Bayer to Highlight New Research at ASCO GI 2018 Cancer Symposium
WHIPPANY, N.J., Jan. 17, 2018 /PRNewswire/ -- Bayer announced today that new data from the continued research on Stivarga(®) (regorafenib) and Nexavar(®) (sorafenib) in advanced liver, colorectal and biliary tract cancers will be presented at the 2018 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancer Symposium taking place on January 18 - 20 in San Francisco.
The Bayer data include analyses from the RESORCE trial in hepatocellular carcinoma (HCC) in addition to the LiverT study in HCC. Additionally, exploratory analyses from independent Phase II studies examining the dosing and sequencing in metastatic colorectal cancer (mCRC) as well as the activity in advanced biliary tract cancer (aBTC) will be presented.
"We look forward to presenting several data sets that continue to affirm the impact of Stivarga and Nexavar at this year's ASCO GI Cancer Symposium," said Dario F. Mirski, MD, Bayer's senior vice president and head of Medical Affairs, Americas. "Our latest research in hepatocellular carcinoma and colorectal cancer underscores our continued commitment to investigating and providing meaningful treatment options for patients who need it most."
Notable regorafenib and sorafenib studies at the ASCO GI 2018 Cancer Symposium include the following:
Regorafenib
-- Hand-foot skin reaction (HFSR) and overall survival (OS) in the phase 3
RESORCE trial of regorafenib for treatment of hepatocellular carcinoma
(HCC) progressing on sorafenib
-- Abstract 412, Poster Session B: Cancers of the Pancreas, Small
Bowel, and Hepatobiliary Tract
-- Date: Friday, January 19, 2018, Time: 11:30 AM - 1:00 PM and 5:30 PM
- 6:30 PM
-- Location: Level 1 - West Hall
-- Regorafenib in antiangiogenic-naive, chemotherapy-refractory advanced
colorectal cancer: a phase IIb trial
-- Abstract 782, Poster Session C: Cancers of the Colon, Rectum, and
Anus
-- Date: Saturday, January 20, 2018, Time: 7:00 AM - 7:55 AM and 12:30
PM - 2:00 PM
-- Location: Level 1 - West Hall
-- Regorafenib Dose Optimization Study (ReDOS): Randomized Phase II Trial
to Evaluate Dosing Strategies for Regorafenib in Refractory Metastatic
Colorectal Cancer (mCRC) - An ACCRU Network Study [IIR]
-- Abstract 611, Poster Session C: Cancers of the Colon, Rectum, and
Anus
-- Date: Saturday, January 20, 2018, Time: 7:00 AM - 7:55 AM and 12:30
PM - 2:00 PM
-- Location: Level 1 - West Hall
-- Phase II dose titration study of regorafenib for patients with
unresectable metastatic colorectal cancer that progressed after standard
chemotherapy [IIR]
-- Abstract 821, Poster Session C: Cancers of the Colon, Rectum, and
Anus
-- Date: Saturday, January 20, 2018, Time: 7:00 AM - 7:55 AM and 12:30
PM - 2:00 PM
-- Location: Level 1 - West Hall
-- A phase II trial of the effect of perindopril on hand foot syndrome
(HFSR) incidence and severity in patients receiving regorafenib with
refractory metastatic colorectal carcinoma (mCRC) [IIR]
-- Abstract 824, Poster Session C: Cancers of the Colon, Rectum, and
Anus
-- Date: Saturday, January 20, 2018, Time: 7:00 AM - 7:55 AM and 12:30
PM - 2:00 PM
-- Location: Level 1 - West Hall
-- Reverce: Randomized phase II study of regorafenib followed by cetuximab
versus the reverse sequence for metastatic colorectal cancer patients
previously treated with fluoropyrimidine, oxaliplatin, and irinotecan
[IIR]
-- Abstract 557, Poster Session C: Cancers of the Colon, Rectum, and
Anus
-- Date: Saturday, January 20, 2018, Time: 7:00 AM - 7:55 AM and 12:30
PM - 2:00 PM
-- Location: Level 1 - West Hall
-- A multicenter phase Ib-IIR trial assessing activity of regorafenib in
combination with modified gemcitabine - oxaliplatin (mGEMOX) in patients
with advanced biliary tract cancer (aBTC) [IIR]
-- Abstract 427, Poster Session B: Cancers of the Pancreas, Small
Bowel, and Hepatobiliary Tract
-- Date: Friday, January 19, 2018, Time: 11:30 AM - 1:00 PM and 5:30 PM
- 6:30 PM
-- Location: Level 1 - West Hall
-- Clinical efficacy and safety of regorafenib (REG) in the treatment of
metastatic colorectal cancer (mCRC) in daily practice in Germany: Final
