Cabozantinib to Be Featured in 13 Presentations at ESMO 2018 Congress

– Presentations to include results from the dose escalation stage
of phase 1b COSMIC-021 study of cabozantinib in combination with
atezolizumab in previously untreated advanced renal cell carcinoma –

ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis,
Inc.
(NASDAQ:EXEL) today announced that data from clinical trials of
cabozantinib will be the subject of 13 presentations at the European
Society for Medical Oncology (ESMO) 2018 Congress, which is being held
October 19-23, 2018 in Munich, Germany.

Poster presentations will include results from the dose escalation stage
of the phase 1b COSMIC-021 study of cabozantinib in combination with
atezolizumab in previously untreated advanced renal cell carcinoma
(RCC). Additionally, a poster discussion session will feature a
late-breaking abstract evaluating the effect of PD-L1 status on clinical
outcomes with cabozantinib in advanced RCC in the CABOSUN and METEOR
trials.

The data at ESMO showcase the potential of cabozantinib across a range
of difficult-to-treat cancers,” said Gisela Schwab, M.D., President,
Product Development and Medical Affairs and Chief Medical Officer,
Exelixis. “We are especially excited to present results from the dose
escalation stage of the COSMIC-021 trial evaluating the combination of
cabozantinib and atezolizumab in advanced kidney cancer and look forward
to sharing these data and more with the oncology community at this
year’s ESMO Congress.”

Cabozantinib to be featured in 13 presentations
The full
schedule of cabozantinib presentations expected at the meeting is as
follows:

Proffered Paper Session

[Abstract LBA67] “Cabozantinib in Patients with Advanced
Osteosarcomas and Ewing Sarcomas: a French Sarcoma Group (FSG)/ US
National Cancer Institute Phase II Collaborative Study”

Antoine
Italiano, M.D., Ph.D., Early Phase Trials Unit, Institut Bergonié,
Bordeaux, France
Session: Sarcoma
Proffered Paper Session
Friday, October 19, 2:00 – 3:30 PM CEST, Hall B3 – Room 21

Poster Discussion

[Abstract LBA34] “PD-L1 Status and Clinical Outcomes to Cabozantinib,
Sunitinib and Everolimus in Patients with Metastatic Clear-Cell RCC
Treated on CABOSUN and METEOR Clinical Trials”

Toni K.
Choueiri, M.D., Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Session:
Genitourinary Tumors, Non Prostate
Poster Discussion Session
Saturday, October 20, 2:45 – 4:05 PM, CEST, ICM – Room 1

[Abstract 1310PD] “Prospective Genome and Transcriptome Sequencing in
Advanced-Stage Neuroendocrine Neoplasms”

Leonidas Apostolidis,
M.D., National Center for Tumor Diseases (NCT), Heidelberg, Germany
Session:
NETs
Poster Discussion Session Monday, October 22, 11:00 AM – 12:15
PM CEST, Hall B3 – Room 22

Poster Presentations

[Abstract 702P] “Outcomes by Baseline Alpha-Fetoprotein (AFP) Levels
in the Phase 3 CELESTIAL Trial of Cabozantinib (C) versus Placebo (P) in
Previously Treated Advanced Hepatocellular Carcinoma (HCC)”

R.
K. Kelley, M.D., University of California San Francisco Helen Diller
Family Comprehensive Cancer Center, San Francisco, California, USA
Session:
Poster Display Session
Poster presented Sunday, October 21, 12:45 –
1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 703P] “Assessment of Disease Burden in the Phase 3
CELESTIAL Trial of Cabozantinib (C) versus Placebo (P) in Advanced
Hepatocellular Carcinoma (HCC)”

Jean Frederic Blanc, M.D.,
Hôpital Haut-Lévêque, CHU Bordeaux, Bordeaux, France
Session:
Poster Display Session
Poster presented Sunday, October 21, 12:45 –
1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 704P] “Outcomes by Prior Transarterial Chemoembolization
(TACE) in the Phase 3 CELESTIAL Trial of Cabozantinib (C) versus Placebo
(P) in Patients (pts) with Advanced Hepatocellular Carcinoma (HCC)”

Thomas
Yau, M.D., Queen Mary Hospital, Hong Kong, China
Session: Poster
Display Session
Poster presented Sunday, October 21, 12:45 – 1:45
PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 1829TiP] “A Noninferiority Trial of Cabozantinib (C)
Comparing 60 mg vs 140 mg Orally per Day to Evaluate the Efficacy and
Safety in Patients (pts) with Progressive, Metastatic Medullary Thyroid
Cancer (MTC)”

