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Exelixis and Ipsen Announce Results from Phase 2 CABOSUN Trial of Cabozantinib versus Sunitinib in Previously Untreated Advanced Renal Cell Carcinoma at ESMO 2017


– Independent Radiology Review Committee confirms primary endpoint
analysis per investigator: cabozantinib provided statistically
significant improvement of progression-free survival, with a 52 percent
reduction in the rate of progression or death compared to sunitinib –

– Exelixis and Ipsen to host investor and media webcast from Madrid
to discuss the data on Sunday, September 10 starting at 6:45 p.m. CEST –

(NASDAQ:EXEL) and Ipsen ((Euronext:IPN, OTCMKTS:IPSEY) today
announced updated results from the CABOSUN randomized phase 2 trial of
cabozantinib in patients with previously untreated advanced renal cell
carcinoma (RCC) with intermediate- or poor-risk disease per the
International Metastatic Renal Cell Carcinoma Database Consortium
(IMDC). Principal investigator Toni K. Choueiri, M.D., will present
detailed data from late-breaking CABOSUN abstract [#LBA38_PD] today in
the Genitourinary Tumors, Non-Prostate poster discussion session,
starting at 2:45 p.m. CEST (local Madrid time) / 8:45 a.m. EDT / 5:45
a.m. PDT at the European Society for Medical Oncology (ESMO) 2017
Congress, which is being held September 8-12, 2017 in Madrid, Spain.

CABOSUN is being conducted by The Alliance for Clinical Trials in
Oncology as part of Exelixis' collaboration with the National Cancer
Institute's Cancer Therapy Evaluation Program (NCI-CTEP). The data
presented at ESMO 2017 included the analysis from a blinded independent
radiology review committee (IRC), which confirmed the primary efficacy
endpoint results of investigator-assessed progression-free survival
(PFS), as well as an updated investigator-assessed analysis. Per the IRC
analysis, cabozantinib demonstrated a clinically meaningful and
statistically significant 52 percent reduction in the rate of disease
progression or death (HR 0.48, 95% CI 0.31-0.74, two-sided P=0.0008).
The median PFS for cabozantinib was 8.6 months versus 5.3 months for
sunitinib, corresponding to a 3.3 month (62 percent) improvement
favoring cabozantinib over sunitinib.

"These updated analyses from CABOSUN consistently show that cabozantinib
provided a statistically significant decrease in the rate of disease
progression or death compared to sunitinib, a current standard of care –
potentially offering a new treatment option for physicians to treat
patients in the first-line advanced renal cell carcinoma setting," said
Toni K. Choueiri, M.D., Director, Lank Center for Genitourinary
Oncology, Dana-Farber Cancer Institute. "The CABOSUN trial included
patients with intermediate or poor prognostic factors per the IMDC
criteria; in addition, patients had a notable number of other
independent adverse prognostic risk factors. These included a high rate
of bone metastases, two or more sites of metastatic disease, ECOG 2
performance status, and lack of prior nephrectomy. This patient
population fares poorly and is in need of new therapies to better
control their disease."

The following chart outlines data from the CABOSUN trial presented today
at ESMO 2017, as compared to the data previously published in the Journal
of Clinical Oncology
(JCO) in October 2016:


(April 11, 2016 Cut-off)

      ESMO 2017

(Sept 15, 2016 Cut-off)

      ESMO 2017

IRC Review

(Sept 15, 2016 Cut-off)

N = 79
N = 78
N = 79
N = 78
N = 79
N = 78
Progression-free survival
Median PFS, months 8.2       5.6       8.3       5.4       8.6       5.3
Stratified HR
(95% CI)
0.66 (0.46-0.95)       0.56 (0.37-0.83)       0.48 (0.31-0.74)
P value 0.012 (1-sided)       0.0042 (2-sided)       0.0008 (2-sided)
Tumor Response
Objective response rate (95% CI),a % 46 (34-57)       18 (10-28)       33 (23-44)       12 (5-21)       20 (12-31)       9 (4-18)
Disease control rate,b % 78       54       76       49       75       47
Progressive disease,c % 18       26       18       24       18       29
Not evaluable or missing, % 4       21       6       27       8       23
Any reduction in target lesions, % 87       44       85       38       80       50
a   One complete response was observed with cabozantinib for both
investigator assessments, and one complete response was observed
with sunitinib for the original investigator assessment, all other
responses were partial responses; b Complete response +
partial response + stable disease; c Progressive disease
as best overall response.

