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                                                  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
                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  PP-NUB-CA-0237-1

                                                                                                               2021-11-16   12:53 PM
         ON1119730 NUB Journal Ad OS Data Update_EN_r5e-CUAJ.indd   1                                          2021-11-16   12:53 PM
         ON1119730 NUB Journal Ad OS Data Update_EN_r5e-CUAJ.indd   1
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