WHIPPANY, N.J., Sept. 14,
2015 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc.
announced today that data from its growing oncology portfolio will
be presented at the 2015 European Cancer Congress (ECC2015),
September 25 - 29, in Vienna, Austria. These data include further
analyses from the CONSIGN and CONCUR trials of Stivarga®
(regorafenib) tablets in previously treated metastatic colorectal
cancer (mCRC) patients, and findings from the Phase III ALSYMPCA
trial and the U.S. expanded access program (EAP) of
Xofigo® (radium Ra 223 dichloride) injection in patients
with metastatic castration-resistant prostate cancer (mCRPC),
symptomatic bone metastases and no known visceral metastatic
disease.
In addition, Bayer will present early clinical findings on its
investigational compound, roniciclib (BAY-1000394), a
cyclin-dependent kinase (CDK) inhibitor currently in Phase II
clinical development as a first-line therapy in combination with
chemotherapy for extensive disease small cell lung cancer
(ED-SCLC).
"Building on the clinical success of our approved oncology
portfolio, we continue to prioritize the treatment development
programs that show promise for combating the toughest cancers with
high unmet medical needs," said Joerg
Moeller, M.D., member of Bayer's HealthCare Executive
Committee and head of Global Development. "The research Bayer is
presenting at ECC2015 represents our ongoing commitment to
advancing our understanding of therapeutic options for cancer
patients worldwide."
Notable studies evaluating products and compounds from Bayer at
ECC2015 are listed below:
Radium Ra 223 Dichloride (radium-223)
- Baseline characteristics, number of radium-223 dichloride
injections, and overall survival (OS) in US Expanded Access Program
(EAP) and ALSYMPCA
- Abstract #2530, Board P021, Poster Session: Genitourinary
Malignancies (Hall C)
- September 28, 2015 at
4:45PM – 6:45PM (CEST)
- 3-year follow-up of chemotherapy following radium-223
dichloride (Ra-223) in castration-resistant prostate cancer (CRPC)
patients (pts) with symptomatic bone metastases (mets) from
ALSYMPCA
- Abstract #2510, Poster Discussion Session: Genitourinary
Malignancies (Hall C2)
- September 28, 2015 at
8:00AM – 9:00AM (CEST)
- Abstract #2510, Board P001, Poster Session: Genitourinary
Malignancies (Hall C)
- September 28, 2015 at
4:45PM – 6:45PM (CEST)
- Effects of concomitant use of abiraterone and/or
enzalutamide with radium-223 on safety and overall survival in
metastatic castration-resistant prostate cancer (mCRPC) patients
treated in an international early access program (EAP)
- Abstract #2561, Board P052, Poster Session: Genitourinary
Malignancies – Prostate Cancer (Hall C)
- September 28, 2015 at
4:45PM – 6:45PM (CEST)
- Experience with radium-223 as a systemic treatment for
patients (pts) with castration-resistant prostate cancer (CRPC) out
of a clinical trial in Spain
- Abstract #2540, Board P031, Poster Session: Genitourinary
Malignancies – Prostate Cancer (Hall C)
- September 28, 2015 at
4:45PM – 6:45PM (CEST)
Regorafenib
mCRC
- Regorafenib for previously treated metastatic colorectal
cancer (mCRC): Results from 683 Italian patients treated in the
open-label phase 3B CONSIGN study
- Abstract #2143, Board P133, Poster Session: Gastrointestinal
Malignancies – Colorectal Cancer (Hall C)
- September 27, 2015 at
9:15 AM – 11:15 AM (CEST)
- CONSIGN: An open-label phase 3B study of regorafenib in
patients with metastatic colorectal cancer (mCRC) who failed
standard therapy
- Abstract #2139, Board P129, Poster Session: Gastrointestinal
Malignancies – Colorectal Cancer (Hall C)
- September 27, 2015 at
9:15 AM – 11:15 AM (CEST)
- Analysis of biomarkers in circulating tumor DNA from the
phase 3 CONCUR study of regorafenib in Asian patients with
metastatic colorectal cancer (mCRC): Correlation with clinical
outcome
- Abstract #2013, Poster Discussion Session: Gastrointestinal
Malignancies – Colorectal Cancer (Hall A1)
- September 27, 2015 at
8:00 AM – 9:00
AM (CEST)
- Abstract #2013, Board P003, Poster Session: Gastrointestinal
Malignancies – Colorectal Cancer (Hall C)
- September 27, 2015 at
9:15 AM – 11:15 AM (CEST)
Gastrointestinal stromal tumour (GIST)
- Tumor genotyping and clonal evolution in KIT during
regorafenib treatment in the phase III GRID study of regorafenib vs
placebo in tyrosine kinase inhibitor (TKI)-refractory GIST
- Abstract #2341, Board P303, Poster Session: Gastrointestinal
Malignancies –Noncolorectal Cancer (Hall C)
- September 28, 2015 at
9:15 AM – 11:15 AM (CEST)
Pipeline
- Phase Ib/II study of the CDK inhibitor roniciclib
(BAY-1000394) in combination with chemotherapy as first-line
therapy in subjects with extensive disease in small-cell lung
cancer
- Abstract #3100, Board P352, Poster Session: Lung Cancer -
Metastatic Disease
(Hall C)
- September 27, 2015 at
9:15 AM – 11:15 AM (CEST)
About Xofigo® (radium Ra 223 dichloride)
Injection
Xofigo is indicated for the treatment of patients
with castration-resistant prostate cancer, symptomatic bone
metastases and no known visceral metastatic disease.
Xofigo is an alpha particle-emitting radioactive therapeutic
agent with an anti-tumor effect on bone metastases. The active
ingredient in Xofigo is the alpha particle-emitting isotope
radium-223, which mimics calcium and forms complexes with the bone
mineral hydroxyapatite at areas of increased bone turnover, such as
bone metastases. The high linear energy transfer of Xofigo may
cause double-strand DNA breaks in adjacent cells, resulting in an
anti-tumor effect on bone metastases. The alpha particle range from
radium Ra 223 dichloride is less than 100 micrometers which may
limit the damage to the surrounding normal tissue.1
Important Safety Information for Xofigo® (radium
Ra 223 dichloride) Injection
- Contraindications: Xofigo is contraindicated in
women who are or may become pregnant. Xofigo can cause fetal harm
when administered to a pregnant woman.
- Bone Marrow Suppression: In the randomized trial,
2% of patients in the Xofigo arm experienced bone marrow failure or
ongoing pancytopenia, compared to no patients treated with placebo.
There were two deaths due to bone marrow failure. For 7 of 13
patients treated with Xofigo bone marrow failure was ongoing at the
time of death. Among the 13 patients who experienced bone marrow
failure, 54% required blood transfusions. Four percent (4%) of
patients in the Xofigo arm and 2% in the placebo arm permanently
discontinued therapy due to bone marrow suppression. In the
randomized trial, deaths related to vascular hemorrhage in
association with myelosuppression were observed in 1% of
Xofigo-treated patients compared to 0.3% of patients treated with
placebo. The incidence of infection-related deaths (2%), serious
infections (10%), and febrile neutropenia (<1%) was similar for
patients treated with Xofigo and placebo. Myelosuppression –
notably thrombocytopenia, neutropenia, pancytopenia, and leucopenia
– has been reported in patients treated with Xofigo.
Monitor patients with evidence of compromised bone marrow reserve
closely and provide supportive care measures when clinically
indicated. Discontinue Xofigo in patients who experience
life-threatening complications despite supportive care for bone
marrow failure.
- Hematological Evaluation: Monitor blood counts at
baseline and prior to every dose of Xofigo. Prior to first
administering Xofigo, the absolute neutrophil count (ANC) should be
greater than or equal to 1.5 × 109/L, the platelet
count greater than or equal to 100 × 109/L, and
hemoglobin greater than or equal to 10 g/dL. Prior to subsequent
administrations, the ANC should be greater than or equal to 1 ×
109/L and the platelet count greater than or equal to 50
× 109/L. Discontinue Xofigo if hematologic values do not
recover within 6 to 8 weeks after the last administration despite
receiving supportive care.
- Concomitant Use with Chemotherapy: Safety and
efficacy of concomitant chemotherapy with Xofigo have not been
established. Outside of a clinical trial, concomitant use of Xofigo
in patients on chemotherapy is not recommended due to the potential
for additive myelosuppression. If chemotherapy, other systemic
radioisotopes, or hemibody external radiotherapy are administered
during the treatment period, Xofigo should be discontinued.
