Roche: Avastin, Tarceva Combination Improves Survival
February 03 2009 - 1:36AM
Dow Jones News
Swiss drugmaker Roche Holding AG said Tuesday interim results
from a phase III study, ATLAS, in patients with advanced non small
cell lung cancer shows a combination of Avastin and Tarceva
significantly improves the time patients with advanced lung cancer
can live without their disease worsening.
The study was stopped early because of the significance of the
interim data. The results showed that Tarceva (erlotinib) plus
Avastin (bevacizumab) given as first line maintenance treatment
following initial therapy with Avastin plus chemotherapy extends
the time patients live without their disease getting worse
(progression free survival) compared to maintenance therapy with
Avastin plus placebo. The results will be welcome news for patients
and their physicians as extending the time patients live without
their disease advancing is a key treatment aim in lung cancer. Most
people with lung cancer are diagnosed with advanced stage disease
and die within 12 months of diagnosis1.
"ATLAS is the second study to show that people with lung cancer
who took the daily pill Tarceva following initial treatment lived
longer without their cancer getting worse" said William M. Burns,
CEO Division Roche Pharmaceuticals. " The results build on the
strong data currently available for Avastin in first line treatment
and Tarceva in second line therapy, and offer a new option to help
extend the time these patients live without their disease
progressing." A preliminary safety analysis showed adverse events
were consistent with previous Avastin or Tarceva studies, as well
as trials evaluating the two medicines together, and no new safety
signals were observed.
Avastin and Tarceva are already available for the treatment of
patients with advanced lung cancer in the US and Europe. Avastin
used first line is proven to deliver the longest survival times for
patients while Tarceva has a proven record as second and third line
treatment for advanced lung cancer. In addition, the SATURN study
showed that Tarceva when given in first line maintenance -
immediately following initial treatment with platinum based
chemotherapy - significantly extended the time patients with NSCLC
lived without their cancer getting worse compared to placebo.
Data from the ATLAS study will be submitted for presentation to
a forthcoming medical meeting. Roche plans to discuss these data
with the regulatory authorities to determine next steps.
About ATLAS (AVF3671g) ATLAS is a global, multicentre,
randomised, double blind, placebo controlled study that enrolled
1,157 patients with locally advanced, recurrent or metastatic
NSCLC. Patients were initially given first line treatment of four
cycles of Avastin in combination with investigators' choice of
multiple chemotherapy regimens (carboplatin/gemcitabine,
carboplatin/paclitaxel, carboplatin/docetaxel,
cisplatin/vinorelbine, cisplatin/docetaxel or
cisplatin/gemcitabine). If their cancer did not progress and they
did not experience significant toxicity, patients were then
randomised (n=768) to receive maintenance therapy with Avastin plus
Tarceva or Avastin plus placebo until disease progression. The
study's primary efficacy endpoint was postchemotherapy PFS, defined
as the length of time from randomisation to either disease
progression or death on study treatment. Secondary endpoints
included overall survival, incidence of all and serious adverse
events, and incidence of treatment discontinuation.
Company Web Site: http://www.roche.com
-Zurich Bureau, Dow Jones Newswires; +41 43 443 8040;
zurichdjnews@dowjones.com
Click here to go to Dow Jones NewsPlus, a web front
page of today's most important business and market news, analysis
and commentary. You can use this link on the day this article is
published and the following day.