mardi 22 septembre 2020


Exelixis to Host Investor/Analyst Webcast During European Cancer Congress 2015

Par Rédaction , dans Communiqués , le 23 septembre 2015

Tuesday, September 22nd 2015 at 9:08pm UTC

– Briefing to Discuss Results from METEOR Phase 3 Pivotal Trial of
Cabozantinib in Advanced Renal Cell Carcinoma Presented at the Meeting –

– Cabozantinib and Exelixis-Discovered Cobimetinib to be Subject of
Three Presentations –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)– Exelixis, Inc. (NASDAQ:EXEL) reiterated its slate of activities at the
European Cancer Congress (ECC) 2015, which will be held September 25-29,
2015 in Vienna, Austria. As previously announced, data from clinical
trials of cabozantinib and cobimetinib will be the subject of three
presentations at the meeting. The company will also host a live
investor/analyst webcast on Saturday, September 26.

METEOR Data to be Presented during the ECC 2015 Presidential Session I

As previously announced, detailed data from METEOR will be presented at
the ECC as a late-breaking abstract in the Presidential Session I on
Saturday, September 26, 2015. 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)

Hall D1

 

Investor/Analyst Webcast to Review METEOR Data

The investor/analyst webcast will be held following the presentation on
Saturday, September 26, 2015, from 12:30-2:00 p.m. EDT / 9:30-11:00 a.m.
PDT (18:30-20:00 local time in Vienna). During the webcast, Exelixis
management and Dr. Toni Choueiri, principal investigator of the METEOR
trial, will review and provide context for the late-breaking data
presented at the Congress.

To access the webcast link, log onto www.exelixis.com
and proceed to the Event Calendar page under Investors & Media. Please
connect to the company’s website at least 15 minutes prior to the
webcast to ensure adequate time for any software download that may be
required to listen to the webcast. Alternatively, you may access the
webcast at this address: http://edge.media-server.com/m/p/c7qgq2ma/lan/en.

An archived replay of the webcast will be available on the Event
Calendar page under Investors & Media at www.exelixis.com
for one year. A telephone replay of the webcast will be available until
11:59 p.m. EDT on September 28, 2015. Access numbers for the telephone
replay are: (855) 859-2056 (domestic) and (404) 537-3406
(international); the passcode is 47549145.

Cobimetinib Data Accepted for Proffered Paper and Poster Sessions

Also at the meeting, Exelixis’ collaborator Genentech, a member of the
Roche Group, will present data on cobimetinib, an Exelixis-discovered
compound, in combination with vemurafenib in previously untreated
patients with advanced malignant melanoma harboring the BRAF V600
mutation.

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 capsules) 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
cabozantinib, its wholly-owned inhibitor of multiple receptor tyrosine
kinases. Another Exelixis-discovered compound, cobimetinib, a selective
inhibitor of MEK, received its first regulatory approval and 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.

Exelixis and the Exelixis logo are registered U.S. trademarks.

Contacts

Investor Contact:
Exelixis, Inc.
Susan
Hubbard, 650-837-8194

Investor Relations and Corporate
Communications

shubbard@exelixis.com
or
Media
Contact:

For Exelixis, Inc.
Hal Mackins,
415-994-0040

hal@torchcommunications.com

Source: Exelixis, Inc.

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