Media Release
Basel, 26 April 2004
New
cancer drug Tarceva - a breakthrough with significant survival benefit in patients with advanced lung
cancer
First and only drug in a new class (HER1/EGFR-inhibitors) to show survival
benefit in a randomized phase III trial
Roche, Genentech, Inc. and OSI Pharmaceuticals, Inc., today announced positive results from a phase III study of Tarceva (erlotinib) in relapsed non-small cell lung cancer (NSCLC) patients. The study met its primary endpoint of improving overall survival with patients on Tarceva living longer than those in the placebo arm. The trial also met secondary endpoints including improving time to symptomatic deterioration, progression-free survival and response rate.
“These Tarceva results are great news, confirming the earlier promising single agent activity in patients with relapsed non-small cell lung cancer. Tarceva is the first and only EGFR-targeted drug showing improved survival in patients with NSCLC. We will be striving to make Tarceva available as quickly as possible to patients,” said William M. Burns, Head of Roche’s Pharmaceuticals Division. “Tarceva joins Herceptin, MabThera, Xeloda and Avastin as the fifth cancer medicine in our portfolio with a proven survival benefit. This puts us in an unparalleled position and further underlines Roche’s leadership in oncology.”
“Tarceva is the first EGFR-inhibitor that has been shown to extend survival in patients with relapsed non-small cell lung cancer, for whom there are very limited treatments possible,” said Professor Nick Thatcher, Chairman on Lung Cancer Group, Christie and Wythenshawe Hospitals Manchester, UK. “The results of this controlled trial with Tarceva are very exciting for all of us in the oncology community. But even more so for people with lung cancer, the biggest cancer killer in Europe.”
About
the Study
The international study was conducted by the National
Cancer Institute of Canada, Clinical Trials Group at Queens University (NCIC CTG) in collaboration with
OSI. The primary endpoint in this study was overall survival. Secondary endpoints include time to symptomatic
deterioration, progression-free survival, safety, and tumour response.
The alliance of Roche, OSI and Genentech will work with the NCIC CTG to submit data from this phase III trial for presentation at the upcoming 2004 Annual Meeting of the American Society of Clinical Oncology (ASCO) in New Orleans from June 5 8.
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. Results of a phase III trial of Tarceva in pancreatic cancer are expected in the second half of 2004. Early-stage trials of Tarceva are being conducted in other solid tumours, such as ovarian, colorectal,
head and neck, renal cell carcinoma, glioma and gastrointestinal cancers.
About
Non-Small Cell Lung Cancer
According to the World Health Organization,
there are more than 1.2 million cases worldwide of lung and bronchial cancer each year, causing approximately
1.1 million deaths annually. Non-small cell lung cancer is the most common form of the disease and accounts
for almost 80 percent of all lung cancer.
Roche
in Oncology
Within the last five years the Roche Group 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: Herceptin,
MabThera, Xeloda and Avastin which has been launched in the US recently, treat a range of malignancies
such as breast cancer, non-Hodgkin’s lymphoma and colorectal cancer. Other key products include NeoRecormon
(anaemia in various cancer settings), Bondronat (prevention of skeletal events in breast cancer and
bone metastases patients, hypercalcemia of malignancy), Kytril (chemotherapy and radiotherapy-induced
nausea and vomiting) and Roferon-A (leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma).
Roche’s cancer medicines generated sales of more than 6 billion Swiss francs in 2003.
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
the Companies
Headquartered in Basel, Switzerland, Roche is one
of the world’s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals
and diagnostics. Roche is number one in the global diagnostics market, the leading supplier of pharmaceuticals
for cancer and a leader in virology and transplantation. 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 employs roughly 65,000 people in 150 countries.
The Group has alliances and R&D agreements with numerous partners, including majority ownership
interests in Genentech and Chugai.
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercialises biotherapeutics for significant unmet medical needs. Eighteen of the currently approved biotechnology products originated from, or are based on, Genentech science. Genentech manufactures and commercialises 13 biotechnology products in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange under the symbol DNA.
OSI Pharmaceuticals is a leading biotechnology company focused on the discovery, development, and commercialisation of high-quality, next-generation oncology products that both extend life and improve the quality of life for cancer patients worldwide. OSI has a balanced pipeline of oncology drug candidates that includes both novel mechanism-based, gene-targeted therapies focused in the areas of signal transduction and apoptosis and next-generation cytotoxic chemotherapy agents. OSI has a commercial presence in the U.S. oncology market where it exclusively markets Novantrone (mitoxantrone concentrate for injection) for approved oncology indications and Gelclair for the relief of pain associated with oral mucositis.
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