Page 2 - CUAJFeb2023

Discover a new reason to choose
NUBEQA
®

Indicated in nmCRPC and now in mCSPC

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.
• patients with metastatic castration-sensitive prostate cancer
(mCSPC) in combination with docetaxel.

ARASENS study (mCSPC) ARAMIS study (nmCRPC)

NUBEQA + docetaxel + ADT improved NUBEQA + ADT improved overall
overall survival vs. docetaxel + ADT alone survival vs. ADT alone
(primary endpoint) * (secondary endpoint) 1,3‡§
1,2 †
32.5% Reduction in risk of death 31.5% Reduction in risk of death
HR=0.675 (0.568, 0.801), p<0.0001 HR=0.685 (0.533, 0.881), p=0.003048

Number of events: NUBEQA + docetaxel + ADT 229/651 Number of events: NUBEQA + ADT 148/955
vs. placebo + docetaxel + ADT 304/654 vs. placebo + ADT 106/554 **

Discontinuations due to adverse events: 1 Discontinuations due to adverse events: 1
13.5% NUBEQA + docetaxel + ADT 8.9% NUBEQA + ADT
vs. 10.6% placebo + docetaxel + ADT vs. 8.7% placebo + ADT

CUA mCSPC Guidelines: Darolutamide + CUA nmCRPC Guidelines: Darolutamide is a
docetaxel + ADT is a recommended option for recommended option in high-risk patients with life
patients regardless of volume of disease expectancy >5 years
(Level 1, Strong recommendation). 4 (Level 1, Strong recommendation). 5
See respective 2022 Guidelines for full recommendations.

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 treatment with NUBEQA
Relevant warnings and precautions • Monitor for disease progression radiographically in addition to PSA
• Monitor for signs and symptoms of ischemic heart disease and optimize For more information
management of CV risk factors Consult the Product Monograph at https://www.bayer.com/sites/default/
• Potential for drug-induced liver injury with increases in ALT and AST files/2020-11/nubeqa-pm-en.pdf for important information relating to adverse
• Risk of seizure reactions, interactions and dosing information. The Product Monograph is also
• Not indicated in women available by calling Bayer Medical Information at 1-800-265-7382.
• May cause harm to developing fetus or lead to loss of pregnancy; a
condom and/or other highly effective contraceptive should be used during
treatment and for 3 months after treatment with NUBEQA
ADT = androgen deprivation therapy; CUA = Canadian Urological Association; GnRH = gonadotropin-releasing hormone; PSADT = prostate-specific antigen doubling time.
* ARASENS: Randomized, double-blind, placebo-controlled study in patients with mCSPC. Patients were randomized 1:1 to NUBEQA 600 mg BID (n=651) or placebo (n=655),
in combination with docetaxel 75 mg/m Q3W for 6 cycles. All patients received concurrent GnRH analog or had bilateral orchiectomy.
2
† p-value based on one-sided stratified log-rank test.

‡ ARAMIS: Randomized, double-blind, placebo-controlled study in patients with nmCRPC with PSADT of ≤10 months (high risk of metastatic disease). Patients were randomized
2:1 to NUBEQA 600 mg BID (n=955) or placebo (n=554). All patients received concurrent GnRH analog or had bilateral orchiectomy.
§ p-value based on two-sided log-rank test stratified by PSADT (≤6 months vs. >6 months) and use of osteoclast-targeted therapy (yes vs. no). Final OS analysis occurred14 months

after analysis of the primary endpoint and was not adjusted for confounding cross-over effects.
** Includes 170 patients who crossed over to open-label NUBEQA.
References: 1. NUBEQA (darolutamide) Product Monograph. Bayer Inc. 2. Smith MR, et al. NEJM. 2022;386(12):1132-1142.
3. Fizazi K, et al. NEJM. 2020;383(11):1040-1049. 4. So AI, et al. CUA/CUOG Guideline: mCSPC. CUAJ. 2022;
16(12):E581-E589. 5. Saad F, et al. CUA/CUOG Guideline: Management of CRPC. CUAJ. 2022;16(11):E506-E515.
© 2023 Bayer Inc.
® TM see www.bayer.ca/tm-mc PP-NUB-CA-0398-1