NSCLC Vaccine Shows Limited Maintenance Therapy Potential

Maintenance treatment vaccine shows some efficacy in non-small-cell lung cancer patients treated within 12 weeks of induction chemoradiotherapy

medwireNews: Survival may be prolonged in advanced non-small-cell lung cancer (NSCLC) patients given an allogeneic whole tumour cell vaccine as a maintenance therapy within 3 months of first-line, platinum-based chemoradiotherapy, study findings suggest.

The phase III trial included 270 patients with stage III/IV NSCLC who were randomly assigned to receive belagenpumatucel-L – a vaccine consisting of four NSCLC cell lines genetically modified using a transforming growth factor (TGF)-β2-antisense vector – within 1 to 4 months of achieving stable disease or a response to induction chemotherapy and 262 patients given placebo.

The researchers report in the European Journal of Cancer that belagenpumatucel-L did not meet the primary endpoint of a significant increase in median overall survival (OS) or progression-free survival compared with placebo, but that the vaccine did show “encouraging results in predefined subsets of patients”.

Regression analysis revealed a “clinically meaningful” trend towards greater OS for patients who received belagenpumatucel-L within 12 weeks of completing induction chemotherapy compared with placebo-treated controls, at a median of 20.7 versus 13.4 months, say Giuseppe Giaccone, from the National Cancer Institute in Bethesda, Maryland, USA, and co-authors.

Moreover, receipt of radiation before belagenpumatucel-L was a significant positive predictor for OS, at a median of 28.4 months versus 16.0 months for placebo-treated patients given chemoradiation beforehand, giving a hazard ratio (HR) of 0.61.

In all, 46 patients received chemoradiation and belagenpumatucel-L within 12 weeks, as did 38 patients who were assigned to receive placebo. Median OS was 28.4 and 10.3 months, respectively, giving a significant HR of 0.47.

The authors write that tumour irradiation is known to have positive effects on anti-tumour immunity, and suggest that their study, viewed alongside findings for a MUC1 vaccine, “generates an important hypothesis for the further study of tumour vaccines and should be considered in the design of future immunotherapy vaccine protocols.”

Noting that the vaccine’s toxicity profile compares “very favorably” with those of existing maintenance therapies, the researchers believe that a study to confirm the relationships between belagenpumatucel-L and treatment timing and radiation receipt is warranted.

Research to investigate potential treatment combinations of the vaccine with drugs targeting programmed cell death protein 1 or programmed death-ligand 1 could also be considered, they suggest.


Giaccone G, Bazhenova LA, Nemunaitis J, et al. A phase III study of belagenpumatucel-L, an allogeneic tumour cell vaccine, as maintenance therapy for non-small cell lung cancer. Eur J Cancer 2015; Advance online publication 14 August. doi:10.1016/j.ejca.2015.07.035

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