On February 3, 2021 The Janssen Pharmaceutical Companies of Johnson & Johnson reported it will highlight the depth of its solid tumour portfolio at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (ASCO GU) Cancers Symposium with 12 data presentations, including three company-sponsored oral presentations from the apalutamide clinical development program (Press release, Johnson & Johnson, FEB 3, 2021, View Source [SID1234574575]). The virtual meeting will take place 11-13 February.
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"Janssen’s extensive data presentations at ASCO (Free ASCO Whitepaper) GU are testament of our commitment to clinical research in genitourinary cancers — to deliver innovative therapies that improve patient outcomes and address critical unmet needs," said Dr Joaquín Casariego, M.D., Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A. "The latest research from the TITAN Phase 3 trial and our prostate cancer portfolio improves clinical understanding and opens new treatment pathways for a broader group of patients."
New Analyses for Apalutamide Phase 3 Studies Highlight Breadth of Ongoing Clinical Development Program
Data from three Phase 3 registrational clinical trials will be featured in oral presentations:
ACIS: Analysis evaluating apalutamide in combination with abiraterone acetate plus prednisone versus abiraterone acetate plus prednisone in patients with chemo-naïve metastatic castration-resistant prostate cancer (Abstract #9)1
TITAN: Final analysis with close to four years of follow-up data evaluating apalutamide versus placebo on overall survival (OS) and other endpoints in patients with metastatic hormone-sensitive prostate cancer (mHSPC) receiving hormone therapy (Abstract #11)2
SPARTAN: Post-hoc analysis data from a biomarker cohort study identifying the molecular signatures associated with long-term response to apalutamide (Abstract #8)3
Combined, the apalutamide focused presentations include data from more than 2,000 patients across multiple studies. Apalutamide has shown a statistically significant improvement in OS in its approved indications of metastatic hormone-sensitive prostate cancer (TITAN) and non-metastatic castration-resistant prostate cancer (SPARTAN).4 Both TITAN and SPARTAN trials confirm the safety of apalutamide, with over four years of patient follow-up demonstrating exposure-adjusted rates of Grade 3 and 4 adverse events for apalutamide that are comparable to androgen deprivation therapy alone.5
Further details about these data and the science that Janssen is advancing for patients with genitourinary cancers will be made available at ASCO (Free ASCO Whitepaper) GU via the Janssen media event, Prioritising Prostate Cancer (February 12th, 2021 at 16:30 CET).
Abstracts to be presented at the meeting include:
Abstract No.
Title
Date/Time
Apalutamide
Oral Presentations
Abstract #8
Molecular Determinants Associated with Long-Term Response to Apalutamide in Non-Metastatic Castration-Resistant Prostate Cancer
Thursday,
February 11
6:45 PM – 8:00 PM CET
Abstract #9
Results from ACIS, a Randomized, Placebo-Controlled Double-Blind Phase 3 Study of Apalutamide and Abiraterone Acetate Plus Prednisone (AAP) Versus AAP in Patients with Chemo-Naive Metastatic Castration-Resistant Prostate Cancer
Thursday,
February 11
6:45 PM – 8:00 PM CET
Abstract #11
Final Analysis Results From TITAN: A Phase 3 Study of Apalutamide vs Placebo in Patients with Metastatic Castration-Sensitive Prostate Cancer Receiving Androgen Deprivation Therapy
Thursday,
February 11
9:30 PM – 10:15 PM CET
Poster Presentations
Abstract #44
Medication Adherence Among Prostate Cancer Patients Using Advanced Oral Therapies
Poster Session: Prostate Cancer – Advanced Disease, available on-demand throughout the meeting
Abstract #64
Health-Related Quality of Life Analysis from a Randomized Phase 2 Trial of Androgen Signaling Inhibitors with or without Androgen Deprivation Therapy for Castration-Sensitive Prostate Cancer: LACOG0415
Poster Session: Prostate Cancer – Advanced Disease, available on-demand throughout the meeting
Abstract #83
Outcomes in Men with Metastatic Castrate-Resistant Prostate Cancer Treated with Early Platinum-Based Chemotherapy Following an Unsatisfactory Response to Androgen Receptor Inhibition as Part of the Phase 2 Dynamic Allocation Modular Sequential (DynAMo) Trial
Poster Session: Prostate Cancer – Advanced Disease, available on-demand throughout the meeting
Abstract #90
