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Discover
NUBEQA
®
For your nmCRPC patients
NUBEQA (darolutamide) is indicated for the treatment of patients
with non-metastatic castration resistant prostate cancer (nmCRPC).
NUBEQA has not been studied in patients with nmCRPC at low
risk of developing metastases. The benefit and risk profile in these
patients is unknown.
NUBEQA + ADT significantly improved NUBEQA + ADT significantly improved OS
MFS vs. placebo + ADT (primary analysis)* with a demonstrated 31% reduction in risk
HR (95% CI): 0.41 (0.34, 0.50); p<0.000001 †‡ of death vs. placebo + ADT (final analysis)*
HR (95% CI): 0.69 (0.53, 0.88); p=0.003048 †‡
NUBEQA + ADT Placebo + ADT
40.4 MONTHS, 18.4 MONTHS, NUBEQA + ADT Placebo + ADT
median (34.3, NR) median (15.5, 22.3)
15.5% 19.1%
23.1% 39.0% (n/N=148/955) (n/N=106/554 ) §
(n/N=221/955) (n/N=216/554)
Rates of permanent discontinuation due to NUBEQA + ADT Placebo + ADT
adverse reactions were <9% in both groups 8.9% 8.7%
Clinical use • May impair fertility, patients should be advised not to donate sperm during
• Pediatrics (<18 years of age): Not authorized for pediatric use treatment and for 3 months after
Relevant warnings and precautions • Monitor for disease progression radiographically in addition to PSA
• Not indicated in women For more information
• May cause harm to developing fetus or lead to loss of pregnancy if Consult the Product Monograph at https://www.bayer.com/sites/default/
engaging in sexual activity with women; a condom and/or other highly files/2020-11/nubeqa-pm-en.pdf for important information relating to adverse
effective contraceptive should be used during treatment and for 3 months reactions, interactions and dosing information. The Product Monograph is also
after completion of treatment with NUBEQA available by calling Bayer Medical Information at 1-800-265-7382.
ADT=androgen deprivation therapy; MFS=metastasis-free survival; CI=confidence interval; HR=hazard ratio; NR=not reached; OS=overall survival.
* ARAMIS, a phase III, randomized, double-blind, placebo-controlled, multicentre clinical study to assess NUBEQA (n=955) vs. placebo (n=554) in patients with
nmCRPC. Patients were randomized 2:1 to receive NUBEQA 600 mg orally twice daily, or matching placebo. All patients received a gonadotropin-releasing
hormone (GnRH) analog concurrently or had a bilateral orchiectomy. Treatment with NUBEQA continued until radiographic disease progression as assessed by
conventional imaging (CT, MRI, Tc99m bone scan) by blinded central review, unacceptable toxicity or withdrawal. The primary efficacy endpoint was metastasis-
free survival (MFS) which was defined as the time from randomization to confirmed evidence of metastasis or death from any cause, whichever occurred first.
† Hazard ratio <1 favours NUBEQA.
‡ p-value is based on a log-rank test stratified by PSADT (≤6 months vs. >6 months) and use of osteoclast-targeted therapy (yes vs. no).
§ Includes 170 patients who crossed over to open-label NUBEQA.
Reference: NUBEQA Product Monograph, Bayer Inc., July 14, 2021.
®
© 2021, Bayer Inc.
® TM see www.bayer.ca/tm-mc PP-NUB-CA-0237-1
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