Jolanta Krajewska, M.D., Ph.D., M.
Sklodowska-Curie Institute – Oncology Center, Gliwice, Poland
Session:
Poster Display Session
Poster presented Sunday, October 21, 12:45 –
1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 1913P] “A Guided and Personnalized Treatment in Metastatic
Breast Cancer: Optimisation of Gene and Protein Expression in Tumor
Tissue”

Emmanuel Seront, M.D., Cliniques Universitaires
Saint-Luc King Albert II Institute, Brussels, Belgium
Session:
Poster Display Session
Poster presented Sunday, October 21, 12:45 –
1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 872P] “Phase 1b Study (COSMIC-021) of Cabozantinib in
Combination with Atezolizumab: Results of the Dose Escalation Stage in
Patients (pts) with Treatment-Naïve Advanced Renal Cell Carcinoma (RCC)”

Neeraj
Agarwal, M.D., Huntsman Cancer Center, Salt Lake City, Utah, USA
Session:
Poster Display Session
Poster presented Monday, October 22, 12:45 –
1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 893P] “Cabozantinib in Metastatic Renal Cell Carcinoma
(mRCC): Data from UK Expanded Access Program (EAP)”

Alfonso
Gomez de Liano Lista, M.D., Barts Cancer Institute, London, England
Session:
Poster Display Session
Poster presented Monday, October 22, 12:45 –
1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 879P] “Activity of Cabozantinib (cabo) after PD-1/PD-L1
Immune Checkpoint Blockade (ICB) in Metastatic Clear Cell Renal Cell
Carcinoma (mccRCC)”

Bradley A. McGregor, M.D., Dana-Farber
Cancer Institute, Boston, Massachusetts, USA
Session: Poster
Display Session
Poster presented Monday, October 22, 12:45 – 1:45
PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 882P] “Potent Natural Killer (NK) and Myeloid Blood Cell
Remodeling by Cabozantinib (Cabo) in Pretreated Metastatic Renal Cell
Carcinoma (mRCC) Patients (pts)”

Elena Verzoni, M.D.,
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy
Session:
Poster Display Session
Poster presented Monday, October 22, 12:45 –
1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 889P] “Clinical Outcomes of Patients with Metastatic Renal
Cell Carcinoma (mRCC) Treated with Vascular Endothelial Growth Factor
Receptor (VEGFR) Tyrosine Kinase Inhibitors (TKI) and Mammalian Target
of Rapamycin Inhibitors (mTORI) after Immuno-oncology (IO) Checkpoint
Inhibitors”

Jeffrey Graham, M.D., Tom Baker Cancer Centre,
University of Calgary, Calgary, Alberta, Canada
Session: Poster
Display Session
Poster presented Monday, October 22, 12:45 – 1:45
PM CEST, Hall A3 – Poster Area Networking Hub

About CABOMETYX® (cabozantinib)

CABOMETYX tablets are approved in the United States for the treatment of
patients with advanced RCC. CABOMETYX tablets are also approved in the
European Union, Norway, Iceland, Australia, Switzerland, South Korea and
Canada for the treatment of advanced RCC in adults who have received
prior VEGF-targeted therapy, and in the European Union for previously
untreated intermediate- or poor-risk advanced RCC. In March 2017, the
FDA granted orphan drug designation to cabozantinib for the treatment of
advanced HCC. In May 2018, the FDA accepted Exelixis’ supplemental New
Drug Application for CABOMETYX as a treatment for patients with
previously treated HCC and assigned it a Prescription Drug User Fee Act
action date of January 14, 2019. On March 28, 2018, Ipsen announced that
the European Medicines Agency validated its application for a new
indication for cabozantinib as a treatment for previously treated
advanced HCC in the European Union; on September 20, 2018 the CHMP
provided a positive opinion for CABOMETYX as a monotherapy for the
treatment of HCC in adults who have been previously treated with
sorafenib. 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.

