-Objective Response Rates Presented for Both
Antibody-Drug Conjugate Programs-
-Enfortumab Vedotin Demonstrates 59 Percent
Objective Response Rate at Recommended Phase 2 Dose of 1.25 mg/kg,
Supporting Advancement of the Development Program-
Seattle Genetics, Inc. (NASDAQ: SGEN) and Agensys, an affiliate
of Astellas, today presented updated clinical data for enfortumab
vedotin (ASG-22ME) and ASG-15ME at the European Society for Medical
Oncology (ESMO) Congress being held October 7-11, 2016 in
Copenhagen, Denmark. Enfortumab vedotin and ASG-15ME are
investigational antibody-drug conjugates (ADCs) that target the
cell surface proteins Nectin-4 and SLITRK6, respectively. The
clinical data for both agents continue to demonstrate overall
response rates in patients with previously treated metastatic
urothelial cancer, including those with prior checkpoint
inhibitors. Safety and recommended phase 2 doses were also
presented for both programs. While both phase 1 studies will
continue to enroll patients, the companies plan to advance
enfortumab vedotin and discuss next steps with regulatory agencies.
Evaluation of next developmental steps for ASG-15ME is ongoing.
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“We are pleased to advance the enfortumab vedotin development
program for patients with metastatic urothelial cancer. These
patients are in dire need of new treatment options as their
prognosis is grim, with a five-year survival rate of about 15
percent,” said Jonathan Drachman, M.D., chief medical officer and
executive vice president, Research and Development at Seattle
Genetics. “The antitumor activity and safety profile of enfortumab
vedotin in heavily pretreated metastatic patients is encouraging,
particularly in those patients who have failed both platinum-based
chemotherapy and checkpoint inhibitors. We look forward to
discussions with regulatory agencies.”
“Both enfortumab vedotin and ASG-15ME hold potential promise for
metastatic urothelial cancer patients,” said Steven Benner, M.D.,
senior vice president, therapeutic area head for oncology
development, Astellas. “As we consider our next steps in these two
development programs, we also pause to thank the patients,
caregivers and clinical investigators who participate in these
clinical trials for the important role they play in advancing the
science of cancer care.”
Interim data from two phase 1 dose-escalation studies of
enfortumab vedotin and ASG-15ME monotherapy in patients with
metastatic urothelial cancer will be presented at the ESMO Congress
during poster sessions on Sunday, October 9, 2016. The respective
clinical trial data showed that each agent had antitumor activity
in patients previously treated with platinum-based chemotherapy,
checkpoint inhibitors, taxanes and those with liver metastases.
Enfortumab vedotin and ASG-15ME were generally well-tolerated, and
phase 1 enrollment is ongoing with both agents, with an increased
focus on checkpoint-inhibitor treated patients to further
understand safety and activity in this population. Detailed
findings are summarized below:
Interim Analysis of a Phase 1 Dose Escalation Trial of
ASG-22CE (ASG-22ME; enfortumab vedotin), an Antibody-Drug Conjugate
(ADC) in Patients (Pts) with Metastatic Urothelial Cancer (mUC)
(Abstract #788P, poster presentation on Sunday, October 9,
2016)
Data were reported from 58 patients with metastatic urothelial
cancer having a median age of 67 years. Of these patients, 56
patients (97 percent) had undergone treatment with a platinum-based
chemotherapy regimen and 20 patients (35 percent) had progressed on
or after treatment with checkpoint inhibitors. Thirty-six patients
(62 percent) had received two or more prior systemic therapies. The
primary endpoints of the ongoing clinical trial are to evaluate
pharmacokinetics and safety of enfortumab vedotin as a monotherapy
at escalating doses of 0.5 to 1.25 milligrams per kilogram (mg/kg)
weekly for three of every four week cycles. In addition, the trial
is evaluating antitumor activity, objective response rate and
disease control rate. Key findings include:
- Of the 49 patients evaluable for
response, 18 patients (37 percent) had an objective response,
including one patient (two percent) who achieved a complete
response and 17 patients (35 percent) who achieved a partial
response. The preliminary estimate of median progression-free
survival is 16.6 weeks.
- The recommended phase 2 dose is 1.25
mg/kg. In 17 patients treated at the 1.25 mg/kg dose level, 10
patients (59 percent) had a partial response. Disease control was
achieved for 14 patients (82 percent), defined as achieving
complete response, partial response or stable disease.
- In the 16 patients across dose levels
who had previously been treated with checkpoint inhibitors, six
patients (38 percent) achieved a partial response. At the
recommended phase 2 dose, four out of seven patients (57 percent)
previously treated with checkpoint inhibitors achieved a partial
response.
- In the 12 patients whose cancer had
metastasized to the liver, which typically has a poor prognosis,
five patients (42 percent) achieved an objective response. Of 20
patients previously treated with taxanes, eight (40 percent)
achieved an objective response.
