It was the EPIC-A trial which is a phase II trial of cemiplimab plus standard of care chemotherapy for locally advanced or metastatic penile cancer followed by maintenance cemiplimab.

What was the study design?

It was a phase II study with two arms to the study but the EPIC-A ,which is the first arm, is the combination of standard of care chemotherapy for four cycles with cemiplimab given three weekly for four cycles followed by maintenance cemiplimab for a total of 34 cycles. So in all two years of treatment. Arm 2, which is EPIC-B, is single agent cemiplimab treatment in patients who were ineligible for chemotherapy. The data that we presented in the oral presentation at ASCO GU was on the EPIC-A which is the chemoimmunotherapy combination arm followed by maintenance cemiplimab. The study was conducted in 11 centres in the UK.

What were the results of this study?

The study met its primary endpoint by showing a clinical benefit rate of 62.1% and an objective response rate of greater than 50% which was the primary endpoint which was the clinical benefit rate. The median progression free survival was 6.2 months and the median overall survival was 15.5 months which, in this rare group of patients, is the best reported median overall survival in advanced or metastatic penile cancer.

What is the clinical significance of these results?

These results show significant promise of combining cemiplimab with standard of care chemotherapy. Obviously in rare cancers advances are difficult to make because it is difficult and challenging to do randomised trials. But based on our results and also the results of the HERCULES trial we now see that combining immunotherapy to standard of care chemotherapy should be considered as an option for first-line treatment for patients with locally advanced or metastatic penile cancer.