The updated 2017 data sets and methods differ from the initial
investigator analyses presented in 2016. The comprehensive image
collection for IRC review used a later cut-off point (5 months) than the
initial investigator analysis and followed a rigorous IRC review
process. The analysis of IRC data applied U.S. Food and Drug
Administration (FDA) guidance for PFS analyses in oncology studies,
including recommended censoring rules (i.e., censoring at the last
adequate tumor assessment prior to initiation of subsequent anti-cancer
therapy, and censoring for events that occur after two or more missing
adequate tumor assessments).1 Both the updated investigator
assessment and IRC analysis demonstrated consistent and statistically
significant improvement of PFS with cabozantinib as compared to

The updated overall survival (OS) analysis had a data cut-off of July 1,
2017, and showed a favorable trend for patients randomized to
cabozantinib compared to sunitinib that was not statistically
significant. Median overall survival was 26.6 months for patients
receiving cabozantinib versus 21.2 months for those receiving sunitinib
(HR= 0.80, 95% CI 0.53-1.21, two-sided P=0.29).

"We are very encouraged by the clinically meaningful and statistically
significant efficacy results on the primary endpoint of progression-free
survival, which formed the basis of the recent supplemental New Drug
Application submitted to the U.S. Food and Drug Administration for
cabozantinib in first-line advanced renal cell carcinoma," said Michael
M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis.
"The latest CABOSUN data continue to underscore the value that
cabozantinib may offer patients with previously untreated renal cell
carcinoma, and we are working tirelessly in our efforts to bring this
option to patients and their physicians as quickly as possible."

David Meek, Chief Executive Officer of Ipsen stated, "Following the
recent European approval of cabozantinib for second-line treatment of
patients with advanced renal cell carcinoma following prior
VEGF-targeted therapy, the latest data from the CABOSUN study being
presented this year at ESMO extends the clinical benefit of cabozantinib
in first-line therapy setting for patients with advanced RCC. With our
partner Exelixis, we are committed to strengthening the medical value of
cabozantinib and to continuing to bring innovative therapeutic solutions
for the treatment of patients with RCC."

The most common all-causality grade 3 or 4 adverse events in more than 5
percent of patients for cabozantinib (N=78) and sunitinib (N=72),
respectively, were diarrhea (10 vs. 11 percent), hypertension (28 vs. 21
percent), fatigue (6 vs. 17 percent), increased alanine aminotransferase
(ALT; 5 vs. 0 percent), decreased appetite (5 vs. 1 percent),
palmar-plantar erythrodysesthesia syndrome (PPES; 8 vs. 4 percent),
decreased platelet count (1 vs. 11 percent) and stomatitis (5 vs. 6
percent). Twenty-one percent of patients in the cabozantinib arm and 22
percent of patients in the sunitinib arm discontinued treatment due to
adverse events.

Exelixis filed a supplemental New Drug Application based on the CABOSUN
data with the FDA for cabozantinib as a treatment for previously
untreated advanced RCC on August 16, 2017. Ipsen also submitted to EMA
the regulatory dossier for cabozantinib as a treatment for first-line
advanced RCC in the European Union on August 28, 2017; on September 8,
2017, Ipsen announced that the EMA validated the application.

About the CABOSUN Study

On May 23, 2016, Exelixis announced that CABOSUN met its primary
endpoint, demonstrating a statistically significant and clinically
meaningful improvement in PFS compared with sunitinib in patients with
advanced intermediate- or poor-risk RCC as determined by investigator
assessment. The CABOSUN trial is being conducted by The Alliance for
Clinical Trials in Oncology as part of Exelixis' collaboration with the
NCI-CTEP. These results were first presented in a plenary session by Dr.
Toni Choueiri at the ESMO 2016 Congress, and published in the JCO.2
In June 2017, a blinded IRC confirmed that cabozantinib provided a
clinically meaningful and statistically significant improvement in the
primary efficacy endpoint of investigator-assessed PFS.

CABOSUN is a randomized, open-label, active-controlled phase 2 trial
that enrolled 157 patients with advanced RCC determined to be
intermediate- or poor-risk by the IMDC criteria. Patients were
randomized 1:1 to receive cabozantinib (60 mg once daily) or sunitinib
(50 mg once daily, 4 weeks on followed by 2 weeks off). The primary
endpoint was PFS. Secondary endpoints included OS and objective response

Eligible patients were required to have locally advanced or metastatic
clear-cell RCC, ECOG performance status 0-2 and had to be intermediate
or poor risk per the IMDC criteria (Heng, JCO, 2009).3
Prior systemic treatment for RCC was not permitted. Baseline
characteristics included:

Characteristic Cabozantinib
ECOG performance status, %    
  0 46 46
  1 42 41
  2 13 13
IMDC risk group, %    
  Intermediate 81 81
  Poor 19 19
Bone metastasis per IxRS,a %    
  Yes 37 36
  No 63 64
Prior nephrectomy, %    
  Yes 72 77
  No 28 23
Number of metastatic sites per investigator, %    
  1 22 33
  2 47 26
  ≥3 32 41
a interactive voice/web response system

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

Webcast for the Financial Community and Media

Exelixis and its partner Ipsen will jointly host a live webcast on
Sunday, September 10. The webcast will begin at 6:45 p.m. CEST (local
Madrid time) / 12:45 p.m. EDT / 9:45 a.m. PDT. During the webcast,
Exelixis and Ipsen management and invited guest speakers will review
results from the CABOSUN trial, along with the other relevant data sets
presented at the conference.

To access the webcast link, log onto
and proceed to the News & Events / Event Calendar page under the
Investors & Media heading. Please connect to the company's website at
least 15 minutes prior to the webcast to ensure adequate time for any
software download that may be required to view the program. To listen to
an audio-only version of the program by phone, please dial (855)
793-2457 (domestic) or (631) 485-4921 (international/toll dial) and use
passcode 68961937. A telephone replay will be available until 11:59 p.m.
EDT on September 17, 2017. Access numbers for the telephone replay are:
855-859-2056 (domestic) and 404-537-3406 (international); the passcode
is 68961937. A webcast replay will also be available archived on
for one year.

About Advanced Renal Cell Carcinoma

The American Cancer Society's 2017 statistics cite kidney cancer as
among the top ten most commonly diagnosed forms of cancer among both men
and women in the U.S.4 Clear cell RCC is the most common type
of kidney cancer in adults.5 If detected in its early stages,
the five-year survival rate for RCC is high; for patients with advanced
or late-stage metastatic RCC, however, the five-year survival rate is
only 12 percent, with no identified cure for the disease.6
Approximately 30,000 patients in the U.S. and 68,000 globally require
treatment, and an estimated 14,000 patients in the U.S. each year are in
need of a first-line treatment for advanced kidney cancer.7

The majority of clear cell RCC tumors have lower than normal levels of a
protein called von Hippel-Lindau, which leads to higher levels of MET,
AXL and VEGF.8,9 These proteins promote tumor angiogenesis
(blood vessel growth), growth, invasiveness and metastasis.10-13
MET and AXL may provide escape pathways that drive resistance to VEGF
receptor inhibitors.8,9

About CABOMETYX® (cabozantinib)

CABOMETYX is the tablet formulation of cabozantinib. Its targets
include MET, AXL and VEGFR-1, -2 and -3. In preclinical models,
cabozantinib has been shown to inhibit the activity of these receptors,
which are involved in normal cellular function and pathologic processes
such as tumor angiogenesis, invasiveness, metastasis and drug
resistance. CABOMETYX is available in 20 mg, 40 mg or 60 mg doses. The
recommended dose is 60 mg orally, once daily.

On April 25, 2016, the FDA approved CABOMETYX tablets for the treatment
of patients with advanced RCC who have received prior anti-angiogenic
therapy. In February of 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. This agreement was amended in December of 2016 to
include commercialization rights for Ipsen in Canada. On September 9,
2016, the European Commission approved CABOMETYX tablets for the
treatment of advanced RCC in adults who have received prior vascular
endothelial growth factor (VEGF)-targeted therapy in the European Union,
Norway and Iceland.

On January 30, 2017, Exelixis and Takeda Pharmaceutical Company Limited
announced an exclusive licensing agreement for the commercialization and
further clinical development of cabozantinib for all future indications
in Japan, including RCC.

CABOMETYX is not indicated for the treatment of previously untreated
advanced RCC.

U.S. Important Safety Information

Hemorrhage: Severe hemorrhage occurred with CABOMETYX. The
incidence of Grade ≥3 hemorrhagic events was 2.1% in CABOMETYX-treated
patients and 1.6% in everolimus-treated patients. Fatal hemorrhages also
occurred in the cabozantinib clinical program. Do not administer
CABOMETYX to patients that have or are at risk for severe hemorrhage.

Gastrointestinal (GI) Perforations and Fistulas: Fistulas were
reported in 1.2% (including 0.6% anal fistula) of CABOMETYX-treated
patients and 0% of everolimus-treated patients. GI perforations were
reported in 0.9% of CABOMETYX-treated patients and 0.6% of
everolimus-treated patients. Fatal perforations occurred in the
cabozantinib clinical program. Monitor patients for symptoms of
fistulas and perforations. Discontinue CABOMETYX in patients who
experience a fistula that cannot be appropriately managed or a GI

Thrombotic Events: CABOMETYX treatment results in an increased
incidence of thrombotic events. Venous thromboembolism was reported in
7.3% of CABOMETYX-treated patients and 2.5% of everolimus-treated
patients. Pulmonary embolism occurred in 3.9% of CABOMETYX-treated
patients and 0.3% of everolimus-treated patients. Events of arterial
thromboembolism were reported in 0.9% of CABOMETYX-treated patients and
0.3% of everolimus-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.
Hypertension was reported in 37% (15% Grade ≥3) of CABOMETYX-treated
patients and 7.1% (3.1% Grade ≥3) of everolimus-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: Diarrhea occurred in 74% of patients treated with
CABOMETYX and in 28% of patients treated with everolimus. Grade 3
diarrhea occurred in 11% of CABOMETYX-treated patients and in 2% of
everolimus-treated patients. 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. Dose modification due to
diarrhea occurred in 26% of patients.

Palmar-Plantar Erythrodysesthesia Syndrome (PPES): Palmar-plantar
erythrodysesthesia syndrome (PPES) occurred in 42% of patients treated
with CABOMETYX and in 6% of patients treated with everolimus. Grade 3
PPES occurred in 8.2% of CABOMETYX-treated patients and in <1% of
everolimus-treated patients. Withhold CABOMETYX in patients who develop
intolerable Grade 2 PPES or Grade 3 PPES until improvement to Grade 1;
resume CABOMETYX at a reduced dose. Dose modification due to PPES
occurred in 16% of patients.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): 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: CABOMETYX can cause fetal harm when
administered to a pregnant woman. Advise pregnant women of the potential
risk to a fetus. Advise females of reproductive potential to use
effective contraception during treatment with CABOMETYX and for 4 months
after the last dose.

Adverse Reactions: The most commonly reported (≥25%) adverse
reactions are: diarrhea, fatigue, nausea, decreased appetite, PPES,
hypertension, vomiting, weight decreased, and constipation.

Drug Interactions: Strong CYP3A4 inhibitors and inducers: Reduce
the dosage of CABOMETYX if concomitant use with strong CYP3A4 inhibitors
cannot be avoided. Increase the dosage of CABOMETYX if concomitant use
with strong CYP3A4 inducers cannot be avoided.

Lactation: Advise a lactating woman not to breastfeed during
treatment with CABOMETYX and for 4 months after the final dose.

Reproductive Potential: Contraception―Advise females of
reproductive potential to use effective contraception during treatment
with CABOMETYX and for 4 months after the final dose. Infertility ―CABOMETYX
may impair fertility in females and males of reproductive potential.

