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Roche Pharmaceuticals

Roche to Present Major Advances With Targeted Cancer Medicines at ASCO

Basel, Switzerland (ots/PRNewswire)

- EMBARGOED: Not for publication until: 14 May at 23:00 BST
More than 500 scientific abstracts to be presented across 20
types of cancers. Results could significantly improve the way cancer
is treated for patients with inoperable stomach cancer; advanced
melanoma; lung and breast cancers.
To view the Multimedia News Release, please click:
http://www.prnewswire.com/mnr/roche/38391/
Roche today provided an overview of results from studies that
further the company's approach to developing targeted medicines for
people with cancer, a diagnosis that will affect more than one in
three people during their lifetime. Results from studies involving
the company's approved and investigational treatments will be
presented during the 45th Annual Meeting of the American Society of
Clinical Oncology (ASCO) taking place May 29 through June 2 in
Orlando, USA.
- Advances in HER2-targeted therapy: Positive Phase III results
      for Herceptin in advanced HER2-positive stomach cancer and encouraging
      Phase II data in metastatic HER2-positive breast cancer with the novel
      Treatment trastuzumab-DM1 (T-DM1) that uses the Herceptin antibody to
      deliver a specialised cancer cell-killing agent to tumour cells.
    - New approaches to treating lung cancer: Positive Phase III
      studies of Avastin and Tarceva as first-line maintenance treatments in
      advanced non-small cell lung cancer (NSCLC), including important
      information about biomarkers in lung cancer.
    - Avastin in early-stage colon cancer: Full results on the first
      Phase III study (C-08).
    - Personalising cancer treatment: encouraging early data for Roche's
      targeted BRAF inhibitor in malignant melanoma.
    - Combined Roche and Genentech oncology pipeline: includes 27
      investigational agents in clinical studies.
William M. Burns, CEO of Roche's Pharmaceuticals Division: "We
are presenting strong data for our targeted medicines for
difficult-to-treat cancers including inoperable stomach cancer, lung
cancer and melanoma. Data on Herceptin will show that it is a very
effective treatment in patients with HER2-positive gastric cancer
where current therapies are associated with poor survival and
toxicity." Burns added: "We will also show very encouraging early
data on a new, highly selective drug for malignant melanoma, the most
serious type of skin cancer for which there are few treatments and no
established standard of care."
Targeted therapy with Herceptin prolongs lives of patients with
HER2-positive advanced stomach cancer
Results from the pivotal ToGA study will demonstrate
unprecedented benefits associated with the targeted therapy Herceptin
(trastuzumab) in helping patients with inoperable stomach cancer live
longer, similar to the proven survival benefit of Herceptin observed
in HER2-positive breast cancer. Results from the ToGA study which
investigated the use of Herceptin in combination with chemotherapy
(Xeloda [capecitabine] /intravenous 5-FU and cisplatin) will show how
biomarker guided therapy could change the treatment of this
devastating disease. Every year one million people worldwide are
diagnosed with stomach cancer and 800,000 people die. ASCO abstract
LBA4509
New combination approach to attack HER2-positive breast cancer
Final efficacy results will be presented from a Phase II study
(TDM4258g) of T-DM1 in women whose breast cancer had progressed
following previous treatment with two or more HER2-targeted
therapies. These patients who have nearly no treatment options left,
still could benefit from T-DM1. T-DM1 is a novel antibody-drug
combination that links Herceptin and the cell-killing agent DM1. A
Phase III study (EMILIA) evaluating T-DM1 for second-line advanced
HER2-positive breast cancer was initiated this year.
Chemo-free targeted maintenance treatment for lung cancer
Two pivotal Phase III studies will show that effective
maintenance treatment can help lung cancer patients continue to fight
their disease without the need for continued chemotherapy,
potentially creating a new treatment strategy in lung cancer. The
first of the studies (SATURN) demonstrates the benefits of the
targeted agent Tarceva (erlotinib) in helping patients with NSCLC
