NORTHBROOK, Ill., May 14, 2015 /PRNewswire/ -- Astellas today
announced several abstracts across multiple cancers that will be
presented at the 2015 American Society of Clinical Oncology (ASCO)
Annual Meeting on May 29-June 2 in
Chicago.
The following abstracts will be presented during oral
presentation sessions:
Title: (Abstract 7003) Results of a first in
human, phase 1/2 trial of ASP2215, a selective, potent inhibitor of
FLT3/Axl in patients with relapsed or refractory (R/R) acute
myeloid leukemia (AML)
Presenter: Mark J.
Levis, M.D., Ph.D, Sidney Kimmel Comprehensive Cancer Center
at Johns Hopkins
- Session Date/Time: Saturday, May
30, 2:07-2:17 PM CDT
- Location: E Arie Crown Theater
Title: (Abstract 1003) Results from a phase 2
study of enzalutamide (ENZA), an androgen receptor (AR) inhibitor,
in advanced AR+ triple-negative breast cancer (TNBC)
Presenter: Tiffany A.
Traina, M.D., Memorial Sloan Kettering Cancer Center
- Session Date/Time: Monday, June
1, 4:00-4:12 PM CDT
- Location: North Hall B1
Title: (Abstract 2503) Phase I studies
of anti-ENPP3 antibody drug conjugates (ADCs) in advanced
refractory renal cell carcinomas (RRCC).
Presenter: John A.
Thompson, M.D., Seattle Cancer Care Alliance
- Session Date/Time: Tuesday, June
2, 8:48-9:00 AM CDT
- Location: S100A
Furthermore, the following abstracts will be presented during
poster discussion sessions:
Title: (Abstract 8014) ASP8273, a mutant-selective
irreversible EGFR inhibitor in patients (pts) with NSCLC harboring
EGFR activating mutations: Preliminary results of first-in-human
phase I study in Japan.
Presenter: Yasushi
Goto, M.D.,Ph.D, National Cancer Center Hospital
- Session Date/Time: Monday, June
1, 8:00-11:30 AM CDT
- Location: S Hall A
Title: (Abstract 8083) Phase I dose escalation
study of ASP8273, a mutant-selective irreversible EGFR inhibitor,
in subjects with EGFR mutation positive NSCLC.
Presenter: Helena Alexandra
Yu, M.D., Memorial Sloan Kettering Cancer Center
- Session Date/Time: Monday, June
1, 8:00-11:30 AM CDT
- Location: East Hall D2
About XTANDI® (enzalutamide) capsules
XTANDI is approved by the U.S. Food and Drug Administration for the
treatment of patients with metastatic castration-resistant prostate
cancer (CRPC).
Enzalutamide Mechanism of Action
Enzalutamide is an androgen receptor inhibitor that acts on three
different steps in the androgen receptor signaling pathway.
Important Safety Information Contraindications:
XTANDI (enzalutamide) capsules can cause fetal harm when
administered to a pregnant woman based on its mechanism of action
and findings in animals. XTANDI is not indicated for use in women.
XTANDI is contraindicated in women who are or may become
pregnant.
Warnings and Precautions: In Study 1, conducted in
patients with metastatic castration-resistant prostate cancer
(CRPC) who previously received docetaxel, seizure occurred in 0.9%
of patients who were treated with XTANDI and 0% treated with
placebo. In Study 2, conducted in patients with chemotherapy-naive
metastatic CRPC, seizure occurred in 0.1% of patients who were
treated with XTANDI and 0.1% treated with placebo. Patients
experiencing a seizure were permanently discontinued from therapy
and all seizure events resolved. There is no clinical trial
experience readministering XTANDI to patients who experienced a
seizure, and limited clinical trial experience in patients with
predisposing factors for seizure. Study 1 excluded the use of
concomitant medications that may lower threshold, whereas Study 2
permitted the use of these medications. Because of the risk of
seizure associated with XTANDI use, patients should be advised of
the risk of engaging in any activity during which sudden loss of
consciousness could cause serious harm to themselves or others.
Permanently discontinue XTANDI in patients who develop a seizure
during treatment.
Adverse Reactions: The most common adverse reactions (≥
10%) reported from the two combined clinical trials that occurred
more commonly (≥ 2% over placebo) in the XTANDI-treated patients
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.
Other Adverse Reactions include:
- Laboratory Abnormalities: In the two studies, Grade 14
neutropenia occurred in 15% of patients treated with XTANDI (1%
Grade 3-4) and in 6% of patients treated with placebo (0.5% Grade
3-4). The incidence of Grade 14 thrombocytopenia was 6% of patients
treated with XTANDI (0.3% Grade 3-4) and 5% of patients on placebo
(0.5% Grade 3-4). Grade 1-4 elevations in ALT occurred in 10% of
patients treated with XTANDI (0.2% Grade 3-4) and 16% of patients
treated with placebo (0.2% Grade 3-4). Grade 1-4 elevations in
bilirubin occurred in 3% of patients treated with XTANDI (0.1%
Grade 3-4) and 2% of patients treated with placebo (no Grade
3-4).
- Infections: In Study 1, 1% of XTANDI versus 0.3% of placebo
patients and in Study 2, 1 patient in each treatment group (0.1%)
had an infection resulting in death.
- Falls: In the two studies, falls including fall-related
injuries occurred in 9% of XTANDI patients vs 4% treated with
placebo. 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: In the two studies, hypertension was reported in
11% of patients receiving XTANDI and 4% of patients receiving
placebo. No patients experienced hypertensive crisis. Medical
history of hypertension was balanced between arms. Hypertension led
to study discontinuation in < 1% of XTANDI or placebo treated
patients.
Drug Interactions:
- Effect of Other Drugs on XTANDI: Administration of strong
CYP2C8 inhibitors can increase the plasma exposure to XTANDI.
Co-administration of XTANDI with strong CYP2C8 inhibitors should be
avoided if possible. If co-administration of XTANDI cannot be
avoided, reduce the dose of XTANDI. Co-administration of XTANDI
with strong or moderate CYP3A4 and CYP2C8 inducers may alter the
plasma exposure of XTANDI and should be avoided if possible.
- Effect of XTANDI on Other Drugs: XTANDI is a strong CYP3A4
inducer and a moderate CYP2C9 and CYP2C19 inducer in humans. 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.
For Full Prescribing Information for XTANDI (enzalutamide)
capsules, please visit www.XtandiHCP.com
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 is a pharmaceutical company
dedicated to improving the health of people around the world
through provision of innovative and reliable pharmaceuticals. For
more information on Astellas, please visit our website
at www.astellas.us, follow us on Twitter
at www.twitter.com/AstellasUS or like our Facebook page
at www.facebook.com/AstellasUS.
About the Medivation/Astellas
Collaboration
In October 2009, Medivation (NASDAQ:
MDVN) and Astellas (Tokyo: 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 advanced breast cancer. 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