Interim Analysis of STARTAR: A Phase 2 Salvage Trial of Androgen Receptor Inhibition with Androgen Deprivation Therapy and Apalutamide with Radiation Therapy Followed by Docetaxel in Men with PSA Recurrent Prostate Cancer After Radical Prostatectomy
Poster Session: Prostate Cancer – Advanced Disease, available on-demand throughout the meeting
Erdafitinib
Poster Presentation
Abstract #426
Management of Fibroblast Growth Factor Receptor Inhibitor Treatment-Emergent Adverse Events of Interest in Patients with Locally Advanced or Metastatic Urothelial Carcinoma
Poster Session: Urothelial Carcinoma, available on-demand throughout the meeting
Niraparib
Poster Presentation
Abstract #TPS176
AMPLITUDE: A Study of Niraparib in Combination with Abiraterone Acetate Plus Prednisone (AAP) Versus AAP for the Treatment of Patients with Deleterious Germline or Somatic Homologous Recombination Repair Gene-Altered Metastatic Castration-Sensitive Prostate Cancer
Trials in Progress Poster Session: Advanced Prostate Cancer, available on-demand throughout the meeting
Other
Poster Presentations
Abstract #47
Real-World Utilization of Docetaxel Among Men with De Novo Metastatic Castration-Sensitive Prostate Cancer: A Population-Based Study in Men Aged 66 or Older
Poster Session: Prostate Cancer – Advanced Disease, available on-demand throughout the meeting
Abstract #50
Geographic Variation in Systemic Therapy in Men Age 66 Years and Older With De Novo Metastatic Castration Sensitive Prostate Cancer: A Population-Based Study in a Single Payer Health-System
Poster Session: Prostate Cancer – Advanced Disease, available on-demand throughout the meeting
Abstract #149
Prognostic Association Between Common Laboratory Tests and Overall Survival in Men with De Novo Metastatic Castration-Sensitive Prostate Cancer: A Population-Based Study
Poster Session: Prostate Cancer – Advanced Disease, available on-demand throughout the meeting
# #END# #
About apalutamide
Apalutamide is an orally administered, selective androgen receptor (AR) inhibitor approved in Europe and is indicated in
adult men for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease, and
in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC), also known as metastatic castration-sensitive prostate cancer (mCSPC), in combination with androgen deprivation therapy (ADT). 4
About abiraterone acetate
Abiraterone acetate, an orally administered androgen biosynthesis inhibitor, in combination with prednisone or prednisolone is approved in Europe for
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 ADT in whom chemotherapy is not yet clinically indicated, and
the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.6
Additionally, abiraterone acetate was approved for the treatment of high-risk metastatic hormone-sensitive prostate cancer (mHSPC) by the U.S. FDA on February 8, 2018.7,8 Since its first approval in Europe in 2011, abiraterone acetate has been approved in combination with prednisone or prednisolone, in more than 105 countries and has been prescribed to more than 700,000 patients worldwide.8
About erdafitinib
Erdafitinib is a once-daily, oral fibroblast growth factor receptor (FGFR) kinase inhibitor that is being studied in patients with selected FGFR gene alterations in locally advanced or metastatic urothelial cancer, in Bacillus Calmette-Guérin (BCG) experienced, high risk non-muscle-invasive bladder cancer and in advanced solid tumours.9,10,11,12,13 In 2019 erdafitinib was approved in the U.S. 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.14 In 2008, Janssen entered into an exclusive worldwide license and collaboration agreement with Astex Pharmaceuticals to develop and commercialise erdafitinib.15
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. Ongoing studies include the Phase 3 AMPLITUDE study evaluating niraparib in combination with abiraterone acetate plus prednisone in a biomarker-selected patient population with mHSPC;16 the Phase 3 MAGNITUDE study evaluating niraparib in combination with abiraterone acetate plus prednisone in adults with mCRPC;17 and QUEST, a Phase 1b/2 study of niraparib combination therapies for the treatment of mCRPC.18
In April 2016, Janssen entered a worldwide (except Japan) collaboration and license agreement with TESARO, Inc. (acquired by GSK in 2018), for exclusive rights to niraparib in prostate cancer.19 In Europe, niraparib is indicated for the maintenance treatment of adult patients with advanced epithelial high-grade ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy; for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.20