Business Wire

Janssen to present growing set of oncology data at the 2016 European Society for Medical Oncology (ESMO) Congress

Del

Janssen-Cilag International NV today announced data from ten company-sponsored abstracts will be presented at the 2016 ESMO Congress in Copenhagen, Denmark, on the 9th and 10th October 2016. The data feature four Janssen medicines spanning multiple disease areas including prostate, urothelial and blood cancer, and showcase Janssen’s broad portfolio in oncology and commitment to patients.

“The data to be presented at ESMO highlights the efficacy and safety profiles of Janssen treatments and also provides insights from a large, real-world prostate cancer patient population on how patients live with, and manage, their disease. Every patient with cancer will face his or her own unique journey and we are committed to helping redefine that journey. We hope that these findings will help us improve outcomes for cancer patients in the future,” said Jane Griffiths, Company Group Chairman, Janssen European, Middle East and Africa (EMEA).

Among the abstracts selected for presentation is data from the Prostate Cancer Registry, the first and largest prospective study of European patients with metastatic castration-resistant prostate cancer (mCRPC).

Also in prostate cancer, a follow-up analysis from the COU-AA-302 study, investigating long-term safety of ZYTIGA® (abiraterone acetate) for the treatment of mCRPC, will be presented. In addition, the design of the TITAN and ATLAS trials will be presented; the trials will study the efficacy and safety profiles of apalutamide, a new generation androgen receptor inhibitor, in patients with newly-diagnosed mCRPC.

In bladder cancer, Phase 1 data will be presented around urothelial carcinoma (UC) examining the safety, efficacy and tolerability in patients treated with the pan-fibroblast growth factor receptor (FGFR) inhibitor erdafitinib.

Haematological malignancy data to be featured includes results from the Phase 3 CASTOR study, evaluating DARZALEX® (daratumumab) in combination with bortezomib and dexamethasone, compared to bortezomib and dexamethasone alone in patients with multiple myeloma who received one or more prior lines of therapy. This study has been published in the New England Journal of Medicine and formed the basis for recent submissions to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), seeking to expand existing licenses for DARZALEX.1

The following Janssen abstracts have been accepted for presentation at the 2016 ESMO congress:

  • Haematological Malignancies, Proffered Paper Session, 9 th October, 11:00-12:00 CEST (Bern):
    • 11:00-11:15: 906O - Phase 3 randomised study of daratumumab, bortezomib and dexamethasone (DVd) vs bortezomib and dexamethasone (Vd) in patients (pts) with relapsed or refractory multiple myeloma (RRMM): CASTOR2
  • Poster Display, 9 th October, 13:00 – 14:00 CEST (Copenhagen, Hall E):
    • 13:00-14:00: 738P - Meta-analysis of randomized clinical trials in metastatic castration resistant prostate cancer: Comparison of hypertension, neurological and psychiatric adverse events on enzalutamide and abiraterone acetate plus prednisone treatment3
    • 13:00-14:00: 740P - Safety of long-term (LT) treatment (tmt) of chemotherapy (chemo)-naïve metastatic castration-resistant prostate cancer (mCRPC) patients (pts) with abiraterone acetate plus prednisone (AA+ P) for ≥ 4 years (yrs)4
    • 13:00-14:00: 746P - The prostate cancer registry: Patient characteristics, treatments and preliminary outcomes from a large observational study of metastatic castration-resistant prostate cancer (mCRPC)5
    • 13:00-14:00: 769 Trial in Progress (TiP) - ATLAS: A phase 3 trial evaluating the efficacy of apalutamide (ARN-509) in patients with high-risk localized or locally advanced prostate cancer receiving primary radiation therapy6
    • 13:00-14:00: 771TiP - TITAN: A randomized, double-blind, placebo-controlled, phase 3 trial of apalutamide (ARN-509) plus androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC)7
    • 13:00-14:00: 789P - Pharmacokinetics (PK) of the pan-FGFR inhibitor erdafitinib in urothelial carcinoma8
    • 13:00-14:00: 845TiP - Ongoing phase 2 study of erdafitinib (JNJ-42756493), a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, in patients (pts) with metastatic or unresectable urothelial carcinoma (M/UR UC) and FGFR gene alterations9
  • Genitourinary Tumours Non-Prostate, Poster Discussion Session, 9 th October, 16:30-17:30 CEST (Athens):
    • 17:10-17:30: 781PD - Safety and activity of the pan–fibroblast growth factor receptor (FGFR) inhibitor erdafitinib in phase 1 study patients with advanced urothelial carcinoma10
  • Poster Display, 10 th October, 13:00 – 14:00 CEST (Copenhagen, Hall E):
    • 13:00-14:00: 1161P - Utility of a targeted NGS oncology assay for circulating tumor DNA in a multi-histology clinical setting11

Please note that all abstracts accepted for presentation at the ESMO congress are subject to the organisers’ embargo policies.

