– Results are the subject of a poster
discussion presentation at ESMO 2016 Congress on Monday, October 10
–
Exelixis, Inc. (NASDAQ:EXEL) today announced that its
collaborator Genentech, a member of the Roche Group, will present
preliminary results from a phase 1b clinical trial evaluating the
safety and clinical activity of the triple combination of
cobimetinib, vemurafenib, and atezolizumab in patients with
previously untreated BRAF V600 mutation-positive advanced melanoma.
The results will be the subject of a poster discussion presentation
(Abstract #1109PD) at the European Society of Medical Oncology
(ESMO) 2016 Congress, which is being held October 7-11 in
Copenhagen, Denmark. Patrick Hwu, M.D., chair of the Department of
Melanoma Medical Oncology at the University of Texas M.D. Anderson
Cancer Center, Houston, Texas, will present the results during a
session on Monday, October 10, 2016, beginning at 11:00 a.m.
CEST.
“Cobimetinib and vemurafenib is FDA-approved to treat specific
forms of BRAF V600 mutation-positive unresectable or metastatic
melanoma and has been associated with significant improvements in
progression-free survival, overall survival and objective response
rate as compared to vemurafenib alone,” said Michael M. Morrissey,
Ph.D., president and chief executive officer of Exelixis. “The
preliminary results to be presented at the ESMO Congress suggest
that adding atezolizumab to the combination regimen is associated
both with a manageable safety profile and promising antitumor
activity.”
The primary objective of the phase 1b trial is the evaluation of
the safety and tolerability of the triple combination. Secondary
endpoints include progression-free survival (PFS), overall survival
(OS), objective response rate (ORR), best overall response, and
duration of response, as well as additional exploratory objectives.
Patients in the trial receive the triple combination of
cobimetinib, vemurafenib, and atezolizumab after a 28-day run-in
cycle of combination cobimetinib and vemurafenib. Atezolizumab is
administered intravenously at 800 mg every two weeks.
As of the June 15, 2016 data cut-off, 30 patients with
previously untreated BRAF V600 mutation-positive unresectable or
advanced melanoma who had received at least one dose of
atezolizumab were evaluable for safety. The median follow-up for
safety was 3.9 months, with a range of 0.7 to 16.8 months.
All-grade AEs occurring in greater than 20 percent of patients and
reported as related to cobimetinib and/or vemurafenib and/or
atezolizumab included elevated liver enzymes, fatigue, arthralgia,
diarrhea, flu-like symptoms, photosensitivity, increased blood
alkaline phosphatase, fever and pyrexia. Twelve patients had
cobimetinib- and/or vemurafenib and/or atezolizumab-related grade
3/4 AEs during the triple combination period; all resolved after
appropriate intervention.
Twenty-nine patients had received at least one dose of
atezolizumab and undergone at least one on-treatment, post baseline
tumor assessment. The ORR, a secondary endpoint, was 83 percent
with 24 patients achieving a response (fifteen of which were
confirmed as of the data cutoff). Three patients (10 percent)
achieved complete responses and 21 patients had partial responses
(72 percent). All but one subject in the trial had a reduction of
tumor burden. Median duration of response and PFS were not
evaluable as a result of limited follow-up time.
Immune biomarkers potentially predictive of clinical responses
were evaluated in this phase 1b trial. Increases in CD8+ T cells in
the tumor were observed following cobimetinib and vemurafenib
treatment during the run-in period.
A pivotal placebo-controlled phase 3 trial evaluating the
combination of cobimetinib, vemurafenib and atezolizumab compared
to cobimetinib, vemurafenib and placebo was recently posted on
ClinicalTrials.gov. Sponsored by Roche, the full title of study
NCT02908672 is “A Study of Atezolizumab Plus Cobimetinib and
Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in
Previously Untreated BRAFv600 Mutation-Positive Participants With
Metastatic or Unresectable Locally Advanced Melanoma.” Exelixis
expects to share additional details of this trial as they become
available from its collaborator Roche.
Cobimetinib is a selective inhibitor of MEK that was discovered
by Exelixis and is the subject of a worldwide collaboration
agreement between Exelixis and Genentech. Cobimetinib is approved
in multiple countries to treat specific forms of BRAF V600
mutation-positive unresectable or metastatic melanoma, in
combination with vemurafenib. Atezolizumab is an anti-PD-L1
antibody developed by Genentech that received FDA approval to treat
previously treated bladder cancer in May 2016.
