A study of a new novel vaccine for the treatment of non-small cell lung cancer (NSCLC) may have found potential benefits for specific patients who initiate immunotherapy within 12 weeks of completing chemotherapy and who have received prior radiation. The study was published in the European Journal of Cancer.
The vaccine, belagenpumatucel-L, was creating by genetically modifying NSCLC tumors and then irradiating and freezing them. When administered, those cells can elicit the immune system to respond against host NSCLC cells and inhibit tumor proliferation. Past studies of the vaccine have demonstrated that it may be useful for maintenance therapy after patients receive their initial treatment.
In a phase III trial, researchers analyzed the effectiveness of belagenpumatucel-L against a placebo in patients whose disease did not progress after treatment with platinum-based chemotherapy. More than 500 patients were enrolled in the study; 270 were treated with belagenpumatucel-L, and 262 patients were placed in a control arm. Randomized follow-ups took place between week 4 and week 17.4.
Overall survival, which was the primary endpoint of the study, was 20.3 months with belagenpumatucel-L and 17.8 months with placebo, leading researchers to conclude that the vaccine did not confer a significant survival benefit.
However, further study showed cancer stage, pretreatment radiation, and histology to be significant prognostic factors. Patients treated with the vaccine after having been treated with radiation had a median overall survival of 40.1 months as compared to just 10.3 months for those receiving placebo. Additionally, patients who had completed their chemotherapy within 12 weeks of beginning treatment of the vaccine had a median overall survival of 19.9 months on belagenpumatucel-L, whereas the placebo group had a median overall survival of only 12.3 months.
These results, coupled with the vaccine being well-tolerated in patients—there was only one serious adverse event, a grade 3 allergic rash associated with injection—led researchers to conclude that the vaccine might be beneficial in these specific groups of patients. Further study is needed to confirm these results.
