Janssen to Present New Data in Urothelial, Haematologic and Prostate Cancers at ASCO 2018, including Best of ASCO Selections

  • Urothelial – Phase 2 data for investigational urothelial cancer
    therapy erdafitinib
  • Haematologic – Imbruvica®(ibrutinib)
    Phase 3 data in first-line and relapsed/refractory Waldenström’s
    macroglobulinemia; Darzalex
    ®▼(daratumumab)
    Phase 1 combination data in relapsed/refractory multiple myeloma
  • Prostate – Apalutamide Phase 3 data analyses evaluating new
    clinical trial endpoints in prostate cancer

BEERSE, Belgium–(BUSINESS WIRE)–The Janssen Pharmaceutical Companies of Johnson & Johnson, today
announced 21 company-sponsored abstracts will be presented at the 2018
American Society of Clinical Oncology (ASCO) Annual Meeting
in
Chicago, IL on June 1-5. New data analyses in support of a portfolio of
products, including the investigational treatments erdafitinib and
apalutamide, as well as approved treatments Imbruvica®
(ibrutinib), Darzalex® (daratumumab), and Zytiga® (abiraterone
acetate)will be highlighted across urothelial, haematologic
and prostate cancers.

Notably, Phase 2 trial results for the investigational compound
erdafitinib, which received U.S. Food and Drug Administration (FDA) Breakthrough
Therapy Designation
, will be presented during an oral presentation
on Sunday, June 3 (Abstract
#4503
).1,2 For haematologic cancers, Phase 3 data from
the iNNOVATE study will provide the first look at ibrutinib plus
rituximab versus placebo plus rituximab in patients with newly diagnosed
and relapsed/refractory Waldenström’s macroglobulinemia (WM) (Abstract
#8003
).3 In addition, Phase 2 data from the CAPTIVATE
study will be presented evaluating ibrutinib plus venetoclax in
first-line chronic lymphocytic leukaemia (CLL) (Abstract
#7502
).4 Oral presentations for erdafitinib and ibrutinib
have been selected to be featured at the Best
of ASCO 2018 Meetings
, which highlight cutting-edge science and
reflect the leading research in oncology.

“The breadth of new data from our portfolio shows our commitment to
finding solutions for patients living with cancer according to their
specific treatment needs,” said Dr Ivo Winiger-Candolfi, Oncology
Therapeutic Area Lead, Janssen Europe, Middle East and Africa. “It
reinforces our dedication to work with our partners and move a step
closer to making cancer a preventable, chronic or curable disease.”

Selected data presentations include:

  • Erdafitinib: Results from the primary analysis of the Phase 2
    study of erdafitinib (ERDA; JNJ-42756493) in patients with metastatic
    or unresectable urothelial carcinoma (mUC) and Fibroblast Growth
    Factor Receptor alterations (FGFRalt).

  • Ibrutinib: Findings from the Phase 3 placebo-controlled
    iNNOVATE study will be presented, assessing ibrutinib plus rituximab
    versus placebo plus rituximab in patients with newly diagnosed and
    relapsed/refractory WM.*

  • Ibrutinib: Early results from the Phase 2 CAPTIVATE study will
    be presented, evaluating ibrutinib in combination with venetoclax in
    first-line CLL.*

  • Daratumumab: Phase 1 data from the MMY1001 study will
    report on the efficacy and safety of daratumumab in combination with
    carfilzomib and dexamethasone in lenalidomide-refractory patients with
    relapsed multiple myeloma.

    • These data will be presented in an oral presentation from 3:09 –
      3:21 p.m. CDT on Friday, June 1 (Abstract
      #8002
      ).5
  • Daratumumab: Follow-up efficacy and safety data from the
    pivotal Phase 3 ALCYONE study will be presented for daratumumab in
    combination with bortezomib, melphalan and prednisone in patients with
    newly diagnosed multiple myeloma who are transplant ineligible.

