reduces the risk of PSA progression.¹¹

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.^8,1

About Prostate Cancer

Prostate cancer is the most common form of male cancer in the western world,² and the second leading cause of cancer death in men in some countries.³ Around 300,000 new cases of prostate cancer are diagnosed in Europe each year.⁴ Worldwide this figure rises to 670,000 new cases.¹⁶ For further media information and news alerts on prostate cancer please visit Ferring’s information website www.ProstateCancerLiving.com

About Ferring

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 90 countries. To learn more about Ferring or its products please visit www.ferring.com .

References

¹ Mason M, et al. Degarelix as neoadjuvant hormone therapy in patients with prostate cancer: Results from a phase IIIb randomised, comparative trial versus goserelin plus bicalutamide. Abstract presented at the 27^th EAU Congress, 2012

² Axcrona K., et al. Androgen deprivation therapy for volume reduction, LUTS relief and quality of life improvement in men with prostate cancer: Degarelix versus goserelin plus bicalutamide. Abstract presented at the 27^th EAU Congress, 2012.

³ Welch G, et al. Urology. 2002 Feb;59(2):245-50.

⁴ Monzón JA, et al. Arch Esp Urol. 2005 Mar;58(2):109-13.

⁵ Payne, H & Mason, M. British Journal of Cancer. 2011; 105: 1628–1634. www.bjcancer.com [Accessed 15 Feb 2012]

⁶ Sugiono M et al Prostate Cancer Prostatic Dis. 2005;8:91-4.

⁷ Gittelman M et al; Degarelix Study Group. J Urol. 2008;180:1986-92.

⁸ Klotz L, et al. BJU Int 2008; 102:1531–1538.

⁹ Firmagon (degarelix). Summary of Product Characteristics. July 2010

¹⁰ Tombal B, et al. Eur Urol 2010;57:836-42

¹¹ Crawford ED, et al. The Journal of Urology September 2011;186(3):889-897

¹² Mahon KL, et al. Endocr Relat Cancer 2011;18:R103–R123.

¹³ Van Poppel H et al. Abstract (23.) Euro Urol Suppl 2007;6(2):28

¹⁴ University of Iowa Hospitals and Clinics. Available at: http://www.uihealthcare.com/topics/medicaldepartments/urology/prostatecancer/index.html [Accessed 15 Feb 2012]

¹⁵ 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 15 Feb 2012]

¹⁶ Cancer Research UK. Available at: http://info.cancerresearchuk.org/cancerstats/types/prostate/index.html [Accessed 25 May 2010]

Contact:

Tonic Life Communications
Jo Husson
Tel: +44 (0) 207 798 9913
Jo.husson@toniclc.com
or
Ferring Pharmaceuticals
Patrick Gorman
Tel: +41 (0) 58 301 00 53
patrick.gorman@ferring.com