Belagenpumatucel-L (NovaRx's Lucanix), is a cell-based therapeutic vaccine that is being studied in non-small cell lung cancer (NSCLC), and results presented at the AACR Annual Meeting 2012 showed significant improvements in long-term survival.
The presentation looked at 5 years of follow-up of a Phase II trial of the vaccine in 75 patients with NSCLC at different stages. Typical 5-year survival rates in NSCLC are 11 percent to 15 percent overall, and less than 5 percent at stage IIIB/IV (advanced cancer). In the belagenpumatucel-L trial, 20 percent of the patients overall and 18 percent of the patients with stage IIIB/IV disease survived for 5 years.
Patients with stage IIIB/IV nonprogressive disease after chemotherapy had a median survival of 44.4 months and the 5-year survival was 50 percent, which is "unheard of for patients with NSCLC," said Dr. Lyudmila Bazhenova, associate clinical professor at the University of California-San Diego Moores Cancer Center. This survival rate fell to 9.1 percent for patients who progressed after first-line chemotherapy.
In another presentation at AACR, patients' level of immune response (both cellular and humoral) to belagenpumatucel-L was shown to correspond with their overall survival, which could be used to predict the outcome of their treatment.
The vaccine is based on four NSCLC cell lines that have been genetically modified to produce antisense RNA against transforming growth factor beta2 (TGF-beta2). This reduces the cancer's ability to damp down the immune system and so improves the immune response. A pivotal Phase III trial to evaluate belagenpumatucel-L in a maintenance setting in stage III/IV NSCLC patients who have stable disease or better after frontline chemotherapy is under way in 8 countries to see if these results can be replicated in larger groups.