BOTHELL, Wash.--(BUSINESS WIRE)--
Seattle Genetics, Inc. (Nasdaq:SGEN - News) today announced that the Journal of Clinical Oncology (JCO) published results of the companys pivotal clinical trial of ADCETRIS (brentuximab vedotin) in Hodgkin lymphoma (HL) patients with relapsed or refractory disease following an autologous stem cell transplant (ASCT). The findings, published today online, demonstrated that treatment with ADCETRIS as a single agent induced durable objective responses in 75 percent of patients and was associated with a manageable safety profile. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in HL and anaplastic large cell lymphoma (ALCL).
Additionally, a separate pivotal clinical trial of ADCETRIS for the treatment of relapsed or refractory systemic ALCL has been accepted for publication and is currently in press for an upcoming issue of JCO.
Although Hodgkin lymphoma is often viewed as a curable disease, up to 30 percent of patients relapse or are refractory following front-line chemotherapy regimens and subsequent treatments, leaving limited therapeutic options, said Dr. Anas Younes, Professor of Medicine and Director, Clinical Investigation and Translational Research Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center. ADCETRIS represents a new approach that is changing the way we treat relapsed and refractory HL patients. The complete response rate and manageable safety profile we observed with ADCETRIS in the pivotal trial have also generated enthusiasm among the medical community for evaluating ADCETRIS in earlier lines of HL therapy.
Data from this pivotal trial served as the basis for the accelerated approval of ADCETRIS in August 2011 for relapsed Hodgkin patients, and is the foundation for our robust clinical development plan to broadly evaluate ADCETRIS in earlier lines of therapy, as well as in other CD30-positive malignancies, said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. We are evaluating ADCETRIS across a broad array of CD30-positive malignancies, towards our goal of bringing it to additional patients in need.
The open-label, phase II study evaluated the efficacy and safety of ADCETRIS in 102 patients with relapsed or refractory, CD30-positive HL after ASCT.
Highlights from the study include:
About ADCETRIS
ADCETRIS (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.
ADCETRIS is being evaluated in a phase III clinical trial (the AETHERA trial) for patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant (ASCT), a phase II trial for relapsed or refractory CD30-positive non-Hodgkin lymphomas, a phase II trial for CD30-positive non-lymphoma malignancies, a phase II retreatment trial for relapsed patients who previously responded to ADCETRIS, a phase I trial in combination with multi-agent chemotherapy for front-line treatment of Hodgkin lymphoma and a phase I trial in combination with multi-agent chemotherapy for front-line treatment of mature T-cell lymphomas. Three additional phase III trials are planned, including a trial in CD30-positive cutaneous T-cell lymphomas to begin in mid-2012, a front-line trial in Hodgkin lymphoma and a front-line trial in mature T-cell lymphomas. The front-line trials are expected to begin by late 2012 or early 2013.
Follow this link:
Seattle Genetics Announces Pivotal ADCETRIS™ (Brentuximab Vedotin) Hodgkin Lymphoma Study Published in Journal of ...
- ACT - Stem Cell Trial for AMD and Stargardt - Phase 1 - September 15th, 2011 [September 15th, 2011]
- Excerpt from: "The Urban Wire" Internet Radio Podcast: FDA Oks embryonic stem cell trials for humans - September 15th, 2011 [September 15th, 2011]
- Advanced Cell Technology (ACT) AMD stem cell clinical phase - September 15th, 2011 [September 15th, 2011]
- Stem Cells Retina and cornea regeneration ACT Dr lanza - Advanced Cell Technology - September 15th, 2011 [September 15th, 2011]
- Spinal Patient Receives Stem Cells in First Experimental Treatment - September 15th, 2011 [September 15th, 2011]
- Bloomberg: Geron, StemCells Rise 4% - September 15th, 2011 [September 15th, 2011]
