On November 3, 2016 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that 18 abstracts including eight oral presentations have been accepted for presentation at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place in San Diego, Calif. from December 3-6, 2016 (Press release, Seattle Genetics, NOV 3, 2016, View Source;p=RssLanding&cat=news&id=2219399 [SID1234516296]). Collectively, the abstracts highlight advancement of the ADCETRIS (brentuximab vedotin) and vadastuximab talirine (SGN-CD33A) development programs and the company’s expanding global leadership in antibody-drug conjugates (ADCs), as well as its commitment to developing investigational compounds that have the potential to improve therapeutic options for patients with blood-related cancers.
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Data accepted for presentation at this year’s ASH (Free ASH Whitepaper) Annual Meeting include the following:
An oral presentation of full results from the phase 3 ALCANZA clinical trial evaluating ADCETRIS in patients with CD30-expressing cutaneous T-cell lymphoma (CTCL)
Numerous oral and poster presentations highlighting additional progress within the ADCETRIS development program including:
Preliminary results from a phase 1/2 study of ADCETRIS in combination with Opdivo (nivolumab) among patients with relapsed or refractory Hodgkin lymphoma (HL)
Long-term (e.g., four-year) survival and durability results in patients with CD30-expressing peripheral T-cell lymphomas who received ADCETRIS with cyclophosphamide, hydroxydaunorubicin, and prednisone (CHP) as frontline therapy
Final five-year survival and durability results in relapsed systemic anaplastic large cell lymphoma (sALCL) patients who received ADCETRIS monotherapy
Four oral presentations featuring data from clinical studies exploring vadastuximab talirine in acute myeloid leukemia (AML), including newly diagnosed patients
"At this year’s ASH (Free ASH Whitepaper) Annual Meeting, we will present data from 18 abstracts, highlighting ADCETRIS, vadastuximab talirine and multiple pipeline programs," said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. "The oral presentation of the complete results of the ALCANZA trial represents the fourth consecutive registrational trial for ADCETRIS with a positive outcome. Data across our pipeline programs continue to support the potential for antibody-drug conjugates to improve outcomes for patients with cancer."
Seattle Genetics is the world leader in the development and commercialization of a new generation of ADCs. The company’s novel, proprietary technology is designed to harness the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. There are more than 20 ADCs in clinical development that utilize Seattle Genetics’ proprietary ADC technology. ADCETRIS is the first drug approved utilizing this technology. The company also has vadastuximab talirine in a global phase 3 clinical study (CASCADE) in newly diagnosed, older AML patients.
ADCETRIS is currently not approved for the treatment of CTCL frontline treatment of non-Hodgkin lymphoma or as a combination therapy for HL.
Multiple corporate and investigator presentations will be featured at ASH (Free ASH Whitepaper). Abstracts can be found at www.hematology.org and include the following:
Saturday, December 3, 2016
Results of an Ongoing Phase 2 Study of Brentuximab Vedotin with RCHP as Frontline Therapy in Patients with High-Intermediate/High-Risk Diffuse Large B-Cell Lymphoma (Abstract #104, oral presentation at 9:45 a.m. PT)
Brentuximab Vedotin Demonstrates Significantly Superior Clinical Outcomes in Patients with CD30-Expressing Cutaneous T-Cell Lymphoma Versus Physician’s Choice (Methotrexate or Bexarotene): the Phase 3 ALCANZA Study (Abstract #182, oral presentation at 2:15 p.m. PT)
A Phase 1b Study of Vadastuximab Talirine in Combination with 7+3 Induction Therapy for Patients with Newly Diagnosed Acute Myeloid Leukemia (Abstract #211, oral presentation at 4:00 p.m. PT)
Safety and Activity of Brentuximab Vedotin plus Ifosfamide, Carboplatin, and Etoposide (ICE) for Relapsed/Refractory Classical Hodgkin Lymphoma: Initial Results of a Phase I/II Trial (Abstract #1834, poster presentation)
Real World Clinical and Economic Burden of Hematopoietic Cell Transplantation Among a Large US Commercially Insured Population (Abstract #2368, poster presentation)
Sunday, December 4, 2016
