First phase III study to appraise continued Avastin through different
lines of therapy.
BASEL, Switzerland, June 4, 2012 /CNW/ - Roche (SIX: RO, ROG; OTCQX:
RHHBY) today announced results from ML18147, a phase III study in
metastatic colorectal cancer (mCRC) that evaluated Avastin
(bevacizumab) continued with second-line chemotherapy in people who
received initial Avastin plus first-line chemotherapy.
The study met its primary endpoint of a significant increase in overall
survival (OS). In the study, the relative risk of death was reduced by
19 percent for people who continued with Avastin plus second-line
chemotherapy compared with those who received chemotherapy alone (HR =
0.81, p = 0.0062). People who continued with Avastin plus second-line
chemotherapy also experienced a significant improvement in progression
free survival (PFS, the time a person lives without the disease getting
worse); the risk of their cancer progressing was reduced by 32 percent
(HR = 0.68, p<0.0001). Adverse events in ML18147 were consistent with
those seen in previous pivotal trials of Avastin across tumour types
and were not increased when continuing Avastin.
"Our study design was based on previous research showing that sustained
VEGF inhibition achieved and maintained anti-tumour activity," said Hal
Barron M.D., chief medical officer and head, Global Product
Development. "While conventional practice is to change treatment
completely at disease progression, the continued use of Avastin with a
new chemotherapy regimen in this study resulted in patients living
longer, compared to a new chemotherapy regimen alone."
These results were featured in a press briefing on Saturday, June 2nd at
the 48th Annual Meeting of the American Society of Clinical Oncology.
Full results will be presented in the ASCO Gastrointestinal
(Colorectal) Cancer Oral Abstracts session by Professor Dirk Arnold,
the ML18147 Principal Investigator and Associate Professor of Medicine
at the Department of Haematology and Oncology, Martin Luther University
Halle-Wittenberg, Halle, Germany (Abstract CRA3503, Sunday, June 3,
10:45 a.m. CDT).
ML18147 Study Results
People with mCRC who received Avastin in combination with standard
chemotherapy in both the first- and second-line settings had a median
OS of 11.2 months compared to 9.8 months for people who received
Median PFS was 5.7 months compared to 4.1 months.
OS and PFS were calculated from the time patients were randomised to the
About the ML18147 study
ML18147 was a randomised, open-label phase III multicentre,
multinational trial evaluating the efficacy and safety profile of
Avastin plus standard second-line chemotherapy in 820 patients with
mCRC whose disease had progressed following Avastin plus standard
first-line chemotherapy (irinotecan or oxaliplatin-based). Patients
were randomised at progression to one of two treatment arms:
Arm A: Chemotherapy* plus Avastin (equivalent of 2.5 mg/kg i.v. per
Arm B: Chemotherapy* alone
*Depending on the first-line chemotherapy backbone (fluoropyrimidine /
irinotecan-based or fluoropyrimidine / oxaliplatin-based) the
chemotherapy backbone was switched in the second-line setting.
The primary endpoint of the study was overall survival measured from the
time patients were randomised to the second-line treatment. The
secondary efficacy endpoints of the study included PFS, overall
response rate and safety profile.
About metastatic Colorectal Cancer (mCRC)
Colorectal cancer is one of the most common cancers in the world, with
over 1.2 million new cases diagnosed each year; it is the second most
common cancer in women and the third most common cancer in men.1
Despite improvements in screening for early diagnosis, colorectal cancer
remains one of the biggest cancer killers in the world and is
responsible for over 600,000 deaths each year.1,2
In general the current treatment options for colorectal cancer are
surgery, chemotherapy, and biological therapies. Early-stage
(localised) cancer has the potential to be cured if the tumour can be
successfully surgically removed. Patients with advanced (metastatic)
disease are usually treated with chemotherapy after surgery, known as
'first-line' treatment. Many people initially respond to chemotherapy,
but unfortunately, in the majority of cases the disease eventually
progresses after first-line treatment and patients may require a
further round of treatment ('second-line'). There is therefore a real
need for effective, tolerable treatments for long-term disease control
in metastatic colorectal cancer.
About Avastin: Over 7 Years of Transforming Cancer Care
With the initial approval in the USA for advanced colorectal cancer in
2004, Avastin became the first anti-angiogenic therapy made widely
available for the treatment of patients with an advanced cancer.
Today, Avastin is continuing to transform cancer care through its proven
survival benefit (overall survival and/or progression free survival)
across several types of cancer. Avastin is approved in Europe for the
treatment of advanced stages of breast cancer, colorectal cancer,
non-small cell lung cancer, kidney cancer and ovarian cancer, and is
available in the US for the treatment of colorectal cancer, non-small
cell lung cancer and kidney cancer. In addition, Avastin is approved in
the US and over 30 other countries for the treatment of patients with
glioblastoma (a type of brain cancer). Avastin is approved in Japan for
the treatment of the advanced stages of colorectal, non-small cell lung
cancer and breast cancer. Avastin is the only anti-angiogenic therapy
available for the treatment of these numerous advanced cancer types,
which collectively cause over 2.5 million deaths each year.
Avastin has made anti-angiogenic therapy a fundamental pillar of cancer
treatment today - over one million patients have been treated with
Avastin so far. A comprehensive clinical programme with more than 500
ongoing clinical trials is investigating the use of Avastin in over 50
About Avastin: Mode of Action
An independent blood supply is critical for a tumour to grow beyond a
certain size (2mm) and spread (metastasise) to other parts of the body.
Tumours develop their own blood supply in a process called angiogenesis
by releasing vascular endothelial growth factor (VEGF) - a key driver
for tumour growth. Avastin is an antibody that precisely targets and
inhibits VEGF for continuous tumour control. Avastin's precise VEGF
inhibition allows it to be combined effectively with a broad range of
chemotherapies and other anti-cancer treatments with limited additional
impact on the side effects of these therapies.
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 2011, Roche had
over 80,000 employees worldwide and invested over 8 billion Swiss
francs in R&D. The Group posted sales of 42.5 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
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1 WHO, IARC GLOBOCAN, Cancer Incidence and Mortality Worldwide in 2008 at
2 Edwards BK et al. Annual Report to the Nation on the Status of Cancer,
1975-2006, Featuring Colorectal Cancer Trends and Impact of
Interventions (Risk Factors, Screening, and Treatment) to Reduce Future
Rates. Cancer (2009) 116(3):544-573
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