- Bringing Stem Cell Cures to the Clinic: UC Davis GMP Facility - September 15th, 2011 [September 15th, 2011]
- Researchers in California Show Results for Spinal Cord Injuries Using Embryonic Stem Cells - September 15th, 2011 [September 15th, 2011]
- Bill Caldwell, Chairman - September 20th, 2011 [September 20th, 2011]
- Advanced Cell Technology OneMedForum 2011 - September 20th, 2011 [September 20th, 2011]
- ACT edmund vision stem cells program Advanced Cell Technology - September 20th, 2011 [September 20th, 2011]
- Texans for Stem Cell Research Learn for Life: KXAN Coverage Aired August 16th, 2011 - September 20th, 2011 [September 20th, 2011]
- ACT - Dr Lanza - Hermangioblast program - Advanced cell technology - September 23rd, 2011 [September 23rd, 2011]
- Anticipating the Next Decade of the Genome - Francis Collins, Director of NIH - September 24th, 2011 [September 24th, 2011]
- New Epilepsy Treatment Under Study For Seizures - Part 1 - September 24th, 2011 [September 24th, 2011]
- A Thank You For Trevor Raborn - September 24th, 2011 [September 24th, 2011]
- CBLI Breaking News - September 24th, 2011 [September 24th, 2011]
- What is Cord Blood Banking? The Medical Potential of Newborn Stem Cells - September 24th, 2011 [September 24th, 2011]
- Stem cell medical breakthrough? - September 24th, 2011 [September 24th, 2011]
- NIST Colloquium Series: Next Generation Neural Implants - September 24th, 2011 [September 24th, 2011]
- Alan Lewis: Embryonic Stem Cell Therapies for diabetes - September 24th, 2011 [September 24th, 2011]
- 2011 Predictions for Hair Transplant Developments | Arocha Hair Restoration - September 24th, 2011 [September 24th, 2011]
- Healthbeat - Stem Cell Research - September 24th, 2011 [September 24th, 2011]
- Living With ALS - September 24th, 2011 [September 24th, 2011]
- A Revolutionary New Potential Treatment for Glioblastoma... - September 24th, 2011 [September 24th, 2011]
- Lyme Disease: Challenges and Innovations - September 24th, 2011 [September 24th, 2011]
- 2010: Cord blood saving lives [CNN: 5-30-2011] - September 24th, 2011 [September 24th, 2011]
- Biotechnology, Diagnostics, and Genomics: Panel Discussion - September 24th, 2011 [September 24th, 2011]
- Pharmacogenomics - September 24th, 2011 [September 24th, 2011]
- Brickheads - Osteobots Practice Skit.mpg - September 24th, 2011 [September 24th, 2011]
- A veteran lives with ALS - September 26th, 2011 [September 26th, 2011]
- Healthy Body = Functional Body. Hollywood Look Side Effect: Healthy Function - September 26th, 2011 [September 26th, 2011]
- 2009 Flu Summit: Opening Remarks - September 26th, 2011 [September 26th, 2011]
- Cord Blood Breakthrough - September 28th, 2011 [September 28th, 2011]
- SENS5 - Leucocyte transfusions as a novel immunotherapy for cancer patients - October 2nd, 2011 [October 2nd, 2011]
- Lymphoma Drug SGN-35 - The Nebraska Medical Center - October 2nd, 2011 [October 2nd, 2011]
- ACell Hair Restoration with Dr. Gary Hitzig and Dr. Amiya Prasad - Video - October 14th, 2011 [October 14th, 2011]
- Hans Keirstead: Developing therapies based on embryonic stem cells - Video - October 14th, 2011 [October 14th, 2011]
- NJN News Healthwatch Report - Cornea Treatment Study - Video - October 20th, 2011 [October 20th, 2011]
- HIV/AIDS may be prevented by new lubricant - Video - October 22nd, 2011 [October 22nd, 2011]
- MFIII Switzerland PE Sheep Placenta Glandular therapy Study - Client Interviews - Video - October 22nd, 2011 [October 22nd, 2011]
- Love Diabetes: BCG and Noncompliant Patients - Video - October 25th, 2011 [October 25th, 2011]
- Dr. Alimorad Farshchian statement on embryonic stem cells - Video - October 27th, 2011 [October 27th, 2011]
- StemCellTV Daily Report-October 29, 2011 - Video - October 30th, 2011 [October 30th, 2011]
- Stephen McKenna MD - 8 - Video - October 31st, 2011 [October 31st, 2011]
- ALS Stem Cell Trial at Emory - Video - November 22nd, 2011 [November 22nd, 2011]
- Target Product Profile: Ellen Feigal - 2011 CIRM Grantee Meeting - Video - December 6th, 2011 [December 6th, 2011]