results of the prospective multicentre non-interventional RECORA study
-- Abstract: 748, Poster Session C: Cancers of the Colon, Rectum and
Anus
-- Date: Saturday, January 20, 2018, Time: 7:00 AM - 7:55 AM and 12:30
PM - 2:00 PM
-- Location: Level 1 - West Hall
Sorafenib
-- Randomized, open label, multicenter, phase II trial comparing
transarterial chemoembolization (TACE) plus sorafenib with TACE alone in
patients with hepatocellular carcinoma (HCC): TACTICS trial [IIR]
-- Abstract 206, Oral Abstract Session B: Cancers of the Pancreas,
Small Bowel, and Hepatobiliary Tract
-- Date: Friday, January 19, 2018, Time: 2:15 PM - 3:45 PM
-- Location: Level 2 - Ballroom
-- Poster Session B: Cancers of the Pancreas, Small Bowel, and
Hepatobiliary Tract
-- Date: Friday, January 19, 2018, Time: 11:30 AM - 1:00 PM and
5:30 PM - 6:30 PM
-- Location: Level 1 - West Hall
General HCC
-- Changes in liver function following real-world transarterial
chemoembolization (TACE) in US patients (pts) with hepatocellular
carcinoma (HCC): The LiverT study
-- Abstract 441, Poster Session B: Cancers of the Pancreas, Small
Bowel, and Hepatobiliary Tract
-- Date: Friday, January 19, 2018, Time: 11:30 AM - 1:00 PM and 5:30 PM
- 6:30 PM
-- Location: Level 1 - West Hall
-- Acute and chronic deterioration in liver function after transarterial
radioembolization (TARE) in US patients (pts) with hepatocellular
carcinoma (HCC)
-- Abstract 439, Poster Session B: Cancers of the Pancreas, Small
Bowel, and Hepatobiliary Tract
-- Date: Friday, January 19, 2018, Time: 11:30 AM - 1:00 PM and 5:30 PM
- 6:30 PM
-- Location: Level 1 - West Hall
-- Deterioration of liver function after transarterial chemoembolization
(TACE) in hepatocellular carcinoma (HCC): An exploratory analysis of
OPTIMIS - An international observational study assessing the use of
sorafenib after TACE
-- Abstract 368, Poster Session B: Cancers of the Pancreas, Small
Bowel, and Hepatobiliary Tract
-- Date: Friday, January 19, 2018, Time: 11:30 AM - 1:00 PM and 5:30 PM
- 6:30 PM
-- Location: Level 1 - West Hall
About Stivarga(®) (regorafenib)
In April 2017, Stivarga was approved for use in patients with hepatocellular carcinoma who have been previously treated with Nexavar(® )(sorafenib). In the United States, Stivarga is also 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 RAS 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.(1)
Regorafenib is a compound developed by Bayer. In 2011, Bayer entered into an agreement with Onyx, now an Amgen subsidiary, under which Onyx receives a royalty on all global net sales of regorafenib in oncology.
Important Safety Information
WARNING: HEPATOTOXICITY
Severe and sometimes fatal hepatotoxicity has occurred
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 STIVARGA-treated patients across all clinical trials. In most cases, liver dysfunction occurred within the first 2 months of therapy and was characterized by a hepatocellular pattern of injury. 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. In gastrointestinal stromal tumor (GIST), fatal hepatic failure occurred in 0.8% of patients in the STIVARGA arm. In hepatocellular carcinoma (HCC), there was no increase in the incidence of fatal hepatic failure as compared to placebo.
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.
Infections: STIVARGA caused an increased risk of infections. The overall incidence of infection (Grades 1-5) was higher (32% vs 17%) in 1142 STIVARGA-treated patients as compared to the control arm in randomized placebo-controlled trials. The incidence of grade 3 or greater infections in STIVARGA treated patients was 9%. The most common infections were urinary tract infections (5.7%), nasopharyngitis (4.0%), mucocutaneous and systemic fungal infections (3.3%) and pneumonia (2.6%). Fatal outcomes caused by infection occurred more often in patients treated with STIVARGA (1.0%) as compared to patients receiving placebo (0.3%); the most common fatal infections were respiratory (0.6% vs 0.2%). Withhold STIVARGA for Grade 3 or 4 infections, or worsening infection of any grade. Resume STIVARGA at the same dose following resolution of infection.
