FINAL RESULTS FOR
Metastasis-free survival (MFS) was the primary endpoint, and overall survival (OS) was a key secondary endpoint.1
This is an independent, peer-reviewed article that may contain data, conclusions, and recommendations that do not conform to the FDA-approved labeling.NUBEQA® should be used only as specified in the full Prescribing Information. Please see full Prescribing Information.
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For your patient with non-metastatic castration-resistant prostate cancer (nmCRPC)
HELP HIM LIVE FOR WHAT HE LOVES
Powerful efficacy, proven tolerability. Extend patient survival with NUBEQA1-3
*95% CI: 34.3-NE. †95% CI: 15.5-22.3. ‡Medians NE.
§All-grade laboratory abnormalities in patients treated with NUBEQA + ADT vs ADT alone were, respectively, decreased neutrophil count (20% vs 9%), increased AST (23% vs 14%), and increased bilirubin (16% vs 7%). Grade 3/4 for same lab abnormalities were, respectively, 4% vs 0.6%, 0.5% vs 0.2%, and 0.1% vs 0%.
Overall, serious adverse reactions occurred in 25% of men receiving NUBEQA + ADT and in 20% of men receiving ADT alone. Serious adverse reactions in ≥1% of men who received NUBEQA + ADT included urinary retention, pneumonia, and hematuria.
Additionally, clinically significant adverse reactions occurring in ≥2% of men treated with NUBEQA + ADT vs ADT alone included ischemic heart disease (4.0% vs 3.4%) and heart failure (2.1% vs 0.9%).
Study Design: The efficacy and safety of NUBEQA were assessed in a randomized, double-blind, placebo-controlled, international, multicenter phase III study (ARAMIS) in patients with nmCRPC with a PSA doubling time of ≤10 months. 1509 patients were randomized 2:1 to receive either 600 mg NUBEQA twice daily (n=995) or matching placebo (n=554). All patients received concurrent ADT (treatment with GnRH analog or previous bilateral orchiectomy). The primary endpoint was MFS, defined as the time from randomization to the time of first evidence of BICR-confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first. Treatment continued until radiographic disease progression, as assessed by CT, MRI, 99mTc bone scan by BICR, unacceptable toxicity, or withdrawal. The final analysis of OS and time to initiation of cytotoxic chemotherapy was event-driven and conducted after 254 OS events had occurred and 14 months after MFS analysis.1,2
ADT=androgen deprivation therapy; HR=hazard ratio; CI=confidence interval; MFS=metastasis-free survival; OS=overall survival; NE=not estimable; AST=aspartate aminotransferase; PSA=prostate-specific antigen; GnRH=gonadotropin-releasing hormone; BICR=blinded independent central review; CT=computed tomography; MRI=magnetic resonance imaging.
ISI - Important Safety Information
NUBEQA® (darolutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.
IMPORTANT SAFETY INFORMATION
Embryo-Fetal Toxicity: Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.
Serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥1 % of patients who received NUBEQA were urinary retention, pneumonia, and hematuria. Overall, 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo died from adverse reactions, which included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%) for NUBEQA.
Adverse reactions occurring more frequently in the NUBEQA arm (≥2% over placebo) were fatigue (16% vs 11%), pain in extremity (6% vs 3%) and rash (3% vs 1%).
Clinically significant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease (4.0% vs 3.4% on placebo) and heart failure (2.1% vs 0.9% on placebo).
Effect of Other Drugs on NUBEQA – Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity. Avoid concomitant use.
Combined P-gp and strong CYP3A4 inhibitors increase NUBEQA exposure, which may increase the risk of NUBEQA adverse reactions. Monitor more frequently and modify NUBEQA dose as needed.
Effects of NUBEQA on Other Drugs – NUBEQA inhibits breast cancer resistance protein (BCRP) transporter. Concomitant use increases exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use where possible. If used together, monitor more frequently for adverse reactions, and consider dose reduction of the BCRP substrate.
NUBEQA inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor more frequently for adverse reactions and consider dose reduction of these substrates.
Review the prescribing information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA.
For important risk and use information about NUBEQA, please see the full Prescribing Information.
References: 1. NUBEQA (darolutamide) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; January 2021. 2. Fizazi K, Shore N, Tammela TL, et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2019;380(13):1235-1246. 3. Fizazi K, Shore N, Tammela TL, et al. Nonmetastatic, castration-resistant prostate cancer and survival with darolutamide. N Engl J Med. 2020;383(11):1040-1049.