Additional Cobimetinib Data Presented at the ESMO 2016
Congress
The poster discussion presentation in advanced melanoma is one
of seven cobimetinib abstracts being presented at the ESMO 2016
Congress. Additional data presentations include studies of
cobimetinib in combination with other therapies to treat metastatic
colorectal cancer and triple-negative breast cancer and BRAF-mutant
melanoma. For full logistical information on these other
presentations, please see Exelixis’ ESMO announcement press release
issued on August 31, 2016, available online here.
About the Cobimetinib Development Collaboration
Exelixis discovered cobimetinib internally and advanced the
compound to investigational new drug (IND) status. In late 2006,
Exelixis entered into a worldwide collaboration agreement with
Genentech, under which Exelixis received initial upfront and
milestone payments for signing the agreement and submitting the
IND. Following the determination of the maximum tolerated dose in
phase 1 by Exelixis, Genentech exercised its option to further
develop cobimetinib.
Under the terms of the collaboration, Exelixis is entitled to an
initial equal share of U.S. profits and losses, which will decrease
as sales increase, and shares U.S. commercialization costs. In
November 2013, Exelixis exercised its option to co-promote
cobimetinib in the United States and fields 25 percent of the U.S.
sales force, closely coordinating its efforts with Genentech.
Outside of the United States, Exelixis is eligible to receive
royalties on any sales.
Cobimetinib is now approved in multiple countries, including the
United States, European Union, Switzerland, Canada, Australia and
Brazil, to treat specific forms of BRAF mutation-positive
unresectable or metastatic melanoma, in combination with
vemurafenib. The trade name for cobimetinib is COTELLIC®.
Further country approvals are anticipated in 2016 and beyond.
Cobimetinib is also the subject of a clinical development program
aimed at evaluating its potential in combination with a variety of
investigational and approved therapies in disease settings
including metastatic melanoma, triple-negative breast cancer and
advanced solid tumors.
COTELLIC® Indication
COTELLIC (cobimetinib) is a prescription medicine that is used
with the medicine Zelboraf® (vemurafenib), to treat a type
of skin cancer called melanoma that has spread to other parts of
the body or cannot be removed by surgery, and that has a certain
type of abnormal “BRAF” gene.
A patient’s healthcare provider will perform a test for the BRAF
gene to make sure that COTELLIC is right for them. It is not known
if COTELLIC is safe and effective in children under 18 years of
age.
COTELLIC® Important Safety Information
Patients should avoid sunlight during treatment with COTELLIC
and Zelboraf. COTELLIC and Zelboraf can make a patient’s skin
sensitive to sunlight. They may burn more easily and get severe
sunburns. When a patient goes outside, they should wear clothes
that protect their skin, including their head, face, hands, arms
and legs. They should use lip balm and a broad-spectrum sunscreen
with SPF 30 or higher.
COTELLIC and Zelboraf may cause serious side effects, including
risk of new skin cancers, risk of other cancers, bleeding problems,
heart problems, allergic reactions, severe rash and other severe
skin reactions, eye problems, changes in the electrical activity of
the heart (QT prolongation), liver problems or liver injury, muscle
problems (rhabdomyolysis), skin sensitivity to sunlight
(photosensitivity), worsening side effects from radiation
treatment, and kidney injury.
Patients should tell their doctor if they are pregnant or plan
to become pregnant, as COTELLIC and Zelboraf can harm an unborn
baby. Females who are able to become pregnant should use effective
birth control during treatment with COTELLIC and Zelboraf and for
two weeks after the final dose of COTELLIC or Zelboraf (whichever
is taken later).
Patients should not breastfeed during treatment and for two
weeks after the final dose of COTELLIC or Zelboraf (whichever is
taken later). Patients should talk to their healthcare provider
about the best way to feed their baby during this time.
Patients should tell their healthcare provider about all the
medicines they take. Some types of medicines will affect the blood
levels of COTELLIC.
Common side effects of COTELLIC in combination with Zelboraf
include diarrhea, sunburn or sun sensitivity, nausea, fever and
vomiting. COTELLIC and Zelboraf can also cause changes in blood
test results.