live longer without their disease progressing when given after
chemotherapy. The second study (ATLAS) will highlight efficacy data
in patients treated with 'Avastin (bevacizumab) followed by combined
maintenance treatment with Avastin and Tarceva. SATURN ASCO abstract
8001: http://www.abstract.asco.org
First trial results of Avastin in the adjuvant setting
Full results from the first trial of Avastin in early-stage colon
cancer (known as NSABP C-08) will be presented. Although the study
did not meet its primary endpoint of improving disease free survival,
initial review of the data suggests Avastin may be active in patients
with early-stage colon cancer. The ongoing adjuvant program in colon,
breast and lung cancer involves over 26,000 patients. This includes
the AVANT trial in early-stage colon cancer, results of which are
expected in 2010. These results also do not impact Avastin's approved
use in advanced or metastatic colorectal cancer.
Continuing proof in metastatic colorectal cancer
A number of significant data presentations will be made at ASCO
which confirm Avastin-based therapy as the standard of care in
metastatic colorectal cancer with proven efficacy in all patient
sub-groups. These will also highlight the extensive ongoing research
program which will help unlock Avastin's full potential across all
stages of the disease.
CO-8 and ATLAS are two of 10 oral presentations on Avastin at the
meeting. Results will be presented for mid-stage studies in other
types of cancer as well. Avastin is being studied in more than 450
clinical studies worldwide and more than 30 different tumour types.
Potential new personalised treatment for malignant melanoma
Roche and its partner, Plexxikon Inc., will present promising
results from a Phase I trial of PLX4032/R7204. This is a highly
selective medicine that targets the mutated cancer-causing BRAF
protein that occurs in 60% of melanoma (skin) cancers and up to eight
percent of all solid tumours. Based on the significant responses seen
in the phase I study, the medicine could enter registration trials
for malignant melanoma later this year. Melanoma is an aggressive
cancer for which few treatment options are currently available. If
successful in treating melanoma PLX4032 is expected to be launched
with a companion diagnostic, also being co-developed by Roche and
Plexxikon which would be another step forward in personalising this
cancer treatment. ASCO abstract 9000: http://www.abstract.asco.org
The 2009 ASCO Annual Meeting takes place from 29 May to 2 June,
Orlando, Florida, USA. Full details can be found at
http://www.asco.org/ASCO/Meetings/ASCO+Annual+Meeting.
Full details of key Roche data presentations will be given on
Friday 29 May at an invitation-only media event for non-USA
journalists. If you or your media colleagues are interested in
attending this event please contact Roche Group Media Relations.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in
research-focused healthcare with combined strengths in
pharmaceuticals and diagnostics. Roche is the world's largest biotech
company with truly differentiated medicines in oncology, virology,
inflammation, metabolism and CNS. Roche is also the world leader in
in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer
in diabetes management. Roche's personalised healthcare strategy aims
at providing medicines and diagnostic tools that enable tangible
improvements in the health, quality of life and survival of patients.
In 2008, Roche had over 80'000 employees worldwide and invested
almost 9 billion Swiss francs in R&D.
The Group posted sales of 45.6 billion Swiss francs. Genentech,
United States, is a wholly owned member of the Roche Group. Roche has
a majority stake in Chugai Pharmaceutical, Japan.
For more information: http://www.roche.com.
All trademarks used or mentioned in this release are protected by
law.
Roche Group Media Relations:
    Phone: +41-61-688-8888
    e-mail:  basel.mediaoffice@roche.com
    - Daniel Piller (Head)
    - Alexander Klauser
    - Martina Rupp
    - Claudia Schmitt
    - Nina Schwab-Hautzinger

Contact:

Roche Group Media Relations: Phone: +41-61-688-8888, e-mail:
basel.mediaoffice@roche.com, Daniel Piller (Head), Alexander Klauser,
Martina Rupp, Claudia Schmitt, Nina Schwab-Hautzinger

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