This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Exelixis Announces Data Presentation For GDC-0973 (XL518)

The most common adverse events (AEs) attributed to either vemurafenib or GDC-0973 in the 70 patients treated to date were: non-acneiform rash (52.9%; 7.1% Grade 3 or 4), diarrhea (51.4%; 5.7%), photosensitivity/sunburn (31.4%; 0%), fatigue (30.0%; 1.4%), and nausea (28.6%; 1.4%). Selected AEs attributed to either vemurafenib or GDC-0973 were: creatinine phosphokinase elevation (20.0%; 4.3%), liver function test elevation (20.0%; 4.3%), arthralgia (12.9%; 1.4%), serous choreoretinopathy (4.3%; 0%), and cutaneous squamous cell carcinoma (1.4%; 1.4%).

Temporary interruptions in vemurafenib, GDC-0973, or the combination of both agents were reported in 24.3%, 21.4%, and 8.6% of patients, respectively. One patient receiving the combination discontinued vemurafenib permanently because of QT interval prolongation. No patients receiving the combination of vemurafenib and GDC-0973 discontinued treatment due to an adverse event.

All 24 BRAFi-naïve patients evaluable for tumor responses had a decrease in tumor size from baseline, however, further follow-up is required to determine the confirmed objective response rate.

About GDC-0973 (XL518)

GDC-0973 is a potent, highly selective 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 GDC-0973 resulted in potent and sustained inhibition of MEK in RAS or BRAF mutant tumor models. GDC-0973 is being developed by Genentech, a member of the Roche Group under a collaboration agreement with Exelixis.

About Collaboration

Exelixis discovered GDC-0973 (XL518) internally and advanced the compound to investigational new drug (IND) status. In late 2006, Exelixis entered into a worldwide co-development agreement with Genentech, under which Exelixis received initial upfront and milestone payments for signing the agreement and submitting the IND. Exelixis was responsible for development of GDC-0973 through the end of Phase I, at which point Genentech exercised its option to further develop the compound.

2 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 17,826.30 -279.47 -1.54%
S&P 500 2,081.18 -23.81 -1.13%
NASDAQ 4,931.8150 -75.9760 -1.52%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs