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Roche Pharmaceuticals

Significant Survival Benefit for Breakthrough Drug Tarceva in Advanced Pancreatic Cancer

Basel, Switzerland (ots/PRNewswire)

- Study Shows a Significant Improvement in Overall Survival for
Patients  Given Tarceva Combined with Chemotherapy Versus
Chemotherapy Alone
Roche, Genentech, Inc. and OSI Pharmaceuticals, Inc., today
announced positive results from a phase III study of investigational
drug Tarceva (erlotinib) in locally advanced or metastatic pancreatic
cancer patients. The study met its primary endpoint of improving
overall survival.
This study demonstrated a statistically significant 23.5 per cent
improvement in overall survival for patients with locally advanced or
metastatic pancreatic cancer receiving Tarceva plus gemcitabine, when
compared to patients receiving gemcitabine alone (a hazard ratio of
0.81 and a p-value of 0.025 were observed). A statistically
significant improvement in progression-free survival was also
demonstrated although no differences in tumour response were
observed.
Pancreatic cancer is the fourth leading cause of all cancer
deaths; in Europe each year 60,000 people are diagnosed with
pancreatic cancer and current treatment options are limited.
"The survival benefit delivered in this study is particularly
exciting, as these results come on top of the good data in lung
cancer. This means new hope for pancreatic patients who currently
have a poor prognosis and further encourages us that Tarceva may have
significant potential in a number of cancers," said William M. Burns,
Head of Roche's Pharmaceuticals Division. "This study reaffirms
Tarceva's position as the fifth product in our oncology portfolio
with a proven survival benefit alongside Herceptin, MabThera, Xeloda
and Avastin, underlining Roche's leadership in oncology."
"The results of this trial of Tarceva in combination with
gemcitabine represent an important advancement in treating patients
with pancreatic cancer," stated Dr. Malcolm Moore, Study Chair and
Medical Oncologist at Princess Margaret Hospital and Chair of the
Gastrointestinal Disease Site, NCIC Clinical Trials Group.
"Pancreatic cancer is widely recognised as a difficult disease to
treat and new therapeutic regimens are desperately needed. These
results also demonstrate that the HER1/EGFR signalling pathway is an
important target in pancreatic cancer, and offer hope that further
progress can be made."
In a recent study, Tarceva was shown to significantly improve
survival in non-small cell lung cancer (NSCLC), the most common type
of cancer worldwide. A Marketing Authorisation Application for
Tarceva monotherapy treatment of advanced non-small cell lung cancer
was recently made to the European health authorities and to the US
Food and Drug Administration (FDA). Early-stage trials of Tarceva are
also being conducted in other solid tumours, such as ovarian,
colorectal, head and neck, renal cell carcinoma, glioma and
gastrointestinal cancers.
About the Study
The multi-centre, randomised, double-blind, placebo-controlled
Phase III international study was conducted by the National Cancer
Institute of Canada, Clinical Trials Group at Queens University (NCIC
CTG) in collaboration with OSI Pharmaceuticals. The study evaluated
Tarceva at 100mg/day or 150mg/day in patients with locally advanced
or metastatic pancreatic cancer. Patients received either gemcitabine
with Tarceva or gemcitabine plus placebo. A total of 569 patients
were randomised into the study, with 521 patients receiving 100mg/day
Tarceva or placebo and 48 patients receiving 150mg/day Tarceva or
placebo. The study was an international study with sites in the U.S.,
Asia, Canada, Europe, Australia and South America.
This international study demonstrated a statistically significant
23.5 percent improvement in overall survival for patients with
locally advanced or metastatic pancreatic cancer when compared with
overall survival in patients receiving gemcitabine plus placebo. A
hazard ratio of 0.81 and a p-value of 0.025 were observed (a hazard
ratio of less than one indicates a reduction in the risk of death and
a p-value of less than 0.05 indicates statistical significance). A
statistically significant improvement in progression-free survival
was also demonstrated although no differences in tumour response were
observed. A preliminary analysis of the safety data did not reveal
any unexpected safety signal beyond that seen in prior experience of
Tarceva use in both monotherapy and combination settings.
About Tarceva
Tarceva is a small molecule designed to target the human epidermal
