New immunotherapy for non-small cell lung cancer

This trial assessed the effectiveness of combining a TG4010, a type of immunotherapy, with chemotherapy for non-small-cell lung cancer. It also examined whether TG4010 was more effective in patients with a low level of certain immune cells, called triple positive activated lymphocytes (TrPAL).

The study concluded that TG4010 was effective and safe when combined with chemotherapy and was more effective in patients with low levels of TrPAL.

Immunotherapies are treatments that help the immune system attack certain proteins responsible for cancer growth. MUC1, for example, is a protein present in many non-small cell lung cancers. TG4010 is a type of immunotherapy that activates an immune response against MUC1. Previous studies have suggested that TG4010 combined with chemotherapy may be effective in patients with non-small cell lung cancer and low levels of TrPAL. 

This study examined whether TG4010 was an effective treatment when combined with chemotherapy.

A total of 222 patients with non-small cell lung cancer that had spread beyond the lungs were randomly assigned to one of two groups. 111 patients received TG4010 and chemotherapy (group 1) and 111 patients received placebo (a substance with no effect on the body) and chemotherapy (group 2). Progression free survival (PFS, time following treatment before the disease progresses), adverse side effects and duration of response were compared.

PFS was longer in group 1 (5.9 months) compared to group 2 (5.1 months). 33% of group 1 had a reaction at the injection site compared to 4% of group 2. 4% of patients in group 1 had more severe side effects (including low levels of both white and red blood cells) compared to 11% in group 2. A response to treatment was seen in group 1 for an average of 30.1 weeks compared to 18.7 weeks for group 2.

TG4010 was most effective in patients with low levels of TrPAL.

This study concluded that combining TG4010 with chemotherapy was safe and effective in non-small cell lung cancer. This treatment combination was particularly effective in patients with low levels of TrPAL.

This study was funded by Transgene, the producers of TG4010.