STIMUVAX BEGINS STUDY OF CANCER VACCINE IN NSCLC

Merck KGaA announced that the first patient has been enrolled in its global Phase III clinical study, START, assessing the efficacy and safety of Stimuvax (BLP25 liposome vaccine) as a potential treatment for patients with unresectable stage III non-small-cell lung cancer (NSCLC).

The study will enroll more than 1,300 patients in approximately 30 countries. Currently, there are no approved maintenance therapies for patients responding to first-line treatment for unresectable stage III NSCLC.

"The START study is the first Phase III program to evaluate a cancer vaccine in unresectable stage III non-small-cell lung cancer and marks an important milestone for the company in its growing oncology business," Wolfgang Wein, senior executive vice president of oncology for Merck Serono, said.

The START study is a randomized, double-blind, placebo-controlled study that will evaluate patients who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The study has been designed considering scientific advice from the European Medicines Agency and has been agreed upon by the FDA through the special protocol assessment process.

Stimuvax is an innovative cancer vaccine designed to induce an immune response to cancer cells that express MUC1, a protein antigen widely expressed on common cancers. MUC1 is over-expressed in many cancers such as lung cancer, breast cancer and colorectal cancer. Stimuvax is thought to work by stimulating the body's immune system to identify and destroy cancer cells expressing MUC1.