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Janssen to Present 14 Abstracts in Prostate and Urothelial Cancers at ASCO GU 2018, Including New Data on apalutamide (ARN-509), ZYTIGA® (abiraterone acetate) and erdafitinib

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New data from the Janssen Pharmaceutical Companies of Johnson & Johnson will be presented at this year’s American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium 2018 taking place February 8-10 in San Francisco. In total, 14 company-sponsored abstracts with data for both investigational and approved compounds have been accepted for presentation, including for apalutamide and ZYTIGA® (abiraterone acetate) in prostate cancer, and for erdafitinib in urothelial cancer. Most notably, Phase 3 data results from the SPARTAN clinical trial, assessing apalutamide in non-metastatic castration-resistant prostate cancer, will be featured as part of the Prostate Cancer Oral Abstract Session on Thursday, February 8.

The data, which is being presented at ASCO GU and features a number of approved and investigational compounds, reinforces our commitment to helping transform patient outcomes. We understand that every patient with cancer will face his or her own unique journey and we are committed to helping redefine that journey,” said Dr. Ivo Winiger-Candolfi, Oncology Solid Tumor Therapy Area Lead, Janssen Pharmaceutical Companies of Johnson & Johnson. “We particularly look forward to presenting results from the pivotal SPARTAN clinical trial.”

Key company-sponsored data presentations include:

Apalutamide:

  • SPARTAN, a phase 3 double-blind, randomized study of apalutamide (APA) vs placebo (PBO) in patients (pts) with non-metastatic castration-resistant prostate cancer (nmCRPC) (Abstract #161)
    • These data will be featured in an Oral Abstract Presentation during Session A of the Prostate Cancer Program from 1:00 pm – 2:30 pm PST on Thursday, February 8th

ZYTIGA ® :

  • Abiraterone acetate plus prednisone (P) 5 mg QD in metastatic castration-naïve prostate cancer (nCNPC): detailed safety analyses from the LATITUDE phase 3 trial (Abstract #182)
    • These data will be presented in a Poster Presentation Session A from 11:30am-1:00pm and 5:15 pm – 6:15 pm PST on Thursday, February 8th
  • Medical resource utilization (MRU) of abiraterone acetate plus prednisone (AAP) added to androgen deprivation therapy (ADT) in metastatic castration-naïve prostate cancer: results from LATITUDE (Abstract #201)
    • These data will be presented in a Poster Presentation Session A from 11:30am-1:00pm and 5:15 pm – 6:15 pm PST on Thursday, February 8th
  • Efficacy and safety of abiraterone acetate (AA) and low-dose prednisone (P) in Japanese patients with newly diagnosed, metastatic, hormone-naïve prostate cancer (mHNPC); Subgroup analysis of LATITUDE trial (Abstract #286)
    • These data will be featured at a Poster Session B from 12:15 pm – 1:45 pm and 6:00 pm – 7:00 pm PST on Friday, February 9th

Erdafitinib:

  • Erdafitinib (ERDA; JNJ-42756493), a pan-fibroblast growth factor receptor (FGFR) inhibitor, in patients (pts) with metastatic or unresectable urothelial carcinoma (mUC) and FGFR alterations (FGFRa): phase 2 continuous versus intermittent dosing (Abstract #411)

    • These data will be featured at the Rapid Fire Abstract Session during the Urothelial Carcinoma Program from 6:00 pm –7:00 pm PST on Friday, February 9th

A full list of company-sponsored abstracts to be presented at the meeting follows below:

Abstract No.

 

Title

 

Date/Time

Apalutamide
Abstract #161   SPARTAN, a phase 3 double-blind, randomized study of apalutamide (APA) vs placebo (PBO) in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC)   Oral Abstract Session A

Thursday, February 8th

1:00 pm – 2:30 pm PST

Abstract #27   Association of prostate-specific antigen (PSA) trajectories with risk for metastasis and mortality in non-metastatic castration-resistant prostate cancer (nmCRPC)   Poster Session A

Thursday, February 8th

11:30 am – 1:00 pm and 5:15 pm – 6:15 pm PST

ZYTIGA ®
Abstract #182   Abiraterone acetate (AA) plus prednisone (P) 5 mg QD in metastatic castration-naïve prostate cancer (mCNPC): detailed safety analyses from the LATITUDE phase 3 trial   Poster Session A

Thursday, February 8th

11:30 am – 1:00 pm and 5:15 pm – 6:15 pm PST

Abstract #201   Medical resource utilization (MRU) of abiraterone acetate plus prednisone (AAP) added to androgen deprivation therapy (ADT) in metastatic castration-naïve prostate cancer: results from LATITUDE   Poster Session A