-ENDS-

NOTES TO EDITORS

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 www.twitter.com/janssenEMEA.

References:

1 Palumbo A et al. Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016;375(8):754-66.

2 Weisel K. Phase 3 randomised study of daratumumab, bortezomib and dexamethasone (DVd) vs bortezomib and dexamethasone (Vd) in patients (pts) with relapsed or refractory multiple myeloma (RRMM): CASTOR. Abstract #906O.

3 Ruiz Gracia, P. Meta-analysis of randomized clinical trials in metastatic castration resistant prostate cancer: Comparison of hypertension, neurological and psychiatric adverse events on enzalutamide and abiraterone acetate plus prednisone treatment. Abstract #738P. Available at: https://cslide.ctimeetingtech.com/library/esmo/browse/search/LXm#2z95v0T9.Last accessed September 2016.

4 Carles, J. Safety of long-term (LT) treatment (tmt) of chemotherapy (chemo)-naïve metastatic castration-resistant prostate cancer (mCRPC) patients (pts) with abiraterone acetate plus prednisone (AA+ P) for ≥ 4 years (yrs). Abstract #740P. Available at: https://cslide.ctimeetingtech.com/library/esmo/browse/search/LXP#2z95v0Ko. Last accessed September 2016.

5 Chowdhury, S. The prostate cancer registry: Patient characteristics, treatments and preliminary outcomes from a large observational study of metastatic castration-resistant prostate cancer (mCRPC). Abstract #746P. Available at: https://cslide.ctimeetingtech.com/library/esmo/browse/search/LWu#2z95v0qo. Last accessed September 2016.

6 Bossi, A. ATLAS: A phase 3 trial evaluating the efficacy of apalutamide (ARN-509) in patients with high-risk localized or locally advanced prostate cancer receiving primary radiation therapy. Abstract #769TiP. Available at: https://cslide.ctimeetingtech.com/library/esmo/browse/search/LY6#2z95v0oF. Last accessed September 2016

7 Chi, K. TITAN: A randomized, double-blind, placebo-controlled, phase 3 trial of apalutamide (ARN-509) plus androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC). Abstract #771TiP. Available at: https://cslide.ctimeetingtech.com/library/esmo/browse/search/LYf#2z95v0yr. Last accessed September 2016.

8 Tabernero, J. Pharmacokinetics (PK) of the pan-FGFR inhibitor erdafitinib in urothelial carcinoma. Abstract #789P. Available at: https://cslide.ctimeetingtech.com/library/esmo/browse/search/Kws#2z95v0uv. Last accessed September 2016.

9 Siefker-Radtke, A. Ongoing phase 2 study of erdafitinib (JNJ-42756493), a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, in patients (pts) with metastatic or unresectable urothelial carcinoma (M/UR UC) and FGFR gene alterations. Abstract #845TiP. Available at: https://cslide.ctimeetingtech.com/library/esmo/browse/search/LYJ#2z95v0wX. Last accessed September 2016.

10 Soria, J.C. Safety and activity of the pan–fibroblast growth factor receptor (FGFR) inhibitor erdafitinib in phase 1 study patients with advanced urothelial carcinoma. Abstract #781PD. Available at: https://cslide.ctimeetingtech.com/library/esmo/browse/search/LYX#2z94X0Jt. Last accessed September 2016.

11 Eerkes, T. Utility of a targeted NGS oncology assay for circulating tumor DNA in a multi-histology clinical setting. Abstract #1161P. Available at: https://cslide.ctimeetingtech.com/library/esmo/browse/search/LZj#2z95w0Yd. Last accessed September 2016.

Date of preparation: September 2016
Job number: PHEM/ONCS/0916/0002

Contact information

Media Enquiries:
Natalie Buhl
+353-85-7446696
or
Investor contacts:
Lesley Fishman
+1-732-524-3922
or
Joseph J. Wolk
+1-732-524-1142

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

ADC Therapeutics Presents Interim Phase I Data from its Novel Antibody-Drug Conjugate ADCT-40211.12.2017 06:00Pressemelding

ADC Therapeutics (ADCT), an oncology drug discovery and development company that specializes in the development of proprietary Antibody Drug Conjugates (ADCs) targeting major cancers, today announced clinical data from two ongoing Phase I clinical trials evaluating ADCT-402 (loncastuximab tesirine or “Lonca-T”) in important subtypes of lymphoma and leukemia. The data were presented at the 59th American Society of Hematology (ASH) Annual Meeting in Atlanta, USA. 1. Interim results of a Phase I open label, single agent, dose-escalating study of ADCT-402 evaluating tolerability, safety, pharmacokinetics and efficacy in patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma Dr. Brad Kahl, M.D., Professor for Medical Oncology at the Washington University School of Medicine in St. Louis, said: “A significant number

GA Telesis Launches Leveraged Finance Group with the Appointments of David Lloyd and Nolan Heske11.12.2017 05:01Pressemelding