- Monoclonal Antibodies: Stanford Academia-Industry Collaboration - Video - December 8th, 2011 [December 8th, 2011]
- Parkinson's Disease Guidelines (Part 2) - Video - December 9th, 2011 [December 9th, 2011]
- Macular Degeneration Drugs - Video - December 13th, 2011 [December 13th, 2011]
- BrainStorm Cell Therapeutics (OTCBB:BCLI) Has Potentially Developed A Treatment For ALS - January 31st, 2012 [January 31st, 2012]
- StemCells, Inc. Receives FDA Authorization for Age-Related Macular Degeneration Clinical Trial - February 3rd, 2012 [February 3rd, 2012]
- Stemedica Cell Technologies - Documentary - Video - February 4th, 2012 [February 4th, 2012]
- (GMCR, STEM, DSCO) CRWENewswire.com Stocks In Action - Video - February 7th, 2012 [February 7th, 2012]
- Bioheart Acquires Exclusive Rights to Ageless Regenerative Institute's Adipose Cell Technology - February 14th, 2012 [February 14th, 2012]
- Neuralstem Announces Closing of $5.2-Million Registered Direct Offering - February 14th, 2012 [February 14th, 2012]
- Scientists Repair Heart Attack Damage Using Patient's Own Stem Cells To Regrow Healthy Heart Muscle - February 14th, 2012 [February 14th, 2012]
- Stem Cells Regrow Healthy Heart Muscle In Heart Attack Patients - February 15th, 2012 [February 15th, 2012]
- Groundbreaking Clinical Trials Study Cord Blood Stem Cells to Help Treat Brain Injury and Hearing Loss - February 17th, 2012 [February 17th, 2012]
- Novelos Therapeutics Announces Enrollment of First Patient in Lung Cancer Trial With I-124-CLR1404 (Light) Cancer ... - February 22nd, 2012 [February 22nd, 2012]
- IntelliCell BioScience Inc. Procedure Enables Norwegian Star Basketball Player to Fully Recover from Patella ... - February 22nd, 2012 [February 22nd, 2012]
- The Lancet Publishes Results from Gentium's Phase III Defibrotide Trial for the Prevention of VOD in Paediatric Patients - February 27th, 2012 [February 27th, 2012]
- Bioheart Issues Shareholder Letter Announcing Progress and New Initiatives - March 1st, 2012 [March 1st, 2012]
- Bioheart Issues Shareholder Letter Announcing Progress - March 1st, 2012 [March 1st, 2012]
- Novelos Therapeutics and Academic Collaborators Have Three Abstracts Accepted for Presentation at 2012 AACR Annual ... - March 1st, 2012 [March 1st, 2012]
- Marshall Edwards Submits Investigational New Drug Application for Oncology Drug Candidate ME-344 - March 6th, 2012 [March 6th, 2012]
- Will StemCells Walk The Talk? - March 7th, 2012 [March 7th, 2012]
- Internationally Recognized Leukemia Physician and Researcher to Lead Sylvester Comprehensive Cancer Center - March 7th, 2012 [March 7th, 2012]
- Criminal investigation after patient dies at office of doctor linked to stem cell - March 9th, 2012 [March 9th, 2012]
- Novelos Therapeutics Announces Enrollment of First Patient in Brain Cancer Trial with I-124-CLR1404 (LIGHT) Cancer ... - March 15th, 2012 [March 15th, 2012]
- Vitro Biopharma Receives Approval for Presentation to the International Society for Cellular Therapy - March 20th, 2012 [March 20th, 2012]
- Looking for Innovative Small-Cap Biotech Companies: George Zavoico - March 26th, 2012 [March 26th, 2012]
- Gentium Reports Fourth Quarter and Year End 2011 Financial Results - March 28th, 2012 [March 28th, 2012]
- Basketball’s influence on stem cell treatments in sports medicine - March 30th, 2012 [March 30th, 2012]
- Cardium Announces U.S. Market Introduction of Excellagen™ - March 31st, 2012 [March 31st, 2012]
- Optimer Pharmaceuticals, Inc. Announces Presentation at ECCMID of Post-Hoc Subgroup Analysis of DIFICID in Adult ... - March 31st, 2012 [March 31st, 2012]
- New Data Demonstrates DIFICLIR™ May Offer Benefits for Cancer Patients, who are at High Risk of Clostridium Difficile ... - April 1st, 2012 [April 1st, 2012]
- SynGen Inc. Receives $5 million Equity Investment from Bay City Capital, LLC - April 19th, 2012 [April 19th, 2012]
- Gene Ray, Founder of $2.6 Billion Titan Corp, Invests in Medistem's ERC Technology and Joins Advisory Board - April 26th, 2012 [April 26th, 2012]
- Small Biotech Companies Look to Benefit From Shift to "First to File" Patent System - May 4th, 2012 [May 4th, 2012]