Merck KGaA (Merck) has initiated 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 is expected to investigate if Stimuvax can extend overall survival in Asian patients with unresectable stage III NSCLC.
Reportedly, 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 company said that 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, randomised clinical studies.
These trials is expected to 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.
Tony Mok, principal investigator of the study, said: “There is a large unmet need in the treatment of stage III lung cancer, which is associated with a high mortality rate. That is why the initiation of the Inspire trial is such an important milestone.”
Oliver Kisker, senior vice-president of global clinical development unit oncology at Merck, said: “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.”