Janssen to Highlight Depth of Solid Tumour Portfolio with Multiple Data Presentations at ESMO 2019

• Second interim analysis from the Phase 3 SPARTAN study reporting overall survival in patients with high-risk non-metastatic castration-resistant prostate cancer treated with ERLEADA® (apalutamide)
• Patient-reported outcomes from the Phase 3 TITAN study reporting maintenance of overall health-related quality of life in patients receiving ERLEADA
• Interim analysis from the Phase 2 GALAHAD study evaluating niraparib in the treatment of patients with metastatic castration-resistant prostate cancer featured as late-breaking abstract
• Further response analysis from the Phase 2 BLC2001 study evaluating erdafitinib in fibroblast growth factor receptor (FGFR)-positive patients with metastatic urothelial carcinoma

Beerse, Belgium, September 18, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced multiple data presentations from its solid tumour portfolio, including key prostate cancer data, will be featured at the European Society for Medical Oncology (ESMO) 2019 Annual Congress, taking place 27th September to 1st October in Barcelona, Spain. Among Janssen’s 12 accepted abstracts is an oral presentation reporting overall survival from the Phase 3 SPARTAN study investigating the use of apalutamide in patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC); patient-reported outcomes from the Phase 3 TITAN study in patients with metastatic hormone-sensitive prostate cancer (mHSPC) demonstrating maintenance of overall health-related quality of life with apalutamide; and a late-breaking interim analysis from the Phase 2 GALAHAD study evaluating niraparib in the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) and biallelic DNA-repair gene defects (DRD).

“We are delighted to share key data from our solid tumour portfolio at this year’s ESMO Congress, including new findings for apalutamide and niraparib in the treatment of prostate cancer,” said Dr. Joaquín Casariego, Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A.. “We continue to pursue areas of oncology where there is the greatest unmet need, and the data being presented in Barcelona reflects our ongoing passion and commitment to improving patient outcomes.”

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

Abstract No.	Title	Date/Time
Apalutamide
Oral Presentation
Abstract #843O	Apalutamide and Overall Survival in Patients with Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC): Updated Results from the Phase 3 SPARTAN Study	Friday 27th September 14:00 - 14:15 CET
Poster Presentations
Abstract #851PD	Patient-Reported Outcomes (PROs) From TITAN: A Phase 3, Randomized, Double-Blind Study of Apalutamide Versus Placebo Added to Androgen Deprivation Therapy in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)	Sunday 29th September 09:20 CET
Abstract #883P	Androgen Receptor Aberrations in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) Treated with Apalutamide Plus Androgen Deprivation Therapy in TITAN	Monday 30th September 12:00 – 13:00 CET
Abstract #900TiP	A Phase 2 randomized, open-label study comparing salvage radiotherapy in combination with 6 months of androgen-deprivation therapy with LHRH agonist or antagonist versus anti-androgen therapy with apalutamide in patients with biochemical progression after radical prostatectomy	Monday 30th September 12:00 – 13:00CET
Abiraterone acetate
Poster Presentation
Abstract #95P	Evaluation of markers associated with efficacy of abiraterone acetate plus prednisone in patients with castration-sensitive prostate cancer (mCSPC) from the LATITUDE study	Monday 30th September 12:00 – 13:00 CET
Niraparib
Poster Presentations
Abstract #LBA50	Pre-specified interim analysis of GALAHAD: A Phase 2 study of niraparib in patients with metastatic castration-resistant prostate cancer (mCRPC) and biallelic DNA-repair gene defects	Sunday, 29th September 08:30 CET
Abstract #897TiP	A Phase 3 randomized, placebo-controlled, double-blind study of niraparib plus abiraterone acetate and prednisone versus abiraterone acetate and prednisone in patients with metastatic prostate cancer (NCT03748641)	Monday 30th September 12:00 – 13:00 CET
Abstract #1412P	Analytical performance of the Resolution-HRD plasma assay used to identify mCRPC patients with biallelic disruption of DNA repair genes for treatment with niraparib	Monday 30th September 12:00 – 13:00 CET
Erdafitinib
Poster Presentations
Abstract #925P	Analysis of response to prior therapies and therapies after treatment with erdafitinib in fibroblast growth factor receptor (FGFR)-positive patients with metastatic urothelial carcinoma	Monday 30th September 12:00 CET
Abstract #926P	Erdafitinib versus available therapies in advanced urothelial cancer: A matching adjusted indirect comparison	Monday 30th September 30 12:00 CET
Abstract #932P	Hyperphosphatemia due to Erdafitinib (a Pan-FGFR Inhibitor) and Antitumor Activity Among Patients with Advanced Urothelial Carcinoma	Monday 30th September 12:00 CET
Solid Tumor Portfolio
Poster Presentation
Abstract #488P	Correlation of Progression Free Survival-2 and Overall Survival in Solid Tumors	Saturday 28th September 12:00 CET

