|[May 14, 2014]
Cabozantinib and Cobimetinib to Be Featured in Ten Presentations at 2014 ASCO Annual Meeting
SOUTH SAN FRANCISCO, Calif. --(Business Wire)--
Exelixis, Inc. (NASDAQ: EXEL) today announced that cabozantinib and
cobimetinib will be the subject of ten presentations at the upcoming
2014 Annual Meeting of the American Society of Clinical Oncology (ASCO).
The meeting, which will be held May 30 to June 3, 2014 in Chicago,
Illinois, is expected to draw more than 25,000 oncology professionals
from around the world.
The full roster of cabozantinib presentations expected at the meeting
(all times Central Daylight Time):
Abstract 4501: "Effect of cabozantinib on immunosuppressive
subsets in metastatic urothelial carcinoma."
[Note: This is
an NCI-CTEP study.]
Dr. Andrea Apolo, Center for Cancer
Research, National Cancer Institute, Bethesda, MD
Session: Genitourinary Cancer
Monday, June 2, 9:45 a.m. - 12:45
p.m., E Hall D1 (talk from 9:57-10:09 a.m.)
Poster Discussion Presentation
Abstract 5027/Poster 42: "Phase 1 dose finding study of
cabozantinib (cabo) + abiraterone (abi) combination therapy in
castration resistant prostate cancer (CRPC): An investigator-sponsored
[Note: This is an Investigator-Sponsored Trial.]
Sweeney, The Dana Farber Cancer Institute, Boston, MA
Highlights Session: Genitourinary (Prostate) Cancer
31, 1:15-4:15 p.m. (poster display, E354b); 4:45-6:00 p.m.
Abstract 8014/Poster 28: "Phase II trial of XL184 (cabozantinib)
plus erlotinib in patients (pts) with advanced EGFR-mutant non-small
cell lung cancer (NSCLC) with progressive disease (PD) on epidermal
growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy:
a California Cancer Consortium phase II trial (NCI 9303)."
This is an NCI-CTEP study.]
Dr. Karen Reckamp, City of Hope
Cancer Center, Duarte, California
Poster Highlights Session: Lung
Tuesday, June 3, 8:00-11:00 a.m. (poster display, room E354b);
11:30 a.m.-12:45 p.m. (discussion, E354b)
General Poster Presentations
Abstract TPS4150/Poster 234A: "Phase 3 randomized, double-blind,
controlled study of cabozantinib (XL184) versus placebo in subjects
with hepatocellular carcinoma who have received prior sorafenib
Dr. Ghassan K. Abou-Alfa,
Memorial Sloan-Kettering Cancer Center, New York
Session: Gastrointestinal (Noncolorectal) Cancer
31, 8:00-11:45 a.m., South Hall A2
[Note: This is a Trials in
Abstract TPS4157/Poster 237B: "A phase II trial of cabozantinib in
patients with carcinoid and pancreatic neuroendocrine tumors."
This is an Investigator-Sponsored Trial, and a Trials in Progress
Dr. Jason Faris, Massachusetts General Hospital,
General Poster Session: Gastrointestinal
Saturday, May 31, 8:00-11:45 a.m., South
Abstract TPS5629/Poster 402A: "Phase II study of XL184
(Cabozantinib) in recurrent or metastatic endometrial cancer: A trial
of the PMH, Chicago and California Phase II Consortia."
This is an NCI-CTEP study, and a Trials in Progress abstract.]
Michelle Wilson, Princess Margaret Cancer Centre, Toronto, Ontario,
General Poster Session: Gynecologic Cancer
May 31, 8:00-11:45 a.m., South Hall A2
Abstract 10078/Poster 379: "A phase I study of Cabozantinib (XL184)
in children and adolescents with recurrent or refractory solid tumors,
including CNS tumors: A Children's Oncology Group phase I consortium
[Note: This is an NCI-CTEP study.]
Meredith K. Chuk, The Johns Hopkins Hospital, Baltimore, MD
Poster Session: Pediatric Oncology
Monday, June 2, 8:00-11:45
a.m., South Hall A2
Abstract TPS4601/Poster 163A: "Phase 3 randomized study of
cabozantinib (XL184) versus everolimus in subjects with clear cell
renal cell carcinoma (METEOR)."
[Note: This is a Trials in
Dr. Toni K. Choueiri, Dana Farber
Cancer Institute, Boston, MA
General Poster Session:
Monday, June 2, 1:15-5:00 p.m., South
Abstract 5072/Poster 201: "A safety study of cabozantinib (C) plus
docetaxel (D) and prednisone (P) in metastatic castrate-resistant
prostate cancer (mCRPC)."
[Note: This is an NCI-CTEP study.]
Fatima Karzai, Center for Cancer Research, National Cancer Institute,
General Poster Session: Genitourinary Cancer
June 2, 1:15-5:00 p.m., South Hall A2
The cobimetinib oral presentation expected at the meeting (time
Central Daylight Time):
Abstract 9006: "Metabolic tumor burden for prediction
of overall survival following combined BRAF/MEK inhibition in patients
with advanced BRAF mutant melanoma."
Prof. Grant A.
MacArthur, Peter MacCallum Cancer Centre, Victoria, Australia
Abstract Session: Melanoma/Skin Cancers
Monday, June 2, 3:00-6:00
p.m, E Arie Crown Theater (talk from 4:36-4:48 p.m.)
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
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
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
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
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,
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
Cobimetinib (formerly GDC-0973/XL518) is an inhibitor of MEK, a
serine/threonine kinase that is a component of the RAS/RAF/MEK/ERK
pathway. This pathway mediates signaling downstream of growth factor
receptors, and is prominently activated in a wide variety of human
tumors. In preclinical studies, oral dosing of cobimetinib resulted in
sustained inhibition of MEK in RAS or BRAF mutant tumor models.
Cobimetinib is being developed by Roche and Genentech, a member of the
Roche Group, under a collaboration with 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, Inc. (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.
Exelixis, the Exelixis logo, and COMETRIQ are registered U.S.
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