GA Telesis, LLC (“GAT”) announces the launch of its Leveraged Finance Group (“LFG”) to provide secured aircraft financing for lessors, investors, and airlines. GAT has appointed David Lloyd and Nolan Heske as Managing Directors of LFG to pursue the development, execution and growth of this strategy. The LFG management team has over 35 years of combined experience in the aircraft and transportation finance sector. Prior to joining GAT, Mr. Lloyd and Mr. Heske cofounded Air Funding in 2016 to provide an alternative source of direct lending on commercial aircraft to lessors and airlines. Prior to Air Funding, David Lloyd spent 12 years at Carlson Capital as Head of Credit, Airlines & Aerospace. Mr. Lloyd was the group founder and was responsible for a portfolio with peak assets of $475 million. Mr. Lloyd also held executive positions at Credit Suisse and Chase Securities. No

AstraZeneca’s Calquence (acalabrutinib) Shows Potential in Chronic Lymphocytic Leukaemia Trials10.12.2017 22:45Pressemelding

AstraZeneca and Acerta Pharma, its haematology research and development centre of excellence, today presented results from the Phase Ib/II ACE-CL-003 clinical trial (Abstract #432) and updated results from the Phase I/II ACE-CL-001 (Abstract #498) clinical trial that are testing Calquence (acalabrutinib) alone and in combination for the treatment of chronic lymphocytic leukaemia (CLL) in multiple treatment settings. The findings were presented during two oral sessions at the 59th American Society of Hematology (ASH) Annual Meeting & Exhibition in Atlanta, USA. Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “These data add to the growing body of evidence that supports the potential of Calquence in the treatment of chronic lymphocytic leukaemia, a life-threatening disease that affects tens of thousands of people aroun

Celgene Corporation and bluebird bio Announce Updated Results from Ongoing Multicenter Phase 1 Study of bb2121 Anti-BCMA CAR T Cell Therapy in Patients with Late Stage Relapsed/Refractory Multiple Myeloma at ASH Annual Meeting10.12.2017 15:30Pressemelding

Celgene Corporation (NASDAQ: CELG) and bluebird bio, Inc. (Nasdaq: BLUE) today announced that updated results from the ongoing CRB-401 Phase 1 clinical study of bb2121, an investigational anti-B-cell maturation antigen (BCMA) CAR T cell therapy, in 21 patients with late-stage relapsed/refractory multiple myeloma will be presented in an oral presentation at the American Society of Hematology (ASH) Annual Meeting in Atlanta, Georgia. The objective of this Phase 1 dose-escalation study is to evaluate safety and efficacy of bb2121 and determine a recommended Phase 2 dose. “Celgene has a longstanding commitment to patients with multiple myeloma through our extensive research efforts in this deadly blood cancer,” said Nadim Ahmed, President, Hematology and Oncology for Celgene. “Looking ahead, we see BCMA as an important target in this disease and we believe bb2121 has the potenti

Kite Announces Long-Term Data From Pivotal ZUMA-1 Study of Yescarta™ (Axicabtagene Ciloleucel) in Patients With Refractory Large B-cell Lymphoma10.12.2017 15:30Pressemelding

Kite, a Gilead Company (Nasdaq: GILD), announced long-term follow-up data from the pivotal ZUMA-1 study of Yescarta™ (axicabtagene ciloleucel) in patients with refractory large B-cell lymphoma. With a minimum follow-up of one year after a single infusion of Yescarta (median follow-up of 15.4 months), 42 percent of patients continued to respond to therapy, including 40 percent with a complete remission. Detailed results from this updated analysis were simultaneously presented at the Annual Meeting of the American Society of Hematology (ASH) in Atlanta and published in The New England Journal of Medicine. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171210005072/en/ Yescarta is the first chimeric antigen receptor T (CAR T) cell therapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult

Takeda and Seattle Genetics to Present Positive Data from Phase 3 ECHELON-1 Clinical Trial Evaluating ADCETRIS® (brentuximab vedotin) in Frontline Advanced Hodgkin Lymphoma10.12.2017 13:00Pressemelding

Takeda Pharmaceutical Company Limited (TSE:4502) and Seattle Genetics, Inc. (NASDAQ: SGEN) today announced that data from the Phase 3 ECHELON-1 clinical trial evaluating ADCETRIS (brentuximab vedotin) as part of a frontline combination chemotherapy regimen in untreated advanced classical Hodgkin lymphoma will be presented in the Plenary Scientific Session at the 59th American Society of Hematology (ASH) annual meeting on Sunday, December 10, 2017. The data were also simultaneously published online in the New England Journal of Medicine and will be published in the print edition on January 25, 2017. Topline data were reported in June 2017 demonstrating the ECHELON-1 trial met its primary endpoint of a statistically significant improvement in modified progression-free survival (modified PFS) per Independent Review Facility (IRF) versus the control arm. ADCETRIS is an antibody-drug con

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom