WHIPPANY, N.J., May 18, 2016 /PRNewswire/ -- Bayer announced
today that data from several studies across its oncology portfolio
will be presented at the 52nd Annual Meeting of the
American Society of Clinical Oncology (ASCO), taking place
June 3-7 in Chicago. The data represent clinical research
on Bayer's oncology products, as well as continued investigation of
Xofigo® (radium Ra 223 dichloride) injection in other
areas of metastatic castration-resistant prostate cancer
(CRPC).
"Bayer's scientific presence at ASCO demonstrates our commitment
to cancer research," said Dario
Mirski, M.D., Bayer's senior vice president and head of
medical affairs for the Americas. "At this meeting, we will be
presenting research from our robust clinical program including
investigational research of our approved portfolio along with
information on our approach to discovering compounds that may
address unmet needs in some of the toughest cancers."
Other data to be presented include subgroup analysis by age from
the Phase IIIb CONSIGN trial investigating Stivarga®
(regorafenib) tablets as well as analysis of possible prognostic or
predictive biomarkers in patients from the Phase III DECISION trial
evaluating Nexavar® (sorafenib) tablets. Additionally,
results from the International Prostate Cancer Symptoms Survey
addressing symptom burden in advanced prostate cancer from the
perspectives of patients and caregivers will be presented.
Bayer will also present research from investigational uses of
approved products and compounds currently in development, including
BAY-1841788 (ODM-201), an androgen receptor (AR) antagonist Bayer
is jointly developing with Orion Corporation, investigated in men
with high-risk nonmetastatic CRPC, as well as anetumab ravtansine
(BAY 94-9343), an anti-mesothelin antibody drug conjugate currently
in Phase II investigational studies for mesothelioma.
Notable Bayer studies at ASCO 2016 include the following:
Radium-223 Dichloride (radium-223)
- Re-treatment with radium-223: an international, prospective,
open-label study in patients with castration-resistant prostate
cancer and bone metastases
- Abstract #5074, Board #331, Poster Session: Genitourinary
(Prostate) Cancer
- Saturday, June 4, 1:00 PM – 4:30 PM
(CDT)
- Updated results: a phase 1/2a randomized trial of radium-223
+ docetaxel versus docetaxel in patients with castration-resistant
prostate cancer and bone metastases
- Abstract #5075, Board #332, Poster Session: Genitourinary
(Prostate) Cancer
- Saturday, June 4, 1:00 PM – 4:30 PM
(CDT)
- Analysis of overall survival by number of radium-223
injections received in an international expanded access program
(iEAP)
- Abstract #5082, Board #433, Poster Session: Genitourinary
(Prostate) Cancer
- Saturday, June 4, 1:00 PM – 4:30 PM
(CDT)
- ERA 223: a phase 3 trial of radium-223 dichloride in
combination with abiraterone acetate and prednisone in the
treatment of asymptomatic or mildly symptomatic chemotherapy-naïve
patients with bone-predominant metastatic castration-resistant
prostate cancer
- Abstract #TPS5088, Board #437b, Poster Session: Genitourinary
(Prostate) Cancer
- Saturday, June 4, 1:00 PM – 4:30 PM
(CDT)
- A phase 2 randomized, double-blind, placebo-controlled trial
of radium-223 dichloride with exemestane and everolimus in patients
with HER2–negative hormone receptor–positive breast cancer and bone
metastases
- Abstract #TPS621, Board #105a, Poster Session: Breast
Cancer—HER2/ER
- Sunday, June 5, 8:00 AM – 11:30 AM
(CDT)
- A phase 2 randomized, double-blind, placebo-controlled trial
of endocrine therapy ± radium-223 dichloride (Ra-223) in HER2-
hormone receptor+ breast cancer patients with bone metastases
- Abstract #TPS622, Board #105b, Poster Session: Breast
Cancer—HER2/ER
- Sunday, June 5, 8:00 AM – 11:30 AM
(CDT)
Regorafenib
- Regorafenib in previously treated metastatic colorectal
cancer (mCRC): Analysis of age subgroups in the open-label phase 3b
CONSIGN trial
- Abstract #3524, Board #221, Poster Session: Gastrointestinal
(Colorectal) Cancer
- Saturday, June 4, 8:00 AM – 11:30 AM
(CDT)
- Phase I dose-escalation and pharmacokinetic (PK) study of
regorafenib in pediatric patients with recurrent or refractory
solid malignancies
- Abstract #10542, Board #233, Poster Session: Pediatric
Oncology
- Monday, June 6, 8:00 AM – 11:30 AM
(CDT)
Sorafenib
- Biomarkers of Prognosis in Patients With Differentiated
Thyroid Cancer: Results from the DECISION Trial
- Abstract #6059, Board #381, Poster Session: Head and Neck
Cancer
- Saturday, June 4, 1:00 PM – 4:30 PM
(CDT)
International Prostate Cancer Symptoms Survey
- Recognizing symptom burden in advanced prostate cancer: a
global patient and caregiver survey
- Abstract #10124, Board #112, Poster Session: Patient and
Survivor Care
- Monday, June 6, 1:00 PM – 4:30 PM
(CDT)
Pipeline
- ARAMIS trial: Efficacy and safety of ODM-201 in men with
high-risk nonmetastatic castration-resistant prostate cancer
- Abstract #TPS5094, Board #440b, Poster Session: Genitourinary
(Prostate) Cancer
- Saturday, June 4, 1:00 PM – 4:30 PM
(CDT)
- Phase I study of anti-mesothelin antibody drug conjugate
anetumab ravtansine (AR)
- Abstract #2509, Board #209, Poster Session: Developmental
Therapeutics—Clinical Pharmacology and Experimental
Therapeutics
- Sunday, June 5, 8:00 AM – 11:30 AM
(CDT)
- A pivotal randomized phase II study of anetumab ravtansine
or vinorelbine in patients with advanced or metastatic pleural
mesothelioma after progression on platinum/pemetrexed-based
chemotherapy (NCT02610140)
- Abstract #TPS8576, Board #201a, Poster Session: Lung
Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic
Cancers
- Saturday, June 4, 8:00 AM – 11:30 AM
(CDT)
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.
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 metastatic colorectal cancer (CRC)
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 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 Laukoencephalopathy Syndrome (RPLS):
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
(≥30%): 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
(≥30%): The most frequently observed adverse drug reactions
(≥30%) in Stivarga-treated patients vs placebo-treated patients in
GIST, respectively, were: HFSR/PPE (67% vs 12%), 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 NEXAVAR® (sorafenib) Tablets
NEXAVAR
is approved in the U.S. for the treatment of patients with
unresectable hepatocellular carcinoma, patients with advanced renal
cell carcinoma and patients with locally recurrent or metastatic,
progressive, differentiated thyroid carcinoma that is refractory to
radioactive iodine treatment.
Important Safety Considerations For NEXAVAR®
(sorafenib) Tablets
- NEXAVAR is contraindicated in patients with known severe
hypersensitivity to sorafenib or any other component of
NEXAVAR
- NEXAVAR in combination with carboplatin and paclitaxel is
contraindicated in patients with squamous cell lung cancer
- Cardiac ischemia and/or myocardial infarction may occur. The
incidence of cardiac ischemia/infarction in NEXAVAR-treated vs
placebo-treated patients was 2.7% vs 1.3%, 2.9% vs 0.4%, and 1.9%
vs 0% in the HCC, RCC, and DTC studies, respectively. Temporary or
permanent discontinuation of NEXAVAR should be considered in
patients who develop cardiac ischemia and/or myocardial
infarction
- An increased risk of bleeding may occur following NEXAVAR
administration. The following bleeding adverse reactions were
reported in the NEXAVAR-treated vs placebo-treated patients,
respectively, in the HCC study: bleeding from esophageal varices
(2.4% vs 4%) and bleeding with fatal outcome at any site (2.4% vs
4%); in the RCC study: bleeding regardless of causality (15.3% vs
8.2%), Grade 3 bleeding (2.0% vs 1.3%), Grade 4 bleeding (0% vs
0.2%), and one fatal hemorrhage in each treatment group; in the DTC
study: bleeding (17.4% vs 9.6%) and Grade 3 bleeding (1% vs
1.4%).There was no Grade 4 bleeding reported and there was one
fatal hemorrhage in a placebo-treated patient. If bleeding
necessitates medical intervention, consider permanent
