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Abiraterone Acetate Plus Prednisone Provided Significant Clinical Benefit in Patients with High-Risk Metastatic Hormone-Naïve Prostate Cancer (mHNPC), Improving Overall Survival and Radiographic Progression-Free Survival | Business Wire

BEERSE, Belgium–([HR])–Janssen-Cilag International NV today announced data from the pivotal

Phase 3 LATITUDE clinical trial, which showed Zytiga^®

(abiraterone acetate) plus prednisone, in combination with androgen

deprivation therapy (ADT), compared to ADT plus placebo, demonstrated a

significant improvement in overall survival (OS) and radiographic

progression-free survival (rPFS) in patients with newly diagnosed

high-risk metastatic hormone-naïve prostate cancer (mHNPC) (patients who

had not been previously treated with ADT).¹ These data were

selected as one of four data sets for inclusion in the 2017 American

Society of Clinical Oncology (ASCO) Annual Meeting Press Program in

Chicago, today at 8 – 9 a.m. CDT. Additionally, the data results will be

presented during the “Plenary Session: Including the Science of Oncology

Award and Lecture,” on Sunday, 4^th June, at 2:40 – 2:55 p.m.

CDT (Abstract LBA3). The data have been selected for “Best of ASCO”

Meetings, which highlight the most cutting-edge science and education

from the ASCO Annual Meeting, and reflect the foremost oncology research

and strategies that will directly impact patient care.

Study findings indicated that treatment with abiraterone acetate plus

prednisone, in combination with ADT, reduced the risk of death by 38%

compared to ADT and placebo (hazard ratio [HR]=0.62; 95% CI [0.51 to

0.76], pThis is important new information, as not all

patients respond well to the current standard of care. LATITUDE suggests

that abiraterone acetate plus prednisone, in combination with androgen

deprivation therapy, can offer a new and much-needed option for patients

with high-risk newly diagnosed mHNPC.”

There are approximately 420,000 men diagnosed with prostate cancer in

Europe per year.² Around 2%-43% (up to 180,000) have

metastatic prostate cancer.^3,4,5 Historically, ADT and

docetaxel have been the standard of care for patients with metastatic

prostate cancer. This is often very effective at shrinking or slowing

the growth of prostate cancer that has spread, but it usually becomes

less effective over time.^6,7,8

In addition to achieving significant improvement on both primary

endpoints of OS and rPFS, the LATITUDE study met all secondary

endpoints, with statistically significant improvements in the

abiraterone acetate plus prednisone arm for time to: pain progression,

initiation of next subsequent therapy for prostate cancer, initiation of

chemotherapy, prostate-specific antigen (PSA) progression (all

pJanssen has played an important role in addressing treatment

the future.”

-ENDS-

NOTES TO EDITORS

About high-risk metastatic hormone-naïve

prostate cancer (mHNPC)

Not all prostate cancer is the same. It ranges from cancer confined to

the prostate gland to cancer that has spread outside of the prostate to

the lymph nodes, bones, or other parts of the body. The extent or spread

of prostate cancer determines the stage.⁹ Hormone-naïve

prostate cancer (HNPC) refers to a stage of the disease when the patient

has not been treated with ADT.¹⁰ Patients with newly

diagnosed mHNPC, particularly with high-risk characteristics, have a

poor prognosis. ADT plus docetaxel has shown improved outcomes in mHNPC,

but many patients are not candidates for docetaxel and may benefit from

alternative therapy.¹¹ Also, while the majority of patients

initially start on ADT, it usually becomes less effective over time.^6,7,8

About the LATITUDE Trial¹

The Phase 3, multinational, multicentre, randomised, double-blind,

placebo-controlled LATITUDE study enrolled 1,199 newly diagnosed

patients with mHNPC and was conducted at 235 sites in 34 countries in

Europe, Asia-Pacific, Latin America, and Canada. A total number of 597

patients were randomised to receive ADT in combination with abiraterone

acetate plus prednisone (n=597), while 602 patients were randomised to

receive ADT and placebo (n=602). Patients included had high-risk mHNPC

documented by positive bone scan or metastatic lesions at the time of

diagnosis on computed tomography (CT) or magnetic resonance imaging

(MRI). Additionally, patients had to have at least two of the three

following high-risk factors associated with poor prognosis:

