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.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/astellas-announces-oncology-portfolio-updates-300459680.html
SOURCE Astellas Pharma Inc.