ARAMIS - Clinical Trial

^{ARAMIS Study Design  |  ARAMIS Baseline Characteristics  |  Summary of ARAMIS  |  ARAMIS Trial Results  |  ARAMIS Trial Results: Primary endpoint  |  ARAMIS Secondary endpoints  |  Tolerability}

In high-risk non-metastatic castration-resistant prostate cancer (

nmCRPC)

, NUBEQA (darolutamide) + ADT was investigated in the ARAMIS clinical trial, the largest Phase III study of an ARI of this patient population to date.

^{‡ The eligibility criteria for treatment with darolutamide for patients with high-risk nmCRPC is: No metastases detected in recent imaging, pelvic lymph nodes <2 cm permissible; castration-resistant prostate carcinoma (testosterone <1.7 nmol/L PSA increase while on ADT, PSA 2 ng/ml); PSA doubling time of 10 months (This list is not exhaustive)}

^{‡ Absolute risk at 3 years: 5.7%; HR: 0.69; 95% CI: 0.53-0.88; p=0.003.}

^{‡‡ Number of patients with events 148/955 (15.5%) vs 106/554 (19.1%) with placebo + ADT. Final analysis for OS was conducted after 254 deaths. An OS survival benefit was observed for NUBEQA + ADT, despite over half of patients in the placebo group subsequently receiving NUBEQA or another life-prolonging treatment. Patients who discontinued placebo or NUBEQA at any time point could choose to receive a life-prolonging therapy. In total, 55% (n=307) of 554 patients initially receiving placebo + ADT subsequently received at least one life prolonging therapy for CRPC vs 15% (n=141) of 955 patients receiving NUBEQA. Of those discontinuing placebo, 137 patients did so before unblinding occurred. Life-prolonging therapies received by those discontinuing placebo were darolutamide (31%), docetaxel (14%), abiraterone/ abiraterone acetate (6%), enzalutamide (5%), sipuleucel-T (<1%); cabazitaxel (0%).}

• In the Phase III ARAMIS trial, there was <1% increase in discontinuation due to AEs with NUBEQA + ADT vs. ADT + placebo (8.9% vs. 8.7%).
• In the pooled analysis of ARANOTE and ARAMIS, the most common adverse reactions in patients receiving NUBEQA were fatigue/asthenic conditions (13.7%). ^§§
• The most common serious adverse reactions were ischaemic heart disease (1.9%), cardiac arrhythmias (1.8%)^††, pneumonia (1.5%), urinary retention (1.3%), urinary tract infection (1.1%) and fractures (1.0%)^¶¶.

^{* versus placebo ¥ versus Apalutamide and Enzalutamide. §§ Includes fatigue and asthenia, lethargy and malaise. †† Includes arteriosclerosis coronary artery, coronary artery disease, coronary artery occlusion, coronary artery stenosis, acute coronary syndrome, acute myocardial infarction, angina pectoris, angina unstable, myocardial infarction, myocardial ischaemia. ¶¶Excluding pathologic fractures. This category combines the following MedDRA terms: any fractures and dislocations, limb fractures and dislocations, pelvic fractures and dislocations, spinal fractures and dislocations, and thoracic cage fractures and dislocations.}