• Gleason score ≥8

• ≥3 bone lesions

• presence of measurable visceral metastases

These results served the basis for Janssen’s Type II variation

application submission to the European Medicines Agency (EMA), seeking

to expand the existing marketing authorisation for abiraterone acetate

plus prednisone or prednisolone to include the treatment of men with

newly-diagnosed metastatic hormone sensitive prostate cancer (mHSPC). If

approved, this will broaden the use of abiraterone acetate plus

prednisone to include an earlier stage of prostate cancer than its

current indications.

Overall, the safety profile of ADT in combination with abiraterone

acetate plus prednisone was consistent with prior studies in patients

with metastatic castration-resistant prostate cancer (mCRPC). Most

common and anticipated adverse events were elevated incidences of

mineralocorticoid-related hypertension and hypokalemia in the ADT in

combination with abiraterone acetate plus prednisone arm compared with

ADT and placebo. The incidence rate of grade 3 or higher hypertension

(20% vs. 10%) was greater than that observed in prior studies of

abiraterone acetate in mCRPC patients. There were no serious sequelae

from the increased rate of hypertension. The incidence of hypokalemia

was higher than that reported in prior Phase 3 studies of abiraterone

acetate in mCRPC; however, only two patients discontinued treatment due

to hypokalemia and there were no hypokalemia-related deaths.

Mineralocorticoid-associated adverse events were medically manageable,

resulting in the use of the lower 5mg prednisone dose, compared with the

10mg in prior studies.

About abiraterone acetate

Abiraterone acetate plus prednisone / prednisolone is the only approved

therapy in mCRPC that inhibits production of androgens (which fuel

prostate cancer growth) at all three sources that are important in

prostate cancer – the testes, adrenals and the tumour itself.^12,13,14

Abiraterone acetate plus prednisone / prednisolone has been approved in

more than 90 countries to date, and has been prescribed to approximately

290,000 men worldwide.^15,16

Indications¹²

In 2011, abiraterone acetate in combination with prednisone /

prednisolone was approved by the European Commission (EC) for the

treatment of mCRPC in adult men whose disease has progressed on or after

a docetaxel-based chemotherapy regimen.

In December 2012, the EC granted an extension of the indication for

abiraterone acetate permitting its use, in combination with prednisone

or prednisolone, for the treatment of mCRPC, in adult men who are

asymptomatic or mildly symptomatic after failure of androgen deprivation

therapy in whom chemotherapy is not yet clinically indicated.¹²

Further Information¹²

The most common adverse reactions seen with abiraterone acetate plus

prednisone / prednisolone include urinary tract infection, hypokalaemia,

hypertension, and peripheral oedema.

For a full list of side effects and for further information on dosage

and administration, contraindications and other precautions when using

abiraterone acetate plus prednisone / prednisolone please refer to the

summary of product characteristics, which is available at: [0.51 to

0.76]

About the Janssen Pharmaceutical Companies

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are

working to create a world without disease. Transforming lives by finding

new and better ways to prevent, intercept, treat and cure disease

inspires us. We bring together the best minds and pursue the most

promising science. We are Janssen. We collaborate with the world for the

health of everyone in it. Learn more at www.janssen.com/emea.

Follow us on http://www.twitter.com/janssenEMEA

for our latest news.

Cilag GmbH International; Janssen Biotech, Inc.; and Janssen-Cilag

International NV are part of the Janssen Pharmaceutical Companies of

Johnson & Johnson.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined

and Exchange Commission. Copies of these filings are available online at www.sec.gov,

www.jnj.com

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