discontinuation of NEXAVAR. Due to the potential risk of bleeding,
tracheal, bronchial, and esophageal infiltration should be treated
with local therapy prior to administering NEXAVAR in patients with
DTC
- Monitor blood pressure weekly during the first 6 weeks and
periodically thereafter, and treat, if required. In the HCC study,
hypertension was reported in approximately 9.4% of NEXAVAR-treated
patients and 4.3% of patients in the placebo-treated group. In the
RCC study, hypertension was reported in approximately 16.9% of
NEXAVAR-treated patients and 1.8% of patients in the
placebo-treated group. In the DTC study, hypertension was reported
in 40.6% of NEXAVAR-treated patients and 12.4% of the
placebo-treated patients. Hypertension was usually mild to
moderate, occurred early in the course of treatment, and was
managed with standard antihypertensive therapy. In cases of severe
or persistent hypertension despite institution of antihypertensive
therapy, consider temporary or permanent discontinuation of
NEXAVAR
- Hand-foot skin reaction and rash are the most common adverse
reactions attributed to NEXAVAR. Management may include topical
therapies for symptomatic relief. In cases of any severe or
persistent adverse reactions, temporary treatment interruption,
dose modification, or permanent discontinuation of NEXAVAR should
be considered. There have been reports of severe dermatologic
toxicities, including Stevens-Johnson syndrome (SJS) and toxic
epidermal necrolysis (TEN). These cases may be life-threatening.
Discontinue NEXAVAR if SJS or TEN are suspected
- Gastrointestinal perforation was an uncommon adverse reaction
and has been reported in less than 1% of patients taking NEXAVAR.
Discontinue NEXAVAR in the event of a gastrointestinal
perforation
- Infrequent bleeding or elevations in the International
Normalized Ratio (INR) have been reported in some patients taking
warfarin while on NEXAVAR. Monitor patients taking concomitant
warfarin regularly for changes in prothrombin time (PT), INR, or
clinical bleeding episodes
- Temporary interruption of NEXAVAR therapy is recommended in
patients undergoing major surgical procedures
- In a subset analysis of two randomized controlled trials in
chemo-naïve patients with Stage IIIB-IV non-small cell lung cancer,
patients with squamous cell carcinoma experienced higher mortality
with the addition of NEXAVAR compared to those treated with
carboplatin/paclitaxel alone (HR 1.81, 95% CI 1.19–2.74) and
gemcitabine/cisplatin alone (HR 1.22, 95% CI 0.82-1.80). NEXAVAR,
in combination with gemcitabine/cisplatin, is not recommended in
patients with squamous cell lung cancer. The safety and
effectiveness of NEXAVAR has not been established in patients with
non-small cell lung cancer
- NEXAVAR can prolong the QT/QTc interval and increase the risk
for ventricular arrhythmias. Avoid use in patients with congenital
long QT syndrome and monitor electrolytes and electrocardiograms in
patients with congestive heart failure, bradyarrhythmias, drugs
known to prolong the QT interval, including Class Ia and III
antiarrhythmics, and electrolyte abnormalities. Correct electrolyte
abnormalities (magnesium, potassium, calcium). Interrupt NEXAVAR if
QTc interval is greater than 500 milliseconds or for an increase
from baseline of 60 milliseconds or greater
- Sorafenib-induced hepatitis is characterized by a
hepatocellular pattern of liver damage with significant increases
of transaminases which may result in hepatic failure and death.
Increases in bilirubin and INR may also occur. Liver function tests
should be monitored regularly and in cases of increased
transaminases without alternative explanation NEXAVAR should be
discontinued
- NEXAVAR may cause fetal harm when administered to a pregnant
woman. Women of child-bearing potential should be advised to avoid
becoming pregnant while on NEXAVAR
- Female patients should be advised against breastfeeding while
receiving NEXAVAR
- In DTC, NEXAVAR impairs exogenous thyroid suppression.