Hepatic Impairment: Reduce the CABOMETYX dose in patients with
mild (Child-Pugh score [C-P] A) or moderate (C-P B) hepatic impairment.
CABOMETYX is not recommended for use in patients with severe hepatic

Please see full Prescribing Information at

About Exelixis

Founded in 1994, Exelixis,
(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 lead compounds,
cabozantinib and cobimetinib, and advanced them into clinical
development before entering into partnerships with leading
biopharmaceutical companies in our efforts to bring them to patients
globally. With growing revenues from the three resulting commercialized
products – CABOMETYX®, COMETRIQ®, and COTELLIC® – we are reinvesting in
our business to maximize the potential of our pipeline, which we intend
to supplement 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. For more information
about Exelixis, please visit
or follow @ExelixisInc on Twitter.

About Ipsen

Ipsen is a global specialty-driven pharmaceutical group with total sales
exceeding €1.4 billion in 2015. Ipsen sells more than 20 drugs in more
than 115 countries, with a direct commercial presence in more than 30
countries. Ipsen's ambition is to become a leader in specialty
healthcare solutions for targeted debilitating diseases. Its fields of
expertise cover oncology, neurosciences and endocrinology (adult &
pediatric). Ipsen's commitment to oncology is exemplified through its
growing portfolio of key therapies improving the care of patients
suffering from prostate cancer, bladder cancer and neuro-endocrine
tumors. Ipsen also has a significant presence in primary care. Moreover,
the Group has an active policy of partnerships. Ipsen's R&D is focused
on its innovative and differentiated technological platforms, peptides
and toxins, located in the heart of the leading biotechnological and
life sciences hubs (Les Ulis/Paris-Saclay, France; Slough/Oxford, UK;
Cambridge, US). In 2015, R&D expenditure totaled close to €193 million.
The Group has more than 4,600 employees worldwide. Ipsen's shares are
traded on segment A of Euronext Paris (stock code: IPN, ISIN code:
FR0010259150) and eligible to the "Service de Règlement Différé"
("SRD"). The Group is part of the SBF 120 index. Ipsen has implemented a
Sponsored Level I American Depositary Receipt (ADR) program, which trade
on the over-the-counter market in the United States under the symbol
IPSEY. For more information on Ipsen, visit

Exelixis Forward-Looking Statement Disclaimer

This press release contains forward-looking statements, including,
without limitation, statements related to: the presentation of detailed
data from CABOSUN at ESMO; the therapeutic potential of cabozantinib as
a treatment for patients with previously untreated RCC; the commitment
of Exelixis its partner Ipsen to strengthening the medical value of
cabozantinib and to continuing to bring innovative therapeutic solutions
for the treatment of patients with RCC; and the continued development of
cobimetinib and its potential in a variety of forms of cancer. Words
such as "will," "potentially," "may," "committed," "continue," or other
similar expressions identify forward-looking statements, but the absence
of these words does not necessarily mean that a statement is not
forward-looking. In addition, any statements that refer to expectations,
projections or other characterizations of future events or circumstances
are forward-looking statements. These forward-looking statements 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
related to the potential failure of cabozantinib to demonstrate safety
and efficacy in clinical testing; risks and uncertainties related to
regulatory review and approval processes and Exelixis' compliance with
applicable legal and regulatory requirements; Exelixis' dependence on
its relationship with Genentech/Roche with respect to cobimetinib and
Exelixis' ability to maintain its rights under the collaboration;
Exelixis' ability to protect the company's intellectual property rights;
market competition; changes in economic and business conditions, and
other factors discussed under the caption "Risk Factors" in Exelixis'
quarterly report on Form 10-Q filed with the Securities and Exchange
Commission (SEC) on August 2, 2017, and in Exelixis' future filings with
the SEC. The forward-looking statements made in this press release speak
only as of the date of this press release. Exelixis expressly disclaims
any duty, obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to reflect
any change in Exelixis' expectations with regard thereto or any change
in events, conditions or circumstances on which any such statements are

Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are
registered U.S. trademarks.


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