- The most common treatment related
adverse events of any grade occurring in 20 percent or more of
patients were pruritis (31 percent), fatigue (30 percent), diarrhea
(29 percent), nausea (28 percent), rash (26 percent) and alopecia
(21 percent).
- Eight of 19 patients (42 percent)
experienced a rash at the recommended phase 2 dose and none of
these patients required dose modification or discontinued therapy
as a result.
- Enrollment is ongoing at 1.25 mg/kg and
the study has been amended to include a checkpoint
inhibitor-treated cohort to further understand safety and activity
in this population.
Interim Analysis of a Phase 1 Dose Escalation Trial of the
Antibody-Drug Conjugate (ADC) AGS15E (ASG-15ME) in Patients (Pts)
with Metastatic Urothelial Cancer (mUC) (Abstract #780PD, poster
presentation with discussion on Sunday, October 9, 2016)
Data were reported from 54 patients with metastatic urothelial
cancer having a median age of 64 years. Of these patients, 52
patients (96 percent) had previously undergone treatment with a
platinum-based chemotherapy regimen and 17 patients (32 percent)
had progressed on or after treatment with checkpoint inhibitors.
Thirty patients (56 percent) had received two or more prior
systemic therapies. The primary endpoints of the ongoing clinical
trial are to evaluate the pharmacokinetics and safety of ASG-15ME
as a monotherapy at escalating doses of 0.1 to 1.25 mg/kg weekly
for three of every four week cycles. In addition, the trial is
evaluating antitumor activity, objective response rate and disease
control rate. Key findings include:
- Of the 48 patients evaluable for
response, 18 patients (38 percent) had an objective response,
including one patient (two percent) who achieved a complete
response and 17 patients (35 percent) who achieved a partial
response. The preliminary estimate of median progression-free
survival is 16.1 weeks.
- The recommended phase 2 dose is 1.0
mg/kg. In 20 patients treated at the 1.0 mg/kg dose level, 10
patients (50 percent) had an objective response, including one
patient (five percent) who achieved a complete response and nine
patients (45 percent) who achieved a partial response. Disease
control was achieved for 14 patients (70 percent), defined as
achieving complete response, partial response or stable
disease.
- Of the 14 patients across dose levels
who had previously been treated with checkpoint inhibitors, six
patients (43 percent) achieved a partial response. At the
recommended phase 2 dose, three out of seven patients (43 percent)
previously treated with checkpoint inhibitors achieved a partial
response.
- In the 13 patients whose cancer had
metastasized to the liver, which typically has a poor prognosis,
six patients (46 percent) achieved an objective response. Of 22
patients previously treated with taxanes, nine (41 percent)
achieved an objective response.
- The most common treatment related
adverse events of any grade occurring in 20 percent or more of
patients were fatigue (44 percent), nausea (22 percent) and
decreased appetite (20 percent).
- Fourteen patients (26 percent)
experienced ocular adverse events and six patients (11 percent)
developed ocular symptoms with corneal abnormalities at the
recommended phase 2 dose. All events resolved with appropriate
management.
- Enrollment is ongoing at 1.0 mg/kg and
the study has been amended to include a checkpoint
inhibitor-treated cohort to further understand safety and activity
in this population.
More information about these clinical trials, including
enrolling centers, is available by visiting
www.clinicaltrials.gov.
About Urothelial Cancer
Urothelial cancers include carcinomas of the bladder, ureter,
and renal pelvis, which occur at a ratio of 50:3:1, respectively.
Most bladder cancers start in the innermost lining of the bladder,
which is called the urothelium or transitional epithelium.
Urothelial cancer begins when urothelial cells in the urinary
bladder, ureter, or renal pelvis start to grow uncontrollably.
While patients with early stage urothelial cancer are treated
with curative intent, outcomes are poor for patients diagnosed with
locally advanced or metastatic disease. For the approximately 10
percent of patients with urothelial cancer whose initial diagnoses
occur when they have metastatic disease, the average five-year
survival is approximately 15 percent. According to the American
Cancer Society, in 2016 approximately 77,000 people will be
diagnosed and more than 16,000 will die from urothelial bladder
cancer.
About Enfortumab Vedotin and ASG-15ME
Enfortumab vedotin is an investigational ADC composed of an
anti-Nectin-4 monoclonal antibody attached to a
microtubule-disrupting agent, MMAE, using Seattle Genetics
proprietary, industry-leading linker technology. Enfortumab vedotin
is the first and only agent to target Nectin-4, a cell adhesion
molecule identified as an ADC target by Agensys (now Astellas),
which is expressed on many solid tumors. Preclinical data
demonstrate that enfortumab vedotin effectively binds to target
cells, internalizes and induces cell-killing activity.
