Efficacy and safety of degarelix in patients with prostate cancer: Results from a phase III study in China

doi:10.1016/j.ajur.2019.09.003

Asian Journal of Urology, 2020, 7 (3): 301-308 doi: 10.1016/j.ajur.2019.09.003

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Efficacy and safety of degarelix in patients with prostate cancer: Results from a phase III study in China

Yinghao Sun^a,Liping Xie^b,Tao Xu^c,Jørn S. Jakobsen^d,*(

),Weiqing Han^e,Per S. Sørensen^d,Xiaofeng Wang^c

^a Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China
^b Department of Urology, First Affiliated Hospital, Zhejiang University, Hangzhou, China
^c Department of Urology, Peking University People's Hospital, Beijing, China
^d Global Clinical Research and Development, Ferring Pharmaceuticals A/S, Copenhagen, Denmark
^e Department of Urology, Hunan Cancer Hospital, Hunan Province, China

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Abstract

Objective: To establish non-inferiority of gonadotropin-releasing hormone degarelix compared with goserelin in suppressing and maintaining castrate testosterone levels from Day 28 to Day 364 in Chinese patients with prostate cancer.
Methods: This is an open-label, multi-centre study in which men aged ≥18 years were randomised in a 1:1 ratio to once-a-month subcutaneous injection of either degarelix (240/80 mg) or goserelin (3.6 mg) for 12 months. The primary endpoint was difference in 1-year cumulative probability of suppressing testosterone to ≤0.5 ng/mL. Non-inferiority was to be established if the lower 95% confidence interval (CI) limit for difference in cumulative probability between the treatment arms was greater than -10%. Secondary endpoints included cumulative probability of prostate-specific-antigen-progression-free-survival (PSA-PFS). Safety was also assessed.
Results: Baseline demographics and disease characteristics were similar between degarelix (n=142) and goserelin (n=141) treatment arms. The difference in cumulative probability of maintaining castrate levels from Day 28-364 was 3.6% (95% CI:-1.5%, 8.7%), demonstrating non-inferiority of degarelix. The cumulative probability of PSA-PFS at Day 364 was higher for degarelix (82.3%, 95% CI: 74.7%, 87.7%) versus goserelin (71.7%, 95% CI: 63.2%, 78.5%, p=0.038). Adverse events (AEs) were similar between treatment arms, except for more injection site reactions with degarelix versus goserelin. Four (2.8%) and nine (6.4%) patients discontinued due to AEs in degarelix and goserelin groups, respectively.
Conclusion: Degarelix was non-inferior to goserelin in achieving and maintaining testosterone suppression at castrate levels during 1-year treatment. PSA-PFS was significantly higher with degarelix, suggesting improved disease control. Both treatments were well tolerated.

Key words： Degarelix Goserelin GnRH antagonist GnRH agonist Prostate cancer China

Received: 19 December 2018 Available online: 20 July 2020

Corresponding Authors: J?rn S. Jakobsen E-mail: joern.jakobsen@ferring.com

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	Per S. S?rensen
	Xiaofeng Wang

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Cite this article:

Yinghao Sun,Liping Xie,Tao Xu, et al. Efficacy and safety of degarelix in patients with prostate cancer: Results from a phase III study in China[J]. Asian Journal of Urology, 2020, 7(3): 301-308.

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http://www.ajurology.com/EN/10.1016/j.ajur.2019.09.003 OR http://www.ajurology.com/EN/Y2020/V7/I3/301

Study design. *End of study visit was conducted after 12 months (364 days of treatment). Discontinued patients were called in for end of study assessments after a decision of discontinuation was taken; s.c, subcutaneous.

Patient disposition. ITT, intention-to-treat analysis set.

Baseline characteristics—full analysis set.

Cumulative probability of testosterone at castrate level (≤0.5 ng/mL) from Day 28 to Day 364.

Time concentration curve of testosterone: Median values (interquartile range).

Percentage change from baseline in PSA: Median values (interquartile range). PSA, prostate-specific antigen.

Estimate of disease progression at Day 364—full analysis set.

Treatment-emergent adverse events—safety analysis set (5% in either group).

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