ARAMIS IS THE LARGEST PHASE III STUDY IN nmCRPC TO DATE1-3nmCRPC

    DOUBLE-BLIND, PLACEBO-CONTROLLED, INTERNATIONAL, MULTICENTER STUDY1,4
    NON-METASTATIC CRPC* (N=1509)
    • Treatment continued until radiographic disease progression as assessed by conventional imaging (CT, MRI, 99mTc bone scan) by blinded independent central review, discontinuation due to adverse reactions, or withdrawal of consent

    *All patients received concurrent ADT (treatment with GnRH analog or previous bilateral orchiectomy).

    †Lymph nodes located below the aortic bifurcation as measured by the short axis.

    CRPC=castration-resistant prostate cancer; PSADT=prostate-specific antigen doubling time; PSA=prostate-specific antigen; ECOG PS=Eastern Cooperative Oncology Group performance status; ADT=androgen deprivation therapy; CT=computed tomography; MRI=magnetic resonance imaging; GnRH=gonadotropin-releasing hormone.

    STUDY ENDPOINTS

    PRIMARY ENDPOINT1

    • Metastasis-free survival

    SECONDARY ENDPOINTS1,4

    • Overall survival
    • Time to pain progression*
    • Time to first cytotoxic chemotherapy
    • Time to first symptomatic skeletal event

    EXPLORATORY ENDPOINTS4

    • Progression-free survival
    • Time to first prostate cancer–related procedure
    • Time to initiation of subsequent chemotherapy
    • PSA progression and response
    • Deterioration in ECOG PS
    • Quality of life†

    *Time to pain progression was defined as at least a 2-point worsening from baseline of pain score on BPI-SF (a validated health-related quality-of-life instrument) or initiation of opioids
    and reported in 28% of all patients on study.

    †Tools used to prespecify quality-of-life exploratory endpoints are the EQ-5D-3L, a preference-based instrument, and the FACT-P, BPI-SF, and EORTC-QLQ-PR25 prostate-specific questionnaires.

    PSA=prostate-specific antigen; ECOG PS=Eastern Cooperative Oncology Group performance status; EQ-5D-3L=EuroQol Group 5-dimension 3-level; FACT-P=Functional Assessment of Cancer
    Therapy–Prostate; BPI-SF=Brief Pain Inventory Short Form; EORTC-QLQ-PR25=European Organization for Research and Treatment of Cancer quality of life questionnaire, a 25-item questionnaire.

    WELL-BALANCED PATIENT CHARACTERISTICS IN ARAMIS4,5

    The majority of patients (68%) had an ECOG PS of 0 at baseline, defined as fully active and able to carry on all pre-disease performance without restriction4,6

    Table outlines patient characteristic baselines in NUBEQA (darolutamide) ARAMIS study.
    See DDIs
    • 43% of patients were on an antithrombotic, such as apixaban, clopidogrel, rivaroxaban, or warfarin5
    • More than a third of patients were on a statin (34.5%), such as atorvastatin, pravastatin, or rosuvastatin5

    Bone-sparing agents included bisphosphonates, denosumab, vitamin D and analogs, calcium and calcium combinations, fluorides, and calcitonins.5

    ECOG PS is graded according to the following criteria: 0: Fully active,
    able to carry on all pre-disease performance without restriction;
    1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg, light housework, office work.6

    Smiling man with arms crossed. He is wearing glasses, a blue shirt and striped apron.

        MORE THAN 1 IN 6 PATIENTS HAD LOCAL OR REGIONAL
    LYMPH NODE METASTASES AT BASELINE4

    Man next to copy saying “More than 1 in 6 patients had local or regional lymph node metastases at baseline.”

    ECOG PS=Eastern Cooperative Oncology Group performance status; ADT=androgen deprivation therapy; PSA=prostate-specific antigen; DDIs=drug-drug interactions.

    DELAY METASTASIS, HELP PATIENTS LIVE LONGER WITHOUT PROGRESSION1,4nmCRPC

    Men lived 2X longer without cancer spreading1,4

    Significant increase in MFS vs ADT alone

    HR: 0.41; 95% CI: 0.34-0.50; P<0.0001 (intent to treat)

    Bar Graph: Significant increase in MFS vs ADT Alone. MORE THAN 2X LONGER MFS vs ADT Alone
    • Consistent results for MFS across patient subgroups4:
      • PSADT (≤6 months or >6 months)
      • Prior use of bone-targeting agents (yes or no)

    *95% CI: 34.3-NE. †95% CI: 15.5-22.3.