U.S. Important Safety Information

  • Hemorrhage: Severe and fatal hemorrhages have occurred with
    CABOMETYX. In two RCC studies, the incidence of Grade ≥ 3 hemorrhagic
    events was 3% in CABOMETYX-treated patients. Do not administer
    CABOMETYX to patients that have or are at risk for severe hemorrhage.
  • Gastrointestinal (GI) Perforations and Fistulas: In RCC
    studies, fistulas were reported in 1% of CABOMETYX-treated patients.
    Fatal perforations occurred in patients treated with CABOMETYX. In RCC
    studies, gastrointestinal (GI) perforations were reported in 1% of
    CABOMETYX-treated patients. Monitor patients for symptoms of fistulas
    and perforations, including abscess and sepsis. Discontinue CABOMETYX
    in patients who experience a fistula which cannot be appropriately
    managed or a GI perforation.
  • Thrombotic Events: CABOMETYX treatment results in an increased
    incidence of thrombotic events. In RCC studies, venous thromboembolism
    occurred in 9% (including 5% pulmonary embolism) and arterial
    thromboembolism occurred in 1% of CABOMETYX-treated patients. Fatal
    thrombotic events occurred in the cabozantinib clinical program.
    Discontinue CABOMETYX in patients who develop an acute myocardial
    infarction or any other arterial thromboembolic complication.
  • Hypertension and Hypertensive Crisis: CABOMETYX treatment
    results in an increased incidence of treatment-emergent hypertension,
    including hypertensive crisis. In RCC studies, hypertension was
    reported in 44% (18% Grade ≥ 3) of CABOMETYX-treated patients. Monitor
    blood pressure prior to initiation and regularly during CABOMETYX
    treatment. Withhold CABOMETYX for hypertension that is not adequately
    controlled with medical management; when controlled, resume CABOMETYX
    at a reduced dose. Discontinue CABOMETYX for severe hypertension that
    cannot be controlled with anti-hypertensive therapy. Discontinue
    CABOMETYX if there is evidence of hypertensive crisis or severe
    hypertension despite optimal medical management.
  • Diarrhea: In RCC studies, diarrhea occurred in 74% of patients
    treated with CABOMETYX. Grade 3 diarrhea occurred in 11% of patients
    treated with CABOMETYX. Withhold CABOMETYX in patients who develop
    intolerable Grade 2 diarrhea or Grade 3-4 diarrhea that cannot be
    managed with standard antidiarrheal treatments until improvement to
    Grade 1; resume CABOMETYX at a reduced dose.
  • Palmar-Plantar Erythrodysesthesia (PPE): In RCC studies,
    palmar-plantar erythrodysesthesia (PPE) occurred in 42% of patients
    treated with CABOMETYX. Grade 3 PPE occurred in 8% of patients treated
    with CABOMETYX. Withhold CABOMETYX in patients who develop intolerable
    Grade 2 PPE or Grade 3 PPE until improvement to Grade 1; resume
    CABOMETYX at a reduced dose.
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS), a
    syndrome of subcortical vasogenic edema diagnosed by characteristic
    finding on MRI, occurred in the cabozantinib clinical program. Perform
    an evaluation for RPLS in any patient presenting with seizures,
    headache, visual disturbances, confusion or altered mental function.
    Discontinue CABOMETYX in patients who develop RPLS.
  • Embryo-fetal Toxicity may be associated with CABOMETYX. Advise
    pregnant women of the potential risk to a fetus. Advise females of
    reproductive potential to use effective contraception during CABOMETYX
    treatment and for 4 months after the last dose.
  • Adverse Reactions: The most commonly reported (≥25%) adverse
    reactions are: diarrhea, fatigue, nausea, decreased appetite,
    hypertension, PPE, weight decreased, vomiting, dysgeusia, and
    stomatitis.
  • Strong CYP3A4 Inhibitors: If concomitant use with strong CYP3A4
    inhibitors cannot be avoided, reduce the CABOMETYX dosage.
  • Strong CYP3A4 Inducers: If concomitant use with strong CYP3A4
    inducers cannot be avoided, increase the CABOMETYX dosage.
  • Lactation: Advise women not to breastfeed while taking
    CABOMETYX and for 4 months after the final dose.
  • Hepatic Impairment: In patients with mild to 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
genetic systems, 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. We discovered our three
commercially available products, CABOMETYX® (cabozantinib), COMETRIQ®
(cabozantinib) and COTELLIC® (cobimetinib), and 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. In July 2018, Exelixis was added to
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 Statement Disclaimer

This press release contains forward-looking statements, including,
without limitation, statements related to: the planned presentation of
data from clinical trials of cabozantinib at the ESMO 2019 Congress; the
potential of cabozantinib to treat a range of difficult-to-treat
cancers; 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;
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, as well as Exelixis’ dependence on third-party
vendors for the development, manufacture and supply of cabozantinib;
Exelixis’ ability to protect its intellectual property rights; market
competition; 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 August 1,
2018, 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.

Contacts

Investors:
Exelixis, Inc.
Susan Hubbard,
650-837-8194

EVP, Public Affairs and
Investor
Relations

shubbard@exelixis.com
or
Media:
Exelixis,
Inc.

Lindsay Treadway, 650-837-7522
Senior
Director, Public Affairs and Advocacy Relations

ltreadway@exelixis.com

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