    • These data will be presented in a poster presentation from 8:00 –
      11:30 a.m. CDT on Monday, June 4 (Abstract
      #8031
      ).6
  • Daratumumab: Safety run-in results from the Phase 3 ANDROMEDA
    study will be presented evaluating the subcutaneous use of daratumumab
    in combination with cyclophosphamide, bortezomib, and dexamethasone in
    patients with newly diagnosed amyloid light chain (AL) amyloidosis.7
    Amyloidosis is an incurable disease in which cells that normally
    produce antibodies make an abnormal protein that deposits in and
    causes damage to organs such as the heart and kidneys.8

    • These data will be presented in a poster discussion presentation
      from 3:00 – 4:15 p.m. CDT on Monday, June 4 (Abstract
      #8011
      ).
  • Apalutamide: New analyses from the pivotal Phase 3 SPARTAN
    clinical trial will be presented examining the relationship between
    time to metastasis (TTM) and site of metastases in patients with
    non-metastatic castration-resistant prostate cancer (nmCRPC).

    • These data will be presented in a poster presentation from 1:15 –
      4:45 p.m. CDT on Saturday, June 2 (Abstract
      #5033
      ).9
  • Abiraterone acetate: New findings from the pivotal Phase 3
    LATITUDE clinical trial in patients with metastatic high-risk
    castration-sensitive prostate cancer (CSPC) will be presented.

    • These data will be presented in a poster presentation from 1:15 –
      4:45 p.m. CDT on Saturday, June 2 (Abstract
      #5028
      ).10
  • Prostate Cancer: New analysis exploring the association between
    metastasis-free survival (MFS) and overall survival (OS) will be
    presented in nmCRPC for the first time.

    • These data will be presented in a poster presentation from 1:15 –
      4:45 p.m. CDT on Saturday, June 2 (Abstract
      #5032
      ).11

For more information on the abstracts presented by Janssen, please click here.

*Abstracts were submitted by ibrutinib co-developer partner,
Pharmacyclics, an AbbVie company.

#ENDS#

About erdafitinib

Erdafitinib is an investigational, once-daily pan-fibroblast growth
factor receptor (FGFR) tyrosine kinase inhibitor being evaluated by
Janssen Research and Development in Phase 2 and 3 clinical trials in
patients with advanced urothelial cancer and other solid tumours. FGFRs
are a family of receptor tyrosine kinases which may be upregulated in
various tumour cell types and may be involved in tumour cell
differentiation and proliferation, tumour angiogenesis, and tumour cell
survival.12 In 2008, Janssen entered into an exclusive
worldwide license and collaboration agreement with Astex Therapeutics
Ltd. to develop and commercialise erdafitinib.

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.13
By blocking this BTK protein, ibrutinib helps kill and reduce the number
of cancer cells, thereby delaying progression of the cancer.14

Ibrutinib is currently approved in Europe for the following uses:15

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

The most common adverse reactions seen with ibrutinib include diarrhoea,
neutropenia, haemorrhage (e.g., bruising), musculoskeletal pain, nausea,
rash, and pyrexia.15

For a full list of side effects and for further information on dosage
and administration, contraindications and other precautions when using
ibrutinib please refer to the Summary
of Product Characteristics
for further information.15

About daratumumab

Daratumumab is a first-in-class biologic targeting CD38, a surface
protein that is highly expressed across multiple myeloma cells,
regardless of disease stage.16,17,18 Daratumumab is believed
to induce tumour cell death through multiple immune-mediated mechanisms
of action, including complement-dependent cytotoxicity (CDC),
antibody-dependent cell-mediated cytotoxicity (ADCC) and
antibody-dependent cellular phagocytosis (ADCP), as well as through
apoptosis, in which a series of molecular steps in a cell lead to its
death.19 A subset of myeloid derived suppressor cells
(MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were
decreased by daratumumab.19 Daratumumab is being evaluated in
a comprehensive clinical development program across a range of treatment
settings in multiple myeloma, such as in frontline and relapsed settings.20,21,22,23,24,25,26,27,28
Additional studies are ongoing or planned to assess its potential for a
solid tumour indication and in other malignant and pre-malignant
diseases in which CD38 is expressed, such as smouldering myeloma.29,30,31,32
For more information, please see www.clinicaltrials.gov.

