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Janssen to showcase robust oncology portfolio at ESMO 2018

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The Janssen Pharmaceutical Companies of Johnson & Johnson will present updates from across its oncology portfolio at the European Society for Medical Oncology (ESMO) 2018 annual congress, taking place on 19-23 October in Munich, Germany. Phase 3 data from the SPARTAN study reporting health-related quality of life outcomes in patients with non-metastatic castration-resistant prostate cancer treated with apalutamide will be included in a poster session, with a further poster session highlighting data for ZYTIGA® (abiraterone acetate) in metastatic hormone-sensitive prostate cancer. For erdafitinib in metastatic bladder cancer, a poster session will include an overview of the Phase 3 clinical trial design, and results from a Phase 2a study in advanced cholangiocarcinoma will be featured in a poster discussion.

We are proud to share such robust data and across a range of tumor types at this year’s ESMO congress,” said Dr. Ivo Winiger-Candolfi M.D., Europe, Middle East and Africa Oncology Solid Tumor Therapy Area Lead, Cilag GmbH International. “We are particularly excited to present health-related quality of life data from the SPARTAN trial, results that were recently published in The Lancet Oncology. Transforming patient outcomes is a key commitment for us at Janssen, and helping patients maintain quality of life while on treatment can be as important as their clinical outcome.”

Company-sponsored abstracts to be presented at the meeting include:

Abstract no.   Title   Date/time
Apalutamide
Abstract #804P Health-Related Quality of Life (HRQoL) After Progressive Disease (PD) in SPARTAN: a Phase 3 Trial of Apalutamide (APA) Versus Placebo (PBO) in Men with Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC) Poster display session

Monday 22 October

12:45 - 13:45

Hall A3

Abstract #806P Relationship Between Apalutamide (APA) Exposure and Metastasis-Free Survival (MFS) in Patients (pts) With Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC) From SPARTAN Poster display session

Monday 22 October

Time: 12:45 - 13:45

Hall A3

ZYTIGA ®
Abstract #797PD LATITUDE study: PSA response characteristics and correlation with overall survival (OS) and radiological progression-free survival (rPFS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) receiving ADT + abiraterone acetate and prednisone (AAP) or placebo (PBO) Poster discussion session - genitourinary tumours, prostate (ID 167)

Sunday 21 October

09:15 - 10:30

ICM - Room 14b

Erdafitinib    
Abstract #920TiP Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Patients (pts) With Metastatic or Surgically Unresectable (M/UR) Urothelial Carcinoma (UC) and Selected FGFR Gene Alterations (FGFRalt): the Phase 3 THOR Study Poster display session

Monday 22 October

12:45-13:45

Hall A3

Abstract #624PD Preliminary Results of a Phase2a Study to Evaluate the Clinical Efficacy and Safety of Erdafitinib in Asian Patients with Biomarker-Selected Advanced Cholangiocarcinoma (CCA) Poster discussion session: gastrointestinal, non-colorectal 1 (ID 261)

Friday 19 October

15:45 - 17:20

Hall B3 - Room 21

Niraparib    
Abstract #834P Interim Results of a Phase 1b Study of Niraparib plus Androgen Receptor-Targeted Therapy in Men with Metastatic Castration-Resistant Prostate Cancer Poster display session

Monday 22 October

12:45-13:45

Hall A3

JNJ-61186372    
Abstract #1497P JNJ-61186372 (JNJ-372), an EGFR-cMET Bispecific Antibody, in Advanced Non-Small Cell Lung Cancer (NSCLC): An Update on Phase 1 Results Poster display session

Saturday 20 October

12:30-13:30

Hall A3

VELCADE ® (bortezomib)    
Abstract # 1004O Final Overall Survival Results of Frontline Bortezomib plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR-CAP) vs R-CHOP in Transplantation-ineligible Patients (Pts) with Newly Diagnosed Mantle-Cell Lymphoma (MCL): A Randomized, Open-Label, Phase 3 (LYM3002) Study Proffered paper session

Sunday 21 October

11:00 – 11:15

Hall A3

ENDS

About abiraterone acetate

Abiraterone acetate plus prednisone/prednisolone is the only approved oral therapy in metastatic prostate cancer that inhibits production of androgens (which fuel prostate cancer growth) at all three sources – the testes, adrenals and the tumour itself.1,2,3

Indications 3

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 for whom chemotherapy is not yet clinically indicated.3

