Market Overview

Exelixis Further Expands Prostate Cancer Cohort in Phase 1b COSMIC-021 Trial of Cabozantinib in Combination with Atezolizumab in Patients with Advanced Solid Tumors


Based on continued encouraging efficacy and safety data,
metastatic castration-resistant prostate cancer cohort further expanded
to 130 patients

– Initial data to be presented on February 13 at the 2020 American
Society of Clinical Oncology's Genitourinary Cancers Symposium (ASCO GU
2020) in San Francisco, CA –

(NASDAQ:EXEL) today announced that based on continued
encouraging efficacy and safety data, the company plans to further
expand the metastatic castration-resistant prostate cancer (CRPC) cohort
of COSMIC-021, the phase 1b trial of cabozantinib (CABOMETYX®)
in combination with atezolizumab (TECENTRIQ®) in patients
with locally advanced or metastatic solid tumors. The cohort, which was
previously expanded from 30 to 80 patients in July 2019, will now
include up to 130 patients.

"We continue to see encouraging efficacy and safety data from the
prostate cancer cohort in COSMIC-021," said Gisela Schwab, M.D.,
President, Product Development and Medical Affairs and Chief Medical
Officer, Exelixis. "Expanding this cohort by an additional 50 patients
will allow us to further document how the combination of cabozantinib
and atezolizumab may benefit this patient population as we assess our
potential regulatory plans for the combination and prepare to initiate a
phase 3 pivotal trial. We look forward to the presentation of initial
data from this cohort of CRPC patients at ASCO GU 2020 in February."

Based on preliminary encouraging activity, as determined by response
assessment per Response Evaluation Criteria in Solid Tumors (version
1.1) (RECISTv1.1), and safety data of patients enrolled in the
metastatic CRPC cohort, 50 additional patients with metastatic CRPC (130
total) who have histologically or cytologically confirmed adenocarcinoma
of the prostate are being enrolled in the trial.

Initial data from the CRPC cohort in COSMIC-021 will be presented at
ASCO GU 2020 in San Francisco on Thursday, February 13th
during Poster Session A: Prostate Cancer at 11:30 a.m. – 1:00 p.m. PT
and again at 5:30 – 6:30 p.m. PT.

COSMIC-021 includes 24 cohorts and aims to enroll up to 1,732 patients
with advanced or metastatic solid tumors including CRPC, renal cell
carcinoma (RCC), hepatocellular carcinoma (HCC), non-small cell lung
cancer (NSCLC), colorectal cancer, ovarian cancer, and urothelial
carcinoma (UC), among others. The primary objective in the expansion
stage of this trial is to determine the objective response rate in each
cohort. More information about the currently enrolling cohorts in this
trial is available at
To date, early data from various cohorts of this study have informed the
initiation or planned initiation of several phase 3 pivotal trials,
evaluating the combination in advanced HCC, CRPC, NSCLC and RCC.

TECENTRIQ® (atezolizumab) is a registered trademark of
Genentech, a member of the Roche Group.

About the COSMIC-021 Study

COSMIC-021 is a multicenter, phase 1b, open-label study that is divided
into two parts: a dose-escalation phase and an expansion cohort phase.
The dose-escalation phase was designed to enroll patients either with
advanced RCC with or without prior systemic therapy or with inoperable,
locally advanced, metastatic or recurrent UC (including renal, pelvis,
ureter, urinary bladder and urethra) after prior platinum-based therapy.
Ultimately, all 12 patients enrolled in this stage of the trial were
patients with advanced RCC. The dose-escalation phase of the study
determined the optimal dose of cabozantinib to be 40 mg daily when given
in combination with atezolizumab (1200 mg infusion once every 3 weeks).
These results were presented at the European Society for Medical
Oncology 2018 Congress.

In the expansion phase, the trial is enrolling 24 cohorts in 12 tumor
types: RCC, UC, NSCLC, CRPC, HCC, triple-negative breast cancer,
epithelial ovarian cancer, endometrial cancer, gastric or
gastroesophageal junction adenocarcinoma, colorectal adenocarcinoma,
head and neck cancer, and differentiated thyroid cancer. Up to 1,720
patients may enroll in this phase of the trial: each expansion cohort
will initially enroll approximately 30 patients, and up to 10 cohorts
may expand enrollment up to 1,000 additional patients in the expansion

Four of the cohorts are exploratory: three are enrolling approximately
30 patients each with advanced UC, CRPC or NSCLC to be treated with
cabozantinib as a single-agent, and one is enrolling approximately 10
patients with advanced CRPC to be treated with single-agent
atezolizumab. Exploratory cohorts have the option to be expanded up to
80 patients (cabozantinib) and 30 patients (atezolizumab) total.

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. In 2016, Exelixis granted Ipsen
exclusive rights for the commercialization and further clinical
development of cabozantinib outside of the United States and Japan. In
2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company
Limited for the commercialization and further clinical development of
cabozantinib for all future indications in Japan.

Please see Important Safety Information below and full U.S. prescribing
information at

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
  • 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
  • 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

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,
follow @ExelixisInc on
Twitter or like Exelixis,
 on Facebook.

Forward-Looking Statements

This press release contains forward-looking statements, including,
without limitation, statements related to: Exelixis' plans to further
expand the metastatic CRPC cohort of COSMIC-021 to include up to 130
patients and Exelixis' belief that this expansion will allow Exelixis to
further understand how the combination of cabozantinib and atezolizumab
may benefit this patient population; Exelixis' potential regulatory
plans for the combination of cabozantinib and atezolizumab in patients
with metastatic CRPC and preparations to initiate a phase 3 pivotal
trial; Exelixis' plans to present initial data from this cohort of
metastatic CRPC patients at ASCO GU 2020; Exelixis' plans to initiate
several phase 3 pivotal trials evaluating the combination of
cabozantinib and atezolizumab in CRPC, NSCLC and RCC based on early data
from various cohorts of COSMIC-021; 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 availability
of data at the referenced times; 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.

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