New Data Reveal That Presence of Metastases at Initial Prostate Cancer Diagnosis May Have a Critical Impact on Prognosis for Metastatic Castration-Resistant Patients

NOTE: this press release relates to ASCO 2016 Congress abstract
#5024, poster board #281, presented 4 June 2016.
1

BEERSE, Belgium–(BUSINESS WIRE)–Janssen-Cilag International NV today announced that data from an interim
analysis of The Prostate Cancer Registry, Europe’s first and
largest prospective study of men with metastatic castration-resistant
prostate cancer (mCRPC), indicate that the presence of distant
metastases (M1) at initial diagnosis may be a critical indicator of
future treatment and prognosis for mCRPC patients.

The data, presented today at the American Society of Clinical Oncology
(ASCO) 2016 Congress, Chicago, USA, described characteristics at study
entry of men with mCRPC who had distant metastases at primary diagnosis
(M1) as compared to those whose cancer had not metastasised at primary
diagnosis (M0). The data demonstrated higher prostate-specific antigen
(PSA) levels, increased incidence of bone lesions and slightly worse
level of functioning, in terms of their ability to care for themselves,
daily activity, and physical ability (measured by ECOG Scale of
Performance Status) for patients with M1 at initial diagnosis compared
to patients with no metastases (M0) at initial diagnosis.

  • PSA levels were 34.4% higher (61.7 ng/mL vs 45.9 ng/mL) for M1 vs M0
  • Incidence of bone lesions (>5) were 24% higher (51% vs 41%) for M1 vs
    M0
  • ECOG Scale of Performance Status >2 were higher (17% vs 13%) for M1 vs
    M0

“These data can help to better inform the way we treat mCRPC
patients. It demonstrates that patients who present with metastases at
diagnosis require particularly close attention from healthcare
professionals to tackle the disease head on with prompt and effective
treatment for the best possible outcome,”
said Dr Simon Chowdhury,
Guy’s Hospital, London. “Real world data, such as these, provide us
with valuable insight into the true patient journey. They include a
wider population, such as men of a broader age range and with other
existing health problems, than the more restricted and closely monitored
populations seen in interventional clinical trials.”

The Prostate Cancer Registry has enrolled over 3,000 mCRPC
patients in 199 centres across 16 European countries. It aims to address
the key medical and scientific questions concerning the optimal care of
mCRPC patients in routine practice. The size of the database will enable
analysis on sub-populations relevant to healthcare professionals. In
this dataset, 1323 patients with mCRPC were analysed, including 549 who
had M1 (41.5%) and 526 who had M0 (39.8%) disease at initial diagnosis,
and 248 men for whom state of metastasis was not measureable (Mx, 18.7%)
at initial diagnosis. Follow-up of these patients over time will clarify
how these clinical differences and subsequent treatment may affect
clinical outcome.

Jane Griffiths, Company Group Chairman, Janssen Europe, the Middle East
and Africa (EMEA) said: “Janssen is proud to be supporting The
Prostate Cancer Registry, which is the largest of its kind in Europe. As
there is currently limited data available on the everyday experience of
mCRPC patients we hope that the insights from the trial will lead to an
improvement in the quality of care and prognosis for men with mCRPC.”

Prostate cancer is the most commonly diagnosed cancer in men, with over
400,000 new cases diagnosed in Europe each year.2 Latest
prostate cancer figures show that there are currently three million men
living with the disease in Europe.3

-ENDS-

NOTES TO EDITORS

About The Prostate Cancer Registry

The Prostate Cancer Registry was initiated in 2013 as a long-term
commitment by Janssen to address optimal treatment of mCRPC in routine
practice. The Registry was designed in consultation with specialists in
mCRPC and examines patients being managed in a range of oncology and
urology settings, with the aim of reflecting routine clinical practice.

Patients are enrolled upon initiating a mCRPC treatment or a period of
surveillance, defined as not currently receiving an active treatment for
castration resistance. The Registry is collecting data on a pan-European
scale on patient demography and status, treatment sequencing and
effectiveness, ongoing disease management, quality of life, medical
resource utilisation and outcomes.

The first analysis was presented at the 2015 European Cancer Congress
(ECC) in Vienna Austria and final analysis is planned for 2019.

About Janssen

Janssen-Cilag International NV is one of the Janssen Pharmaceutical
Companies. Janssen Pharmaceutical Companies of Johnson & Johnson are
dedicated to addressing and solving the most important unmet medical
needs of our time, including oncology (e.g. multiple myeloma and
prostate cancer), immunology (e.g. psoriasis), neuroscience (e.g.
schizophrenia, dementia and pain), infectious disease (e.g. HIV/AIDS,
hepatitis C and tuberculosis) and cardiovascular and metabolic diseases
(e.g. diabetes). Driven by our commitment to patients, we develop
sustainable, integrated healthcare solutions by working side-by-side
with healthcare stakeholders, based on partnerships of trust and
transparency. More information can be found on www.janssen-emea.com.
Follow us on www.twitter.com/janssenEMEA
for our latest news.

Janssen in Oncology

In oncology, our goal is to fundamentally alter the way cancer is
understood, diagnosed, and managed, reinforcing our commitment to the
patients who inspire us. In looking to find innovative ways to address
the cancer challenge, our primary efforts focus on several treatment and
prevention solutions. These include disease area strongholds that focus
on haematologic malignancies and prostate cancer; cancer interception
with the goal of developing products that interrupt the carcinogenic
process; biomarkers that may help guide targeted, individualised use of
our therapies; as well as safe and effective identification and
treatment of early changes in the tumour microenvironment.

References:

1 Chowdhury S et al. The Prostate Cancer Registry: Do
patients with metastatic castration-resistant prostate cancer (mCRPC)
differ according to metastatic status at diagnosis? Poster presented at
the American Society of Clinical Oncology (ASCO) 2016 Congress, 4 June,
Chicago, USA. Poster Presentation. ASCO abstract #5024. Available at: http://abstract.asco.org/176/AbstView_176_161487.html.
Last accessed May 2016.

2 Ferlay J et al. Cancer incidence and mortality patterns in
Europe: Estimates for 40 countries in 2012. European Journal of Cancer.
2013; 49: p1374–1403.

3 European Commission. CORDIS Express: Prevention, diagnosis
and treatment of prostate cancer. Available at: http://cordis.europa.eu/news/rcn/122705_en.html.
Last accessed September 2015.

Contacts

Janssen
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ebone1@its.jnj.com
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Lesley Fishman
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