In November 2017, the EC granted approval for broadening the existing marketing authorisation for abiraterone acetate plus prednisone/prednisolone for the treatment of newly-diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).3

Further information 3

The most common adverse reactions seen with abiraterone acetate plus prednisone/prednisolone observed in ≥10% of patients were peripheral oedema, hypokalaemia, hypertension urinary tract infection, and alanine aminotransferase increased and/or aspartate aminotransferase increased. Other important adverse reactions include cardiac disorders, hepatotoxicity, fractures, and allergic alveolitis. 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: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002321/WC500112858.pdf

About apalutamide

Apalutamide is an investigational, next-generation oral androgen receptor (AR) inhibitor that blocks the androgen signaling pathway in prostate cancer cells. 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.4

Janssen has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) for apalutamide for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). ERLEADA™ (apalutamide) was approved in the United States for the treatment of patients with nmCRPC in February 2018.5

About erdafitinib 6

Erdafitinib is an investigational, once-daily oral pan-fibroblast growth factor receptor (FGFR) inhibitor being studied in Phase 2 and Phase 3 clinical trials for the treatment of patients with locally advanced or metastatic urothelial cancer.7 FGFRs are a family of receptor tyrosine kinases, which can be activated by genetic alterations in a variety of tumor types, and these alterations may lead to increased tumor cell growth and survival.

About niraparib

Niraparib is an orally-administered highly-selective PARP inhibitor that is currently being studied for the treatment of patients with prostate cancer. In April 2016, Janssen entered a worldwide collaboration and license agreement with TESARO, Inc., for exclusive rights to niraparib in prostate cancer. Niraparib is approved in Europe, Switzerland and the United States for the treatment of ovarian cancer and is marketed by TESARO.8

About JNJ-372

JNJ-61186372 (JNJ-372) is a fully human, IgG1 bispecific antibody that binds to both EGFR and cMET and is being developed by Janssen for the treatment of advanced non-small cell lung cancer.9

About bortezomib

Bortezomib is the first in a specific class of medicines known as proteasome inhibitors. Proteasomes are present in all cells and play an important role in controlling cell function, growth and also how cells interact with other cells around them. Bortezomib reversibly interrupts the normal working of cell proteasomes, inducing the cancerous cells, to stop growing and die.10

About the Janssen Pharmaceutical Companies of Johnson & Johnson

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 http://www.twitter.com/janssenEMEA. Janssen-Cilag International N.V. and Cilag GmbH International 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 product development and the potential benefits and treatment impact. 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 materialise, 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 behaviour and spending patterns or financial distress 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 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. Neither 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 Hoy, SM. et al. Abiraterone Acetate: A review of its use in patients with metastatic castration-resistant prostate cancer drugs. Drugs 2013; 73:2077-2091.

2 Ritch, CR. Cookson, MS. Advances in the management of castration resistant prostate cancer. BMJ. 2016 Oct 17;355:i4405. Doi: 10.1136/bmj.i4405.

3 ZYTIGA® summary of product characteristics (July 2018). Available at: https://www.ema.europa.eu/documents/product-information/zytiga-epar-product-information_en.pdf. Last accessed October 2018.

4 Clegg NJ, et al. ARN-509: a novel antiandrogen for prostate cancer treatment. Cancer Res. 2012;72:1494-1503.

5 FDA. FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint. Available at https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm596768.htm. Last accessed October 2018.

6 Soria JC, et al. Poster presented at European Society for Medical Oncology conference, 7-11 October, 2016, Copenhagen, Denmark. Poster number: 781PD ClinicalTrials.Gov: NCT02365597

7 Tabernero J, Bahleda R, Dienstmann R, Infante JR, Mita A, Italiano A, Calvo E, Moreno V, Adamo B, Gazzah A, et al. Phase I dose-escalation study of JNJ-42756493, an oral pan-fibroblast growth factor receptor inhibitor, in patients with advanced solid tumors. J Clin Oncol. 2015;33:3401–3408. doi: 10.1200/JCO.2014.60.7341.

8 EMA. EPAR summary for the public Zejula (niraparib). Available at: https://www.ema.europa.eu/documents/overview/zejula-epar-summary-public_en.pdf. Last accessed October 2018

9 Immuno-oncology news. Available at: https://immuno-oncologynews.com/jnj-61186372/. Last accessed October 2018.

10 VELCADE EPAR summary for the public February 2014. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000539/WC500048136.pdf. Last accessed October 2018

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