– New pivotal trials will evaluate the
combination of cabozantinib and atezolizumab in patients with
advanced non-small cell lung cancer, castration-resistant prostate
cancer and renal cell carcinoma –
– Collaboration based on data from phase 1b
COSMIC-021 trial –
Exelixis, Inc. (NASDAQ:EXEL) today announced a collaboration
agreement with Roche to evaluate cabozantinib (CABOMETYX®),
Exelixis’ small molecule inhibitor of receptor tyrosine kinases, in
combination with atezolizumab (TECENTRIQ®), Roche’s PD-L1 immune
checkpoint inhibitor, in patients with locally advanced or
metastatic solid tumors. The clinical program, which will be
co-funded by the companies, is expected to include three phase 3
pivotal trials in advanced non-small cell lung cancer (NSCLC),
castration-resistant prostate cancer (CRPC) and renal cell
carcinoma (RCC).
“Encouraging phase 1 data suggests this combination of
cabozantinib and atezolizumab may improve outcomes for patients
with prostate, lung and kidney cancers, and we look forward to
collaborating with Roche to learn more in these pivotal trials,”
said Michael M. Morrissey, Ph.D., President and Chief Executive
Officer of Exelixis. “This clinical collaboration is an important
further step in our committed efforts to maximize the value of the
cabozantinib franchise through these cost-sharing clinical
collaborations in additional high-impact indications, while
building value with new compounds from internal and external
sources in 2020 and beyond.”
The clinical development collaboration builds on encouraging
activity observed in the phase 1b COSMIC-021 trial. The trial is
currently enrolling 24 expansion cohorts in 12 tumor types
including RCC, NSCLC and CRPC.
TECENTRIQ® (atezolizumab) is a registered trademark of
Genentech, a member of the Roche Group.
About CABOMETYX® (cabozantinib)
In the U.S., CABOMETYX tablets are approved for the treatment of
patients with advanced RCC and for the treatment of patients with
hepatocellular carcinoma who have been previously treated with
sorafenib. CABOMETYX tablets have also received regulatory
approvals in the European Union and additional countries and
regions worldwide.
About Exelixis’ Collaboration with Ipsen
On February 29, 2016, Exelixis and Ipsen jointly announced an
exclusive licensing agreement for the commercialization and further
development of cabozantinib indications outside of the United
States, Canada and Japan. On December 21, 2016, this agreement was
amended to include commercialization rights for Ipsen in Canada.
Under the parties’ collaboration agreement, if Ipsen opts to
participate in funding these phase 3 trials, or future studies,
Ipsen will have access to the respective study results to support
potential future regulatory submissions in their territory.
About Exelixis’ Collaboration with Takeda
On January 30, 2017, Exelixis and Takeda jointly announced an
exclusive licensing agreement for the commercialization and further
development of cabozantinib indications in Japan. Under the
parties’ collaboration agreement, if Takeda opts to participate in
funding these phase 3 trials, or future studies, Takeda will have
access to the respective study results to support potential future
regulatory submissions in their territory.
Exelixis holds the exclusive rights to develop and commercialize
cabozantinib in the United States.
U.S. Important Safety Information
- Hemorrhage: Severe and fatal hemorrhages occurred with
CABOMETYX. The incidence of Grade 3 to 5 hemorrhagic events was 5%
in CABOMETYX patients. Discontinue CABOMETYX for Grade 3 or 4
hemorrhage. Do not administer CABOMETYX to patients who have a
recent history of hemorrhage, including hemoptysis, hematemesis, or
melena.
- Perforations and Fistulas: GastrointestinaI (GI)
perforations, including fatal cases, occurred in 1% of CABOMETYX
patients. Fistulas, including fatal cases, occurred in 1% of
CABOMETYX patients. Monitor patients for signs and symptoms of
perforations and fistulas, including abscess and sepsis.
Discontinue CABOMETYX in patients who experience a fistula that
cannot be appropriately managed or a GI perforation.
- Thrombotic Events: CABOMETYX increased the risk of
thrombotic events. Venous thromboembolism occurred in 7% (including
4% pulmonary embolism) and arterial thromboembolism in 2% of
CABOMETYX patients. Fatal thrombotic events occurred in CABOMETYX
patients. Discontinue CABOMETYX in patients who develop an acute
myocardial infarction or serious arterial or venous thromboembolic
event requiring medical intervention.
- Hypertension and Hypertensive Crisis: CABOMETYX can
cause hypertension, including hypertensive crisis. Hypertension
occurred in 36% (17% Grade 3 and <1% Grade 4) of CABOMETYX
patients. Do not initiate CABOMETYX in patients with uncontrolled
hypertension. Monitor blood pressure regularly during CABOMETYX
treatment. Withhold CABOMETYX for hypertension that is not
adequately controlled with medical management; when controlled,
resume at a reduced dose. Discontinue CABOMETYX for severe
hypertension that cannot be controlled with anti-hypertensive
therapy or for hypertensive crisis.
- Diarrhea: Diarrhea occurred in 63% of CABOMETYX
patients. Grade 3 diarrhea occurred in 11% of CABOMETYX patients.
Withhold CABOMETYX until improvement to Grade 1 and resume at a
reduced dose for intolerable Grade 2 diarrhea, Grade 3 diarrhea
that cannot be managed with standard antidiarrheal treatments, or
Grade 4 diarrhea.
- Palmar-Plantar Erythrodysesthesia (PPE): PPE occurred in
44% of CABOMETYX patients. Grade 3 PPE occurred in 13% of CABOMETYX
patients. Withhold CABOMETYX until improvement to Grade 1 and
resume at a reduced dose for intolerable Grade 2 PPE or Grade 3
PPE.
- Proteinuria: Proteinuria occurred in 7% of CABOMETYX
patients. Monitor urine protein regularly during CABOMETYX
treatment. Discontinue CABOMETYX in patients who develop nephrotic
syndrome.
- Osteonecrosis of the Jaw (ONJ): ONJ occurred in <1%
of CABOMETYX patients. ONJ can manifest as jaw pain, osteomyelitis,
osteitis, bone erosion, tooth or periodontal infection, toothache,
gingival ulceration or erosion, persistent jaw pain, or slow
healing of the mouth or jaw after dental surgery. Perform an oral
examination prior to CABOMETYX initiation and periodically during
treatment. Advise patients regarding good oral hygiene practices.
Withhold CABOMETYX for at least 28 days prior to scheduled dental
surgery or invasive dental procedures. Withhold CABOMETYX for
development of ONJ until complete resolution.
- Wound Complications: Wound complications were reported
with CABOMETYX. Stop CABOMETYX at least 28 days prior to scheduled
surgery. Resume CABOMETYX after surgery based on clinical judgment
of adequate wound healing. Withhold CABOMETYX in patients with
dehiscence or wound healing complications requiring medical
intervention.
- Reversible Posterior Leukoencephalopathy Syndrome
(RPLS): RPLS, a syndrome of subcortical vasogenic edema
diagnosed by characteristic finding on MRI, can occur with
CABOMETYX. Evaluate for RPLS in patients presenting with seizures,
headache, visual disturbances, confusion, or altered mental
function. Discontinue CABOMETYX in patients who develop RPLS.
- Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm.
Advise pregnant women and females of reproductive potential of the
potential risk to a fetus. Verify the pregnancy status of females
of reproductive potential prior to initiating CABOMETYX and advise
them to use effective contraception during treatment and for 4
months after the last dose.
- Adverse Reactions: The most commonly reported (≥25%)
adverse reactions are: diarrhea, fatigue, decreased appetite, PPE,
nausea, hypertension, and vomiting.
- Strong CYP3A4 Inhibitors: If coadministration with
strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX
dosage. Avoid grapefruit or grapefruit juice.
- Strong CYP3A4 Inducers: If coadministration with strong
CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage.
Avoid St. John’s wort.
- Lactation: Advise women not to breastfeed during
CABOMETYX treatment and for 4 months after the final dose.
- Hepatic Impairment: In patients with moderate hepatic
impairment, reduce the CABOMETYX dosage. CABOMETYX is not
recommended for use in patients with severe hepatic
impairment.
