Press Release
Press Release
Data From METEOR Pivotal Trial of Cabozantinib in Advanced Renal Cell Carcinoma Accepted as Late-Breaker Presentation in Presidential Session at European Cancer Congress 2015
-- Two Presentations of Cobimetinib in Advanced Melanoma Also Accepted --
METEOR Data Accepted for Oral Presentation in Presidential Session
Detailed data from METEOR, the phase 3 pivotal trial of cabozantinib in
advanced renal cell carcinoma, will be presented at the ECC as a
late-breaking abstract in the Presidential Session I on
The details of the presentation are as follows:
- Abstract 4LBA: Late-Breaking Abstract: Cabozantinib versus Everolimus in Patients with Advanced Renal Cell Carcinoma: Results of the Randomized Phase 3 METEOR Trial
Toni K. Choueiri, M.D. | |||||||
Presidential Session I | |||||||
Saturday, September 26, 2015 | |||||||
Session from 14:30-16:40 CEST (8:30-10:40 a.m. EDT); presentation expected to begin at 16:20 CEST (10:20 a.m. EDT) | |||||||
Cobimetinib Data Accepted for Proffered Paper and Poster Sessions
Also at the meeting, Exelixis’ collaborator Genentech, a member of the
The details of the cobimetinib presentations are as follows:
- Abstract 25LBA: Late-Breaking Abstract: Impact of Baseline Genetic Heterogeneities on Progression-Free Survival (PFS) in Patients (pts) with Advanced BRAFV600-mutated Melanoma Treated with Cobimetinib (COBI) + Vemurafenib (VEM) in the phase 3 coBRIM Study
Professor Grant McArthur | |||||||
Proffered Paper Session: Melanoma and Skin Cancer I | |||||||
Sunday, September 27, 2015 | |||||||
Session from 11:30-12:30 CEST (5:30-6:30 a.m. EDT); presentation expected to begin at 12:10 CEST (6:10 a.m. EDT) | |||||||
Hall A2 | |||||||
- Abstract 3340: Treatment beyond Progression in Advanced BRAF-mutated Melanoma with Vemurafenib and Cobimetinib: Results from the BRIM7 Trial
Karl Lewis, M.D. | |||||||
Poster Session: Melanoma and Skin Cancer | |||||||
Sunday, September 27, 2015 | |||||||
Session from 16:45-18:45 CEST (10:45 a.m. - 12:45 p.m. EDT) | |||||||
Hall C, Poster 217 | |||||||
About Cabozantinib
Cabozantinib inhibits the activity of tyrosine kinases including MET, VEGF receptors, AXL, 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
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
About the Cobimetinib Development Collaboration
In
About
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Source:
Investors Contact:
Exelixis, Inc.
Susan
Hubbard, 650-837-8194
Investor Relations and Corporate
Communications
shubbard@exelixis.com
Media
Contact:
For Exelixis, Inc.
Hal Mackins,
415-994-0040
hal@torchcommunications.com