On October 20, 2016 Seattle Genetics, Inc. (Nasdaq: SGEN) today highlighted multiple data presentations at the 10th International Symposium on Hodgkin Lymphoma (ISHL) taking place in Cologne, Germany, October 22-25, 2016, evaluating ADCETRIS (brentuximab vedotin) across a broad range of Hodgkin lymphoma (HL) disease settings (Press release, Seattle Genetics, OCT 20, 2016, View Source;p=RssLanding&cat=news&id=2213330 [SID1234515932]). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL that plays a role in tumor pathogenesis. ADCETRIS is being evaluated globally as the foundation of therapy for HL in more than 45 ongoing corporate- and investigator-sponsored clinical trials.
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"For more than a decade, we have been committed to improving treatment outcomes for classical HL patients. We have made tremendous progress with ADCETRIS, which is now FDA-approved for two HL indications in the U.S. and Europe and is being evaluated broadly across all lines of therapy and in many novel regimens," said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. "The data presented at ISHL continue to advance our goal of establishing ADCETRIS as the foundation of care for HL. With 21 abstracts accepted for presentation, we, along with our partner Takeda, are pleased to share new and updated data with the scientific community at ISHL to help move the field forward."
Data presented at ISHL include an update of the progression-free survival and safety from the phase 3 AETHERA trial approximately four years since the last patient was enrolled, demonstrating sustained progression-free survival benefit after extended observation. In addition, updates will be presented from trials evaluating ADCETRIS as both mono- and combination therapy in frontline HL patients age 60 and older, and as second-line therapy for relapsed or refractory HL. Lastly, preclinical data will be presented indicating additional potential mechanisms of action for ADCETRIS, including immunogenic cell death, supporting evaluation of combination therapy with immuno-oncology agents.
Multiple corporate and investigator presentations will be featured at ISHL. Abstracts can be found at www.hodgkinsymposium.org and include the following:
Immune Systems Engagement Results in Non-Classical Antibody-Drug Conjugate Antitumor Activity of Brentuximab Vedotin (Abstract #P099, poster presentation)
Evaluation of Serum TARC Levels in Patients at Risk of Progression Following Autologous Stem Cell Transplant for Hodgkin Lymphoma: Results from the AETHERA Trial (Abstract #P060, poster presentation)
Brentuximab Vedotin After Autologous Stem Cell Transplant Yields the Strongest Benefit in Hodgkin lymphoma Patients with ≥ 2 Risk Factors: Results of a Multivariate Analysis (Abstract #P089 , poster presentation)
Brentuximab Vedotin Alone and in Combination With Dacarbazine or Bendamustine in Patients Aged ≥60 Years With Newly Diagnosed Hodgkin Lymphoma: Interim Results of a Phase 2 Study (Abstract #P023, poster presentation)
Brentuximab Vedotin Plus Bendamustine as a Salvage Treatment Regimen for Patients with Relapsed or Refractory Hodgkin Lymphoma (Abstract #P082, poster presentation)
PET Adapted Dose Escalation of Brentuximab Vedotin as First Line Salvage Therapy in Relapse/Refractory HL (Abstract #P083, poster presentation)
Post Transplant Outcomes in a Multicenter Phase II Study of Brentuximab Vedotin as First Line Salvage Therapy in Relapsed/Refractory HL Prior to ASCT (Abstract #P086, poster presentation)
Pharmacokinetics, Immunogenicity and Safety of Weekly Dosing of Brentuximab Vedotin in Pediatric Patients with Hodgkin Lymphoma (Abstract #P067, oral presentation)
A Phase I Study with an Expansion Cohort of the Combination of Ipilimumab and Brentuximab Vedotin in Patients with Relapsed/Refractory Hodgkin Lymphoma: A trial of the ECOG-ACRIN Cancer Research Group (Abstract #P080, poster presentation)
The Pharmacokinetic and Pharmacodynamic Properties of Brentuximab Vedotin in a Patient Undergoing Hemodialysis (Abstract #P098, poster presentation)
Single-Arm Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin lymphoma who are Ineligible for Stem Cell Transplantation or Multiagent Chemotherapy (Abstract #P104, poster presentation)
