New Study Suggests Combining Breakthrough Therapies Tarceva(R) and Avastin(R) May Provide More Hope for Lung Cancer Patients

New Study Suggests Combining Breakthrough Therapies Tarceva(R) and Avastin(R) May Provide More Hope for Lung Cancer Patients

June 06, 2006

    BASEL, Switzerland, June 6 /Xinhua-PRNewswire/ -- A new
study(1) suggests that treatment with the combination of the
innovative cancer drugs Avastin (bevacizumab) and Tarceva
(erlotinib) or Avastin with chemotherapy, improves
progression-free survival in patients with recurrent or
refractory non-small cell lung cancer (NSCLC), the most
common form of lung cancer, when compared with standard
chemotherapy alone. Progression-free survival is the time
patients live without their cancer advancing. These data
were presented today at the 42nd Annual Meeting of the
American Society of Clinical Oncology (ASCO), Atlanta.

    "These findings signal the potential for combining
novel therapies that target different cancer growth
pathways, to achieve better overall patient outcomes, with
a low incidence of serious side effects," said Willem
Verhoofstad, Global Business Director for Roche Oncology.
"We are continuing to invest and explore the safety
and efficacy of the Avastin and Tarceva combination and are
currently conducting Phase III trials with both products in
first-line and relapsed NSCLC settings."

    The randomised, Phase II exploratory study evaluated
three treatment regimens in patients with recurrent or
refractory NSCLC:

     -- Avastin in addition to Tarceva

     -- Avastin in addition to chemotherapy (either
pemetrexed or docetaxel)

     -- Chemotherapy alone (either pemetrexed or docetaxel)
as control arm

    The study suggests that Avastin in combination with
Tarceva or chemotherapy improves progression-free survival,
the primary study endpoint, compared to chemotherapy alone.
Median progression-free survival in the Avastin plus
chemotherapy arm was 4.8 months, and was 4.4 months in the
Avastin plus Tarceva arm, compared to just 3.0 months in
the chemotherapy alone arm. The study results also showed
that the toxicity profile of the Avastin plus Tarceva
combination was favourable, resulting in fewer serious
adverse events, when compared to either
chemotherapy-containing arm. Due to the exploratory nature
of this randomised Phase II study, these data do not
provide definitive conclusions with respect to differences
between the three treatment arms.

    About the Phase II Exploratory Study

    120 patients with recurrent or refractory NSCLC, who
had not received previous treatment with Avastin or
Tarceva, were enrolled into this study. Patients in the
study had histologically or cytologically confirmed
non-squamous NSCLC and had experienced clinical or
radiographic disease progression during or following one
platinum-based chemotherapy regimen for advanced stage
disease (IIIb or IV).

    The key study results showed:

     -- Treatment with Avastin plus Tarceva reduced the
risk of cancer progression or death by 28 per cent compared
to chemotherapy alone (based on a hazard ratio of 0.72)

     -- Treatment with Avastin plus chemotherapy reduced
the risk of cancer progression or death by 34 per cent
compared to chemotherapy alone (based on a hazard ratio of
0.66)

     -- Treatment with Avastin plus Tarceva saw 78% of
patients alive at six months (median progression-free
survival 4.4 months)

     -- Treatment with Avastin plus chemotherapy saw 72% of
patients alive at six months (median progression-free
survival 4.8 months)

     -- Treatment with chemotherapy alone saw 62% of
patients alive at six months (median progression-free
survival 3.0 months)

     -- The toxicity profile of the Avastin plus Tarceva
combination was favourable, resulting in fewer serious
adverse events, when compared to either
chemotherapy-containing arm

     -- Adverse events in the Avastin plus Tarceva arm were
similar to those observed in previous clinical trials of
Avastin in combination with Tarceva, and included diarrhoea
and rash

     -- Adverse events in the Avastin plus chemotherapy arm
were similar to those observed in previous clinical trials
of Avastin in combination with chemotherapy, and included
hypertension and bleeding

    About Tarceva

    Tarceva is an investigational small molecule that
targets the human epidermal growth factor receptor (HER1)
pathway. HER1, also known as EGFR, is a key component of
this signalling pathway, which plays a role in the
formation and growth of numerous cancers. Tarceva blocks
tumour cell growth by inhibiting the tyrosine kinase
activity of the HER1 signalling pathway inside the cell.

    Taken as an oral, once-daily therapy, Tarceva is the
only EGFR-inhibitor to have demonstrated a survival benefit
in lung cancer. Currently most lung cancer patients are
treated with chemotherapy which can be very debilitating
due to its toxic nature. Tarceva works differently to
chemotherapy by specifically targeting tumour cells, and
avoids the typical side-effects of chemotherapy.

    Tarceva is approved in the US and across the European
Union for patients with locally advanced or metastatic
non-small cell lung cancer (NSCLC) after failure of at
least one prior chemotherapy regimen. Tarceva is approved
in the US in combination with gemcitabine chemotherapy for
the treatment of patients with locally advanced, inoperable
or metastatic pancreatic cancer. A Marketing Authorisation
Application was submitted to the European health
authorities in November 2005.

    Tarceva is currently being evaluated in an extensive
clinical development programme by a global alliance among
OSI Pharmaceuticals, Genentech, and Roche, focussing on
earlier stages of NSCLC. Additionally, Tarceva is being
studied in combination with Avastin in NSCLC. Trials are
also being conducted with Tarceva in other solid tumours,
such as ovarian, bronchioloalveolar (BAC), colorectal,
pancreatic, head and neck and glioma (brain).

