Merck KGaA, Darmstadt, Germany, today announced the initiation of its
multi-national Phase III study of the investigational therapeutic cancer
vaccine Stimuvax® (BLP25 liposome vaccine) in Asian patients
with advanced non-small cell lung cancer (NSCLC). The INSPIRE
study will investigate if Stimuvax can extend overall survival in Asian
patients with unresectable stage III NSCLC.
INSPIRE is being initiated in five Asian regions. Enrollment in the
study, which will involve approximately 420 patients across China, Hong
Kong, South Korea, Singapore and Taiwan, is now open in Hong Kong and
will subsequently expand to the additional countries.
“There is a large unmet need in the treatment of stage III lung cancer,
which is associated with a high mortality rate,” said the Principal
Investigator of the study Professor Tony Mok, Department of Clinical
Oncology, Chinese University of Hong Kong. “The incidence of lung cancer
is rising in Asia, and more so, the genetic profile of the illness is
unique. That is why the initiation of the INSPIRE trial is such an
important milestone.”
The design of the INSPIRE trial is almost identical to that of the START
study; both are multi-national, Phase III, double-blind,
placebo-controlled, randomized clinical studies. These trials will
evaluate the efficacy, safety and tolerability of Stimuvax in patients
with unresectable, stage III NSCLC who have demonstrated either stable
disease or objective response following primary chemo-radiotherapy.
Progression-free survival, quality of life and safety will also be
assessed in INSPIRE and START.
“The initiation of the INSPIRE study demonstrates our global commitment
to the development of Stimuvax and to the investigation of
difficult-to-treat cancers such as advanced stage lung cancer,” said Dr
Oliver Kisker, Senior Vice-President, Global Clinical Development Unit
Oncology, Merck KGaA.
Stimuvax is an investigational therapeutic cancer vaccine designed to
stimulate the body’s immune system to identify and target cancer cells
that express MUC1, an antigen commonly expressed in NSCLC as well as in
other common cancer types such as breast cancer, multiple myeloma,
colorectal, prostate and ovarian cancers. Stimuvax was the
first investigational cancer vaccine to enter Phase III clinical testing
in NSCLC with the launch of the START study in February 2007. Stimuvax
is also being investigated in the Phase III STRIDE study,
which is currently enrolling patients who have hormone
receptor-positive, locally advanced, recurrent or metastatic breast
cancer.
Lung cancer – burden of disease
Asia