The EMPOWER-Lung 1 study was a randomised phase III trial designed to assess clinical benefit of cemiplimab monotherapy in patients with newly diagnosed non-small cell lung cancer with PD-L1 expression of 50% or more and no EGFR, ALK or ROS1aberrations. The primary endpoints were overall survival and progression free survival and at ELCC I was presenting the 6-year follow-up data from this trial.

These findings represent a significant milestone, showcasing one of the longest ever follow-ups for a trial of an immune checkpoint inhibitor in this treatment setting. Advanced non-small cell lung cancer is very difficult to treat and having long-term data helps to understand the potential role of treatment options like cemiplimab.

What were the key findings?

The trial demonstrated significant improvements in overall survival, progression free survival and objective response rate compared to chemotherapy. For example, 26 months median overall survival was for the cemiplimab arm compared to the chemotherapy arm of 13 months, representing a 40% reduction in the risk of death; 23% probability of survival at 6 years for cemiplimab versus 13%; 8 months median progression free survival versus 5 months, representing a 49% reduction in the risk of disease progression. About objective response rate it was 46% versus 21%.

What could be the clinical significance of these results?

It’s very important for treatment decision making for oncologists, for us, because having this data, this long-term data, helps us to decide what treatment to give the patient.

Is there anything else you would like to add?

Efficacy was demonstrated in both squamous and non-squamous histology and the greatest benefits were observed in the highest PD-L1 expression subgroup where PD-L1 was ≥ 90%. Also these findings validate the long-term clinical benefit of cemiplimab first line monotherapy in PD-L1 high advanced non-small cell lung cancer and reinforce the value of long-term immune checkpoint inhibition.