ASG-15ME is an investigational antibody-drug conjugate (ADC)
composed of an anti-SLITRK6 monoclonal antibody attached to a
microtubule-disrupting agent, monomethyl auristatin E (MMAE), using
Seattle Genetics proprietary, industry-leading linker technology.
ASG-15ME is the first and only agent to target SLITRK6, a
transmembrane protein identified as an ADC target by Agensys, which
is expressed on many solid tumors. Preclinical data demonstrate
that ASG-15ME effectively binds to target cells, internalizes and
induces cell-killing activity.
Nectin-4 and SLITRK6 are highly expressed in urothelial cancers,
particularly bladder cancer. Enfortumab vedotin and ASG-15ME
consist of monoclonal antibodies which selectively target and kill
tumor cells with microtubule-disrupting agents. This approach is
intended to spare non-targeted cells and thus reduce many of the
toxic effects of traditional chemotherapy while enhancing antitumor
activity.
About Seattle Genetics
Seattle Genetics is an innovative biotechnology company that
develops and commercializes novel antibody-based therapies for the
treatment of cancer. 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.
ADCETRIS® (brentuximab vedotin), the company’s lead product, in
collaboration with Takeda Pharmaceutical Company Limited, is the
first in a new class of ADCs commercially available globally in 65
countries for relapsed classical Hodgkin lymphoma (HL) and relapsed
systemic anaplastic large cell lymphoma (sALCL). Seattle Genetics
is also advancing vadastuximab talirine (SGN-CD33A; 33A), an ADC in
a phase 3 trial for acute myeloid leukemia. Headquartered in
Bothell, Washington, Seattle Genetics has a robust pipeline of
innovative therapies for blood-related cancers and solid tumors
designed to address significant unmet medical needs and improve
treatment outcomes for patients. The company has collaborations for
its proprietary ADC technology with a number of companies including
AbbVie, Astellas, Bayer, Celldex, Genentech, GlaxoSmithKline and
Pfizer. More information can be found at
www.seattlegenetics.com
About Astellas
Astellas Pharma Inc., based in Tokyo, Japan, is a company
dedicated to improving the health of people around the world
through the provision of innovative and reliable pharmaceutical
products. We focus on Urology, Oncology, Immunology, Nephrology and
Neuroscience as prioritized therapeutic areas while advancing new
therapeutic areas and discovery research leveraging new
technologies/modalities. We are also creating new value by
combining internal capabilities and external expertise in the
medical/healthcare business. Astellas is on the forefront of
healthcare change to turn innovative science into value for
patients. For more information, please visit our website at
www.astellas.com/en.
About the Astellas and Seattle Genetics Collaboration
Agensys (an affiliate of Astellas) and Seattle Genetics entered
into the ADC collaboration in January 2007 and expanded it in
November 2009. Under the collaboration, the companies are
co-developing and have options to globally co-commercialize
ASG-15ME and enfortumab vedotin.
Forward Looking Statements for Seattle Genetics
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the therapeutic
potential of enfortumab vedotin and ASG-15ME their possible safety
and efficacy and anticipated development activities including
future clinical trials. 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
inability to show sufficient activity in the clinical trials and
risk of adverse events as enfortumab vedotin and ASG-15ME advance
in clinical trials even after promising results in earlier clinical
trials. In addition, as our drug candidates or those of our
collaborators advance in clinical trials, adverse events and/or
regulatory actions may occur which affect the future development of
those drug candidates and possibly other compounds using similar
technology. 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 June 30, 2016 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.
Astellas Forward-Looking Statement
In this press release, statements made with respect to current
plans, estimates, strategies and beliefs and other statements that
are not historical facts are forward-looking statements about the
future performance of Astellas. These statements are based on
management’s current assumptions and beliefs in light of the
information currently available to it and involve known and unknown
risks and uncertainties. A number of factors could cause actual
results to differ materially from those discussed in the
forward-looking statements. Such factors include, but are not
limited to: (i) changes in general economic conditions and in laws
and regulations, relating to pharmaceutical markets, (ii) currency
exchange rate fluctuations, (iii) delays in new product launches,
(iv) the inability of Astellas to market existing and new products
effectively, (v) the inability of Astellas to continue to
effectively research and develop products accepted by customers in
highly competitive markets, and (vi) infringements of Astellas’
intellectual property rights by third parties.
Information about pharmaceutical products (including products
currently in development) which is included in this press release
is not intended to constitute an advertisement or medical
advice.
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Astellas Contacts:For MediaDirector, Corporate
AffairsTyler Marciniak,
847-736-7145tyler.marciniak@astellas.comorFor InvestorsSenior
Manager, Investor RelationsSo Sekine,
847-224-9557sou.sekine@astellas.comorSeattle Genetics
Contacts:For MediaKavita V. Shah,
425-527-4188kshah@seagen.comorFor InvestorsPeggy Pinkston,
425-527-4160ppinkston@seagen.com
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