On September 18, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson reported multiple data presentations from its solid tumour portfolio, including key prostate cancer data, will be featured at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Annual Congress, taking place 27th September to 1st October in Barcelona, Spain (Press release, Janssen Pharmaceuticals, SEP 18, 2019, View Source [SID1234539622]). 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).

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"We are delighted to share key data from our solid tumour portfolio at this year’s ESMO (Free ESMO Whitepaper) 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