Initiation of multi-national Phase III study of Stimuvax announced

Dec 11 2009

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

• In 2007, lung cancer was responsible for 20.9% of all cancer-related deaths in Eastern Asia and 17.8% of all cancer-related deaths in South-Eastern Asia
• Lung cancer accounted for 17.1% of newly diagnosed cancer cases in Eastern Asia and 13.3% of newly diagnosed cancer cases in South-Eastern Asia in 2007
• The incidence of lung cancer is predicted to increase substantially throughout Asia, particularly among males

Worldwide

• It is estimated that 1,351,000 people worldwide die from lung cancer every year
• Around 80% of lung cancer patients have NSCLC and first present with advanced disease, which is difficult to treat
• Only 10% of lung cancer patients are alive 5 years after diagnosis, compared to 81% of melanoma and 75% of breast cancer patients
• At diagnosis, most patients with NSCLC present with advanced, inoperable (also called unresectable) disease, which is associated with poor prognosis
• Approximately 25 to 30% of cases are diagnosed as locally advanced disease (stage III) and 40 to 50% are diagnosed as metastatic disease (stage IV)