Merck KGaA Starts Stimuvax Phase III Study INSPIRE in Asian Patients with Advanced NSCLC
Study with investigational therapeutic cancer vaccine Stimuvax initiated in five Asian regions
Merck KGaA 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 INSPIREa 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.
The design of the INSPIRE trial is almost identical to that of the STARTb 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.
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 STRIDEc study, which is currently enrolling patients who have hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer.
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