Combining Brentuximab Vedotin with DHAP as Salvage Treatment in Relapsed/Refractory Hodgkin lymphoma: a Phase 1 Dose-Escalation study (Abstract #T024, oral presentation)
Preliminary Results of a Phase II Study of Brentuximab Vedotin Using a Response Adapted Design in the First Line Treatment of Patients with Hodgkin lymphoma Unsuitable for Chemotherapy Due to Age, Frailty or Co-morbidity (BREVITY) (Abstract #P002, poster presentation)
Real-World Effectiveness of Brentuximab Vedotin vs. Other Treatments in Patients with Relapsed/Refractory Hodgkin Lymphoma post Autologous Stem-Cell Transplantation (Abstract #P094, poster presentation)
Brentuximab Vedotin in Patients who are Ineligible for Autologous Stem Cell Transplant with Relapsed or Refractory Hodgkin Lymphoma: A UK and Germany Retrospective Study (Abstract #P093, poster presentation)
Risk Factors for Relapse in Patients with Relapsed or Refractory Hodgkin Lymphoma after Autologous Stem Cell Transplant: A Real-World Analysis in Germany and the United Kingdom (Abstract #P095, poster presentation)
Superiority of Modified Progression Free Survival to Evaluate Chemotherapy Effectiveness for Advanced Stage Hodgkin Lymphoma (Abstract #P007, poster presentation)
Sequential Brentuximab Vedotin and Adriamycin, Vinblastine and Darabazine (AVD) for Older Patients with Untreated Hodgkin Lymphoma: Findings from a Phase II Window study (Abstracts #P001, poster presentation)
PET-adapted Therapy with Brentuximab Vedotin and Augmented ICE for Relapsed/Refractory Hodgkin Lymphoma – Lack of Improvement with 3 versus 2 Cycles of Weekly BV (Abstract #P088, poster presentation)
An International Multicenter Phase I/II Study of Brentuximab Vedotin and Bendamustine in Patients with Heavily Treated Relapsed or Refractory Hodgkin Lymphoma and Anaplastic Large T-Cell Lymphoma (Abstract #P085, poster presentation)
HALO Study: a Phase 1/2 Clinical Trial of Brentuximab Vedotin and Bendamustine in Elderly Patients with Previously Untreated Advanced Hodgkin Lymphoma (Abstract #P011, poster presentation)
ADCETRIS is currently not approved for the treatment of frontline or salvage HL in patients eligible for autologous transplant, graft-versus-host disease (GVHD) or as a combination therapy for HL.
About Classical Hodgkin Lymphoma
Lymphoma is a general term for a group of cancers that originate in the lymphatic system and is the most common type of blood cancer. There are two major categories of lymphoma: HL and non-Hodgkin lymphoma. Classical HL is distinguished from other lymphomas by the characteristic presence of CD30-positive Reed-Sternberg cells.
According to the American Cancer Society, approximately 8,500 cases of HL will be diagnosed in the United States during 2016 and more than 1,100 will die from the disease. According to the Lymphoma Coalition, over 62,000 people worldwide are diagnosed with HL each year and approximately 25,000 people die each year from this cancer.
About ADCETRIS
ADCETRIS is being evaluated broadly in more than 70 ongoing clinical trials, including two phase 3 studies, ECHELON-1 in frontline classical HL and ECHELON-2 in frontline mature T-cell lymphomas, as well as trials in many additional types of CD30-expressing malignancies, including B-cell lymphomas.
ADCETRIS 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 for intravenous injection has received approval from the FDA for three indications: (1) regular approval for the treatment of patients with classical Hodgkin lymphoma after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (2) regular approval for the treatment of classical Hodgkin lymphoma patients at high risk of relapse or progression as post-auto-HSCT consolidation, and (3) accelerated approval for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for the sALCL indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL.
ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for two indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory sALCL. ADCETRIS has received marketing authorization by regulatory authorities in 65 countries.
In June 2016, the European Commission extended the current conditional approval of ADCETRIS and approved ADCETRIS for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT. See important safety information below.
Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.