Patients should tell their healthcare provider if they have any
side effect that bothers them or that does not go away. These are
not all the possible side effects of COTELLIC and Zelboraf.
Patients should call their doctor for medical advice about side
effects. Patients may report side effects to FDA at (800) FDA-1088
or www.fda.gov/medwatch. Patients may also report side effects to
Genentech at (888) 835-2555.
Please see both Full COTELLIC Prescribing Information and
Patient Information and Full Zelboraf Prescribing Information and
Medication Guide for additional Important Safety Information at
www.cotellic.com and
www.zelboraf.com.
About Exelixis
Exelixis, Inc. (Nasdaq:EXEL) is a biopharmaceutical company
committed to the discovery, development and commercialization of
new medicines with the potential to improve care and outcomes for
people with cancer. Since its founding in 1994, three medicines
discovered at Exelixis have progressed through clinical development
to receive regulatory approval. Currently, Exelixis is focused on
advancing cabozantinib, an inhibitor of multiple tyrosine kinases
including MET, AXL and VEGF receptors, which has shown clinical
anti-tumor activity in more than 20 forms of cancer and is the
subject of a broad clinical development program. Two separate
formulations of cabozantinib have received regulatory approval to
treat certain forms of kidney and thyroid cancer and are marketed
for those purposes as CABOMETYX™ tablets (U.S. and EU) and
COMETRIQ® capsules (U.S. and EU), respectively. Another
Exelixis-discovered compound, COTELLIC® (cobimetinib), a selective
inhibitor of MEK, has been approved in major territories including
the United States and European Union, and is being evaluated for
further potential indications by Roche and Genentech (a member of
the Roche Group) under a collaboration with Exelixis. For more
information on Exelixis, please visit www.exelixis.com or follow
@ExelixisInc on Twitter.
Forward-Looking Statement Disclaimer
This press release contains forward-looking statements,
including, without limitation, statements related to: the
presentation of data from a phase 1b clinical trial evaluating the
safety and clinical activity of the triple combination of
cobimetinib, vemurafenib, atezolizumab at the ESMO 2016 Congress;
the clinical and therapeutic potential of adding atezolizumab to
the combination regimen of cobimetinib and vemurafenib; the
potential for cobimetinib in combination with a variety of
investigational and approved therapies in disease settings,
including metastatic melanoma, triple-negative breast cancer and
advanced solid tumors; the financial terms of Exelixis’
collaboration for cobimetinib with Genentech, including, the plan
to share U.S. profits and losses for cobimetinib, and Exelixis’
potential receipt of royalties on sales of cobimetinib products
outside the U.S.; further country approvals of cobimetinib in
combination with vemurafenib anticipated in 2016 and beyond;
Exelixis’ commitment to the discovery, development and
commercialization of new medicines with the potential to improve
care and outcomes for people with cancer; Exelixis’ focus on
advancing cabozantinib; and the continued development of
cobimetinib. Words such as “will,” “to be,” suggest,” “promising,”
“eligible,” “anticipated,” “potential,” “committed,” “focused,” 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 cobimetinib to
demonstrate safety and efficacy in clinical testing; Exelixis’
dependence on its relationship with Genentech/Roche with respect to
cobimetinib and ability to maintain its rights under the
collaboration; the degree of market acceptance of and the
availability of coverage and reimbursement for COTELLIC; the risk
that unanticipated developments could adversely affect the
commercialization of COTELLIC; risks related to the potential
failure of cabozantinib to demonstrate safety and efficacy in
clinical testing; market competition; changes in economic and
business conditions; and other factors discussed under the caption
“Risk Factors” in Exelixis’ annual report on Form 10-Q filed with
the Securities and Exchange Commission (SEC) on August 3, 2016, 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 based.
Exelixis, the Exelixis logo, COMETRIQ and
COTELLIC are registered U.S. trademarks, and CABOMETYX is a U.S.
trademark.
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version on businesswire.com: http://www.businesswire.com/news/home/20161007005206/en/
Investors Contact:Exelixis, Inc.Susan Hubbard,
650-837-8194Investor Relations & Public
Affairsshubbard@exelixis.comorMedia Contact:For Exelixis,
Inc.Hal Mackins, 415-994-0040hal@torchcomllc.com
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