Roche study showed that adding Avastin to radiation and chemotherapy
significantly extended the time people with an aggressive form of brain cancer
lived without their disease worsening
The Phase III AVAglio study met its co-primary endpoint of significantly improving progression-free
survival in people with glioblastoma.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the phase III AVAglio study of Avastin plus
radiation and temozolomide chemotherapy in people with newly diagnosed glioblastoma met its co-primary
endpoint of a significant improvement in progression-free survival (PFS). In the study, Avastin in
combination with radiation and temozolomide chemotherapy significantly extended the time people with
this aggressive form of primary brain cancer lived without their disease getting worse (PFS), compared to
those treated with radiation and temozolomide chemotherapy plus placebo. Data for final overall survival
(OS), the other co-primary endpoint, are expected in 2013.
No new safety findings were observed in the AVAglio study and adverse events were consistent with those
seen in previous trials of Avastin across tumour types for approved indications. Full data from the AVAglio
study will be submitted for presentation at an upcoming medical meeting.
“This study showed that people with glioblastoma, a particularly devastating and aggressive cancer without
many treatment options, lived significantly longer without their disease worsening when Avastin was added
to radiation and temozolomide chemotherapy,” said Hal Barron M.D., Chief Medical Officer and Head
Global Product Development.
Avastin is currently approved in the United States and over 30 countries worldwide for the treatment of
glioblastoma as a single agent and in some countries in combination with irinotecan for adult patients with
progressive disease following prior therapy (relapsed setting). The approval in the USA was granted under
the Food and Drug Administration’s (FDA) accelerated approval programme.
Roche plans to discuss these phase III results with global regulatory authorities, including the European
Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
About the AVAglio study
AVAglio is a phase III, randomised, double blind, placebo controlled trial that assessed the efficacy and safety
profile of Avastin in combination with radiation and temozolomide chemotherapy following surgery or
biopsy in patients with newly diagnosed glioblastoma. Patients were randomised to receive either:
• Avastin plus radiation and temozolomide chemotherapy for six weeks followed by a four-week break.
Patients then received Avastin and temozolomide for up to six cycles, followed by Avastin alone until
disease progression.
• Radiation, temozolomide and placebo for six weeks followed by a four-week break. Patients then
received temozolomide and placebo for up to six cycles, followed by placebo until disease
progression.
The co-primary endpoints of the study were OS and PFS as assessed by trial investigators. Secondary
endpoints included one- and two-year survival rates, PFS as assessed by an independent review committee,
safety profile, and quality of life measures.
About glioblastoma
Glioma (cancer of the glial cells) is the most common type of malignant primary brain tumour (a tumour
that originates in the brain), accounting for approximately one third of all cases diagnosed1. Glioblastoma (or
glioblastoma multiforme; GBM) is the most common and the most aggressive type of glioma1. Glioblastoma
affects approximately 13,000 people per year in the EU1. Glioblastoma is a rational therapeutic target for
Avastin as these tumours have among the highest levels of vascular endothelial growth factor (VEGF) of any
solid tumour.
About Avastin: Over 8 Years of Transforming Cancer Care
With the initial approval in the USA for advanced colorectal cancer in 2004, Avastin became the first antiangiogenic
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 USA for the treatment of colorectal cancer, non-small cell lung
cancer and kidney cancer. In addition, Avastin is approved in the USA and over 30 other countries for the
treatment of patients with progressive glioblastoma following prior therapy. 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 tumour types.
