Three-Year Follow-Up Data Showed Patients Achieved Four-Fold Progression-Free Survival Benefit with Single Agent Imbruvica®▼ (ibrutinib) vs Temsirolimus at First Relapse in Mantle Cell Lymphoma

Data presented as an oral presentation at the 14th
International Conference on Malignant Lymphoma (ICML)

BEERSE, Belgium–(BUSINESS WIRE)–Janssen-Cilag International NV (“Janssen”) today announced three-year
follow-up data from the Phase 3 RAY study in patients with relapsed or
refractory mantle cell lymphoma (MCL). These results demonstrated that
the subset of patients treated with IMBRUVICA®▼ (ibrutinib)
at first relapse after one prior line of therapy achieved a median
progression-free survival (PFS) of more than two years (25.4 months).1
This was four-fold longer than treatment with temsirolimus (6.2 months
[HR, 0.40; 95% CI, 0.25–0.64]).1 Data showed median overall
survival (OS) with ibrutinib after one prior line of therapy of 3.5
years (42.1 months vs 27.0 months with temsirolimus [HR, 0.74; 95% CI,
0.43–1.30]).1

Results from the Phase 3, international, randomised, open-label RAY
study were presented on June 17, 2017 during an oral session at the 14th
International Conference on Malignant Lymphoma (ICML) in Lugano,
Switzerland. Ibrutinib, a first-in-class Bruton’s tyrosine kinase (BTK)
inhibitor, is jointly developed and commercialised by Janssen Biotech,
Inc. and Pharmacyclics LLC, an AbbVie company.

In the overall study patient population, which included patients who had
received more than one prior line of therapy (median two prior
therapies), median PFS was also significantly increased in patients
treated with ibrutinib vs temsirolimus (15.6 months vs 6.2 months [HR,
0.45; 95% CI, 0.35-0.60; p< 0.0001]).1 In addition,
ibrutinib tended to increase OS, with a median OS with ibrutinib of 30.3
vs 23.5 months with temsirolimus (HR, 0.74; 95% CI, 0.54-1.02; p=0.0621).1

“The data from this long-term follow-up further highlight the potential
of ibrutinib for patients with mantle cell lymphoma, especially if used
at first relapse,” said Simon Rule, M.D., Professor of Clinical
Haematology at Plymouth University, Peninsula Schools of Medicine &
Dentistry.*

Complete response (CR) was achieved in nearly a quarter (23.0%) of all
patients who received ibrutinib.1 The CR rate in patients who
had received one line of therapy prior to ibrutinib (33.3%) was more
than double that achieved in patients who had received more than one
line of therapy prior to ibrutinib (15.9%).1 The duration of
response in all patients who achieved a CR with ibrutinib was almost
three years (35.6 months).1

The safety profile was consistent with primary analysis and known safety
data on ibrutinib. No new safety signals for ibrutinib were observed in
the trial. Overall frequencies of adverse events (AEs) were similar or
lower in the ibrutinib arm, even with longer treatment exposure.1
Nearly twice as many patients discontinued temsirolimus due to AEs vs
ibrutinib (31.7% vs 17.3%).1 In addition, exposure adjusted
rates of atrial fibrillation were similar between the two groups (0.392
vs 0.331 with ibrutinib and temsirolimus, respectively) and exposure
adjusted bleeding rates were lower with ibrutinib vs temsirolimus (2.880
vs 6.683).1 In the ibrutinib arm, Grade ≥3 AEs included
thrombocytopenia, anaemia and neutropenia in 9.4%, 8.6% and 12.9% of
patients respectively.1

MCL is an incurable, aggressive B-cell malignancy with a median OS of
three to four years.2 Most patients relapse after first-line
therapy and have a poor prognosis.2,3 Despite recent advances
and with the exception of a small patient population eligible for
allogeneic stem cell transplant, there is no globally recognised
standard of care in relapsed MCL.4,5,6

“We are encouraged by these long-term data which demonstrated the
efficacy and safety of ibrutinib after one prior line of therapy in
patients with previously treated mantle cell lymphoma. These data add to
the growing body of evidence which shows that using ibrutinib earlier in
the treatment pathway may have significant benefits for patients,” said
Dr Catherine Taylor, Haematology Therapeutic Area Lead, Janssen Europe,
Middle East and Africa. “We are committed to addressing critical unmet
need in B-cell malignancies such as mantle cell lymphoma which has
traditionally had poor outcomes and are aiming to make this a more
manageable disease for patients in the future.”

#ENDS#

About the RAY study
The Phase 3, randomised, open-label RAY
study compared ibrutinib with temsirolimus in patients with relapsed or
refractory mantle cell lymphoma and ≥1 prior rituximab-containing
therapy.7 Two hundred and eighty patients were randomised 1:1
to oral ibrutinib (560 mg once-daily; n = 139) or intravenous
temsirolimus (175 mg: days 1, 8, 15 of cycle 1; 75 mg: days 1, 8, 15 of
subsequent cycles; n = 141) until disease progression/unacceptable
toxicity. Long-term efficacy was investigator-assessed.7

About ibrutinib
Ibrutinib is a first-in-class Bruton’s
tyrosine kinase (BTK) inhibitor, which works by forming a strong
covalent bond with BTK to block the transmission of cell survival
signals within the malignant B-cells.8 By blocking this BTK
protein, ibrutinib helps kill and reduce the number of cancer cells,
thereby delaying progression of the cancer.9

Ibrutinib is currently approved in Europe for the following uses:10

  • As a single agent for the treatment of adult patients with previously
    untreated chronic lymphocytic leukaemia (CLL), adult patients with
    relapsed or refractory mantle cell lymphoma (MCL), or adult patients
    with Waldenström’s Macroglobulinaemia (WM) who have received at least
    one prior therapy or in first-line treatment for patients unsuitable
    for chemo-immunotherapy.
  • As a single agent or in combination with bendamustine and rituximab
    (BR) for the treatment of adult patients with CLL who have received at
    least one prior therapy.

