HonCode

Go Back   HER2 Support Group Forums > Articles of Interest
Register Gallery FAQ Members List Calendar Search Today's Posts Mark Forums Read

Reply
 
Thread Tools Display Modes
Old 11-30-2005, 10:25 AM   #1
Tom
Senior Member
 
Tom's Avatar
 
Join Date: Sep 2005
Posts: 290
Thumbs up Latest on Lapatinib (now Tykerb)

Here is the latest from Glaxo-Smith Kline on the progress of Lapatinib, which is now being called Tykerb. The information is from a November 30th company conference call for shareholders. Here is the link and the part of the text that concerns Tykerb:

http://www.gsk.com/ControllerServlet...402&newsid=697#





- Tykerb — a targeted oral therapy with thepotential to become an essential component in the treatment of breast cancer



World-wide, 400,000 women die each year as a result of breast cancer, and its prevalence is increasing with approximately 1.5 million new cases diagnosed every year. Tykerb, a dual-kinase inhibitor, is an oral once-daily treatment currently being developed for breast cancer and other tumors. It works by inhibiting two well-validated targets in oncology, the kinase components of ErbB1 (EGFR) and ErbB2 receptors, which are associated with cancer-cell proliferation and tumor growth.



Data presented at today’s seminar, and at the recent European Cancer Conference (ECCO) in Paris, illustrate the promising efficacy and safety profile of Tykerb. Interim results from an international phase II trial of Tykerb as first-line therapy in 40 patients with advanced or metastatic breast cancer (with ErbB2 overexpression) showed that 33% of patients had tumor reductions, with 40% of patients experiencing clinical benefit (tumor reduction or stable disease for at least 24 weeks). A further update will be presented at the San Antonio Breast Cancer Symposium on 8th December.



Tykerb has also shown preliminary activity in the treatment of brain metastases, which represents a significant unmet medical need for breast cancer patients.



Results were recently analyzed from a 416 patient phase II/III clinical trial in the treatment of renal cancer. While the primary end-point was not met in the full population, a preliminary analysis of the sub-group of 241 patients with over-expression of EGFR demonstrated a statistically significant survival benefit for patients receiving Tykerb. This data is expected to be presented at ASCO in 2006.



In the 3,500 patients who are part of its clinical development program, Tykerb to date has shown a low incidence of cardiotoxicity, a condition associated with some breast cancer treatments. The most frequently reported adverse events associated with Tykerb have been mild to moderate itching, rash, diarrhea, acne, and dry skin.



Tykerb’s clinical program has been expanded, with three new phase III trials being initiated by January 2006, two in first-line therapy and one in refractory breast cancer. A large phase II trial in the treatment of brain metastases associated with breast cancer started in November 2005. In mid-November, GSK and the Breast International Group - one of the world’s premier cancer research groups - agreed to collaborate on a large-scale global clinical trial to evaluate Tykerb as adjuvant therapy in early-stage breast cancer.

GSK expects to file Tykerb for US Food and Drug Administration (FDA) approval at the end of 2006 or in the first half of 2007.

Tom is offline   Reply With Quote
Old 12-02-2005, 07:28 AM   #2
Shell
Senior Member
 
Join Date: Sep 2005
Location: Philadelphia
Posts: 301
I wish GSK talked some about the cinical trial I am in. I am in phase III of xeloda with or without lapatinib. I got the arm without the lapatinib, but fortunately am doing fine. It just would be nice to hear some positive hype about this trial as well.


Thanks for the name explanation of Tykerb -- interesting...

Shell
Shell is offline   Reply With Quote
Reply

Thread Tools
Display Modes

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is On

Forum Jump


All times are GMT -7. The time now is 12:39 PM.


Powered by vBulletin® Version 3.8.7
Copyright ©2000 - 2024, vBulletin Solutions, Inc.
Copyright HER2 Support Group 2007 - 2021
free webpage hit counter