– Initiation follows positive results from
cohort 7 of phase 1b COSMIC-021 trial –
– CONTACT-01 is the first of three phase 3
pivotal trials that are part of a previously announced clinical
collaboration with Roche –
Exelixis, Inc. (NASDAQ: EXEL) today announced the initiation of
CONTACT-01, a global phase 3 pivotal trial of cabozantinib
(CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) in
patients with metastatic non-small cell lung cancer (NSCLC) who
have been previously treated with an immune checkpoint inhibitor
(ICI) and platinum-containing chemotherapy. Two additional phase 3
pivotal trials in metastatic castration-resistant prostate cancer
(CRPC; CONTACT-02) and renal cell carcinoma (RCC; CONTACT-03) are
planned as part of the clinical trial collaboration between
Exelixis and Roche.
“Survival rates for patients with metastatic non-small cell lung
cancer are low, and since more than half of these patients are
diagnosed at an advanced stage, the patient community is in need of
new treatment options, especially for those who progress following
immunotherapy and chemotherapy,” said Gisela Schwab, M.D.,
President, Product Development and Medical Affairs and Chief
Medical Officer, Exelixis. “We were pleased to see the positive
results from cohort 7 of the COSMIC-021 trial further supporting
the growing body of preclinical and clinical evidence that
cabozantinib may promote a more immune-permissive environment
potentially resulting in additive or synergistic effects with
immune checkpoint inhibitors such as atezolizumab. We look forward
to forthcoming findings for the combination in this disease in
CONTACT-01, as well as in other difficult-to-treat cancers in
planned phase 3 studies.”
Results from the ongoing COSMIC-021 trial — a phase 1b study of
cabozantinib and atezolizumab in multiple advanced solid tumors
including NSCLC, CRPC and RCC — informed the design of this phase 3
pivotal trial. Initial results from the COSMIC-021 cohort of
patients with advanced NSCLC who progressed after treatment with an
ICI were presented at the 2020 American Society of Clinical
Oncology Virtual Scientific Program.
CONTACT-01 is a global, multicenter, randomized, phase 3,
open-label study that aims to enroll approximately 350 patients.
Patients will be randomized 1:1 to the experimental arm of
cabozantinib in combination with atezolizumab and the control arm
of docetaxel. The primary endpoint of the trial is overall
survival. Secondary endpoints include progression-free survival,
objective response rate and duration of response. The trial is
sponsored by Roche and co-funded by Exelixis.
About NSCLC
Lung cancer is the second most common type of cancer in the
U.S., with more than 220,000 new cases expected to be diagnosed in
2020.1 The disease is the leading cause of cancer-related mortality
in both men and women, causing 25% of all cancer-related deaths.1
The majority (84%) of lung cancer cases are NSCLC, which mainly
comprise adenocarcinoma, squamous cell carcinoma and large cell
carcinoma.1 The five-year survival rate for patients with NSCLC is
24%, but that rate falls to just 6% for those with advanced or
metastatic disease.2 More than half of lung cancer cases are
diagnosed at an advanced stage, and more options are needed for
these patients.3
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
HCC who have been previously treated with sorafenib. CABOMETYX
tablets have also received regulatory approvals in the European
Union and additional countries and regions worldwide.
CABOMETYX in combination with atezolizumab is not indicated for
previously treated metastatic non-small cell lung cancer.
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 this phase 3 trial, 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 this phase 3 trial, 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.
Important Safety Information
Warnings and Precautions
Hemorrhage: Severe and fatal hemorrhages occurred with
CABOMETYX. The incidence of Grade 3 to 5 hemorrhagic events was 5%
in CABOMETYX patients in RCC and HCC studies. 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: Gastrointestinal (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 Grade 4 fistula
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 3 weeks prior to scheduled dental
surgery or invasive dental procedures, if possible. Withhold
CABOMETYX for development of ONJ until complete resolution.
Impaired Wound Healing: Wound complications occurred with
CABOMETYX. Withhold CABOMETYX for at least 3 weeks prior to
elective surgery. Do not administer CABOMETYX for at least 2 weeks
after major surgery and until adequate wound healing is observed.
The safety of resumption of CABOMETYX after resolution of wound
healing complications has not been established.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS):
RPLS, a syndrome of subcortical vasogenic edema diagnosed by
characteristic findings 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.
Drug Interactions
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.
USE IN SPECIFIC POPULATIONS
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.
Forward-Looking Statements
This press release contains forward-looking statements,
including, without limitation, statements related to: Exelixis’
plans to initiate two additional phase 3 pivotal trials in
metastatic CRPC and RCC as part of the clinical trial collaboration
between Exelixis and Roche; the potential for cabozantinib to
promote a more immune-permissive environment, which could result in
additive or synergistic effects with immune checkpoint inhibitors
such as atezolizumab; 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: the continuing COVID-19 pandemic and
its impact on Exelixis’ research and development operations,
including Exelixis’ ability to initiate new clinical trials and
clinical trial sites, enroll clinical trial patients, conduct
trials per protocol, and conduct drug research and discovery
operations and related activities; complexities and the
unpredictability of the regulatory review and approval processes in
the U.S. and elsewhere; Exelixis’ and Roche’s continuing compliance
with applicable legal and regulatory requirements; the potential
failure of the combination of cabozantinib and atezolizumab to
demonstrate safety and/or efficacy in CONTACT-01; 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 May 5,
2020, 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, except as required
by law.
Exelixis, the Exelixis logo, CABOMETYX,
COMETRIQ and COTELLIC are registered U.S. trademarks. MINNEBRO is a
Japanese trademark.
TECENTRIQ® (atezolizumab) is a registered
trademark of Genentech, a member of the Roche Group.
1American Cancer Society. About Lung Cancer.
https://www.cancer.org/content/dam/CRC/PDF/Public/8703.00.pdf.
Accessed June 2020.
2American Society of Clinical Oncology. Cancer.Net. Lung Cancer
- Non-Small Cell: Statistics.
https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics.
Accessed June 2020.
3National Cancer Institute. SEER Stat Fact Sheets: Lung and
Bronchus Cancer. https://seer.cancer.gov/statfacts/html/lungb.html.
Accessed June 2020.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200611005094/en/
Investors Contact: Susan Hubbard EVP, Public Affairs and
Investor Relations Exelixis, Inc. (650) 837-8194
shubbard@exelixis.com
Media Contact: Lindsay Treadway Senior Director, Public
Affairs and Advocacy Relations Exelixis, Inc. (650) 837-7522
ltreadway@exelixis.com
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