Elevation of thyroid stimulating hormone (TSH) level above 0.5 mU/L
was observed in 41% of NEXAVAR-treated patients as compared with
16% of placebo-treated patients in the DTC study. For patients with
impaired TSH suppression while receiving NEXAVAR, the median
maximal TSH was 1.6 mU/L and 25% had TSH levels greater than 4.4
mU/L. Monitor TSH levels monthly and adjust thyroid replacement
medication as needed in patients with DTC
- In the HCC study, the most common laboratory abnormalities
observed in the NEXAVAR arm versus the placebo arm, respectively,
were hypoalbuminemia (59% vs. 47%), lymphopenia (47% vs. 42%),
thrombocytopenia (46% vs. 41%), elevation in INR (42% vs. 34%),
elevated lipase (40% vs. 37%), hypophosphatemia (35% vs. 11%),
elevated amylase (34% vs. 29%), hypocalcemia (27% vs. 15%), and
hypokalemia (9.5% vs. 5.9%)
- In the RCC study, the most common laboratory abnormalities
observed in the NEXAVAR arm versus the placebo arm, respectively,
were hypophosphatemia (45% vs. 11%), anemia (44% vs. 49%), elevated
lipase (41% vs. 30%), elevated amylase (30% vs. 23%), lymphopenia
(23% vs. 13%), neutropenia (18% vs. 10%), thrombocytopenia (12% vs.
5%), hypocalcemia (12% vs. 8%), and hypokalemia (5.4% vs.
0.7%)
- In the DTC study, the most common laboratory abnormalities
observed in the NEXAVAR arm versus the placebo arm, respectively,
were elevated ALT (59% vs. 24%), elevated AST (54% vs. 15%), and
hypocalcemia (36% vs. 11%).The relative increase for the following
laboratory abnormalities observed in NEXAVAR-treated DTC patients
as compared to placebo-treated patients is similar to that observed
in the RCC and HCC studies: lipase, amylase, hypokalemia,
hypophosphatemia, neutropenia, lymphopenia, anemia, and
thrombocytopenia
- Avoid concomitant use of strong CYP3A4 inducers, when possible,
because inducers can decrease the systemic exposure of sorafenib.
NEXAVAR exposure decreases when co-administered with oral neomycin.
Effects of other antibiotics on NEXAVAR pharmacokinetics have not
been studied
- Most common adverse reactions reported for NEXAVAR-treated
patients vs placebo-treated patients in unresectable HCC,
respectively, were: diarrhea (55% vs. 25%), fatigue (46% vs. 45%),
abdominal pain (31% vs. 26%), weight loss (30% vs. 10%), anorexia
(29% vs. 18%), nausea (24% vs. 20%), and hand-foot skin reaction
(21% vs. 3%). Grade 3/4 adverse reactions were 45% vs. 32%
- Most common adverse reactions reported for NEXAVAR-treated
patients vs placebo-treated patients in advanced RCC, respectively,
were: diarrhea (43% vs. 13%), rash/desquamation (40% vs. 16%),
fatigue (37% vs. 28%), hand-foot skin reaction (30% vs. 7%),
alopecia (27% vs. 3%), and nausea (23% vs. 19%). Grade 3/4 adverse
reactions were 38% vs. 28%
- Most common adverse reactions reported for NEXAVAR-treated
patients vs placebo-treated patients in DTC, respectively, were:
palmar-plantar erythrodysesthesia syndrome (PPES) (69% vs. 8%),
diarrhea (68% vs. 15%), alopecia (67% vs. 8%), weight loss (49% vs.
14%), fatigue (41% vs. 20%), hypertension (41% vs. 12%), rash (35%
vs. 7%), decreased appetite (30% vs. 5%), stomatitis (24% vs. 3%),
nausea (21% vs. 12%), pruritus (20% vs. 11%), and abdominal pain
(20% vs. 7%). Grade 3/4 adverse reactions were 65% vs. 30%
For full Prescribing Information, visit
http://labeling.bayerhealthcare.com/html/products/pi/Nexavar_PI.pdf.