The Use of a Novel CME Format to Elicit and Develop True Competence in Hematologist Ability to Risk Stratify Patients with Hodgkin Lymphoma (Abstract #3560, poster presentation)
A Phase 1b Study of Vadastuximab Talirine as Maintenance and in Combination with Standard Consolidation for Patients with Acute Myeloid Leukemia (Abstract #340, oral presentation at 10:15 a.m. PT)
Four-Year Survival and Durability Results of Brentuximab Vedotin in Combination with CHP in the Frontline Treatment of Patients with CD30-Expressing Peripheral T-cell Lymphomas (Abstract #2993, poster presentation)
Toxicity Burden of Bleomycin Treatment in Hodgkin Lymphoma: A Systematic Literature Review (Abstract #3566, poster presentation)
Monday, December 5, 2016
Vadastuximab Talirine Monotherapy in Older Patients with Treatment Naive CD33-Positive Acute Myeloid Leukemia (Abstract #590, oral presentation at 7:15 a.m. PT)
Vadastuximab Talirine Plus Hypomethylating Agents: A Well-Tolerated Regimen with High Remission Rate in Frontline Older Patients With Acute Myeloid Leukemia (Abstract #591, oral presentation at 7:30 a.m. PT)
Preliminary Results from a Phase 1/2 Study of Brentuximab Vedotin in Combination with Nivolumab in Patients with Relapsed or Refractory Hodgkin Lymphoma (Abstract #1105, oral presentation at 4:30 p.m. PT)
A Phase I Study with an Expansion Cohort of the Combination of Ipilimumab and Nivolumab and Brentuximab Vedotin in Patients with Relapsed/Refractory Hodgkin Lymphoma: A Trial of the ECOG-ACRIN Cancer Research Group (E4412 Arms D and E) (Abstract #1106 oral presentation at 4:45 p.m. PT)
Brentuximab Vedotin Plus ESHAP (BRESHAP) Is a Highly Effective Combination for Inducing Remission in Refractory and Relapsed Hodgkin Lymphoma Patients Prior to Autologous Stem Cell Transplant: A Trial of the Spanish Group of Lymphoma and Bone Marrow Transplantation (GELTAMO) (Abstract #1109, oral presentation at 5:30 p.m. PT)
Five-Year Survival Data from a Pivotal Phase 2 Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (Abstract #4144, poster presentation)
Denintuzumab Mafodotin Stimulates Immune Responses and Synergizes with CD20 Antibodies to Heighten Anti-tumor Activity in Preclinical Models of Non-Hodgkin Lymphoma (Abstract #4177, poster presentation)
SGN-CD48A: A Novel Humanized Anti-CD48 Antibody-Drug Conjugate for the Treatment of Multiple Myeloma (Abstract #4470, poster presentation)
A Phase 1/2 Clinical Trial of Brentuximab Vedotin and Bendamustine in Elderly Patients with Previously Untreated Advanced Hodgkin Lymphoma (Halo Study): Preliminary Report (Abstract #4154, poster presentation)
About ADCETRIS
ADCETRIS is being evaluated broadly in more than 70 ongoing clinical trials, including two phase 3 studies, ECHELON-1 in frontline classical Hodgkin lymphoma 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.
About Vadastuximab Talirine (SGN-CD33A)
Vadastuximab talirine (SGN-CD33A) is a novel ADC targeted to CD33 utilizing Seattle Genetics’ newest ADC technology. CD33 is expressed on most AML cells. The CD33 antibody is attached to a highly potent DNA binding agent, a pyrrolobenzodiazepine (PBD) dimer, via a proprietary site-specific conjugation technology to a monoclonal antibody with engineered cysteines (EC-mAb). PBD dimers are significantly more potent than systemic chemotherapeutic drugs and the site-specific conjugation technology (EC-mAb) allows uniform drug-loading of the cell-killing PBD agent to the anti-CD33 antibody. The ADC is designed to be stable in the bloodstream and to release its potent DNA binding agent upon internalization into CD33-expressing cells. SGN-CD33A is being evaluated in ongoing phase 1 clinical trials for patients with AML. More information about SGN-CD33A and ongoing clinical trials can be found at www.ADC-CD33.com.
About Denintuzumab Mafodotin (SGN-CD19A)
Denintuzumab mafodotin (SGN-CD19A) is an ADC targeting CD19, a protein expressed broadly on B-cell malignancies. Denintuzumab mafodotin is comprised of an anti-CD19 monoclonal antibody linked to a synthetic cytotoxic cell-killing agent, monomethyl auristatin F (MMAF). The ADC is designed to be stable in the bloodstream, and to release its cytotoxic agent upon internalization into CD19-expressing tumor cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing the antitumor activity. SGN-CD19A is being evaluated in two ongoing phase 1 clinical trials for patients with B-cell ALL and aggressive NHL as well as a phase 2 clinical trial in relapsed or refractory DLBCL.