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. The most commonly
reported adverse events in patients who received Tarceva were rash
(49 percent, 213/438) and diarrhea (20 percent, 88/438).
According to the American Cancer Society, lung cancer is the
leading cause of cancer death in the United States. In 2009,
approximately 159,000 Americans will die from the disease. Most
people are diagnosed with advanced stage disease and only 15
percent survive five years.
About SATURN
SATURN is an international, placebo-controlled, randomized,
double-blind, Phase III study conducted by Roche that enrolled 889
patients with advanced NSCLC at approximately 160 sites worldwide.
Patients were treated with four cycles of standard first-line
platinum-based chemotherapy and were then randomized to Tarceva or
placebo if the cancer did not progress. The primary endpoint of the
study was progression-free survival in the overall population, as
determined by investigators, and was defined as the length of time
from randomization to disease progression or death from any cause.
The co-primary endpoint was PFS in patients with EGFR-positive
tumors by IHC. Secondary endpoints included overall survival,
safety and an evaluation of exploratory biomarkers, including EGFR
mutations and K-ras mutations.
About Tarceva
Tarceva is a once-a-day pill that targets the EGFR pathway.
Tarceva is designed to inhibit the tyrosine kinase activity of the
EGFR signaling pathway inside the cell, one of the critical growth
factors in NSCLC and pancreatic cancers. Tarceva is indicated as a
monotherapy for patients with locally advanced or metastatic NSCLC
whose disease has progressed after one or more courses of
chemotherapy. Results from two multicenter, placebo-controlled,
randomized Phase III trials conducted in first-line patients with
locally advanced or metastatic NSCLC showed no clinical benefit
with the concurrent administration of Tarceva with platinum-based
chemotherapy (carboplatin and paclitaxel or gemcitabine and
cisplatin) and its use is not recommended in that setting.
In pancreatic cancer, Tarceva is indicated in combination with
gemcitabine for the first-line treatment of patients with locally
advanced pancreatic cancer, pancreatic cancer that cannot be
surgically removed or pancreatic cancer that has spread to distant
body organs.
Tarceva Safety
There have been infrequent reports of serious Interstitial Lung
Disease (ILD)-like events including deaths in patients taking
Tarceva. Serious side effects (including deaths) in patients taking
Tarceva include liver and/or kidney problems; gastrointestinal (GI)
perforations (the development of a hole in the stomach, small
intestine, or large intestine); and severe blistering skin
reactions including cases similar to Stevens-
Johnson syndrome. Patients taking Tarceva plus gemcitabine were
more likely to experience bleeding and clotting problems such as
heart attack or stroke. Eye irritation and damage to the cornea
have been reported in patients taking Tarceva. Women should avoid
becoming pregnant and avoid breastfeeding while taking Tarceva.
Patients should call their doctor right away if they have these
signs or symptoms: new or worsening skin rash; serious or ongoing
diarrhea, nausea, loss of appetite, vomiting or stomach pain; new
or worsening shortness of breath or cough; fever; eye irritation.
Rash and diarrhea were the most common side effects associated with
Tarceva in the non-small cell lung cancer clinical study. Fatigue,
rash, nausea, loss of appetite and diarrhea were the most common
side effects associated with Tarceva plus gemcitabine therapy in
the pancreatic cancer clinical study.
For full prescribing information, please call 1-877-TARCEVA or
visit�http://www.tarceva.com.
About OSI Pharmaceuticals
OSI Pharmaceuticals is committed to "shaping medicine and
changing lives" by discovering, developing and commercializing
high-quality, novel and differentiated targeted medicines designed
to extend life and improve the quality of life for patients with
cancer and diabetes/obesity. For additional information about OSI,
please visit http://www.osip.com.
About Genentech
Founded more than 30 years ago,
Genentech is a leading biotechnology company that discovers,
develops, manufactures and commercializes medicines to treat
patients with serious or life-threatening medical conditions. The
company, a wholly-owned member of the Roche Group, has headquarters
in South San Francisco, Calif. For additional information about the
company, please visit http://www.gene.com.
OSI Safe Harbor Statement
This news release contains forward-looking statements. These
statements are subject to known and unknown risks and uncertainties
that may cause actual future experience and results to differ
materially from the statements made. Factors that might cause such
a difference include, among others, OSI's and its collaborators'
abilities to effectively market and sell Tarceva and to expand the
approved indications for Tarceva, OSI�s ability to protect its
intellectual property rights, safety concerns regarding Tarceva,
competition to Tarceva and OSI�s drug candidates from other
biotechnology and pharmaceutical companies, the completion of
clinical trials, the effects of FDA and other governmental
regulation, including pricing controls, OSI's ability to
successfully develop and commercialize drug candidates, and other
factors described in OSI Pharmaceuticals' filings with the
Securities and Exchange Commission.
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