- Administration and Radiation Protection: Xofigo
should be received, used, and administered only by authorized
persons in designated clinical settings. The administration of
Xofigo is associated with potential risks to other persons from
radiation or contamination from spills of bodily fluids such as
urine, feces, or vomit. Therefore, radiation protection precautions
must be taken in accordance with national and local
regulations.
- Fluid Status: Dehydration occurred in 3% of
patients on Xofigo and 1% of patients on placebo. Xofigo increases
adverse reactions such as diarrhea, nausea, and vomiting, which may
result in dehydration. Monitor patients' oral intake and fluid
status carefully and promptly treat patients who display signs or
symptoms of dehydration or hypovolemia.
- Injection Site Reactions: Erythema, pain, and edema
at the injection site were reported in 1% of patients on
Xofigo.
- Secondary Malignant Neoplasms: Xofigo contributes
to a patient's overall long-term cumulative radiation exposure.
Long-term cumulative radiation exposure may be associated with an
increased risk of cancer and hereditary defects. Due to its
mechanism of action and neoplastic changes, including
osteosarcomas, in rats following administration of radium -223
dichloride, Xofigo may increase the risk of osteosarcoma or other
secondary malignant neoplasms. However, the overall incidence of
new malignancies in the randomized trial was lower on the Xofigo
arm compared to placebo (<1% vs 2%; respectively), but the
expected latency period for the development of secondary
malignancies exceeds the duration of follow up for patients on the
trial.
- Subsequent Treatment with Cytotoxic
Chemotherapy: In the randomized clinical trial, 16%
patients in the Xofigo group and 18% patients in the placebo group
received cytotoxic chemotherapy after completion of study
treatments. Adequate safety monitoring and laboratory testing was
not performed to assess how patients treated with Xofigo will
tolerate subsequent cytotoxic chemotherapy.
- Adverse Reactions: The most common adverse
reactions (>10%) in the Xofigo arm vs the placebo arm,
respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%),
vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3
and 4 adverse events were reported in 57% of Xofigo-treated
patients and 63% of placebo-treated patients. The most common
hematologic laboratory abnormalities in the Xofigo arm (>10%) vs
the placebo arm, respectively, were anemia (93% vs 88%),
lymphocytopenia (72% vs 53%), leukopenia (35% vs 10%),
thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%).
For full prescribing information
visit http://labeling.bayerhealthcare.com/html/products/pi/Xofigo_PI.pdf.
About Stivarga (regorafenib)
In the United States, Stivarga is indicated for
the treatment of patients with mCRC who have been previously
treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based
chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an
anti-EGFR therapy. It is also indicated for the treatment of
patients with locally advanced, unresectable or metastatic
gastrointestinal stromal tumor (GIST) who have been previously
treated with imatinib mesylate and sunitinib
malate.2
Stivarga is an inhibitor of multiple kinases involved in normal
cellular functions and in pathologic processes such as oncogenesis,
tumor angiogenesis and maintenance of the tumor
microenvironment.2
Stivarga is a compound developed by Bayer. In 2011, Bayer
entered into an agreement with Onyx Pharmaceuticals, Inc., an Amgen
subsidiary (NASDAQ: AMGN), under which Onyx receives a royalty on
all global net sales of Stivarga in oncology.
Important Safety Information for Stivarga®
(regorafenib) tablets:
WARNING: HEPATOTOXICITY
- Severe and sometimes fatal hepatotoxicity has been observed
in clinical trials.
- Monitor hepatic function prior to and during
treatment.
- Interrupt and then reduce or discontinue Stivarga for
hepatotoxicity as manifested by elevated liver function tests or
hepatocellular necrosis, depending upon severity and
persistence.
Hepatotoxicity: Severe drug-induced liver injury
with fatal outcome occurred in 0.3% of 1200 Stivarga-treated
patients across all clinical trials. In metastatic colorectal
cancer (mCRC), fatal hepatic failure occurred in 1.6% of patients
in the Stivarga arm and in 0.4% of patients in the placebo arm; all
the patients with hepatic failure had metastatic disease in the
liver. In gastrointestinal stromal tumor (GIST), fatal hepatic
failure occurred in 0.8% of patients in the Stivarga arm.
