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– Results are the subject of an oral presentation at
– Phase 3 pivotal trial of combination has been initiated –
“These early data on the combination of cobimetinib, an
This ongoing phase 1b trial includes both a dose escalation stage and dose expansion stage. The trial’s primary objective is the evaluation of the safety and tolerability of the combination. Secondary endpoints include objective response rate (ORR) per RECIST, duration of response, progression-free survival (PFS), overall survival (OS), as well as evaluation of biomarkers.
As of the
The ORR for the combination was 17%, including four confirmed partial responses; additionally five patients achieved stable disease. The median duration of response was not yet reached, with a range of 5.4 to more than 11.1 months.
Median PFS for all CRC patients enrolled in the trial was 2.3 months, with a range of 1.8 to 9.5 months. The six-month PFS was 35%. Median OS for all CRC patients was not evaluable, while six-month OS was 72%.
Recently Initiated COTEZO Phase 3 Pivotal Trial
Additional Cobimetinib Data Presented at
The oral presentation in colorectal cancer is one of eight cobimetinib
abstracts being presented at the
About the Cobimetinib Development Collaboration
Under the terms of the collaboration,
Cobimetinib in combination with vemurafenib is now approved in multiple
COTELLIC (cobimetinib) is a prescription medicine that is used with 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. COTELLIC can make their skin sensitive to sunlight. They may burn more easily and get severe sunburns. To help protect against sunburn, 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 may cause serious side effects, including risk of new skin cancers, bleeding problems, heart problems, severe rash, eye problems, liver problems, muscle problems (rhabdomyolysis), and photosensitivity. Patients should tell their doctor if they are pregnant or plan to become pregnant, as COTELLIC and ZELBORAF can harm an unborn baby. Patients who take COTELLIC should use effective methods of birth control during treatment, for 2 weeks after stopping COTELLIC, and for at least 2 months after stopping ZELBORAF. Do not breastfeed during treatment with COTELLIC and for 2 weeks after the final dose. Patients along with their healthcare provider should decide if they will take ZELBORAF or breastfeed. Patients should not do both.
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 include diarrhea, sunburn or sun sensitivity, nausea, fever, and vomiting. COTELLIC 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. For more information about side effects, patients should ask their healthcare provider or pharmacist.
Patients should call their doctor for medical advice about side effects.
They may report side effects to
Please see full COTELLIC Prescribing Information and Patient Information for additional Important Safety Information.
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 cobimetinib in combination with
atezolizumab in CRC and other cobimetinib data presentations at the 2016
ASCO Annual Meeting; expectations regarding enrollment of COTEZO; 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,” “eligible,” “anticipated,” “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 and atezolizumab 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; 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
Susan Hubbard, 650-837-8194
Investor Relations & Corporate Communications
For Exelixis, Inc.
Hal Mackins, 415-994-0040