Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today announced the
upcoming presentations of data highlighting Nexavar® (sorafenib)
tablets and Stivarga® (regorafenib) tablets at the 2013 European
Cancer Congress (ECCO/ESMO/ESTRO), September 28 - October 1, 2013
in Amsterdam, Netherlands.
"The data to be presented at the European Cancer Congress
highlight the growing body of clinical experience with regorafenib
and sorafenib, and the continued therapeutic advances that could
potentially help patients with cancer," said Pablo Cagnoni, M.D.,
Executive Vice President, Global Research & Development and
Technical Operations at Onyx Pharmaceuticals.
Sorafenib
- Association between tumor BRAF and RAS mutation status and
clinical outcomes in patients with radioactive iodine
(RAI)-refractory differentiated thyroid cancer (DTC) randomized to
sorafenib or placebo: sub-analysis of the phase 3 DECISION trial
- Abstract #3155, Oral Presentation, Proffered Papers Session:
Head and Neck Cancer
- Saturday, September 28, 17:02 PM CEST, Hall 3.1
Regorafenib
- Effects of regorafenib therapy on health-related quality of
life in patients with metastatic colorectal cancer in the phase 3
CORRECT study
- Abstract #2156, Oral Presentation, Proffered Paper Session:
Gastrointestinal Malignancies - Colorectal Cancer II
- Sunday, September 29, 9:00 AM CEST, RAI Auditorium
- Regorafenib dose modifications in patients with metastatic
colorectal cancer in the phase 3 CORRECT study
- Abstract #2360, Poster Session: Gastrointestinal Malignancies -
Colorectal Cancer
- Sunday, September 29, 2:00-4:30 PM CEST, Hall 4
- Time to health status deterioration in regorafenib-treated
patients with metastatic colorectal cancer (mCRC): a post-hoc
analysis of the phase 3 CORRECT study
- Abstract #2361, Poster Session: Gastrointestinal Malignancies -
Colorectal Cancer
- Sunday, September 29, 2:00-4:30 PM CEST, Hall 4
- Transcript profiling of patient-derived (PD) colorectal cancer
(CRC) xenografts for the identification of biomarkers for
regorafenib (REG; BAY 73-4506)
- Abstract #2408, Poster Session: Gastrointestinal Malignancies -
Colorectal Cancer
- Sunday, September 29, 2:00-4:30 PM CEST, Hall 4
- Time course of adverse events in the phase 3 GRID study of
regorafenib in patients with metastatic gastrointestinal stromal
tumors (GIST)
- Abstract #3827, Poster Session: Sarcoma: Soft Tissue and
Bone
- Monday, September 30, 9:30 AM-12:00 PM CEST, Hall 4
- Health-related quality of life (HRQoL) of patients with
advanced gastrointestinal stromal tumors (GIST) treated with
regorafenib (REG) vs placebo (P) in the phase 3 GRID trial
- Abstract #3830, Poster Session: Sarcoma: Soft Tissue and
Bone
- Monday, September 30, 9:30 AM-12:00 PM CEST, Hall 4
- Exposure-efficacy analysis of regorafenib (REG) and its
metabolites M-2 and M-5 in the phase 3 GRID study in patients (pts)
with metastatic gastrointestinal stromal tumor (GIST)
- Abstract #3831, Poster Session: Sarcoma: Soft Tissue and
Bone
- Monday, September 30, 9:30 AM-12:00 PM CEST, Hall 4
About Nexavar®
(sorafenib) Tablets Nexavar is approved in
the U.S. for the treatment of patients with unresectable
hepatocellular carcinoma and for the treatment of patients with
advanced renal cell carcinoma. Nexavar is thought to inhibit both
the tumor cell and tumor vasculature. In in vitro studies, Nexavar
has been shown to inhibit multiple kinases thought to be involved
in both cell proliferation (growth) and angiogenesis (blood supply)
- two important processes that enable cancer growth. These kinases
include Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3
and RET.
Nexavar is currently approved in more than 100 countries.
Nexavar is also being evaluated by Bayer and Onyx, international
study groups, government agencies and individual investigators in a
range of cancers.
