OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) and Genentech, Inc. today
announced that SATURN, a pivotal Phase III study of Tarceva®
(erlotinib), met a key secondary endpoint of extending overall survival
in patients with advanced non-small cell lung cancer (NSCLC) who
received Tarceva immediately after initial chemotherapy. A statistically
significant improvement in overall survival was seen in this pre-planned
final analysis of the total patient population. The new data will be
presented during the 13th World Conference on Lung Cancer to be held
July 31 to August 4, 2009 in San Francisco.
Treating patients immediately following first-line chemotherapy versus
waiting for the cancer to grow or spread before giving additional
treatment represents a new approach in advanced NSCLC.
“This study has now not only confirmed that immediate treatment with
Tarceva after initial chemotherapy delayed the progression of disease,
but also importantly helped patients in the study live longer,” said
Professor Federico Cappuzzo, M.D., Istituto Clinico Humanitas IRCCS,
Milan and principal investigator of the SATURN study. “This is good news
for doctors and their patients since advanced lung cancer is one of the
most challenging cancers to treat and is often associated with a very
short life expectancy.”
The overall survival data will be submitted to the U.S. Food and Drug
Administration (FDA) to support the supplemental New Drug Application
(sNDA) for use of Tarceva as a first-line maintenance treatment for
patients with advanced NSCLC that was submitted on March 17, 2009. The
FDA Prescription Drug User Fee Act (PDUFA) review date will be on or
about January 18, 2010.
Additionally, Roche, OSI’s international collaborator for Tarceva, will
submit the overall survival data to the European Medicines Agency (EMEA)
to support the application for use of Tarceva as a first-line
maintenance treatment submitted in March 2009.
The U.S. and EU submissions were based on positive data from SATURN that
were presented at the 45th Annual Meeting of the American Society of
Clinical Oncology (ASCO) on May 31, 2009 in Orlando, Fla. SATURN met its
primary endpoint and showed patients with advanced NSCLC who received
Tarceva as a first-line maintenance treatment had a 41 percent
improvement in the time they lived without the disease advancing
(progression-free survival or PFS) compared to placebo (hazard
ratio=0.71; 29 percent reduction in the risk of cancer progression or
death). The safety results were consistent with what has been seen
previously and there were no new or unexpected safety signals in the
study.