About ERLEADA® (apalutamide)

ERLEADA® (apalutamide) is an androgen receptor (AR) inhibitor indicated for use in Europe for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC).1 In the U.S. apalutamide is indicated for the treatment of nmCRPC.²

About ZYTIGA® (abiraterone acetate)

ZYTIGA® (abiraterone acetate) in combination with prednisone is indicated in Europe and the U.S. for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) and newly-diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC).3,4

About BALVERSATM (erdafitinib)

BALVERSA™ (erdafitinib) is a once-daily, oral fibroblast growth factor receptor (FGFR) kinase inhibitor that is currently being studied for the treatment of patients with advanced or metastatic urothelial cancer.5 In the U.S. it is indicated for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) that has susceptible FGFR3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.6

About niraparib

Niraparib is an orally-administered selective poly ADP ribose polymerase (PARP) inhibitor that is currently being studied by Janssen for the treatment of patients with prostate cancer.7 In April 2016, Janssen entered a worldwide (except Japan) collaboration and license agreement with TESARO, Inc., for exclusive rights to niraparib in prostate cancer.8 In the U.S., niraparib is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.9 Niraparib is currently marketed by TESARO, an oncology-focused business within GSK, devoted to providing transformative therapies to people facing cancer.10

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding potential benefits and further benefits of ERLEADA® (apalutamide), ZYTIGA® (abiraterone acetate), BALVERSATM (erdafitinib) and niraparib. 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 Research & Development, LLC, 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 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 30, 2018, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, 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 nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

1. European Medicines Agency. ERLEADA Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/erleada-epar-product-information_en.pdf. Last accessed September 2019.
2. ERLEADA product information Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210951s000lbl.pdf. Last accessed September 2019.
3. European Medicines Agency. ZYTIGA Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/zytiga. Last accessed September 2019.
4. U.S. Food and Drug Administration. ZYTIGA Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202379s024lbl.pdf. Last accessed September 2019.
5. U.S. National Library of Medicine. A study of erdafitinib compared with vinflunine or docetaxel or pembrolizumab in participants with advanced urothelial cancer and selected fibroblast growth factor receptor (FGFR) gene aberrations. Available at: https://clinicaltrials.gov/ct2/show/NCT03390504. Last accessed September 2019.
6. U.S. Food and Drug Administration. BALVERSA Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212018s000lbl.pdf. Last accessed September 2019.
7. U.S. National Library of Medicine. A study of niraparib combination therapies for the treatment of metastatic castration-resistant prostate cancer (QUEST). Available at: https://clinicaltrials.gov/ct2/show/NCT03431350. Last accessed September 2019.
8. CISION. Janssen Enters Worldwide Collaboration and License Agreement with TESARO, Inc., for Niraparib in Prostate Cancer. Available at: https://www.prnewswire.com/news-releases/janssen-enters-worldwide-collaboration-and-license-agreement-with-tesaro-inc-for-niraparib-in-prostate-cancer-300246733.html. Last accessed September 2019
9. U.S. Food and Drug Administration. Niraparib Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf. Last accessed September 2019.
10. Zejula® niraparib. Summary of Product Characteristics. Tesaro UK Limited. Available at: https://www.medicines.org.uk/emc/product/8828/smpc. Last accessed September 2019.