Important Safety Considerations For
Nexavar® (sorafenib)
Tablets Nexavar in combination with carboplatin and paclitaxel
is contraindicated in patients with squamous cell lung cancer.
Cardiac ischemia and/or myocardial infarction may occur.
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. If bleeding necessitates medical intervention,
consider permanent discontinuation of Nexavar.
Hypertension may occur early in the course of treatment. Monitor
blood pressure weekly during the first 6 weeks and periodically
thereafter and treat, if required.
Hand-foot skin reaction and rash are common and 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. Nexavar should be discontinued if
Stevens-Johnson Syndrome or toxic epidermal necrolysis are
suspected as these may be life threatening.
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.
Patients taking concomitant warfarin should be monitored
regularly for changes in prothrombin time (PT), International
Normalized Ratio (INR) or clinical bleeding episodes.
Temporary interruption of Nexavar therapy is recommended in
patients undergoing major surgical procedures.
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 patients with congestive heart
failure, bradyarrhythmias, drugs known to prolong the QT interval,
and electrolyte abnormalities.
Drug-induced hepatitis with Nexavar may result in hepatic
failure and death. 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 childbearing potential should be advised to avoid
becoming pregnant while on Nexavar and female patients should also
be advised against breastfeeding while receiving Nexavar.
Elevations in serum lipase and reductions in serum phosphate of
unknown etiology have been associated with Nexavar.
Avoid concomitant use of strong CYP3A4 inducers, when possible,
because inducers can decrease the systemic exposure of Nexavar.
Nexavar exposure decreases when coadministered 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%.
For information about Nexavar including U.S. Nexavar prescribing
information, visit www.nexavar-us.com or call 1.866.NEXAVAR
(1.866.639.2827).
About Stivarga® (regorafenib) Tablets 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.
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.
Stivarga is a Bayer compound developed by Bayer and jointly
promoted by Bayer and Onyx in the United States. In 2011, Bayer
entered into an agreement with Onyx, under which Onyx receives a
royalty on all global net sales of Stivarga in oncology.
For full prescribing information, including BOXED WARNING, visit
www.stivarga-us.com.
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.
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.
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.
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.
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.
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.
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)
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 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.
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.
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.
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.
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%).
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 BOXED WARNING, visit
www.stivarga-us.com.
About Onyx Pharmaceuticals, Inc. Based in
South San Francisco, California, Onyx Pharmaceuticals, Inc. is a
global biopharmaceutical company engaged in the development and
commercialization of innovative therapies for improving the lives
of people with cancer. The company is focused on developing novel
medicines that target key molecular pathways. For more information
about Onyx, visit the company's website at www.onyx.com. Onyx
Pharmaceuticals is on Twitter. Sign up to follow our Twitter feed
@OnyxPharm at http://twitter.com/OnyxPharm.
Stivarga®, Bayer® and the Bayer Cross® are registered trademarks
of Bayer.
Forward-Looking Statements 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.
This news release contains "forward-looking statements" of Onyx
within the meaning of the federal securities laws. These
forward-looking statements include without limitation, statements
regarding the progress and results of the clinical development,
safety, regulatory processes, commercialization efforts or
commercial potential of Stivarga (regorafenib). These statements
are subject to risks and uncertainties that could cause actual
results and events to differ materially from those anticipated,
including, but not limited to, risks related to the development and
commercialization of pharmaceutical products. Any statements
contained in this press release that are not statements of
historical fact may be deemed to be forward-looking statements.
Reference should be made to Onyx's Quarterly Report on Form 10-Q
for the quarterly period ended June 30, 2013, filed with the
Securities and Exchange Commission under the heading "Risk Factors"
for a more detailed description of such factors. Readers are
cautioned not to place undue reliance on these forward-looking
statements that speak only as of the date of this release. Onyx
undertakes no obligation to update publicly any forward-looking
statements to reflect new information, events, or circumstances
after the date of this release except as required by law.
Contacts: Investors Amy Figueroa Senior Director,
Investor Relations (650) 266-2398 Media Danielle Bertrand
Associate Director, Corporate Communications (650) 266-2114
Onyx Pharmaceuticals, Inc. (MM) (NASDAQ:ONXX)
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