PROVEN RESULTS IN mHSPC

mHSPC stands for metastatic hormone-sensitive prostate cancer

**NUBEQA in combination with docetaxel* (chemotherapy) was studied in patients with mHSPC**

The ARASENS study looked at NUBEQA + docetaxel (chemotherapy^†) and hormone therapy^‡ in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to docetaxel* (chemotherapy^†) and hormone therapy.^‡

Select inclusion criteria:

1306 men between the ages of 41 and 89 were included in the study, with a median^§ age of 67
83% of men in the study had stage M1b prostate cancer, meaning their cancer had spread to their bones
71% (928 men) were still physically able to do things they could before their disease^¶

About half of the patients in the study took NUBEQA + doxetaxel (chemotherapy) and hormone therapy, while the other half did not.

NUBEQA group (651 men)
NUBEQA + hormone therapy^‡ + docetaxel* (chemotherapy^†)

Placebo group (655 men)
Hormone therapy^‡ + docetaxel* (chemotherapy^†)

^*Docetaxel is an intravenous (IV) chemotherapy infusion used in combination with NUBEQA to treat mHSPC.

^†Docetaxel 75mg/m² for 21 days for 6 cycles. Note 21 days is one cycle.

^‡Hormone therapy includes drug treatments or surgery to lower testosterone.

^§Median is the middle value in a set of numbers, not the average.

^¶According to the Easter Cooperative Oncology Group Performance Status (ECOG PS) scale. 29% of patients had an ECOG performance status score of 1, meaning they were restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.

In the ARASENS study, the addition of NUBEQA to docetaxel (chemotherapy) helped men live life longer

Men with mHSPC who added NUBEQA + hormone therapy + docetaxel (chemotherapy) had a 32% lower risk of dying than men who only received hormone therapy + chemotherapy.

Median^§ for the treatment groups were: NR (not reached) for NUBEQA + docetaxel (NR, NR) and 48.9 (44.4, NR) for placebo + docetaxel.

At the time of analysis, 35% (229 out of 651) of patients in the NUBEQA with docetaxel group died compared to 46% (304 out of 654) of patients in the placebo with docetaxel group.

In the same study, the addition of NUBEQA to docetaxel (chemotherapy) delayed pain progression^#

It took significantly longer for pain to get worse for men with mHSPC who added NUBEQA to hormone therapy + docetaxel (chemotherapy) compared with men in the placebo group.

^#Pain progression was defined as:

An increase of 2 or more points of the worst pain felt in a 24-hour period, measured twice in a row, 4 weeks apart, OR an initiation of opioids for at least 7 days in a row for patients without pain
An increase of 2 or more points, from a pain score of 4 or more, of the worst pain felt in a 24-hour period, measured twice in a row, 4 weeks apart, OR an initiation of opioids for at least 7 days in a row for patients with pain and a pain score of 1 or more

Patients who used opioids within 4 weeks were removed from the analysis, with 19% removed from the NUBEQA + docetaxel arm and 18% removed from the placebo + docetaxel arm.

Talk to your healthcare provider to see if NUBEQA may be right for you.

Doctor Discussion Guide

Important Safety Information

Before taking NUBEQA, tell your healthcare provider about all your medical conditions, including if you:

have heart problems, high blood pressure, diabetes, or high amounts of fat or cholesterol in your blood (dyslipidemia)
have a history of seizures, brain injury, stroke, or brain tumors
have kidney or liver problems
are pregnant or plan to become pregnant. NUBEQA can cause harm to your unborn baby and loss of pregnancy (miscarriage)
have a partner who may become pregnant. Males who have female partners who may become pregnant should use effective birth control (contraception) during treatment and for 1 week after the last dose of NUBEQA. Talk with your healthcare provider about birth control methods
are breastfeeding or plan to breastfeed. It is not known if NUBEQA passes into breast milk

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. NUBEQA may affect the way other medicines work and other medicines may affect how NUBEQA works.

You should not start or stop any medicine before you talk with the healthcare provider that prescribed NUBEQA.

Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine.

NUBEQA may cause serious side effects, including:

Heart disease. Blockage of the arteries in the heart (ischemic heart disease) that can lead to death has happened in some people during treatment with NUBEQA. Your healthcare provider will monitor you for signs and symptoms of heart problems during your treatment with NUBEQA. Call your healthcare provider or get medical help right away if you get chest pain or discomfort at rest or with activity, or shortness of breath during your treatment with NUBEQA
Seizure. Treatment with NUBEQA may increase your risk of having a seizure. You should avoid activities where a sudden loss of consciousness could cause serious harm to yourself or others. Tell your healthcare provider right away if you have loss of consciousness or seizure

The most common side effects of NUBEQA in people with nmCRPC include:

increase in liver function tests
decreased white blood cells (neutropenia)
feeling more tired than usual
arm, leg, hand, or foot pain
rash

The most common side effects of NUBEQA when used in combination with docetaxel in people with mHSPC include:

constipation
rash
decreased appetite
bleeding
weight gain
high blood pressure
decreased red blood cells (anemia)
high blood sugar levels
decreased white blood cells
increase in liver function tests
low blood calcium levels

NUBEQA may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of NUBEQA.

Call your healthcare provider for medical advice about side effects. 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.

Please see the full Prescribing Information.

WHAT IS NUBEQA<sup>®</sup>?

NUBEQA^® (darolutamide) is a prescription medicine used to treat adults with prostate cancer:

that has not spread to other parts of the body and no longer responds to medical or surgical treatment that lowers testosterone (non-metastatic castration-resistant prostate cancer or nmCRPC),
or
that has spread to other parts of the body and responds to medical or surgical treatment that lowers testosterone (metastatic hormone-sensitive prostate cancer or mHSPC), in combination with docetaxel

It is not known if NUBEQA is safe and effective in women or children.

Date of last update: 5/17/2024