TOKYO, May 17, 2017 /PRNewswire/ -- Astellas Pharma Inc.
(TSE: 4503, President and CEO: Yoshihiko
Hatanaka, "Astellas") announced today an update regarding
the Company's diverse oncology portfolio, including the acceptance
of a wide selection of abstracts across a broad range of cancers
for oral or poster presentation at the 2017 American Society of
Clinical Oncology (ASCO) Annual Meeting, June 2-6 in Chicago.
Astellas is presenting a record number of abstracts at ASCO,
including data for gilteritinib in acute myeloid leukemia,
enfortumab vedotin in urothelial cancer, and IMAB362 from the
recently acquired Ganymed. A number of XTANDI®
(enzalutamide) abstracts accepted for presentation also speak to
the comprehensive clinical trial program in metastatic CRPC and
other prostate cancer populations. In just over a decade, Astellas
has built a leadership position and substantial oncology pipeline
through a thoughtful blend of investments in organic R&D,
strategic business development and strong collaborative
partnerships with some of the most renowned institutions around the
world.
"We are thrilled to announce our largest presence to date at
this year's ASCO meeting," said Steven
Benner, M.D., senior vice president and global therapeutic
area head, oncology development, Astellas. "We believe these data
reflect significant progress in our pursuit to create innovative
treatment options for some of the most difficult-to-treat cancers
and further underscore our ongoing commitment to becoming a
world-class oncology company focusing on patients with cancer."
Additionally, the Company announced today the joint decision
with Pfizer to discontinue the planned ENDEAR trial (A Phase III,
Randomized, International Study Comparing the Efficacy and Safety
of Enzalutamide in Combination With Paclitaxel Chemotherapy or as
Monotherapy Versus Placebo With Paclitaxel in Patients With
Advanced, Diagnostic-Positive, Triple-Negative Breast Cancer); no
patients were ever enrolled in the trial. The companies have also
decided that based on the enzalutamide data from the Phase 2 HER2+
and ER/PR+ breast cancer studies, there will not be follow-on Phase
3 studies at this time.
About XTANDI® (enzalutamide)
capsules
XTANDI (enzalutamide) is an androgen receptor
inhibitor that blocks multiple steps in the androgen receptor
signaling pathway within the tumor cell. In preclinical studies,
enzalutamide has been shown to competitively inhibit androgen
binding to androgen receptors, and inhibit androgen receptor
nuclear translocation and interaction with DNA. The clinical
significance of this mechanism of action (MOA) is unknown.
XTANDI is approved by the U.S. Food and Drug Administration for
the treatment of patients with metastatic castration-resistant
prostate cancer (mCRPC). Enzalutamide is not approved for use in
patients with breast cancer.
Important Safety Information
Contraindications
XTANDI is not indicated for women.
XTANDI can cause fetal harm and potential loss of pregnancy.
Warnings and Precautions
Seizure occurred
in 0.5% of patients receiving XTANDI in clinical studies. In
placebo-controlled studies, 8 of 1671 (0.5%) patients treated with
XTANDI and 1 of 1243 (0.1%) patients treated with placebo
experienced a seizure. In patients who previously received
docetaxel, 7 of 800 (0.9%) patients treated with XTANDI experienced
a seizure and no patients treated with placebo experienced a
seizure. In a placebo-controlled study in chemotherapy-naïve
patients, 1 of 871 (0.1%) treated with XTANDI and 1 of 844 (0.1%)
patients treated with placebo experienced a seizure. In
bicalutamide-controlled studies conducted in chemotherapy-naïve
patients, 3 of 380 (0.8%) patients treated with XTANDI and 1 of 387
(0.3%) patients treated with bicalutamide experienced a seizure.
Permanently discontinue XTANDI in patients who develop a seizure
during treatment.
Posterior Reversible Encephalopathy Syndrome
(PRES)
In post approval use, there have been reports of PRES in patients
receiving XTANDI. PRES is a neurological disorder which can present
with rapidly evolving symptoms including seizure, headache,
lethargy, confusion, blindness, and other visual and neurological
disturbances, with or without associated hypertension. A diagnosis
of PRES requires confirmation by brain imaging, preferably MRI.
Discontinue XTANDI in patients who develop PRES.
