Belagenpumatucel-L, an allogeneic tumor cell vaccine, as maintenance therapy for non-small cell lung cancer (NSCLC) may benefit patients who initiate immunotherapy within 12 weeks of completion of chemotherapy and those who have received prior radiation, a study published in the November issue of the European Journal of Cancer has shown.1
Belagenpumatucel-L is a therapeutic vaccine made up of 4 transforming growth factor (TGF)-β2-antisense gene-modified, irradiated, allogeneic NSCLC cell lines.
Previous studies have demonstrated that the vaccine may be useful for maintenance therapy after patients have received initial treatment.
For the phase 3 study, researchers enrolled 532 patients with stage 3 or 4 NSCLC who did not experience disease progression following platinum-based chemotherapy.
Participants were randomly assigned 1:1 to receive maintenance belagenpumatucel-L or placebo 1 to 4 months from the end of induction chemotherapy.
Results showed that median overall survival was 20.3 months with belagenpumatucel-L compared with 17.8 months with placebo (HR=.94; P=.594) and progression-free survival was 4.3 months and 4.0 months, respectively (HR=.99; P=.947).
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Despite no statistically significant difference in overall survival or progression-free survival between the 2 treatment arms, researchers found that the time elapsed between the end of induction chemotherapy and randomization had a significant impact on survival (P=.002) and that prior radiation improved survival as well (HR=.61; P=.032).
The authors concluded that further studies of the vaccine in NSCLC are warranted.
- Giaccone G, Bazhenova LA, Nemunaitis J, et al. A phase III study of belagenpumatucel-L, an allogeneic tumor cell vaccine, as maintenance therapy for non-small cell lung cancer. E J Cancer. 2015;51(16):2321-2329.