Data from the Phase III ATLAS Study Show Tarceva in Combination with Avastin as First-Line Maintenance Therapy Improved Progr...
31 May 2009 - 1:03AM
Business Wire
OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that
its U.S. partner for Tarceva� (erlotinib), Genentech, Inc., a
wholly-owned member of the Roche Group, informed OSI of detailed
results from a Genentech conducted Phase III study (ATLAS). The
study met its primary endpoint by demonstrating that patients with
advanced non-small cell lung cancer (NSCLC) who received Tarceva in
combination with Avastin� (bevacizumab) as first-line maintenance
treatment had a 39 percent improvement in the time they lived
without the disease worsening (progression-free survival or PFS),
compared with those who received Avastin plus placebo as an active
control (hazard ratio=0.72; p=0.0012; a hazard ratio of less than
one indicates a decreased risk of disease progression and a p-value
of less than 0.05 indicates statistical significance). Adverse
events were consistent with previous Avastin or Tarceva NSCLC
studies, or trials evaluating the two medicines together.
Genentech also informed OSI that median PFS following four
initial cycles of Avastin and chemotherapy was 4.8 months for
patients who received the combination and 3.7 months for those who
received Avastin plus placebo. Overall survival data are expected
in the second half of 2009. In February 2009, it was announced that
ATLAS was stopped early on the recommendation of an independent
data safety monitoring board after a pre-planned interim analysis
showed that combining Tarceva and Avastin significantly extended
PFS, compared with Avastin plus placebo.
Results of the ATLAS study were featured today during a press
briefing at the 45th annual meeting of the American Society of
Clinical Oncology (ASCO). Full results will be presented tomorrow
by Dr. Vincent Miller (Abstract #LBA8002 � Sunday, May 31, 2009,
9:30 a.m. � 9:45 a.m. EDT, West Hall E1).
Full results of the SATURN study, which showed that patients who
received Tarceva alone as a maintenance treatment following initial
chemotherapy had a statistically significant 41% improvement in PFS
compared with placebo (hazard ratio=0.71, p-value
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