Daratumumab is currently approved in Europe for the following uses:19

  • As monotherapy for the treatment of adult patients with relapsed and
    refractory multiple myeloma, whose prior therapy included a proteasome
    inhibitor and an immunomodulatory agent and who have demonstrated
    disease progression on the last therapy.
  • In combination with lenalidomide and dexamethasone, or bortezomib and
    dexamethasone, for the treatment of adult patients with multiple
    myeloma who have received at least one prior therapy.

The most common adverse reactions seen with daratumumab include infusion
reactions, fatigue, nausea, diarrhoea, muscle spasms, pyrexia, cough,
dyspnoea, neutropenia, thrombocytopenia and upper respiratory tract
infection. In addition, in combination with bortezomib, peripheral
oedema and peripheral sensory neuropathy were frequently reported.19

For a full list of side effects and for further information on dosage
and administration, contraindications and other precautions when using
daratumumab please refer to the Summary
of Product Characteristics
.19

In August
2012
, Janssen Biotech, Inc. and Genmab A/S entered a worldwide
agreement, which granted Janssen an exclusive license to develop,
manufacture and commercialise daratumumab.33

About apalutamide

Apalutamide is an investigational, next-generation oral androgen
receptor (AR) inhibitor that blocks the androgen signalling pathway in
prostate cancer cells.34 Apalutamide inhibits the growth of
cancer cells in three ways: by preventing the binding of androgen to the
AR; by stopping the AR from entering the cancer cells; and by preventing
the AR from binding to the DNA of the cancer cell.34 Apalutamide
received US
FDA approval
on February 14, 2018 for the treatment of
non-metastatic CRPC.35 On February 9, 2018 Janssen submitted
a Marketing Authorisation Application
to the European Medicines
Agency (EMA).36

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.37,38

Abiraterone acetate with prednisone / prednisolone is currently approved
in Europe for the following uses:37

  • The treatment of newly diagnosed high risk metastatic hormone
    sensitive prostate cancer (mHSPC) in adult men in combination with
    androgen deprivation therapy (ADT).
  • The treatment of metastatic castration resistant prostate cancer
    (mCRPC) in adult men who are asymptomatic or mildly symptomatic after
    failure of androgen deprivation therapy in whom chemotherapy is not
    yet clinically indicated.
  • The treatment of mCRPC in adult men whose disease has progressed on or
    after a docetaxel-based chemotherapy regimen.

The most common adverse reactions seen with abiraterone acetate plus
prednisone / prednisolone include urinary tract infection, hypokalemia,
hypertension, and peripheral oedema.37

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
.37

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 at www.twitter.com/janssenEMEA
for our latest news.

Cilag GmbH International; Janssen Biotech, Inc.; Janssen Oncology, 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 in
the Private Securities Litigation Reform Act of 1995 regarding
erdafitinib, apalutamide, ibrutinib, daratumumab, and abiraterone
acetate. 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,
the Janssen Pharmaceutical Companies of Johnson & Johnson 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 behaviour
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 December 31, 2017, including in the sections
captioned “Cautionary Note Regarding Forward-Looking Statements” and
“Item 1A. Risk Factors,” and in the company’s subsequent Quarterly
Reports on Form 10-Q and other 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 nor Johnson & Johnson undertakes to update any forward-looking
statement as a result of new information or future events or
developments.

###

1 Siefker-Radtke AO, et al. First results from the primary
analysis population of the phase 2 study of erdafitinib (ERDA;
JNJ-42756493) in patients (pts) with metastatic or unresectable
urothelial carcinoma (mUC) and FGFR alterations (FGFRalt). To be
presented at 2018 ASCO Annual Meeting, Chicago, IL, USA, 1-5 June 2018;
abstract 4503.

2 Janssen. Janssen announces U.S. FDA breakthrough therapy
designation for erdafitinib in the treatment of metastatic urothelial
cancer. Press release March 15, 2018. Available at: http://www.janssen.com/janssen-announces-us-fda-breakthrough-therapy-designation-erdafitinib-treatment-metastatic
Last accessed May 2018.

