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Text Content

ARASENS STUDY DESIGN


THE ONLY PIVOTAL, PROSPECTIVE, DOUBLE-BLIND, MULTICENTER, PHASE III TRIAL TO
EVALUATE THE SUPERIORITY OF THE NUBEQA COMBINATION* VERSUS DOCETAXEL + ADT1,2



*NUBEQA combination=NUBEQA + ADT with docetaxel.

†One patient in the placebo arm was excluded from all analyses due to the
violation of Good Clinical Practices.

All patients received ADT (an LHRH agonist or an LHRH antagonist) or underwent
an orchiectomy within 12 weeks before randomization.


STUDY ENDPOINTS


SECONDARY ENDPOINTS1,2

 * Time to CRPC
 * Time to pain progression
 * Symptomatic skeletal event–free survival
 * Time to first symptomatic skeletal event
 * Time to initiation of subsequent antineoplastic therapy
 * Time to worsening of disease-related physical symptoms
 * Time to initiation of opioid use for ≥7 consecutive days


EXPLORATORY ENDPOINT3

 * Time to PSA progression


PATIENT DEMOGRAPHICS


ARASENS INCLUDED A BROAD RANGE OF PATIENT SUBGROUPS1,2

Baseline demographics and disease characteristics were balanced between
treatment arms



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.4

ADT=androgen deprivation therapy; ALP=alkaline phosphatase;
CRPC=castration-resistant prostate cancer; ECOG PS=Eastern Cooperative Oncology
Group Performance Status; LHRH=luteinizing hormone–releasing hormone;
M1a=nonregional lymph-node metastases only; M1b=bone metastases with or without
lymph-node metastases; M1c=visceral metastases with or without lymph-node or
bone metastases; mHSPC=metastatic hormone-sensitive prostate cancer;
PSA=prostate-specific antigen; q3w=every 3 weeks; ULN=upper limit of normal.

References: 1. NUBEQA (darolutamide) [prescribing information]. Whippany, NJ:
Bayer HealthCare Pharmaceuticals, Inc.; October 2023. 2. Smith MR, Hussain M,
Saad F, et al; ARASENS Trial Investigators. Darolutamide and survival in
metastatic, hormone-sensitive prostate cancer. N Engl J Med.
2022;386(12):1132-1142. 3. Data on file. Bayer HealthCare Pharmaceuticals, Inc.;
Whippany, NJ. 4. ECOG-ACRIN Cancer Research Group. ECOG Performance Status
Scale. https://ecog-acrin.org/resources/ecog-performance-status/. Accessed
September 19, 2023.




ARAMIS STUDY DESIGN


THE LARGEST DOUBLE-BLIND, PLACEBO-CONTROLLED, INTERNATIONAL, MULTICENTER STUDY
IN NMCRPC TO DATE1-5


 * 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
   consent1

*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.


STUDY ENDPOINTS


PRIMARY ENDPOINT1

 * Metastasis-free survival


SECONDARY ENDPOINTS1,5

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

 

 


EXPLORATORY ENDPOINTS5

 * 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.


PATIENT DEMOGRAPHICS


WELL-BALANCED PATIENT CHARACTERISTICS IN ARAMIS2,5

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 restriction2,5,6


 * 43% of patients were on an antithrombotic, such as apixaban, clopidogrel,
   rivaroxaban, or warfarin2
 * More than a third of patients were on a statin (34.5%), such as atorvastatin,
   pravastatin, or rosuvastatin2

Bone-sparing agents included bisphosphonates, denosumab, vitamin D and analogs,
calcium and calcium combinations, fluorides, and calcitonins.2

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

ADT=androgen deprivation therapy; BPI-SF=Brief Pain Inventory-Short Form;
CRPC=castration-resistant prostate cancer; CT=computed tomography; ECOG
PS=Eastern Cooperative Oncology Group Performance Status;
EORTC-QLQ-PR25=European Organization for Research and Treatment of Cancer
quality of life questionnaire, a 25-item questionnaire; EQ-5D-3L=EuroQol Group
5-dimension 3-level; FACT-P=Functional Assessment of Cancer Therapy–Prostate;
GnRH=gonadotropin-releasing hormone; MRI=magnetic resonance imaging;
nmCRPC=non-metastatic castration-resistant prostate cancer;
PSA=prostate-specific antigen; PSADT=prostate-specific antigen doubling time.

References: 1. NUBEQA (darolutamide) [prescribing information]. Whippany, NJ:
Bayer HealthCare Pharmaceuticals, Inc.; October 2023. 2. Data on file. Bayer
HealthCare Pharmaceuticals, Inc.; Whippany, NJ. 3. Xtandi (enzalutamide)
[prescribing information]. Northbrook, IL: Astellas Pharma US, Inc.; January
2022. 4. Erleada (apalutamide) [prescribing information]. Horsham, PA: Janssen
Products, LP; April 2022. 5. Fizazi K, Shore N, Tammela TL, et al. Darolutamide
in nonmetastatic, castration-resistant prostate cancer. N Engl J Med.
2019;380(13):1235-1246. 6. ECOG-ACRIN Cancer Research Group. ECOG Performance
Status Scale. https://ecog-acrin.org/resources/ecog-performance-status/.
Accessed September 19, 2023.




