Merck KGaA announced that the first patient has been enrolled in its global phase III clinical study, START (Stimulating Targeted Antigenic Responses To NSCLC), assessing the efficacy and safety of Stimuvax (BLP25 liposome vaccine) as a potential treatment for patients with unrespectable stage III non-small cell lung cancer (NSCLC).
Enrolment in the study, which will involve more than 1,300 patients in approximately 30 countries, is now open to patients in the US where the first randomisation has occurred. Enrolment will subsequently expand to additional countries. Currently, there are no approved maintenance therapies for patients responding to first-line treatment for unrespectable stage III NSCLC.
"Patients with advanced lung cancer are in need of new therapies that effectively target cancer cells while providing better safety and tolerability," said Dr Frances Shepherd, director of Medical Oncology at Princess Margaret Hospital in Toronto, Ontario and lead investigator of the START study. "Novel therapeutic vaccines such as Stimuvax may help the body's immune system identify and destroy cancer cells without targeting normal, healthy cells."
"The START study is the first phase III programme to evaluate a cancer vaccine in unrespectable stage III non-small cell lung cancer and marks an important milestone for the company in its growing oncology business," said Dr Wolfgang Wein, senior executive vice president, Oncology, Merck Serono. "Our continued investment in research reflects our confidence in Stimuvax and commitment to developing innovative targeted therapies to advance treatment options for patients with cancer."
The START study is a randomised, double-blind, placebo-controlled study that will evaluate patients with documented unrespectable stage III NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemoradiotherapy.