Conference Call on Tuesday, September 2, 2014
at 8:30 a.m. EDT
Exelixis, Inc. (NASDAQ:EXEL) today announced top-line results
from the final analysis of COMET-1, the phase 3 pivotal trial of
cabozantinib in men with metastatic castration-resistant prostate
cancer (mCRPC) whose disease progressed after treatment with
docetaxel as well as abiraterone and/or enzalutamide. The trial did
not meet its primary endpoint of demonstrating a statistically
significant increase in overall survival (OS) for patients treated
with cabozantinib as compared to prednisone. The median OS for the
cabozantinib arm of the trial was 11.0 months versus 9.8 months for
the prednisone arm (hazard ratio 0.90; 95% confidence interval 0.76
– 1.06; p value 0.212).
The COMET-1 results are the subject of ongoing analyses.
Exelixis will submit additional data, including secondary and
exploratory endpoints, for presentation at a future medical
conference. Besides OS, the exploratory endpoint of
progression-free survival (PFS) as assessed by the investigators is
the only time-to-event-based endpoint for which data are available.
Median PFS was 5.5 months for the cabozantinib arm of the trial
versus 2.8 months for the prednisone arm (hazard ratio 0.50; 95%
confidence interval 0.42 – 0.60; p value <0.0001). Safety data
were consistent with those observed in earlier-stage trials of
cabozantinib in mCRPC.
As a result of the outcome of COMET-1, Exelixis will initiate a
significant workforce reduction to enable the company to focus its
financial resources on the late-stage clinical trials of
cabozantinib in metastatic renal cell carcinoma (the METEOR trial)
and advanced hepatocellular carcinoma (the CELESTIAL trial). The
company will reduce its workforce by approximately 70 percent, or
approximately 160 employees, resulting in approximately 70
remaining employees.
Exelixis anticipates the one-time restructuring charge
associated with the workforce reduction to be approximately $6
million - $8 million, with the majority to be completed by the end
of the fourth quarter of 2014. As a result of this and other
cost-saving measures contemplated, the company anticipates that it
has sufficient cash to support its operations through the release
of top-line results of the METEOR trial next year. More financial
details will be provided by the company in its third quarter 2014
financial report.
“We are very disappointed that COMET-1 did not meet its primary
endpoint of extending overall survival in men with mCRPC,” said
Michael M. Morrissey, Ph.D., president and chief executive officer
of Exelixis. “We are grateful to the patients, physicians, nurses,
caregivers, and other study team members who participated in the
trial. We remain focused on the development program for
cabozantinib beyond mCRPC, including the ongoing METEOR and
CELESTIAL phase 3 pivotal trials, from which we expect top-line
data in 2015 and 2017, respectively.”
Dr. Morrissey continued, “We have thoughtfully prepared for this
scenario and the resulting very difficult decisions. The workforce
reduction we have announced today is necessary to significantly
reduce our corporate operating expenses. I would like to personally
express my deep appreciation to the talented and dedicated Exelixis
employees who will be impacted by these actions, both for their
commitment to Exelixis and for their tremendous contributions to
patients with cancer.”
Based on the outcome of COMET-1, Exelixis has deprioritized the
clinical development of cabozantinib in mCRPC. Enrollment in
COMET-2, which is the second pivotal trial in mCRPC and evaluates
pain palliation, has been halted. The company expects top-line data
before the end of this year. Based on the outcome of COMET-2,
Exelixis will discuss with regulatory authorities the potential
regulatory path, if any, of cabozantinib in mCRPC. Other
company-sponsored studies in mCRPC, including a randomized phase 2
study of cabozantinib in combination with abiraterone, will also be
halted.
Investor Conference Call and Webcast
Exelixis management will discuss the COMET-1 top-line results
and the resulting corporate initiatives during a conference call
beginning at 8:30 a.m. EDT/ 5:30 a.m. PDT tomorrow, Tuesday,
September 2, 2014. To join the call, participants may dial
877-546-5020 (domestic) or 857-244-7552 (international) and use
passcode 60161764. To listen to a live webcast of the conference
call, please visit the Event Calendar page under Investors &
Media at www.exelixis.com.
An archived replay of the conference call will be available on
the Event Calendar page under Investors & Media at
www.exelixis.com and via phone until 11:59 p.m. EDT on October 2,
2014. Access numbers for the phone replay are: 888-286-8010
(domestic) and 617-801-6888 (international); the passcode is
69796111.
About the COMET-1 Phase 3 Pivotal Trial
COMET-1 was a randomized, double-blind, controlled trial that
enrolled 960 patients with mCRPC who had previously been treated
with and progressed after treatment with docetaxel, abiraterone
and/or enzalutamide. The primary endpoint of the trial was OS, and
the secondary endpoint was bone scan response as assessed by an
independent radiology committee. All patients in the trial had bone
metastases, and there was no limit to the number or type of prior
treatments. Patients were randomized 2:1 to receive cabozantinib
(60 mg daily) or prednisone (5 mg twice daily). The trial was
event-driven and had 90% power to detect a 25% reduction in the
risk of death (HR = 0.75) at the time of final analysis, which
required 578 events.