Adverse Reactions
The most common adverse reactions (≥
10%) that occurred more commonly (≥ 2% over placebo) in the XTANDI
patients from the two placebo-controlled clinical trials were
asthenia/fatigue, back pain, decreased appetite, constipation,
arthralgia, diarrhea, hot flush, upper respiratory tract infection,
peripheral edema, dyspnea, musculoskeletal pain, weight decreased,
headache, hypertension, and dizziness/vertigo. In the
bicalutamide-controlled study of chemotherapy naïve patients, the
most common adverse reactions (≥ 10%) reported in XTANDI patients
were asthenia/fatigue, back pain, musculoskeletal pain, hot flush,
hypertension, nausea, constipation, upper respiratory tract
infection, diarrhea, and weight loss.
In the study of patients taking XTANDI who previously received
docetaxel, Grade 3 and higher adverse reactions were reported among
47% of XTANDI patients and 53% of placebo patients.
Discontinuations due to adverse events were reported for 16% of
XTANDI patients and 18% of placebo patients. In the
placebo-controlled study of chemotherapy-naïve patients, Grade 3-4
adverse reactions were reported in 44% of XTANDI patients and 37%
of placebo patients. Discontinuations due to adverse events were
reported for 6% of both study groups. In the
bicalutamide-controlled study of chemotherapy naïve patients, Grade
3-4 adverse reactions were reported in 38.8% of XTANDI patients and
37.6% of bicalutamide patients.
Discontinuations due to adverse events were reported for 7.6% of
XTANDI patients and 6.3% of bicalutamide patients.
Lab Abnormalities: In the two placebo-controlled trials Grade
1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4)
and 6% of placebo patients (0.5% Grade 3-4). Grade 1-4
thrombocytopenia occurred in 6% of XTANDI patients (0.3% Grade 3-4)
and 5% of placebo patients (0.5% Grade 3-4). Grade 1-4 elevations
in ALT occurred in 10% of XTANDI patients (0.2% Grade 3-4) and 16%
of placebo patients (0.2% Grade 3-4). Grade 1-4 elevations in
bilirubin occurred in 3% of XTANDI patients (0.1% Grade 3-4) and 2%
of placebo patients (no Grade 3-4).
Infections: In a study of patients taking XTANDI who previously
received docetaxel, 1% of XTANDI patients compared to 0.3% of
placebo patients died from infections or sepsis. In the
placebo-controlled study of chemotherapy-naïve patients, 1 patient
in each treatment group (0.1%) had an infection resulting in
death.
Falls (including fall-related injuries) occurred in 9% of XTANDI
patients and 4% of placebo patients in the two placebo-controlled
trials. Falls were not associated with loss of consciousness or
seizure. Fall-related injuries were more severe in XTANDI patients,
and included non-pathologic fractures, joint injuries, and
hematomas.
Hypertension occurred in 11% of XTANDI patients and 4% of
placebo patients in the two placebo-controlled trials. No patients
experienced hypertensive crisis. Medical history of hypertension
was balanced between arms. Hypertension led to study
discontinuation in < 1% of all patients in each arm.
Drug Interactions
Effect of Other Drugs on
XTANDI
Avoid strong CYP2C8 inhibitors, as they can increase the plasma
exposure to XTANDI. If co-administration is necessary, reduce the
dose of XTANDI.
Avoid strong CYP3A4 inducers as they can decrease the plasma
exposure to XTANDI. If co-administration is necessary, increase the
dose of XTANDI.
Effect of XTANDI on Other Drugs
Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow
therapeutic index, as XTANDI may decrease the plasma exposures of
these drugs. If XTANDI is co-administered with warfarin (CYP2C9
substrate), conduct additional INR monitoring.
Please see Full Prescribing
Information at for additional safety
information.
You are encouraged to report negative side
effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
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.
Cautionary Notes
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.
About the Pfizer/Astellas Collaboration
In
October 2009, Medivation, Inc., which
is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered
into a global agreement to jointly develop and commercialize
enzalutamide. The companies are collaborating on a comprehensive
development program that includes studies to develop enzalutamide
across the full spectrum of advanced prostate cancer as well as
other cancers. The companies jointly commercialize XTANDI in
the United States and Astellas has
responsibility for manufacturing and all additional regulatory
filings globally, as well as commercializing XTANDI outside
the United States.
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SOURCE Astellas Pharma Inc.