Can tecemotide benefit inoperable non-small cell lung cancer patients?

The authors aimed to reanalyze data from phase 3 clinical trial of tecemotide in non-small cell lung cancer (NSCLC) patients.

NSCLC is the most common type of lung cancer. Standard treatments for inoperable NSCLC (cancer that cannot be removed surgically) are chemotherapy, radiation or a combination of both (chemoradiotherapy). Overall benefit from these methods has been limited. Immunotherapy is an alternate treatment that uses the body’s own immune system to recognize and fight cancer cells. Tecemotide is an immunotherapy that targets MUC1, a protein that is overproduced in NSCLC. The role of MUC1 as a possible biomarker in NSCLC is also tested in this analysis. Biomarkers are naturally occurring body substances that are associated with a disease and often used for predicting the outcome of a disease.

In this phase 3 clinical trial, patients with stage III NSCLC were first given chemoradiotherapy. Those who responded to treatment within 4-12 weeks were then randomly assigned to receive tecemotide (829 patients) or placebo (410 patients). The effect of tecemotide on overall survival and correlation between overall survival and possible biomarkers (MUC1, ANA) were analyzed. Biomarker levels of patients were measured after chemoradiotherapy but before the start of tecemotide therapy.

The average overall survival of tecemotide treated patients was 25.8 months compared to 22.4 months in the placebo group. The tecemotide group of patients had 11% reduced risk of death compared to placebo.

A further analysis on overall survival of the subgroup of patients treated with chemotherapy and radiation together (as opposed to one after another) followed with tecemotide treatment was carried out. Overall survival was 29.4 months for those who took tecemotide in this group compared to placebo (20.8 months). 

High levels of MUC1 and ANA were found in patients who were later treated with tecemotide.

Based on the analysis, the authors concluded that tecemotide along with chemoradiotherapy could be a possible treatment option in inoperable NSCLC. Increased level of potential biomarkers MUC1 and ANA could be linked to tecemotide benefit.