Liver Function Monitoring: Obtain liver function tests
(ALT, AST, and bilirubin) before initiation of Stivarga and monitor
at least every 2 weeks during the first 2 months of treatment.
Thereafter, monitor monthly or more frequently as clinically
indicated. Monitor liver function tests weekly in patients
experiencing elevated liver function tests until improvement to
less than 3 times the upper limit of normal (ULN) or baseline
values. Temporarily hold and then reduce or permanently discontinue
Stivarga, depending on the severity and persistence of
hepatotoxicity as manifested by elevated liver function tests or
hepatocellular necrosis.
Hemorrhage: Stivarga caused an increased incidence of
hemorrhage. The overall incidence (Grades 1-5) was 21% and 11% with
Stivarga vs 8% and 3% with placebo in mCRC and GIST patients,
respectively. Fatal hemorrhage occurred in 4 of 632 (0.6%)
Stivarga-treated patients and involved the respiratory,
gastrointestinal, or genitourinary tracts. Permanently discontinue
Stivarga in patients with severe or life-threatening hemorrhage and
monitor INR levels more frequently in patients receiving
warfarin.
Dermatological Toxicity: Stivarga caused an increased
incidence of hand-foot skin reaction (HFSR) (also known as
palmar-plantar erythrodysesthesia [PPE]) and severe rash,
frequently requiring dose modification. The overall incidence was
45% and 67% with Stivarga vs 7% and 12% with placebo in mCRC and
GIST patients, respectively. Incidence of Grade 3 HFSR (17% vs 0%
in mCRC and 22% vs 0% in GIST), Grade 3 rash (6% vs <1% in mCRC
and 7% vs 0% in GIST), serious adverse reactions of erythema
multiforme (0.2% vs 0% in mCRC), and Stevens-Johnson syndrome (0.2%
vs 0% in mCRC) was higher in Stivarga-treated patients. Toxic
epidermal necrolysis occurred in 0.17% of 1200 Stivarga-treated
patients across all clinical trials. Withhold Stivarga, reduce the
dose, or permanently discontinue depending on the severity and
persistence of dermatologic toxicity.
Hypertension: Stivarga caused an increased incidence of
hypertension (30% vs 8% in mCRC and 59% vs 27% in GIST with
Stivarga vs placebo, respectively). Hypertensive crisis occurred in
0.25% of 1200 Stivarga-treated patients across all clinical trials.
Do not initiate Stivarga until blood pressure is adequately
controlled. Monitor blood pressure weekly for the first 6 weeks of
treatment and then every cycle, or more frequently, as clinically
indicated. Temporarily or permanently withhold Stivarga for severe
or uncontrolled hypertension.
Cardiac Ischemia and Infarction: Stivarga increased the
incidence of myocardial ischemia and infarction in mCRC (1.2% with
Stivarga vs 0.4% with placebo). Withhold Stivarga in patients who
develop new or acute cardiac ischemia or infarction, and resume
only after resolution of acute cardiac ischemic events if the
potential benefits outweigh the risks of further cardiac
ischemia.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS):
Reversible Posterior Leukoencephalopathy Syndrome (RPLS) occurred
in 1 of 1200 Stivarga-treated patients across all clinical trials.
Perform an evaluation for RPLS in any patient presenting with
seizures, headache, visual disturbances, confusion, or altered
mental function. Confirm the diagnosis of RPLS with MRI and
discontinue Stivarga in patients who develop RPLS.
Gastrointestinal Perforation or Fistula: Gastrointestinal
perforation or fistula occurred in 0.6% of 1200 patients treated
with Stivarga across clinical trials. In GIST, 2.1% (4/188) of
Stivarga-treated patients developed gastrointestinal fistula or
perforation: of these, 2 cases of gastrointestinal perforation were
fatal. Permanently discontinue Stivarga in patients who develop
gastrointestinal perforation or fistula.
Wound Healing Complications: Treatment with Stivarga
should be stopped at least 2 weeks prior to scheduled surgery.
Resuming treatment after surgery should be based on clinical
judgment of adequate wound healing. Stivarga should be discontinued
in patients with wound dehiscence.
Embryo-Fetal Toxicity: Stivarga can cause fetal harm when
administered to a pregnant woman. Use effective contraception
during treatment and up to 2 months after completion of therapy. If
this drug is used during pregnancy, or if the patient becomes
pregnant while taking this drug, the patient should be apprised of
the potential hazard to the fetus.
