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 Presentation Of Updated Phase 1b Data For Cobimetinib (GDC-0973/XL518) In Combination With Vemurafenib At ECC 2013

Exelixis, Inc. (NASDAQ:EXEL) today announced updated results from BRIM7, an ongoing phase 1b clinical trial conducted by Roche and Genentech, Exelixis' collaborator and a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), of the BRAF inhibitor (BRAFi) vemurafenib in combination with the MEK inhibitor cobimetinib (GDC-0973/XL518) in patients with locally advanced/unresectable or metastatic melanoma carrying a BRAF V600 mutation. Grant McArthur, M.D., Head of the Medical Oncology Skin and Melanoma Clinical Service at the Peter MacCallum Cancer Centre in Australia, and an investigator on the trial, presented the data today at the European Cancer Congress (ECC) 2013 (Abstract #3703) which is taking place in Amsterdam, The Netherlands.

“The data presented today, while early-stage, suggest that the preliminary safety profile and activity of the investigational combination of cobimetinib and vemurafenib is promising in BRAFi-naïve patients,” said Michael Morrissey, Ph.D., president and CEO of Exelixis. “Importantly, responses in these patients generally occurred early in their course of treatment. We are pleased with the progress Roche has made in advancing cobimetinib, and believe that this Exelixis-discovered compound warrants further study in melanoma, as people with this incurable disease desperately need new options.”

Exelixis received notice from Genentech in January 2013 that the first patient was dosed in a phase 3 pivotal trial (coBRIM) evaluating vemurafenib alone or in combination with cobimetinib in previously untreated patients with malignant melanoma harboring the BRAF V600 mutation. This study is ongoing and currently enrolling globally. Top-line data from the trial are expected to be available next year.

Study Design

The phase 1b dose escalation study was designed to evaluate the safety and tolerability of cobimetinib in combination with vemurafenib. The dose escalation stage of the trial comprised 10 dosing cohorts of 3-6 patients and evaluated three different dosing schedules for the two active treatments. Cohorts that met the protocol-specified criteria for MTD were expanded and included BRAFi-naïve or vemurafenib-progressing patients.

1 of 5

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