Phase III Study (SATURN) Showed Tarceva Improved Progression-Free Survival as a First-Line Maintenance Therapy for Advanced Non-Small Cell Lung Cancer
Genentech, Inc. (NYSE:DNA) and OSI Pharmaceuticals, Inc. (Nasdaq:OSIP)
today announced that a global Phase III study (SATURN) met its primary
endpoint and showed Tarceva®
(erlotinib) significantly extended the time patients with advanced
non-small cell lung cancer (NSCLC) lived without their cancer getting
worse when given immediately following initial treatment with
platinum-based chemotherapy, compared to placebo. There were no new or
unexpected safety signals in the study and adverse events were
consistent with those observed in previous NSCLC clinical trials
evaluating Tarceva.
The SATURN study results are being fully analyzed and the data will be
submitted for presentation at a future medical meeting. OSI, Genentech
and Roche will discuss next steps for a potential new indication for
Tarceva with the U.S. Food and Drug Administration (FDA) and European
Health Authorities.
"We believe that Tarceva as a once-a-day oral
therapy, which has a well-established safety profile, may be well-suited
as a maintenance therapy in the first-line setting following
chemotherapy,” said Gabriel Leung, President,
OSI Oncology. "We are excited about the
prospect that for the first time patients may have a treatment
alternative that is different from traditional chemotherapy and extends
the time patients live without their cancer progressing following
initial treatment.”
"We are pleased by the findings as they
represent another step forward in our hopes of providing more options to
patients throughout their battle with lung cancer,”
said Hal Barron, M.D., Genentech’s senior vice
president, Development and chief medical officer.
Tarceva is currently approved as a second-line treatment for patients
with advanced NSCLC, who have progressed following treatment with at
least one prior chemotherapy regimen, based on a 37 percent improvement
in overall survival compared to placebo (hazard ratio 0.73).
"There is an unmet need for treatments that
can be used as early as possible following initial treatment of NSCLC
and the results from the SATURN study provide a strong rationale for
introducing Tarceva as a maintenance therapy in this difficult to treat
disease," said Professor F. Capuzzo, M.D., Istituto Clinico
Humanitas IRCCS, Milan, Italy and lead investigator of the SATURN
study.
According to the American Cancer Society (ACS) lung cancer is the single
largest cause of cancer deaths among men and women in the United States
and is responsible for nearly 30 percent of cancer deaths. The ACS
estimates that in 2008 more than 215,000 Americans will be diagnosed
with lung cancer and 162,000 will die of the disease. NSCLC is the most
common type of lung cancer.
About SATURN
SATURN is a 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
at least four cycles of standard first-line platinum-based chemotherapy
and were then randomized to Tarceva or placebo if their cancer did not
progress. The primary endpoint of the study was progression-free
survival. Secondary endpoints included overall survival, safety and an
evaluation of exploratory biomarkers.
About Tarceva
Tarceva is a small molecule designed to target the EGFR pathway, which
is one of the factors critical to cell growth in NSCLC and pancreatic
cancers. Tarceva is designed to inhibit the tyrosine kinase activity of
the EGFR signaling pathway inside the cell.
Tarceva is FDA-approved for use as a monotherapy in 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.
Tarceva is also approved in combination with gemcitabine for the
treatment of patients who have not received previous chemotherapy for
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 fatalities, in patients receiving Tarceva
for treatment of NSCLC, pancreatic cancer or other advanced solid
tumors. Cases of hepatic failure, hepatorenal syndrome, acute renal
failure (all including fatalities), and renal insufficiency have been
reported during use of Tarceva. When receiving Tarceva therapy, women
should be advised against becoming pregnant or breastfeeding. Tarceva is
pregnancy category D. The most common adverse reactions in patients with
NSCLC receiving Tarceva monotherapy were rash and diarrhea. The most
common adverse reactions in patients with pancreatic cancer receiving
Tarceva plus gemcitabine were fatigue, rash, nausea, anorexia, and
diarrhea.
For full prescribing information, please call 1-877-TARCEVA or visit http://www.tarceva.com.
About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology
company that discovers, develops, manufactures and commercializes
medicines for patients with significant unmet medical needs. The company
has headquarters in South San Francisco, California and is listed on the
New York Stock Exchange under the symbol DNA. For additional information
about the company, please visit http://www.gene.com.
About OSI Pharmaceuticals
OSI Pharmaceuticals is committed to "shaping medicine and changing
lives" by discovering, developing and commercializing high-quality and
novel pharmaceutical products designed to extend life and/or improve the
quality of life for patients with cancer and diabetes/obesity. The
Company's oncology programs are focused on developing molecular targeted
therapies designed to change the paradigm of cancer care. OSI's
diabetes/obesity efforts are committed to the generation of novel,
targeted therapies for the treatment of type 2 diabetes and obesity.
OSI's flagship product, Tarceva®
(erlotinib), is the first drug discovered and developed by OSI to obtain
FDA approval and the only EGFR inhibitor to have demonstrated the
ability to improve survival in both NSCLC and pancreatic cancer patients
in certain settings. OSI markets Tarceva through partnerships with
Genentech, Inc. in the United States and with Roche throughout the rest
of the world. For additional information about OSI, please visit (http://www.osip.com).
Genentech Safe Harbor Statement
This press release contains forward-looking statements regarding the
potential for Tarceva and approval for Tarceva in the first-line
maintenance setting for NSCLC. Such statements are predictions and
involve risks and uncertainties such that actual results may differ
materially. Actual results may be affected by a number of factors
including, but not limited to, unexpected safety, efficacy or
manufacturing issues, the need for additional data, data analysis or
clinical studies, NDA preparation, FDA actions or delays, failure to
obtain or maintain FDA approval, competition, pricing, reimbursement,
the ability to supply product, product withdrawals and new product
approvals and launches, and intellectual property or contract rights.
Please also refer to the risk factors described in Genentech's periodic
reports filed with the Securities and Exchange Commission. Genentech
disclaims, and does not undertake, any obligation to update or revise
any forward-looking statement in this press release.
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, the results from, and the ability to complete, clinical
trials, the FDA review process and other governmental regulation, OSI's
and its collaborators' abilities to successfully develop and
commercialize drug candidates, competition from other pharmaceutical
companies, the ability to effectively market products, and other factors
described in OSI Pharmaceuticals' filings with the Securities and
Exchange Commission.