Thursday, February 8th

11:30 am –1:00 pm and 5:15 pm – 6:15pm PST

Abstract #286   Efficacy and safety of abiraterone acetate (AA) and low-dose prednisone (p) in Japanese patients with newly diagnosed, metastatic, hormone-naïve prostate cancer (mHNPC); Subgroup analysis of LATITUDE Trial   Poster Session B

Friday, February 9th

12:15 pm – 1:45 pm and 6:00 pm – 7:15 pm PST

Abstract #196   Real-world evidence in patient-related outcomes (PROs) of metastatic castrate-resistant prostate cancer (mCRPC) patients treated with abiraterone acetate plus prednisone (AA+P)   Poster Session A

Thursday, February 8th

11:30am –1:00pm and 5:15pm – 6:15pm PST

Abstract #200   Indirect treatment comparison (ITC) of abiraterone acetate (AA) plus prednisone (P) and docetaxel (DOC) on patient-reported outcomes (PROs) in metastatic castration-naïve prostate cancer (mCNPC)   Poster Session A

Thursday, February 8th

11:30 am – 1:00 pm and 5:15 pm – 6:15 pm PST

Abstract #217   Neuropsychiatric adverse events of abiraterone acetate and enzalutamide: meta-analysis of randomized clinical trials with real world reporting patterns from EudraVigilance   Poster Session A

Thursday, February 8th

11:30 am –1:00 pm and 5:15 pm –6:15 pm PST

Abstract #296   Real-world study of enzalutamide and abiraterone acetate (with prednisone) tolerability (REAAcT) - results   Poster Session B

Friday, February 9th

12:15 pm – 1:45 pm and 6:00 pm – 7:15 pm PST

Abstract #320   Real world patterns of treatment sequencing in Canada for metastatic castrate-resistant prostate cancer   Poster Session B

Friday, February 9th

12:15 pm – 1:45 pm and 6:00 pm – 7:15 pm PST

Abstract #321   Patterns of prostate cancer management across Canadian prostate cancer treatment specialists   Poster Session B

Friday, February 9th

12:15 pm – 1:45 pm and 6:00 pm – 7:15 pm PST

Abstract #343   Evolution of neuropsychiatric adverse events of abiraterone acetate and enzalutamide treatments reported in EudraVigilance, in metastatic castration resistant prostate cancer patients   Poster Session B

Friday, February 9th

12:15 pm – 1:45 pm and 6:00 pm – 7:15 pm PST

Erdafitinib
Abstract #411  

Erdafitinib (ERDA: JNJ-42756493), a pan-fibroblast growth factor receptor (FGFR) inhibitor, in patients (pts) with metastatic or unresectable urothelial carcinoma (mUC) and FGFR alterations (FGFRa): phase 2 continuous versus intermittent dosing

  Rapid Fire Abstract Session (Oral Abstract Presentation)

Friday, February 9th

6:00 pm – 7:00 pm PST

Abstract #450   Efficacy of programmed death 1 (PD-1) and programmed death 1 ligand (PD-L1) inhibitors in patients with FGFR mutations and gene fusions: Results from a data analysis of an ongoing phase 2 study of erdafitinib (JNJ-42756493) in patients (pts) with advanced urothelial cancer (UC)   Poster Session B

Friday, February 9th

12:15 pm – 1:45 pm and 6:00 pm – 7:15 pm PST

   

About abiraterone acetate

Abiraterone acetate plus prednisone / prednisolone is the only approved therapy in metastatic prostate cancer 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.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 in whom chemotherapy is not yet clinically indicated.3

On Friday 17th November 2017, the EC granted approval in 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 that were 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 (ARN-509) 4

Apalutamide is an investigational, next-generation oral androgen receptor inhibitor that blocks the androgen signaling pathway in prostate cancer cells, and prevents binding of androgen to the androgen receptor and translocation of the androgen receptor to the nucleus of the cancer cell.

About Erdafitinib 5

Erdafitinib is a pan-fibroblast Growth Factor Receptor (FGFR) tyrosine kinase inhibitor currently being evaluated by Janssen in Phase 2 and 3 clinical trials in patients with advanced urothelial cancer. Additional research is also being conducted to explore the use of erdafitinib in other cancer indications.

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 http://www.twitter.com/janssenEMEA.

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 continued development and potential of abiraterone acetate plus prednisone / prednisolone. 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 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. 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.

Date of preparation: January 2018

Job number: PHEM/ZYT/0118/0002

# # #

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 (November 2017). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002321/WC500112858.pdf. Last accessed January 2018.

4 Clegg NJ, et al. Cancer Res., 2012;72:1494-1503

5 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

Contact information

Janssen
Media Enquiries:
Natalie Buhl
Phone: +353 85-744-6696
or
Investor Relations:
Lesley Fishman
Phone: +1 732-524-3922
or
Joseph J. Wolk
Phone: +1 732-524-1142

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