    About Avastin

    Avastin is the first treatment that inhibits
angiogenesis -- the growth of a network of blood vessels
that supplies nutrients and oxygen to cancerous tissues.
Avastin targets a naturally occurring protein called VEGF
(Vascular Endothelial Growth Factor), a key mediator of
angiogenesis, thus choking off the blood supply that is
essential for the growth of the tumour and its spread
throughout the body (metastasis).

    Avastin is the first and only anti-angiogenic agent to
have demonstrated improved overall and/or progression-free
survival in the three major types of cancer leading to
death: colorectal cancer, non-small cell lung cancer and
breast cancer. In Europe, Avastin was approved in early
2005 for first-line treatment of patients with metastatic
carcinoma of the colon or rectum in combination with the
chemotherapy regimens of intravenous 5-fluorouracil/folinic
acid or intravenous 5-fluorouracil/folinic acid/irinotecan.
Avastin received approval by the US Food and Drug
Administration (FDA) in February 2004. In addition, filing
occurred in the US on April 10, 2006, for use of Avastin in
previously untreated advanced non-squamous, non-small cell
lung cancer, on May 26 for treatment of women with advanced
breast cancer and in Japan on April 21, 2006 for use of
Avastin in patients with advanced or recurrent colorectal
cancer.

    Roche and Genentech are pursuing a comprehensive
clinical programme investigating the use of Avastin in
various tumour types (including colorectal, breast, lung,
pancreatic cancer, ovarian cancer, renal cell carcinoma and
others) and different settings (advanced and adjuvant i.e.
post-operative). The total development programme is
expected to include over 25,000 patients worldwide.

    Roche in Oncology

    The Roche Group, including its members Genentech in the
United States and Chugai in Japan, is the world's leading
provider of cancer care products, including anti-cancer
treatments, supportive care products and diagnostics. Its
oncology business includes an unprecedented five products
proven to provide survival benefit in different major
tumour indications: Avastin, Herceptin, and Xeloda in
advanced-stage breast cancer, Herceptin in early-stage
HER2-positive breast cancer, MabThera in non-Hodgkin's
lymphoma, Avastin and Xeloda in colorectal cancer, Avastin
and Tarceva in non-small cell lung cancer and Tarceva in
pancreatic cancer.

    In addition to these anti-cancer agents, the Roche
oncology portfolio includes a comprehensive collection of
medicines that can help improve the quality of life of
cancer patients: Bondronat (for prevention of skeletal
events in patients with breast cancer and bone metastases,
hypercalcaemia of malignancy), Kytril (for chemotherapy and
radiotherapy-induced nausea and vomiting), Neupogen (for
cancer-related neutropenia), and NeoRecormon (for anaemia
in various cancer settings). CERA is the most recent
demonstration of Roche's commitment to anaemia management.
Other oncology products include Furtulon (for colorectal
cancer) and Roferon-A (for hairy cell and chronic myeloid
leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell
carcinoma).

    In addition to the medicines, Roche is developing new
diagnostic tests that 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, Roche will continue to be the leader in providing
cancer-focused treatments and diagnostics.

    The unmatched Roche oncology portfolio as well as an
extensive external innovation base through collaborations
with companies and academia is what makes it possible for
Roche to provide more effective cancer therapies.

    In the United States Herceptin, MabThera (Rituxan),
Avastin and Tarceva are marketed either by Genentech alone
or together with its partners Biogen Idec Inc. (MabThera)
and OSI (Tarceva). Outside of the United States, Roche and
its Japanese partner Chugai are responsible for the
marketing of these medicines.

    About Roche

    Headquartered in Basel, Switzerland, Roche is one of
the world's leading research-focused healthcare groups in
the fields of pharmaceuticals and diagnostics. As a
supplier of innovative products and services for the early
detection, prevention, diagnosis and treatment of disease,
the Group contributes on a broad range of fronts to improve
people's health and quality of life. Roche is a world leader
in diagnostics, the leading supplier of medicines for cancer
and transplantation and a market leader in virology. In 2005
sales by the Pharmaceuticals Division totalled 27.3 billion
Swiss francs, and the Diagnostics Division posted sales of
8.2 billion Swiss francs. Roche employs roughly 70,000
people in 150 countries and has R&D agreements and
strategic alliances with numerous partners, including
majority ownership interests in Genentech and Chugai.
Additional information about the Roche Group is available
on the Internet ( http://www.roche.com ).

    All trademarks used or mentioned in this release are
legally protected.

    Reference:

    1) Fehrenbacher, C et al, A phase II, multicenter,
randomized clinical trial to evaluate the efficacy and
safety of Avastin (bevacizumab) in combination with either
chemotherapy (docetaxel or pemetrexed) or Tarceva
(erlotinib hydrochloride) compared with chemotherapy alone
for treatment of recurrent or refractory non-small cell
lung cancer, Abstract #7062, presented at the 42nd Annual
Meeting of the American Society of Clinical Oncology (ASCO)
2006.

    For more information, please contact:

     Christine Hill
     International Communications Manager
     Avastin, Roche Pharmaceuticals
     Tel:    [phone]
     Mobile: [phone]
     Email:  [e-mail]

     Martin McInally
     International Communications Manager
     Tarceva, Roche Pharmaceuticals, 
     Tel:    [phone]
     Mobile: [phone]
     Email:  [e-mail]

SOURCE  Roche