About BAY-1841788 (ODM-201)
BAY-1841788 (ODM-201) is
an investigational oral androgen receptor (AR) antagonist. The
compound is currently being studied in a Phase III clinical trial
for men with non-metastatic castration-resistant prostate
cancer.
In 2014, Bayer and Orion Corporation, a pharmaceutical company
based in Espoo, Finland, entered
into a global agreement under which they will jointly develop
BAY-1841788 (ODM-201), with Bayer contributing a major share of the
costs of future development. Bayer will commercialize the product
globally and Orion has the option to co-promote BAY-1841788
(ODM-201) in Europe. Orion will be
responsible for the manufacturing of the product.
BAY-1841788 (ODM-201) is not approved by the U.S. Food and Drug
Administration, the European Medicines Agency or any other health
authority.
About Anetumab Ravtansine (BAY 94-9343)
Anetumab
ravtansine (BAY 94-9343) is an investigational antibody-drug
conjugate (ADC) that is thought to act on the antigen mesothelin on
tumor cells. Bayer recently initiated a global Phase II clinical
study investigating anetumab ravtansine for mesothelioma.
Bayer is developing anetumab ravtansine under a 2008 license
agreement with ImmunoGen that granted the company exclusive rights
to use ImmunoGen's maytansinoid ADC technology to develop
anticancer therapies targeting mesothelin. Bayer is responsible for
the development, registration, and commercialization of anetumab
ravtansine. ImmunoGen is entitled to receive milestone payments
potentially totaling up to $170
million and royalties on commercial sales, if any.
About the International Prostate Cancer Symptoms
Survey
Commissioned by a coalition of eight patient advocacy
organizations from around the world, and supported by Bayer, the
International Prostate Cancer Symptoms Survey was conducted by
Harris Poll online and by telephone in 11 countries across the
globe including Brazil,
France, Germany, Italy, Japan,
Netherlands, Singapore, Spain, Taiwan, UK and the U.S. Questions ranged from
understanding how long men have been living with the disease, to
the symptoms of their prostate cancer, to the impact of prostate
cancer on daily life. The survey collected data from 927 men with
advanced prostate cancer and 400 adults who care for someone with
prostate cancer between February 12 and
October 27, 2015. A global post-weight was applied to ensure
all countries received an equal weight in the global and regional
data. Data were not weighted demographically and therefore were
representative only of the individuals surveyed.
Patients who participated in the survey and caregiver
respondents reported they or the loved one they care for have been
living with prostate cancer for an average of 5 years. 568 of
patients who participated in the survey reported they have prostate
cancer that has spread to the bones.
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.
Bayer: Science For A Better Life
Bayer is a global
enterprise with core competencies in the Life Science fields of
health care and agriculture. Its products and services are designed
to benefit people and improve their quality of life. At the same
time, the Group aims to create value through innovation, growth and
high earning power. Bayer is committed to the principles of
sustainable development and to its social and ethical
responsibilities as a corporate citizen. In fiscal 2015, the Group
employed around 117,000 people and had sales of EUR 46.3 billion. Capital expenditures amounted
to EUR 2.6 billion, R&D expenses
to EUR 4.3 billion. These figures
include those for the high-tech polymers business, which was
floated on the stock market as an independent company named
Covestro on October 6, 2015. For more
information, go to www.bayer.us.
© 2016 Bayer
BAYER, the Bayer Cross, Xofigo, Stivarga and Nexavar 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.
- XOFIGO® (radium Ra 223 dichloride) [Prescribing
Information]. Wayne, NJ: Bayer
HealthCare Pharmaceuticals, March
2016.
- STIVARGA® (regorafenib) [Prescribing Information]. Whippany, NJ: Bayer HealthCare
Pharmaceuticals, April 2015.
- NEXAVAR® (sorafenib) [Prescribing Information]. Whippany, NJ: Bayer HealthCare
Pharmaceuticals, November 2013.
PP-750-US-0073
Abstracts: 2509, 3524, 5074, 5075, 5082, 6059, 10124,
10542, TPS621, TPS622, TPS5088, TPS5094, TPS8576
Intended for U.S. Media Only
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SOURCE Bayer Corporation