On September 14, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson reported multiple data presentations from its oncology portfolio and pipeline, including key data in lung cancer and bladder cancer, will be featured as part of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, Science Weekend taking place 19–21 September (Press release, Janssen Pharmaceuticals, SEP 14, 2020, View Source [SID1234565107]).
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Thirteen abstracts featuring Janssen data have been selected for presentation during the virtual congress, including an oral presentation and live Q&A of the latest data from the Phase 1 dose escalation study investigating amivantamab (JNJ-61186372) in combination with lazertinib in patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC); updates on multiple Phase 1/2 studies evaluating erdafitinib in the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC); an update on patient-reported outcomes on health-related quality of life data from the final analysis of the Phase 3 SPARTAN study of apalutamide in patients with non-metastatic castration resistant prostate cancer (nmCRPC) with over four years of follow up. The full final analysis of the SPARTAN study was also recently published in European Urology.1 In addition, Janssen makes its first presentation of in-human data for early-stage investigational protein arginine methyltransferase 5 (PRMT5) inhibitor JNJ-9178 in multiple tumour models (relapsed/refractory B cell non-Hodgkin lymphoma or advanced solid tumours, including patients with lower risk myelodysplastic syndromes). 2,3
"Janssen’s data at this year’s congress demonstrates our continued commitment to advancing our broad oncology portfolio, driven by the critical unmet needs in solid tumours for some of the most prevalent cancers in Europe," said Dr Joaquín Casariego, M.D., Janssen Therapeutic Area Lead, Oncology for Europe, Middle East & Africa, Janssen-Cilag, S.A. "The advancement of new approaches to cancer treatment and interception at earlier stages of the disease is vital to improve clinical outcomes and ultimately enhancing the quality of life for those affected by an oncologic diagnosis."
Company-sponsored abstracts to be presented at the meeting include:
Abstract/Presentation No.
Title
Amivantamab
Proffered Paper 1: NSCLC Metastatic
Sunday 20th September
14:37–14:49 CET
Abstract #1258O
Amivantamab (JNJ-61186372), an EGFR-MET bispecific antibody, in combination with lazertinib, a 3rd-generation tyrosine kinase inhibitor (TKI), in advanced EGFR NSCLC
On-Demand E-Poster Display Session
Thursday 17th September
Abstract #1405P
Survival of patients with Non-Small Lung Cancer and Exon 20 insertion mutation from the Czech Republic
JNJ-9178
On-Demand Mini Oral Session: Development Therapeutics
Friday 18th September
Abstract #537MO
First-in-Human Study of JNJ-64619178, a Protein Arginine Methyltransferase 5 (PRMT5) inhibitor, in Patients with Advanced Cancers
Erdafitinib
On-Demand E-Poster Display Session
Thursday 17th September
Abstract #603TiP
Phase 2, Open-Label Study of Erdafitinib in Adult and Adolescent Patients with Advanced Solid Tumors Harboring Fibroblast Growth Factor Receptor (FGFR) Gene Alterations
Abstract #750P
Erdafitinib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma (mUC): Subgroup Analyses of Long-Term Efficacy Outcomes of a Pivotal Phase 2 Trial (BLC2001)
Abstract #751P
Analysis of Circulating Tumor DNA (ctDNA) From the Phase 2 BLC2001 Trial of Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma (mUC) to Identify Markers of Intrinsic Resistance to Fibroblast Growth Factor Receptor (FGFR)-Targeted Therapy
Abstract #752P
Updated Data From the NORSE Trial of Erdafitinib Plus Cetrelimab in Patients with Metastatic or Locally Advanced Urothelial Carcinoma (mUC) and Specific Fibroblast Growth Factor Receptor (FGFR) Alterations
Abstract #757P
An Observational Study of Outcomes of Patients with Advanced Urothelial Carcinoma (UC) After Anti-programmed Death-(Ligand) 1 (PD-[L]1) Therapy by Fibroblast Growth Factor Receptor Gene Alteration (FGFRa) Status
Abstract #758P
Assessment of Prognostic and Predictive Value of FGFR Alterations (FGFRa) in a Real-World Cohort of Patients with High-Risk pT1 Non-Muscle-Invasive Bladder Cancer (NMIBC)
Apalutamide
On-Demand E-Poster Display Session
Thursday 17th September
Abstract #632P
Health-Related Quality of Life (HRQoL) at Final Analysis of the SPARTAN Study of Apalutamide vs Placebo in Patients with Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC) Receiving Androgen Deprivation Therapy (ADT)
Abstract #630P
Apalutamide for Non-Metastatic Castration Resistant Prostate Cancer (nmCRPC): A Comparison of Real-Life Experience From an International Named Patient Program vs the Prior Phase 3 Clinical Study
Niraparib
On-Demand E-Poster Display Session
Thursday 17th September
Abstract #689TiP
NRG Oncology’s GU007 (NADIR) TiP: A Randomized Phase II Trial of Niraparib With Standard Combination Androgen Deprivation Therapy (ADT) and Radiotherapy in High-Risk Prostate Cancer (With Initial Phase I)
Big Data and Artificial Intelligence Research
On-Demand E-Poster Display Session
Thursday 17th September
Abstract #695TiP
ORACULUM: A Retrospective Observational Epidemiological Study Using Artificial Intelligence and Natural Language Processing in Electronic Health Records to Characterize the Prostate Cancer pathway, Management and Outcomes in Europe, Middle East and Africa (EMEA region)
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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 In the U.S. apalutamide is also indicated for the treatment of nmCRPC and mCSPC.5
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.6,7,8,9,10,11 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.12 In 2008, Janssen Pharmaceutica N.V. entered into an exclusive worldwide license and collaboration agreement with Astex Pharmaceuticals to develop and commercialise erdafitinib.13
About amivantamab
Amivantamab (JNJ-6372) is an investigational EGFR-MET bispecific antibody with immune cell-directing activity, which targets activating and resistance EGFR mutations, and MET pathway activation.14,15 The production and development of the antibody followed Janssen Biotech, Inc.’s licensing agreement with Genmab for use of its DuoBody technology platform.16
About lazertinib
Lazertinibi is an oral, third-generation, selective inhibitor of certain forms of the epidermal growth factor receptor (EGFR) with activating mutations, including the resistance mutation T790M, exon 19 deletions (Del19), and the L858R mutation, with potential antineoplastic activity.17 It is currently being explored in combination with amivantamab in patients with advanced non-small cell lung cancer.18
About JNJ-9178
JNJ-64619178 is an oral, selective protein arginine methyltransferase 5 inhibitor which is currently being investigated in a Phase 1 study for the treatment of patients with relapsed/refractory B cell non-Hodgkin lymphoma or advanced solid tumours, including patients with lower risk myelodysplastic syndromes.3,19