SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--May. 7, 2013-- Exelixis, Inc. (NASDAQ:EXEL) announced today that cabozantinib will be the subject of nine separate data presentations at the upcoming 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO). The meeting will be held May 31-June 4, 2013, in Chicago, Illinois. Clinical data for cabozantinib will be featured in one oral presentation, one poster discussion, and seven general poster presentations. This year’s ASCO Annual Meeting will be the first in which investigators present overall survival data for CRPC patients treated with cabozantinib as part of the phase 2, non-randomized expansion cohort.

“The nine data presentations at this year’s ASCO Annual Meeting are indicative of the continued maturation and scope of the broad clinical development program for cabozantinib,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “The program encompasses Exelixis-led trials, an ongoing collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP), and an Investigator-Sponsored Trial initiative – all of which will be represented in this year’s ASCO data set. We look forward to these data presentations for cabozantinib in Chicago in just a few weeks.”

The full roster of cabozantinib data presentations expected at the meeting (all times Central Daylight Time):

Oral Presentation

• Abstract 6000: “Efficacy of cabozantinib (Cabo) in medullary thyroid cancer (MTC) patients with RAS or RET mutations: Results from a phase III study.”
  
  Dr. Steven I. Sherman, The University of Texas MD Anderson Cancer Center, Houston, TX
  Oral Abstract Session: Head/Neck Cancer
  Sunday, June 2, 8:00-8:15 a.m., Room E354a

Poster Discussion Presentations

• Abstract 5026: “An exploratory analysis of bone scan lesion area (BSLA), circulating tumor cell (CTC) change, pain reduction, and overall survival (OS) in patients (pts) with castration-resistant prostate cancer (CRPC) treated with cabozantinib (cabo): Updated results of a phase II nonrandomized expansion (NRE) cohort.”
  
  Dr. Howard I. Scher, Memorial Sloan-Kettering Cancer Center, New York, NY
  Poster Discussion Session: Genitourinary (Prostate) Cancer
  Saturday, June 1, 8:00 a.m. – noon (poster display, Room E450a); 12:00 – 1:00 p.m. (discussion, E Arie Crown Theater)

General Poster Presentations

• Abstract 6090: “Long-term disease control of ≥2 years achieved with cabozantinib in subjects with metastatic medullary thyroid carcinoma on a phase I study.”
  
  Dr. Ezra Cohen, The University of Chicago Medicine, Chicago, IL
  General Poster Session: Head/Neck Cancer
  Saturday, June 1, 8:00-11:45 a.m., S Hall A2

• Abstract 9094: “Activity of cabozantinib in metastatic uveal melanoma: Updated results from a phase II randomized discontinuation trial (RDT).”
  
  Dr. Adil Daud, UCSF, San Francisco, CA
  General Poster Session: Melanoma/Skin Cancers
  Saturday, June 1, 8:00-11:45 a.m., S Hall A2

• Abstract 5073: “Post-treatment alterations in 18F-dihydrotestosterone (FDHT) and FDG PET/CT in metastatic castration-resistant prostate cancer (mCRPC) treated with cabozantinib.”
  
  Dr. Josef J. Fox, Memorial Sloan-Kettering Cancer Center, New York, NY
  General Poster Session: Genitourinary (Prostate) Cancer
  Monday, June 3, 8:00-11:45 a.m., S Hall A2

• Abstract TPS5094: “A phase II trial of cabozantinib (Cabo) in patients (pts) with castrate-resistant prostate cancer (CRPC) metastatic to bone (NCT01428219).”
  [Note: This is an Investigator-Sponsored Trial.]
  
  Dr. Petros Grivas, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI
  General Poster Session: Genitourinary Cancers (Trials in Progress subsession)
  Monday, June 3, 8:00-11:45 a.m., S Hall A2

• Abstract TPS4589: “A phase II study of cabozantinib (XL184) in patients with advanced/metastatic urothelial carcinoma.”
  [Note: This is an NCI-CTEP study.]
  
  Dr. Andrea Apolo, Center for Cancer Research, National Cancer Institute, Bethesda, MD
  General Poster Session: Genitourinary (Nonprostate) Cancer (Trials in Progress subsession)
  Monday, June 3, 8:00-11:45 a.m., S Hall A2

• Abstract TPS5095: “A phase I study of cabozantinib (Cabo) plus docetaxel (D) and prednisone (P) in metastatic castrate resistant prostate cancer (mCRPC).”
  [Note: This is an NCI-CTEP study.]
  
  Dr. Fatima Karzai, Center for Cancer Research, National Cancer Institute, Bethesda, MD
  General Poster Session: Genitourinary (Prostate) Cancer (Trials in Progress subsession)
  Monday, June 3, 8:00-11:45 a.m., S Hall A2

• Abstract 4543: “Preclinical and correlative studies of cabozantinib (XL184) in urothelial cancer (UC).”
  [Note: These are NCI-CTEP studies.]
  
  Dr. Andrea Apolo, Center for Cancer Research, National Cancer Institute, Bethesda, MD
  General Poster Session: Genitourinary (Nonprostate) Cancer
  Monday, June 3, 8:00-11:45 a.m., S Hall A2

About Exelixis

Exelixis, Inc. is a biotechnology company committed to developing small molecule therapies for the treatment of cancer. Exelixis is focusing its proprietary resources and development efforts exclusively on COMETRIQ™ (cabozantinib). Exelixis has also established a portfolio of other novel compounds that it believes have the potential to address serious unmet medical needs, many of which are being advanced by partners as part of collaborations. For more information, please visit the company's web site at www.exelixis.com.

Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements related to: the expected referenced data presentations and the continued development and clinical, therapeutic and commercial potential of, and opportunities for, cabozantinib. Words such as “will,” “look forward,” “expected” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Exelixis' current plans, assumptions, beliefs and expectations. Forward-looking statements involve risks and uncertainties. Exelixis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the availability of data at the expected times; risks related to the potential failure of cabozantinib to demonstrate safety and efficacy in clinical testing; the uncertain timing and level of expenses associated with the development of cabozantinib; Exelixis' ability to conduct clinical trials of cabozantinib sufficient to achieve a positive completion; the sufficiency of Exelixis' capital and other resources; market competition; and changes in economic and business conditions. These and other risk factors are discussed under “Risk Factors” and elsewhere in Exelixis' quarterly report on Form 10-Q for the three months ended March 29, 2013, filed with the Securities and Exchange Commission (SEC) on May 7, 2013, and Exelixis' other filings with the SEC. 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.

Source: Exelixis, Inc.

Exelixis, Inc.
Charles Butler, 650-837-7277
Vice President, Investor Relations and Corporate Communications
cbutler@exelixis.com