Seattle Genetics Highlights Leadership in Expanding Field of Antibody-Drug Conjugates (ADCs) at the 36th Annual J.P. Morgan H...
January 08 2018 - 8:00AM
Business Wire
-Continued Progress In Establishing ADCETRIS®
(brentuximab vedotin) as the Foundation of Care for CD30-Expressing
Lymphomas-
-Two Solid Tumor ADC Programs Advancing Under
Accelerated Approval Pathways-
-Multiple Collaborator ADC Programs in
Late-Stage Trials for Range of Tumor Types-
Seattle Genetics, Inc. (NASDAQ: SGEN) highlighted today the
progress of its pipeline of antibody-drug conjugates (ADCs) at the
36th Annual J.P. Morgan Healthcare Conference. Through both
internal efforts and that of its collaborators, the company’s ADC
technology is being employed in more than 20 programs in clinical
trials, including multiple late-state development programs across
hematologic malignancies and solid tumors.
“ADCs continue to advance as an important therapeutic modality,
both as single agents and as part of various combination regimens,
across hematologic malignancies and solid tumors,” said Clay
Siegall, Ph.D., President and Chief Executive Officer of Seattle
Genetics. “We are the industry leader in ADC technology driven by
our scientific expertise in monoclonal antibodies, drug payloads
and stable linker technologies. Our leadership is further
illustrated by the continued clinical and commercial expansion of
ADCETRIS (brentuximab vedotin), progress with our late-stage
programs enfortumab vedotin and tisotumab vedotin, and the breadth
of our pipeline of other ADCs and empowered antibodies. In
addition, our collaborators are making significant advances with
several programs using our technology. ADCs are an integral part of
an evolving cancer treatment paradigm, and we are committed to
bringing important new treatments to patients in need.”
ADCETRIS, which pioneered a new class of ADCs, is commercially
available in 70 countries worldwide and generated more than $600
million in global sales in 2017. On January 2, 2018, the company
announced that the FDA accepted for filing a supplemental Biologics
License Application (BLA) for ADCETRIS in combination with
chemotherapy for the frontline treatment of patients with advanced
classical Hodgkin lymphoma. The FDA granted Priority Review for the
application, and the Prescription Drug User Fee Act (PDUFA) target
action date is May 1, 2018. The submission of the supplemental BLA
is based on positive results from a phase 3 clinical trial called
ECHELON-1. In October 2017, the FDA granted Breakthrough Therapy
Designation (BTD) for ADCETRIS in frontline advanced Hodgkin
lymphoma based on the ECHELON-1 study results.
In addition to advancing ADCETRIS, Seattle Genetics and its
collaborator Astellas have initiated a pivotal phase 2 clinical
trial of enfortumab vedotin for patients with locally advanced or
metastatic urothelial cancer who have been previously treated with
checkpoint inhibitor (CPI) therapy. The study is designed to
support potential registration under the FDA’s accelerated approval
regulations. In addition, Seattle Genetics, in collaboration with
its development partner Genmab, plans to initiate a phase 2
clinical trial of tisotumab vedotin for patients with recurrent
and/or metastatic cervical cancer. This study is intended to
support potential registration under the FDA’s accelerated approval
regulations.
Seattle Genetics’ ADC technologies are also empowering several
collaborator programs in late-stage clinical trials. These
include:
- GSK2857916, an ADC being developed by
GlaxoSmithKline (GSK) for multiple myeloma. GSK recently reported
encouraging data from the program at the 59th American Society of
Hematology (ASH) annual meeting in December 2017;
- Polatuzumab vedotin, an ADC being
developed by Genentech/Roche. Positive results were presented at
ASH from a phase 2 trial in advanced-stage diffuse large B-cell
lymphoma. A phase 3 trial is underway; and,
- Depatuxizumab mafodotin, an ADC for
glioblastoma in development by AbbVie. Encouraging data have been
reported from this ADC, which is currently in a phase 3 clinical
trial.
Polatuzumab vedotin and GSK2857916 have both received BTD from
the FDA and PRIority MEDicines (PRIME) designations from the
European Medicines Agency. These designations signify the
importance of therapies such as these in addressing significant
unmet medical need.
“Through our robust internal development efforts and our strong
licensing and co-development agreements, we are extending the
potential of ADCs globally. We look forward to future results of
studies that include Seattle Genetics’ novel technologies both as
monotherapies, as well as in combination with checkpoint inhibitors
and other agents,” said Dr. Siegall.