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For your patient with metastatic hormone-sensitive prostate cancer (mHSPC) or
non-metastatic castration-resistant prostate cancer (nmCRPC)


HELP HIM LIVE FOR WHAT HE LOVES

Extend patient survival with NUBEQA1-4*


mHSPC
metastatic hormone-sensitive prostate cancer
nmCRPC
non-metastatic castration-resistant prostate cancer

POWERFUL EFFICACY

NUBEQA* REDUCED THE RISK OF DEATH BY >30% ACROSS MHSPC AND NMCRPC1,2,4

 * In mHSPC, NUBEQA is the only ARI approved in combination with docetaxel.
   NUBEQA in combination with docetaxel + ADT significantly extended OS beyond
   docetaxel + ADT; HR: 0.68; 95% CI: 0.57-0.80; P<0.0001
 * In nmCRPC, NUBEQA + ADT reduced the risk of death by nearly a third vs ADT
   alone (OS was a secondary endpoint); HR: 0.69; 95% CI: 0.53-0.88; P=0.003.
   MFS was the primary endpoint

*In combination with docetaxel in mHSPC.

--------------------------------------------------------------------------------

SEE DATA ON PROSTATE CANCER PROGRESSION

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to CRPC
Explore MFS

SEE DATA ON PROSTATE CANCER PROGRESSION

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to CRPC
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CHOOSE NUBEQA* 1ST


FOR POWERFUL EFFICACY AND PROVEN TOLERABILITY FOR YOUR PATIENTS WITH MHSPC AND
NMCRPC1-4

mHSPC Safety &
Tolerability nmCRPC Safety &
Tolerability

ARASENS Study Design: 1305 mHSPC patients on ADT† with docetaxel who received
ADT within 12 weeks before study entry were randomized 1:1 and treated with
concurrent 600 mg NUBEQA twice daily (n=651) or placebo (n=654) in a
multicenter, double-blind, phase III trial. Concomitant docetaxel was
administered at 75 mg/m2 every 21 days for 6 cycles within 6 weeks of starting
NUBEQA or placebo. OS was statistically significant for the NUBEQA arm vs
placebo arm; HR: 0.68; 95% CI: 0.57-0.80; P<0.0001.1,2

ARAMIS Study Design: 1509 nmCRPC patients on ADT† with a PSA doubling time of
≤10 months were randomized 2:1 to receive concurrent 600 mg NUBEQA twice daily
(n=955) or placebo (n=554) in a multicenter, double-blind, phase III trial.
Treatment continued until radiographic disease progression as assessed by CT,
MRI, 99mTc bone scan by BICR, unacceptable toxicity, or withdrawal. MFS was
statistically significant with a median of 40.4 months vs 18.4 months for
placebo; HR: 0.41; 95% CI: 0.34-0.50; P<0.0001. The final analysis of OS was
statistically significant vs placebo; HR: 0.69; 95% CI: 0.53-0.88; P=0.003. MFS
was the primary endpoint and OS was a key secondary endpoint.1,3,4

†Concomitant GnRH analog or prior bilateral orchiectomy.

ADT=androgen deprivation therapy; ARI=androgen receptor inhibitor; BICR=blinded
independent central review; CI=confidence interval; CRPC=castration-resistant
prostate cancer; CT=computed tomography; GnRH=gonadotropin-releasing hormone;
HR=hazard ratio; MFS=metastasis-free survival; MRI=magnetic resonance imaging;
OS=overall survival; PSA=prostate-specific antigen.

NUBEQA is the fastest-growing second-generation ARI across mHSPC and nmCRPC5
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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.

References: 1. NUBEQA (darolutamide) [prescribing information]. Whippany, NJ:
Bayer HealthCare Pharmaceuticals, Inc.; October 2023. 2. Smith MR, Hussain M,
Saad F, et al; ARASENS Trial Investigators. Darolutamide and survival in
metastatic, hormone-sensitive prostate cancer. N Engl J Med.
2022;386(12):1132-1142. 3. Fizazi K, Shore N, Tammela TL, et al. Darolutamide in
nonmetastatic, castration-resistant prostate cancer. N Engl J Med.
2019;380(13):1235-1246. 4. 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. 5. Data on file. Bayer HealthCare Pharmaceuticals,
Inc.; Whippany, NJ.



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registered trademarks of Bayer, and Access Services by Bayer is a trademark of
Bayer.

Date of last update: 4/25/2024



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