Please see the ibrutinib Summary
of Product Characteristics
for further information.10

About MCL
Mantle Cell Lymphoma (MCL) is considered a rare
disease, characterised by high unmet need and small patient populations
impacting fewer than one in 200,000 people in Europe and with a median
age at diagnosis of 65.11,12 MCL predominantly affects more
men than women and accounts for five to 10 percent of all non-Hodgkin’s
lymphomas.6,13 MCL typically involves the lymph nodes, but
can spread to other tissues, such as the bone marrow, liver, spleen and
gastrointestinal tract.12

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.
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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.

# # #

*Disclaimer: Dr. Rule served as an investigator of this clinical
study. Dr. Rule does not have a financial interest in the company.

Cautions Concerning Forward-Looking Statements
This
press release contains “forward-looking statements” as defined in the
Private Securities Litigation Reform Act of 1995 regarding the potential
benefits of ibrutinib. The reader is cautioned not to rely on these
forward-looking statements. These statements are based on current
expectations of future events. If underlying assumptions prove
inaccurate or known or unknown risks or uncertainties materialize,
actual results could vary materially from the expectations and
projections of Janssen-Cilag International NV, any of the other Janssen
Pharmaceutical Companies and/or Johnson & Johnson. Risks and
uncertainties include, but are not limited to: challenges and
uncertainties inherent in product research and development, including
the uncertainty of clinical success and of obtaining regulatory
approvals; uncertainty of commercial success; manufacturing difficulties
and delays; competition, including technological advances, new products
and patents attained by competitors; challenges to patents; product
efficacy or safety concerns resulting in product recalls or regulatory
action; changes in behavior and spending patterns of purchasers of
health care products and services; changes to applicable laws and
regulations, including global health care reforms; and trends toward
health care cost containment. A further list and descriptions of these
risks, uncertainties and other factors can be found in Johnson &
Johnson’s Annual Report on Form 10-K for the fiscal year ended January
1, 2017, including under “Item 1A. Risk Factors,” its most recently
filed Quarterly Report on Form 10-Q, including under the caption
“Cautionary Note Regarding Forward-Looking Statements,” and the
company’s subsequent filings with the Securities and Exchange
Commission. Copies of these filings are available online at
www.sec.gov,
www.jnj.com
or on request from Johnson & Johnson. None of the Janssen Pharmaceutical
Companies or Johnson & Johnson undertakes to update any forward-looking
statement as a result of new information or future events or
developments.

References
__________________________
1.
Rule S, Jurczak W, Jerkeman M, et al. Ibrutinib vs. temsirolimus:
three-year follow-up of patients with previously treated mantle cell
lymphoma from the phase 3, international, randomized, open-label RAY
stidy. Presentation at 14th International Conference on Malignant
Lymphoma, Lugano (Switzerland), 14-17 June 2017.
2.
Herrmann A, Hoster E, Zwingers T, et al. Improvement of overall
survival in advanced stage mantle cell lymphoma. J Clin Oncol. 2009;27:511-518.
3.
Smith A, Crouch S, Lax S, et al. Lymphoma incidence, survival and
prevalence 2004-2014: sub-type analyses from the UK’s Haematological
Malignancy Research Network. Br J Cancer. 2015;112:1575-1584.
4.
Dreyling M, Geisler C, Hermine O, et al. Newly diagnosed and relapsed
mantle cell lymphoma: ESMO Clinical Practice Guidelines for diagnosis,
treatment and follow-up. Ann Oncol. 2014;25(Suppl. 3):iii83-iii92.
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Ferrero S, Dreyling M.The current therapeutic scenario for relapsed
mantle cell lymphoma. Curr Opin Oncol. 2013;25:452-462.
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McKay P, Leach M, Jackson R, et al. Guidelines for the
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2012;159:405-426
7. Dreyling M, Jurczak W, Jerkeman M, et
al
. Ibrutinib versus temsirolimus in patients with relapsed or
refractory mantle-cell lymphoma: an international, randomised,
open-label, phase 3 study. Lancet. 2016;387:770-8.
8.
O’Brien S, Furman RR, Coutre SE, et al. Ibrutinib as initial
therapy for elderly patients with chronic lymphocytic leukaemia or small
lymphocytic lymphoma: an open-label, multicentre, phase 1b/2 trial. Lancet
Oncol
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9. European Medicines Agency.
EPAR summary for the public: Imbruvica (ibrutinib). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/003791/WC500177778.pdf
Last accessed June 2017.
10. Imbruvica Summary of
Product Characteristics, March 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003791/WC500177775.pdf
Last accessed June 2017.
11. Smedby KE, Hjalgrim H.
Epidemiology and etiology of mantle cell lymphoma and other non-Hodgkin
lymphoma subtypes. Semin Cancer Biol 2011;21:293-8.
12.
Leukemia and Lymphoma Society. Mantle cell lymphoma facts. Available at: http://www.lls.org/content/nationalcontent/resourcecenter/freeeducationmaterials/lymphoma/pdf/mantlecelllymphoma.pdf
Last accessed June 2017.
13. Cancer Research UK. Mantle
cell lymphoma. Available at: http://www.cancerresearchuk.org/about-cancer/non-hodgkin-lymphoma/types/mantle-cell
Last accessed June 2017

PHEM/IBR/0617/0002
June 2017

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