Biomera’s new liposomal vaccine for treating non-small cell lung cancer – L-BLP25 – is to move into Phase III testing, following promising data from a Phase II trial presented at the recent American Society of Clinical Oncology meeting.
Professor Nevin Murray of the University of British Columbia said results from the 171-patient study justified a larger trial focussing on a more selective patient population. This is scheduled to start recruiting 1,000 patients early in 2006.
Survival rates following vaccine treatment were substantially higher among patients with stage IIIb disease treated with the L-BLP25 vaccine than among patients with more severe disease – 54% of patients with stage IIIb disease achieved the median survival of 36 months, compared with 33% achieved by unvaccinated patients at the same stage of disease. Patients with stage IV disease had a 20% 36-month median survival rate compared with 15% for unvaccinated controls. The upcoming Phase III trial will focus on stage IIIb patients receiving chemotherapy and high-dose radiotherapy who will receive either L-BLP25 or placebo.
Lung cancer accounts for around 12% of US cancers, and the estimated yearly incidence in the US is 172,000. L-BLP25, which is being developed in North America by Biomira and EMD Pharmaceuticals and in all other territories by Merck KGaA [[04/05/01b]], was fast-tracked for development by the US Food and Drug Administration in September last year [[30/09/04f]].