Nursing Mothers: Because many drugs are excreted in human
milk and because of the potential for serious adverse reactions in
nursing infants from Stivarga, a decision should be made whether to
discontinue nursing or discontinue the drug, taking into account
the importance of the drug to the mother.
Most Frequently Observed Adverse Drug Reactions in mCRC:
The most frequently observed adverse drug reactions (>30%) in
Stivarga-treated patients vs placebo-treated patients in mCRC,
respectively, were: asthenia/fatigue (64% vs 46%), decreased
appetite and food intake (47% vs 28%), HFSR/PPE (45% vs 7%),
diarrhea (43% vs 17%), mucositis (33% vs 5%), weight loss (32% vs
10%), infection (31% vs 17%), hypertension (30% vs 8%), and
dysphonia (30% vs 6%).
Most Frequently Observed Adverse Drug Reactions in GIST:
The most frequently observed adverse drug reactions (>30%) in
Stivarga-treated patients vs placebo-treated patients in GIST,
respectively, were: HFSR/PPE (67% vs 15%), hypertension (59% vs
27%), asthenia/fatigue (52% vs 39%), diarrhea (47% vs 9%),
mucositis (40% vs 8%), dysphonia (39% vs 9%), infection (32% vs
5%), decreased appetite and food intake (31% vs 21%), and rash (30%
vs 3%).
For full prescribing information, including the Boxed Warning,
visit
http://labeling.bayerhealthcare.com/html/products/pi/Stivarga_PI.pdf.
About Roniciclib (BAY-1000394)
Roniciclib
(BAY-1000394) is an investigational oral cyclin dependent kinase
(CDK) inhibitor with potential antineoplastic activity. Roniciclib
binds to and inhibits the activity of CDK1/Cyclin B, CDK2/Cyclin E,
CDK4/Cyclin D1, CDK6/Cyclin D3 and CDK9/Cyclin T1, serine/threonine
kinases that play key roles in the regulation of tumor cell
proliferation and survival.
Roniciclib is currently in Phase II of clinical development and
is being investigated in multiple tumor types, including small cell
lung cancer.
Roniciclib is not approved by the U.S. Food and Drug
Administration, the European Medicines Agency or any other health
authority.
About Oncology at Bayer
Bayer is committed to
delivering science for a better life by advancing a
portfolio of innovative treatments. The oncology franchise at
Bayer now includes three oncology products and several other
compounds in various stages of clinical development. Together,
these products reflect the company's approach to research, which
prioritizes targets and pathways with the potential to impact the
way that cancer is treated.
About Bayer HealthCare Pharmaceuticals
Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based
pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of
Bayer AG. Bayer HealthCare is one of the world's leading,
innovative companies in the healthcare and medical products
industry, and combines the activities of the Animal Health,
Consumer Care, Medical Care, and Pharmaceuticals divisions.
As a specialty pharmaceutical company, Bayer HealthCare
Pharmaceuticals Inc. provides products for General Medicine,
Hematology, Neurology, Oncology and Women's Healthcare. The
company's aim is to discover and manufacture products that will
improve human health worldwide by diagnosing, preventing and
treating diseases.
© 2015 Bayer HealthCare Pharmaceuticals Inc.
BAYER, the Bayer Cross, Xofigo and Stivarga are registered
trademarks of Bayer.
Forward-Looking Statement
This news release may
contain forward-looking statements based on current assumptions and
forecasts made by Bayer Group or subgroup management. Various known
and unknown risks, uncertainties and other factors could lead to
material differences between the actual future results, financial
situation, development or performance of the company and the
estimates given here. These factors include those discussed in
Bayer's public reports which are available on the Bayer website at
www.bayer.com. The company assumes no liability whatsoever to
update these forward-looking statements or to conform them to
future events or developments.
1. XOFIGO® (radium Ra 223 dichloride)
[Prescribing Information]. Wayne,
NJ: Bayer HealthCare Pharmaceuticals, May 2013.
2. STIVARGA® (regorafenib) [Prescribing
Information]. Whippany, NJ: Bayer
HealthCare Pharmaceuticals, April
2015.
PP-910-US-0130
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SOURCE Bayer HealthCare Pharmaceuticals Inc.