This was a phase III for patients with metastatic colorectal cancer. It’s a study for patients  with MSI or dMMR and it is a complex trail with two primary endpoints – one previously published and the second one presented at ASCO GI which is the comparison between nivolumab plus ipilimumab versus nivolumab for these patients.

What was the study design?

The study design was a randomisation between nivolumab plus ipilimumab versus nivolumab monotherapy. It was a primary endpoint on centrally confirmed MSI high and dMMR and the primary endpoint was the PFS analysis between both arms.

What were the results of this study?

The result was an improvement of PFS by combination versus monotherapy. The combination of nivolumab plus ipilimumab had a better PFS compared to nivolumab alone. The hazard ratio is 0.661 and at two years 71% of patients were free of progression in the nivolumab plus ipilimumab arm versus 56% for patients treated with nivolumab alone.

What do you think is the clinical significance of these results?

The results are important because it is the demonstration that the combination is better than monotherapy and it is the case for all subgroups of patients in the subgroup analysis. It makes this therapy a potential standard of care in this situation.

Is there anything else you would like to add?

It’s a simple message I have to give you and also an important message. The fact that this data and this result were published in The Lancet on 25th January, just after the meeting.