3 Dimopoulos MA, et al. Randomized phase 3 trial of
ibrutinib/rituximab vs placebo/rituximab in Waldenström’s
macroglobulinemia. To be presented at 2018 ASCO Annual Meeting, Chicago,
IL, USA, 1-5 June 2018; abstract 8003.

4 Wierda WG, et al. Phase 2 CAPTIVATE results of ibrutinib
(ibr) plus venetoclax (ven) in first-line chronic lymphocytic leukemia
(CLL). To be presented at 2018 ASCO Annual Meeting, Chicago, IL, USA,
1-5 June 2018; abstract 7502.

5 Chari A, et al. Daratumumab (DARA) in combination with
carfilzomib and dexamethasone (D-Kd) in lenalidomide (Len)-refractory
patients (Pts) with relapsed multiple myeloma (MM): subgroup analysis of
MMY1001. To be presented at 2018 ASCO Annual Meeting, Chicago, IL, USA,
1-5 June 2018; abstract 8002.

6 Cavo M, et al. Daratumumab plus
bortezomib-melphalan-prednisone (VMP) in elderly (≥75 y) patients (Pts)
with newly diagnosed multiple myeloma (NDMM) ineligible for
transplantation (ALCYONE). To be presented at 2018 ASCO Annual Meeting,
Chicago, IL, USA, 1-5 June 2018; abstract 8031.

7 Comenzo R, et al. Subcutaneous daratumumab (DARA SC) plus
cyclophosphamide, bortezomib, and dexamethasone (CyBorD) in patients
(Pts) with newly diagnosed amyloid light chain (AL) amyloidosis: safety
run-in results of ANDROMEDA. To be presented at 2018 ASCO Annual
Meeting, Chicago, IL, USA, 1-5 June 2018; abstract 8011.

8 Palladini G, Merlini G. What is new in diagnosis and
management of light chain amyloidosis? Blood. 2016;128:159-168.

9 Smith MR, et al. Relationship of time to metastasis (TTM)
and site of metastases in patients (pts) with nonmetastatic
castration-resistant prostate cancer (nmCRPC): results from the phase 3
SPARTAN trial. To be presented at 2018 ASCO Annual Meeting, Chicago, IL,
USA, 1-5 June 2018; abstract 5033.

10 Chi KN, et al. Subsequent treatment after abiraterone
acetate + prednisone (AA + P) in patients (pts) with newly diagnosed
high-risk metastatic castration-naïve prostate cancer (NDx-HR mCNPC):
detailed analyses from the phase 3 LATITUDE trial. To be presented at
2018 ASCO Annual Meeting, Chicago, IL, USA, 1-5 June 2018; abstract 5028.

11 Smith MR et al. Association of metastasis-free survival
(MFS) and overall survival (OS) in nonmetastatic castration-resistant
prostate cancer (nmCRPC). To be presented at 2018 ASCO Annual Meeting,
Chicago, IL, USA, 1-5 June 2018; abstract 5032.

12 National Cancer Institute. NCI Drug Dictionary: pan FGFR
kinase inhibitor BGJ398. Available at: https://www.cancer.gov/publications/dictionaries/cancer-drug/def/pan-fgfr-kinase-inhibitor-bgj398
Last accessed May 2018.

13 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. 2014;15:48-58.

14 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 May 2018.

15 Imbruvica Summary of Product Characteristics, January
2018. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003791/WC500177775.pdf
Last accessed May 2018.

16 Fedele G, di Girolamo M, Recine U, et al. CD38 ligation in
peripheral blood mononuclear cells of myeloma patients induces release
of protumorigenic IL-6 and impaired secretion of IFNgamma cytokines and
proliferation. Mediat Inflamm. 2013;2013:564687.

17 Lin P, Owens R, Tricot G, et al. Flow cytometric
immunophenotypic analysis of 306 cases of multiple myeloma. Am J Clin
Pathol
. 2004;121:482-8.

18 Santoconito AM, Consoli U, Bagnato S, et al. Flow
cytometric detection of aneuploid CD38++ plasmacells and CD19+
B-lymphocytes in bone marrow, peripheral blood and PBSC harvest in
multiple myeloma patients. Leuk Res. 2004;28:469-77.