In 2018, Seattle Genetics anticipates several milestones,
including:
- Working with FDA towards the May 1
PDUFA action date for ADCETRIS in combination with chemotherapy for
frontline treatment of patients with advanced classical Hodgkin
lymphoma;
- Reporting ECHELON-2 data of ADCETRIS in
combination therapy in frontline CD30-expressing mature T-cell
lymphoma (MTCL);
- Continuing enrollment of the enfortumab
vedotin (EV) pivotal trial in locally advanced or metastatic
urothelial cancer patients previously treated with a checkpoint
inhibitor;
- Continuing enrollment of the EV phase
1b trial in combination with checkpoint inhibitors, for patients
with locally advanced or metastatic urothelial cancer;
- Initiating a phase 2 trial of tisotumab
vedotin (TV) in recurrent and/or metastatic cervical cancer to
potentially support registration; and,
- Initiating a phase 2 trial of TV as
part of a combination regimen for first-line cervical cancer and a
phase 2 trial of TV in other solid tumor types;
- Initiating multiple trials evaluating
ladiratuzumab vedotin in combination with checkpoint inhibitors in
metastatic triple negative breast cancer, as well as evaluation as
a neoadjuvant therapy for early breast cancer as part of the I-SPY
consortium.
ADCETRIS is currently not approved for the frontline treatment
of MTCL or Hodgkin lymphoma.
About Seattle Genetics
Seattle Genetics is an innovative biotechnology company
dedicated to improving the lives of people with cancer through
novel antibody-based therapies. The company’s industry-leading
antibody-drug conjugate (ADC) technology harnesses the targeting
ability of antibodies to deliver cell-killing agents directly to
cancer cells. Seattle Genetics commercializes ADCETRIS®
(brentuximab vedotin) for the treatment of several types of
CD30-expressing lymphomas. The company is also advancing a robust
pipeline of novel therapies for solid tumors and blood-related
cancers designed to address significant unmet medical needs and
improve treatment outcomes for patients. More information can be
found at www.seattlegenetics.com and follow @SeattleGenetics on
Twitter.
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 company’s and
its collaborators’ potential to achieve regulatory and commercial
milestones with respect to their respective products and product
candidates; the company’s goals of establishing ADCETRIS as
foundation of care for CD30-expressing lymphomas; anticipated
approval of ADCETRIS for front-line Hodgkin lymphoma including
potential timing thereof; anticipated accelerated regulatory
approval pathways for enfortumab vedotin and tisotumab vedotin;
anticipated clinical activities, including data availability from
ECHELON-2 and the timing thereof and the initiation and completion
of future clinical trials for the company’s product candidates and
the timing thereof; the opportunities for, and the therapeutic and
commercial potential of, ADCETRIS, enfortumab vedotin, tisotumab
vedotin and the company’s other product candidates; potential
benefits from collaborations; 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 risks
and uncertainties related to delays in planned clinical trial
initiations, enrollment and conduct, obtaining data from clinical
trials, and anticipated regulatory submissions and approvals in
each case for a variety of reasons, including the difficulty and
uncertainty of pharmaceutical product development, unexpected
adverse events and/or adverse regulatory action; the inherent
uncertainty associated with the regulatory approval process,
including the risks that the company’s current and potential future
BLA or supplemental BLA submissions may not be accepted for filing
by, or ultimately approved by, the FDA in a timely manner or at
all, and that the company may otherwise experience a more lengthy
and costly regulatory approval process than anticipated; the
potential for newly-emerging safety signals, failure of clinical
results to support continued development or regulatory approvals;
failure to properly conduct or manage the company’s clinical
trials; and possible, required modifications to clinical trials and
the inability to provide information and institute safety
mitigation measures as required by the FDA or other regulatory
authorities from time to time in which case our clinical trials may
be delayed or discontinued. More information about the risks and
uncertainties faced by Seattle Genetics is contained under the
caption “Risk Factors” included in the company’s Quarterly Report
on Form 10-Q for the quarter ended September 30, 2017 filed with
the Securities and Exchange Commission. Seattle Genetics disclaims
any intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
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version on businesswire.com: http://www.businesswire.com/news/home/20180108005830/en/
Seattle Genetics Inc.Investors:Peggy Pinkston,
425-527-4160ppinkston@seagen.comorMedia:Brandi Robinson,
425-527-2910brobinson@seagen.com
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