|Seattle Genetics Announces ASH 2016 Abstracts Highlighting Company’s Expanding Global Leadership in the Development of Innovative Antibody-Drug Conjugates|
Oral Presentation on Phase 3 ALCANZA Trial in CD30-Expressing Cutaneous T-Cell Lymphoma
Breadth of Data on ADCETRIS® (Brentuximab Vedotin), Vadastuximab Talirine (SGN-CD33A) and Other Pipeline Programs Demonstrate Company’s Commitment to Improve Therapeutic Options in Oncology
Data accepted for presentation at this year’s ASH Annual Meeting include the following:
“At this year’s ASH Annual Meeting, we will present data from 18
abstracts, highlighting ADCETRIS, vadastuximab talirine and multiple
pipeline programs,” said
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. Abstracts can be found at www.hematology.org and include the following:
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
ADCETRIS was granted conditional marketing authorization by the
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
ADCETRIS (brentuximab vedotin) U.S. Important Safety Information
Progressive multifocal leukoencephalopathy (PML): JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS.
ADCETRIS is contraindicated with concomitant bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).
Warnings and Precautions
In two uncontrolled single-arm trials of ADCETRIS as monotherapy in 160 patients with relapsed classical HL and sALCL, the most common adverse reactions (≥20%), regardless of causality, were: neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory tract infection, diarrhea, pyrexia, rash, thrombocytopenia, cough and vomiting.
In a placebo-controlled trial of ADCETRIS in 329 patients with classical HL at high risk of relapse or progression post-auto-HSCT, the most common adverse reactions (≥20%) in the ADCETRIS-treatment arm (167 patients), regardless of causality, were: neutropenia, peripheral sensory neuropathy, thrombocytopenia, anemia, upper respiratory tract infection, fatigue, peripheral motor neuropathy, nausea, cough, and diarrhea.
Concomitant use of strong CYP3A4 inhibitors or inducers, or P-gp inhibitors, has the potential to affect the exposure to monomethyl auristatin E (MMAE).
Use in Specific Populations
MMAE exposure and adverse reactions are increased in patients with moderate or severe hepatic impairment or severe renal impairment. Avoid use.
Advise females of reproductive potential to avoid pregnancy during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.
Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.
Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS.
For Seattle Genetics Forward-Looking Statement:
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the therapeutic and
commercial potential of ADCETRIS, SGN-CD33A (vadastuximab talirine) and
SGN-CD19A (denintuzumab mafodotin), potential development and regulatory
activities including future clinical trials and regulatory submissions,
upcoming presentations and publications, and potential uses of the
product candidates, as well as other statements that are not historical
facts. Actual results or developments may differ materially from those
projected or implied in these forward-looking statements. Factors that
may cause such a difference include the risk that we may also be delayed
in our planned clinical trial initiations, the enrollment in and conduct
of our clinical trials, and obtaining data from clinical trials, and
planned regulatory submissions in each case for a variety of reasons,
including the difficulty and uncertainty of pharmaceutical product
development and unexpected adverse events or regulatory action. We may
also be unable to expand ADCETRIS’ labeled indications due to unexpected
data from our ongoing phase 3 trials or regulatory action or complete
the development of, and obtain regulatory approval for, our product
candidates, each of which are in relatively early stages of development.
More information about the risks and uncertainties faced by