Merck KGaA (MRK) of Germany will conduct a multi-national Phase III clinical trial of the therapeutic cancer vaccine Stimuvax in Asian patients. The trial will enroll 420 patients with advanced non-small cell lung cancer (NSCLC) in five Asian countries: China, Hong Kong, South Korea, Singapore and Taiwan.
In its double-blind Phase IIb trial, the addition of Stimuvax to best supporting care extended median survival from 13.3 months to 30.6 months, an excellent result in a particularly difficult form of cancer.
The Asian trial, called INSPIRE, is almost identical to STARTb, the Phase III multi-national clinical trial being conducted in Western countries that started in June. Both trials will evaluate the efficacy, safety and tolerability of Stimuvax (BLP25 liposome vaccine) 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 be the endpoints of the trial.
Although the theory behind therapeutic cancer vaccines is intriguing, most of the drug candidates developed to date have failed in their clinical trials. Many of these candidates were, unlike Stimuvax, derived from the patientâ€™s own tumor, involving a laborious hands-on process to produce. Stimuvax is an off-the-shelf product. In addition, up to now, Stimuvax has enjoyed a clean safety history.
Stimuvax is based around the mucin -1 (MUC-1) glycoprotein, an antigen that is associated with most tumors. MUC-1 is thought to facilitate immunosuppression, the process by which tumors enable cancer cells to escape detection and destruction by the immune system. It also mediates resistance to anti-cancer agents.