– Initiation follows positive results from
cohort 6 of phase 1b COSMIC-021 trial –
– CONTACT-02 is the second of three
phase 3 pivotal trials that are part of a clinical collaboration
with Roche –
Exelixis, Inc. (NASDAQ: EXEL) today announced the initiation of
CONTACT-02, a global phase 3 pivotal trial of cabozantinib
(CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) in
patients with metastatic castration-resistant prostate cancer
(CRPC) who have been previously treated with one novel hormonal
therapy. CONTACT-02 is part of a clinical trial collaboration
between Exelixis and Roche that includes two additional phase 3
pivotal trials – CONTACT-01 in patients with metastatic non-small
cell lung cancer (NSCLC) who have been previously treated with an
immune checkpoint inhibitor and platinum-containing chemotherapy,
which was initiated in June, and the planned CONTACT-03 trial in
patients with metastatic renal cell carcinoma (RCC) who previously
received an immune checkpoint inhibitor.
“As many patients with advanced, castration-resistant prostate
cancer who have progressed on a novel hormonal therapy wish to
avoid or delay chemotherapy, more treatment options are needed,”
said Gisela Schwab, M.D., President, Product Development and
Medical Affairs and Chief Medical Officer, Exelixis. “We are
encouraged by the positive early stage results for the combination
of cabozantinib and atezolizumab seen for prostate cancer patients
in cohort 6 of the COSMIC-021 trial, and we are pleased to begin
this pivotal trial that will further evaluate how the combination
may improve outcomes for these patients as part of our ongoing
partnership with Roche.”
CONTACT-02 is a global, multicenter, randomized, phase 3,
open-label study that plans to enroll approximately 580 patients at
250 sites. Patients will be randomized 1:1 to the experimental arm
of cabozantinib in combination with atezolizumab and the control
arm of a second novel hormonal therapy (either abiraterone and
prednisone or enzalutamide). The co-primary endpoints of the trial
are progression-free survival and overall survival. Additional
endpoints include objective response rate, prostate-specific
antigen response rate and duration of response. The trial is
sponsored by Exelixis and co-funded by Roche, Ipsen and Takeda
Pharmaceutical Company Limited.
The design of CONTACT-02 was informed by 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. Initial results from cohort 6 were presented at the
2020 American Society of Clinical Oncology’s Genitourinary Cancers
Symposium. The interim analysis was updated with additional
biomarker results and presented at the 2020 American Society of
Clinical Oncology Virtual Scientific Program.
More information about CONTACT-02 is available at
ClinicalTrials.gov (NCT04446117).
About CRPC According to the American Cancer Society, in
2020, approximately 192,000 new cases of prostate cancer will be
diagnosed and 33,000 people will die from the disease.1 Prostate
cancer that has spread beyond the prostate and does not respond to
androgen-suppression therapies — a common treatment for prostate
cancer — is known as metastatic CRPC.2 Researchers estimate that in
2020, 43,000 men will be diagnosed with metastatic CRPC, which has
a median survival of less than two years.3,4,5
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.
CABOMETYX in combination with atezolizumab is not indicated for
previously treated metastatic CRPC.
About Exelixis’ Collaboration with Ipsen On February 29,
2016, Exelixis and Ipsen jointly announced a collaboration
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. Ipsen has opted in to
participate in the funding of CONTACT-01 and CONTACT-02. Under the
parties’ collaboration agreement, 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. Takeda has opted in to
participate in the funding of CONTACT-01 and CONTACT-02. Under the
parties’ collaboration agreement, 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 CONTACT-03, an
additional phase 3 pivotal trial in RCC as part of the clinical
trial collaboration between Exelixis and Roche; the potential for
the combination of cabozantinib and atezolizumab to improve
outcomes for patients with CRPC; 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-02; 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.
1 American Cancer Society: Cancer Facts & Figures 2020.
Available at:
https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdf.
Accessed June 2020. 2 American Society of Clinical Oncology.
Cancer.Net. Treatment of Metastatic Castration-Resistant Prostate
Cancer. September 8, 2014. Available at:
https://www.cancer.net/research-and-advocacy/asco-care-and-treatment-recommendations-patients/treatment-metastatic-castration-resistant-prostate-cancer.
Accessed June 2020. 3 Scher, H.I., Solo, K., Valant, J., Todd,
M.B., Mehra, M. Prevalence of Prostate Cancer Clinical States and
Mortality in the United States: Estimates Using a Dynamic
Progression Model. PLOS ONE. 2015; 10: e0139440. 4 American
Urological Association. Prostate Cancer: Castration Resistant
Guideline. 2018. Available at:
https://www.auanet.org/guidelines/prostate-cancer-castration-resistant-guideline.
Accessed June 2020. 5 Moreira, D. M., Howard, L. E., Sourbeer, K.
N., et al. Predicting Time From Metastasis to Overall Survival in
Castration-Resistant Prostate Cancer: Results From SEARCH. Clin
Genitourin Cancer. 2017; 15: 60–66.e2.
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version on businesswire.com: https://www.businesswire.com/news/home/20200630005244/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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