19 Darzalex Summary of Product Characteristics, March 2018.
Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004077/WC500207296.pdf
Last accessed May 2018.

20 ClinicalTrials.gov. A study of subcutaneous versus (vs.)
intravenous administration of daratumumab in participants with relapsed
or refractory multiple myeloma. NCT03277105. Available at: https://clinicaltrials.gov/ct2/show/NCT03277105
Last accessed May 2018.

21 ClinicalTrials.gov. A study comparing daratumumab,
lenalidomide, and dexamethasone with lenalidomide and dexamethasone in
relapsed or refractory multiple myeloma. NCT02076009. Available at: https://clinicaltrials.gov/ct2/show/NCT02076009
Last accessed May 2018.

22 ClinicalTrials.gov. Addition of daratumumab to combination
of bortezomib and dexamethasone in participants with relapsed or
refractory multiple myeloma. NCT02136134. Available at: https://clinicaltrials.gov/ct2/show/NCT02136134
Last accessed May 2018.

23 ClinicalTrials.gov. A study to evaluate daratumumab in
transplant eligible participants with previously untreated multiple
myeloma (CASSIOPEIA). NCT02541383. Available at: https://clinicaltrials.gov/ct2/show/NCT02541383
Last accessed May 2018.

24 ClinicalTrials.gov. A study of combination of daratumumab
and Velcade (bortezomib) melphalan-prednisone (DVMP) compared to Velcade
melphalan-prednisone (VMP) in participants with previously untreated
multiple myeloma. NCT02195479. Available at: https://clinicaltrials.gov/ct2/show/NCT02195479
Last accessed May 2018.

25 ClinicalTrials.gov. Study comparing daratumumab,
lenalidomide, and dexamethasone with lenalidomide and dexamethasone in
participants with previously untreated multiple myeloma. NCT02252172.
Available at: https://clinicaltrials.gov/ct2/show/NCT02252172
Last accessed May 2018.

26 ClinicalTrials.gov. A study of Velcade (bortezomib)
melphalan-prednisone (VMP) compared to daratumumab in combination with
VMP (D-VMP), in participants with previously untreated multiple myeloma
who are ineligible for high-dose therapy (Asia Pacific Region).
NCT03217812. Available at: https://clinicaltrials.gov/ct2/show/NCT03217812
Last accessed May 2018.

27 ClinicalTrials.gov. Comparison of Pomalidomide and
Dexamethasone With or Without Daratumumab in Subjects With Relapsed or
Refractory Multiple Myeloma Previously Treated With Lenalidomide and a
Proteasome Inhibitor Daratumumab/Pomalidomide/Dexamethasone vs
Pomalidomide/Dexamethasone (EMN14). NCT03180736. Available at: https://clinicaltrials.gov/ct2/show/NCT03180736
Last accessed May 2018.

28 ClincalTrials.gov. Study of carfilzomib, daratumumab and
dexamethasone for patients with relapsed and/or refractory multiple
myeloma. (CANDOR). NCT03158688. Available at: https://clinicaltrials.gov/ct2/show/NCT03158688
Last accessed May 2018.

29 ClinicalTrials.gov. A study of daratumumab in combination
with atezolizumab compared with atezolizumab alone in participants with
previously treated advanced or metastatic non-small cell lung cancer
(DARZALEX). NCT03023423. Available at: https://clinicaltrials.gov/ct2/show/NCT03023423
Last accessed May 2018.

30 ClinicalTrials.gov. A study to evaluate 3 dose schedules
of daratumumab in participants with smoldering multiple myeloma.
NCT02316106. Available at: https://clinicaltrials.gov/ct2/show/NCT02316106
Last accessed May 2018.

31 ClinicalTrials.gov. A study to assess the clinical
efficacy and safety of daratumumab in participants with relapsed or
refractory natural killer/T-cell lymphoma (NKTCL), nasal type.

Contacts

Janssen
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Mobile:
+353 (0)85-744-6696
Email: nbuhl@its.jnj.com
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