Please see accompanying full Prescribing Information
https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.
About Exelixis
Founded in 1994, Exelixis, Inc. (NASDAQ:EXEL) is a commercially
successful, oncology-focused biotechnology company that strives to
accelerate the discovery, development and commercialization of new
medicines for difficult-to-treat cancers. Following early work in
model system genetics, we established a broad drug discovery and
development platform that has served as the foundation for our
continued efforts to bring new cancer therapies to patients in
need. Our discovery efforts have resulted in four commercially
available products, CABOMETYX® (cabozantinib), COMETRIQ®
(cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO®
(esaxerenone), and we have entered into partnerships with leading
pharmaceutical companies to bring these important medicines to
patients worldwide. Supported by revenues from our marketed
products and collaborations, we are committed to prudently
reinvesting in our business to maximize the potential of our
pipeline. We are supplementing our existing therapeutic assets with
targeted business development activities and internal drug
discovery — all to deliver the next generation of Exelixis
medicines and help patients recover stronger and live longer.
Exelixis is a member of the Standard & Poor’s (S&P) MidCap
400 index, which measures the performance of profitable mid-sized
companies. For more information about Exelixis, please visit
www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis,
Inc. on Facebook.
Exelixis Forward-Looking Statements
This press release contains forward-looking statements,
including, without limitation, statements related to: Exelixis’
expectation that the clinical program co-funded by Exelixis and
Roche will include three phase 3 pivotal trials evaluating the
combination of cabozantinib and atezolizumab in NSCLC, CRPC and
RCC; the potential for the combination of cabozantinib and
atezolizumab to improve outcomes for patients with prostate, lung
and kidney cancers; Exelixis’ belief that it can maximize the value
of the cabozantinib franchise through these cost-sharing clinical
collaborations in additional high-impact indications, while
building value with new compounds from internal and external
sources in 2020 and beyond; and Exelixis’ plans to reinvest in its
business to maximize the potential of the company’s pipeline,
including through targeted business development activities and
internal drug discovery. Any statements that refer to expectations,
projections or other characterizations of future events or
circumstances are forward-looking statements and are based upon
Exelixis’ current plans, assumptions, beliefs, expectations,
estimates and projections. Forward-looking statements involve risks
and uncertainties. Actual results and the timing of events could
differ materially from those anticipated in the forward-looking
statements as a result of these risks and uncertainties, which
include, without limitation: risks and uncertainties related to
regulatory review and approval processes and Exelixis’ compliance
with applicable legal and regulatory requirements; the potential
failure of the combination of cabozantinib and atezolizumab to
demonstrate safety and/or efficacy in COSMIC-021 or in future phase
3 pivotal trials; uncertainties inherent in the product development
process; the costs of conducting clinical trials, including the
ability or willingness of Exelixis’ collaboration partners to
invest in the resources necessary to complete the trials; Exelixis’
dependence on third-party vendors for the development, manufacture
and supply of cabozantinib; Exelixis’ ability to protect its
intellectual property rights; market competition, including the
potential for competitors to obtain approval for generic versions
of CABOMETYX; changes in economic and business conditions; and
other factors affecting Exelixis and its development programs
discussed under the caption “Risk Factors” in Exelixis’ Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission (SEC) on October 30, 2019, and in Exelixis’ future
filings with the SEC. All forward-looking statements in this press
release are based on information available to Exelixis as of the
date of this press release, and Exelixis undertakes no obligation
to update or revise any forward-looking statements contained
herein.
Exelixis, the Exelixis logo, CABOMETYX,
COMETRIQ and COTELLIC are registered U.S. trademarks. MINNEBRO is a
Japanese trademark.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191219005123/en/
Investors: Susan Hubbard EVP, Public Affairs and Investor
Relations Exelixis, Inc. (650) 837-8194 shubbard@exelixis.com
Media: Lindsay Treadway Senior Director, Public Affairs
and Advocacy Relations Exelixis, Inc. (650) 837-7522
ltreadway@exelixis.com
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