IN nmCRPC, NUBEQA SIGNIFICANTLY IMPROVED MFS AND OS

nmCRPC

NUBEQA helped men live >2X longer without cancer spreading vs ADT alone^1,2

Significant increase in primary endpoint MFS vs ADT alone

Comparative chart of NUBEQA vs ADT and ADT Alone

ADT=androgen deprivation therapy; CI=confidence interval; HR=hazard ratio; MFS=metastasis-free survival; NE=not estimable.

An elderly man standing on beach and smiling

Consistent results for MFS across patient subgroups:
- PSADT (≤6 months or >6 months)
- Prior use of bone-targeting agents (yes or no)

*95% CI: 15.5-22.3.

†95% CI: 34.3-NE.

ARAMIS safety results

In nmCRPC, NUBEQA reduced risk of death by >30% vs ADT alone^1,3

Statistically significant secondary endpoint: overall survival

Chart showcasing NUBEQA (darolutamide) and ADT with text of 31% reduction in risk of death vs ADT alone

An elderly couple standing at beach with surfing boards

>50% of patients still alive at final analysis: median os not reached³

At 3 years, 83% of patients treated with NUBEQA + ADT were alive vs 77% treated with ADT alone (HR: 0.69; 95% CI: 0.53-0.88; P=0.003)³

At 3 years, 83% of patients treated with NUBEQA + ADT were alive vs 77% treated with ADT alone
(HR: 0.69; 95% CI: 0.53-0.88; P=0.003)³

NUBEQA + ADT provided the relief of an extra 15 months (median) without pain progression^1,3

Statistically significant delay in time to pain progression

SECONDARY ENDPOINT : HR: 0.65; 95% CI: 0.53-0.79;
P<0.0001 (intent to treat)

35% RISK REDUCTION in time to pain progression with NUBEQA + ADT vs ADT alone

Time to pain progression between NUBEQA (darolutamide) + ADT and ADT alone

Time to pain progression was defined as at least a 2-point worsening from baseline of pain score on the BPI-SF
(a validated health-related quality-of-life instrument) or initiation of opioids and reported in 28% of all patients on study^1,3

Postpone cytotoxic chemotherapy for more time before starting chemo^1,3

Significantly delayed time to chemotherapy

SECONDARY ENDPOINT : HR: 0.58; 95% CI: 0.44-0.76;
P<0.001 (intent to treat)

42% RISK REDUCTION in time to initiation of cytotoxic chemotherapy with NUBEQA + ADT vs ADT alone at the final analysis³

Median: NE for both NUBEQA + ADT (n=955) and ADT alone (n=554).

Select exploratory endpoint: time to PSA progression²

These exploratory data are descriptive in nature—the study was not powered to determine statistical significance

PSA is not a reliable surrogate for overall survival. PSA evaluation should be viewed in the context of patient management and the overall physical condition and clinical course of the patient.

Exploratory endpoint: progression in NUBEQA (darolutamide) + ADT patients

*95% CI: 25.9-NR.
^†95% CI: 3.9-7.4.

ADT=androgen deprivation therapy; CI=confidence interval; HR=hazard ratio; NE=not estimable;
PSA=prostate-specific antigen.

Twice-daily dosing of NUBEQA 600 mg in patients with nmCRPC resulted in undetectable PSA levels in 24.2% of patients at 12 months vs 0.4% of patients in the placebo arm¹

OTHER EXPLORATORY ENDPOINTS

Exploratory endpoint results^2,3

Chart with exploratory endpoint results of NUBEQA (darolutamide) + ADT and ADT alone

^‡Median: 36.8 mo, NUBEQA + ADT; 14.8 mo, ADT alone.

^§Median: 33.2 mo, NUBEQA + ADT; 7.3 mo, ADT alone.

^||Median: NE for both NUBEQA + ADT and ADT alone.

CHOOSE NUBEQA FOR YOUR PATIENTS WITH nmCRPC

Patient profiles

ADT=androgen deprivation therapy; BPI-SF=Brief Pain Inventory-Short Form; CI=confidence interval; HR=hazard ratio; MFS=metastasis-free survival; NE=not estimable; nmCRPC=non-metastatic castration-resistant prostate cancer; OS=overall survival; PSA=prostate-specific antigen; PSADT=prostate-specific antigen doubling time.

ARAMIS safety results

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Indications

NUBEQA^® (darolutamide) is an androgen receptor inhibitor indicated for the treatment of adult patients with:

Non-metastatic castration-resistant prostate cancer (nmCRPC)
Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

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Important Safety Information

Warnings & Precautions

Ischemic Heart Disease – In a study of patients with nmCRPC (ARAMIS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA versus 2.5% receiving placebo, including Grade 3-4 events in 1.7% vs. 0.4%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA vs. 0.2% receiving placebo. In a study of patients with mHSPC (ARASENS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA with docetaxel vs. 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% vs. 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel vs. 0% receiving placebo with docetaxel. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease.

Seizure – In ARAMIS, Grade 1-2 seizure occurred in 0.2% of patients receiving NUBEQA vs. 0.2% receiving placebo. Seizure occurred 261 and 456 days after initiation of NUBEQA. In ARASENS, seizure occurred in 0.6% of patients receiving NUBEQA with docetaxel, including one Grade 3 event, vs. 0.2% receiving placebo with docetaxel. Seizure occurred 38 to 340 days after initiation of NUBEQA. It is unknown whether anti-epileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment.

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.

Adverse Reactions

In ARAMIS, serious adverse reactions occurred in 25% of patients receiving NUBEQA vs. 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving NUBEQA vs. 3.2% of patients receiving placebo. Fatal adverse reactions in patients who received NUBEQA included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%). The most common adverse reactions (>2% with a ≥2% increase over placebo), including laboratory test abnormalities, were increased AST, decreased neutrophil count, fatigue, increased bilirubin, pain in extremity, and rash. Clinically relevant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease and heart failure.

In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel vs. 42% of patients receiving placebo with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), decreased neutrophil count (2.8%), musculoskeletal pain (2.6%), and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel vs. 4% of patients receiving placebo with docetaxel. Fatal adverse reactions in patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common adverse reactions (≥10% with a ≥2% increase over placebo with docetaxel) were constipation, rash, decreased appetite, hemorrhage, increased weight, and hypertension. The most common laboratory test abnormalities (≥30%) were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia. Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures, ischemic heart disease, seizures, and drug-induced liver injury.

Drug Interactions

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.

Please see the full Prescribing Information.

You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.