About Cabozantinib
Cabozantinib inhibits the activity of tyrosine kinases including
MET, VEGFRs and RET. These receptor tyrosine kinases are involved
in both normal cellular function and in pathologic processes such
as oncogenesis, metastasis, tumor angiogenesis, and maintenance of
the tumor microenvironment.
COMETRIQ® (cabozantinib) is currently approved by the U.S. Food
and Drug Administration for the treatment of progressive,
metastatic medullary thyroid cancer (MTC).
The European Commission granted COMETRIQ conditional approval
for the treatment of adult patients with progressive, unresectable
locally advanced or metastatic MTC. Similar to another drug
approved in this setting, the approved indication states that for
patients in whom Rearranged during Transfection (RET) mutation
status is not known or is negative, a possible lower benefit should
be taken into account before individual treatment decisions.
Important Safety Information, including Boxed
WARNINGS
WARNING: PERFORATIONS AND FISTULAS, and HEMORRHAGE
- Serious and sometimes fatal
gastrointestinal perforations and fistulas occur in
COMETRIQ-treated patients.
- Severe and sometimes fatal
hemorrhage occurs in COMETRIQ-treated patients.
- COMETRIQ treatment results in an
increase in thrombotic events, such as heart attacks.
- Wound complications have been reported
with COMETRIQ.
- COMETRIQ treatment results in an
increase in hypertension.
- Osteonecrosis of the jaw has been
observed in COMETRIQ-treated patients.
- Palmar-Plantar Erythrodysesthesia
Syndrome (PPES) occurs in patients treated with COMETRIQ.
- The kidneys can be adversely affected
by COMETRIQ. Proteinuria and nephrotic syndrome have been reported
in patients receiving COMETRIQ.
- Reversible Posterior
Leukoencephalopathy Syndrome has been observed with COMETRIQ.
- Avoid administration of COMETRIQ with
agents that are strong CYP3A4 inducers or inhibitors.
- COMETRIQ is not recommended for use in
patients with moderate or severe hepatic impairment.
- COMETRIQ can cause fetal harm when
administered to a pregnant woman.
Adverse Reactions – The most commonly reported adverse drug
reactions (≥25%) are diarrhea, stomatitis, palmar-plantar
erythrodysesthesia syndrome (PPES), decreased weight, decreased
appetite, nausea, fatigue, oral pain, hair color changes,
dysgeusia, hypertension, abdominal pain, and constipation. The most
common laboratory abnormalities (≥25%) are increased AST, increased
ALT, lymphopenia, increased alkaline phosphatase, hypocalcemia,
neutropenia, thrombocytopenia, hypophosphatemia, and
hyperbilirubinemia.
Please see full U.S. prescribing information, including Boxed
WARNINGS, at
www.COMETRIQ.com/downloads/Cometriq_Full_Prescribing_Information.pdf
Please refer to the full European Summary of Product
Characteristics for full European Union prescribing information,
including contraindication, special warnings and precautions for
use at www.sobi.com once posted.
About Exelixis
Exelixis, Inc. is a biopharmaceutical company committed to
developing small molecule therapies for the treatment of cancer.
Exelixis is focusing its development and commercialization efforts
primarily on COMETRIQ® (cabozantinib), its wholly-owned inhibitor
of multiple receptor tyrosine kinases. Another Exelixis-discovered
compound, cobimetinib, a highly selective inhibitor of MEK, is
being evaluated by Roche and Genentech (a member of the Roche
Group) in a broad development program under a collaboration with
Exelixis. For more information, please visit the company's web site
at www.exelixis.com.
Forward-Looking Statements
This press release contains forward-looking statements,
including, without limitation, statements related to: the continued
development and clinical, therapeutic and commercial potential of,
and opportunities for, cabozantinib; the results and implications
of completed, partial, and ongoing clinical data analyses; future
data presentations; future discussions with regulatory authorities;
anticipated developments and timing with respect to Exelixis’
ongoing phase 3 pivotal trials of cabozantinib; plans to focus
financial resources, to halt company-sponsored studies in mCRPC;
and plans to initiate a workforce reduction, including the
objectives and anticipated timing thereof. Words such as “will,”
“enable,” “focus,” “anticipates,” “expect,” “ensure,” “potential,”
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. Exelixis’ 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 expected times; risks related to the potential
failure of cabozantinib to demonstrate safety and efficacy in
clinical study; the clinical, therapeutic and commercial value of
cabozantinib; Exelixis’ ability to conduct clinical trials of
cabozantinib sufficient to achieve a positive completion; risks and
uncertainties related to regulatory review and approval processes
and Exelixis’ compliance with applicable legal and regulatory
requirements; the general sufficiency of Exelixis’ capital and
other resources and the specific risk of unforeseen expenses that
could diminish Exelixis’ financial ability to support its
operations through the release of top-line METEOR results; the
uncertain timing and level of expenses associated with the
development of cabozantinib; risks related to Exelixis’ ability to
implement the referenced workforce reduction according to plan and
its impact on Exelixis’ business; expenses and charges resulting
from the referenced workforce reduction; 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 July 31, 2014 and in Exelixis’ other 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 based.
Exelixis, the Exelixis logo, and COMETRIQ are
registered U.S. trademarks.
Exelixis, Inc.Investors:Susan Hubbard,
650-837-8194shubbard@exelixis.comorMedia:Hal Mackins,
415-994-0040hmackins@exelixis.com
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