growth factor receptor 1 (HER1) pathway, which is one of the factors
critical to cell growth in many cancers. HER1, also known as EGFR, is
a key component of the HER signalling pathway, which plays a role in
the formation and growth of numerous cancers. Tarceva is designed to
inhibit the tyrosine kinase activity of the HER1 signalling pathway
inside the cell, which may block tumour cell growth. Previous studies
have shown that Tarceva is the first agent to show a survival benefit
in patients with relapsed non-small cell lung cancer, resulting in
Roche's recent submission of a Marketing Authorisation Application to
the European health authorities for Tarceva for the monotherapy
treatment of advanced non-small cell lung cancer. A similar
application for Tarceva has also been made to the U.S. Food and Drug
Administration.
About Pancreatic Cancer
The pancreas is a large organ lying behind the stomach that is
essential in the metabolism of sugar and fat. Cancer of the pancreas
strikes about 5 out of every 100,000 people and is one of the
deadliest forms of cancer. Approximately 60,000 new cases of
pancreatic cancer are diagnosed per year in Europe and 30,000 new
cases in the US. The prognosis is poor for pancreatic cancer
patients, with most studies showing 5-year survival of less than 5%.
Those at the highest risk are in their 60s to 80s. Most pancreatic
tumours originate in the cells of the pancreas that produce digestive
enzymes (acinar cells). These adenocarcinomas account for almost 95%
of pancreatic tumours.
About Roche in Oncology
Within the last five years the Roche Group including its partners
Genentech in the US and Chugai in Japan has become the world's
leading provider of anti-cancer treatments, supportive care products
and diagnostics. Its oncology business includes an unprecedented four
marketed products with survival benefit in different major tumour
indications: Xeloda and Herceptin in advanced stage breast cancer,
MabThera in non-Hodgkin's lymphoma, and Avastin in colorectal
carcinoma. In the United States Herceptin, MabThera and Avastin are
marketed either by Genentech alone or together with Biogen Idec Inc.
Outside of the United States, Roche and its Japanese partner Chugai
are responsible for the marketing of these drugs.
The Roche oncology portfolio also includes NeoRecormon (anaemia in
various cancer settings), Bondronat (prevention of skeletal events in
breast cancer and bone metastases patients, hypercalcaemia of
malignancy), Kytril (chemotherapy and radiotherapy-induced nausea and
vomiting) and Roferon-A (hairy cell and chronic myeloid leukaemia,
Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). CERA is
the most recent demonstration of the commitment to anaemia
management. The Roche Group's cancer medicines generated sales of
more than 3.3 billion Swiss francs in the first half of 2004.
Roche is developing new tests, which will have a significant
impact on disease management for cancer patients in the future. With
a broad portfolio of tumour markers for prostate, colorectal, liver,
ovarian, breast, stomach, pancreas and lung cancer, as well as a
range of molecular oncology tests, we will continue to be the leaders
in providing cancer focused treatments and diagnostics.
Roche Oncology has four research sites (two in the US, Germany and
Japan) and four Headquarter Development sites (two in the US, UK and
Switzerland).
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's
leading innovation-driven healthcare groups. Its core businesses are
pharmaceuticals and diagnostics. As a supplier of products and
services for the prevention, diagnosis and treatment of disease, the
Group contributes on a broad range of fronts to improving people's
health and quality of life. Roche is number one in the global
diagnostics market, the leading supplier of pharmaceuticals for
cancer and transplantation and a market leader in virology. In 2003
prescription drug sales by the Pharmaceuticals Division totalled 19.8
billion Swiss francs, while the Diagnostics Division posted sales of
7.4 billion Swiss francs. Roche employs roughly 65,000 people in 150
countries and has alliances and R&D agreements with numerous
partners, including majority ownership interests in Genentech and
Chugai.
All trademarks used or mentioned in this release are legally
protected.
Further Information:

Contact:

tel +41-61-688-88-88, e-mail basel.mediaoffice@roche.com, Baschi
Dürr, Alexander Klauser, Daniel Piller (Head Roche Group Media
Office), Katja Prowald (Head Science Communications), Martina Rupp

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