Hemorrhage: STIVARGA caused an increased incidence of hemorrhage. The overall incidence (Grades 1-5) was 18.2% in 1142 patients treated with STIVARGA vs 9.5% with placebo in randomized, placebo-controlled trials. The incidence of grade 3 or greater hemorrhage in patients treated with STIVARGA was 3.0%. The incidence of fatal hemorrhagic events was 0.7%, involving the central nervous system or 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.
Gastrointestinal Perforation or Fistula: Gastrointestinal perforation occurred in 0.6% of 4518 patients treated with STIVARGA across all clinical trials of STIVARGA administered as a single agent; this included eight fatal events. Gastrointestinal fistula occurred in 0.8% of patients treated with STIVARGA and in 0.2% of patients in the placebo arm across randomized, placebo-controlled trials. Permanently discontinue STIVARGA in patients who develop gastrointestinal perforation or fistula.
Dermatological Toxicity: In randomized, placebo-controlled trials, adverse skin reactions occurred in 71.9% of patients with STIVARGA arm and 25.5% of patients in the placebo arm including hand-foot skin reaction (HFSR) also known as palmar-plantar erythrodysesthesia syndrome (PPES) and severe rash, requiring dose modification. In the randomized, placebo-controlled trials, the overall incidence of HFSR was higher in 1142 STIVARGA-treated patients (53% vs 8%) than in the placebo-treated patients. Most cases of HFSR in STIVARGA-treated patients appeared during the first cycle of treatment. The incidences of Grade 3 HFSR (16% vs <1%), Grade 3 rash (3% vs <1%), serious adverse reactions of erythema multiforme (<0.1% vs 0%), and Stevens-Johnson syndrome (<0.1% vs 0%) were higher in STIVARGA-treated patients. Across all trials, a higher incidence of HFSR was observed in Asian patients treated with STIVARGA (all grades: 72%; Grade 3:18%). Toxic epidermal necrolysis occurred in 0.02% of 4518 STIVARGA-treated patients across all clinical trials of STIVARGA administered as a single agent. Withhold STIVARGA, reduce the dose, or permanently discontinue depending on the severity and persistence of dermatologic toxicity.
Hypertension: Hypertensive crisis occurred in 0.2% in STIVARGA-treated patients and in none of the patients in placebo arm across all randomized, placebo-controlled trials. STIVARGA caused an increased incidence of hypertension (30% vs 8% in mCRC, 59% vs 27% in GIST, and 31% vs 6% in HCC). The onset of hypertension occurred during the first cycle of treatment in most patients who developed hypertension (67% in randomized, placebo controlled 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 (0.9% with STIVARGA vs 0.2% with placebo) in randomized placebo-controlled trials. 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), a syndrome of subcortial vasogenic edema diagnosed by characteristic finding on MRI occurred in one of 4800 STIVARGA-treated patients across all clinical trials. Perform an evaluation for RPLS in any patient presenting with seizures, severe headache, visual disturbances, confusion, or altered mental function. Discontinue STIVARGA in patients who develop RPLS.
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. There are no available data on STIVARGA use in pregnant women. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with STIVARGA and for 2 months after the final dose.
Nursing Mothers: Because of the potential for serious adverse reactions in breastfed infants from STIVARGA, do not breastfeed during treatment with STIVARGA and for 2 weeks after the final dose.
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%), pain (59% vs 48%), 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%), pain (60% vs 55%), 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%).
Most Frequently Observed Adverse Drug Reactions in HCC (>=30%): The most frequently observed adverse drug reactions (>=30%) in STIVARGA-treated patients vs placebo-treated patients in HCC, respectively, were: pain (55% vs 44%), HFSR/PPE (51% vs 7%), asthenia/fatigue (42% vs 33%), diarrhea (41% vs 15%), hypertension (31% vs 6%), infection (31% vs 18%), decreased appetite and food intake (31% vs 15%).
Please see full Prescribing Information, including Boxed Warning.
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 refractory to radioactive iodine treatment.(2)
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 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 four 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 2016, the Group employed around 115,200 people and had sales of EUR 46.8 billion. Capital expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.7 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.
© 2018 Bayer
BAYER, the Bayer Cross, Stivarga and Nexavar are registered trademarks of Bayer.
Media Contact:
Rose Talarico, Tel. +1 862.404.5302
E-Mail: rose.talarico@bayer.com
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. STIVARGA(®) (regorafenib) [Prescribing Information]. Whippany, NJ: Bayer
HealthCare Pharmaceuticals, April 2017.
2. NEXAVAR® (sorafenib) [Prescribing Information]. Whippany, NJ: Bayer
HealthCare Pharmaceuticals, June 2015.
PP-550-US-0713
Abstracts: 412, 782, 611, 821, 824, 557, 427, 748, 441, 439, 368, 206
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