This study is a clinical trial for patients diagnosed with metastatic colorectal cancer with a particular molecular status that is called microsatellite instability or what is the same as deficient mismatch repair tumours. So these tumours are characterised to have a high tumour load of mutations so in this case the role of immunotherapy has been demonstrated, particularly in regards to PD-1 inhibitors.
What this clinical trial did was to compare PD-1, namely nivolumab, compared to a combination of nivolumab/ipilimumab or that standard of care. What we presented at ESMO GI is the results of the comparison of nivolumab/ipilimumab versus nivolumab in terms of quality of life.
What were the study design and results?
The clinical trial had a primary objective of progression free survival and, indeed, we had the results and it was demonstrated on one side that the combination of nivolumab and ipilimumab was superior compared to standard of care, which means chemotherapy plus a biological agent depending on the RAS/BRAF mutational status. Later on were presented the results of the comparison of nivolumab versus nivolumab/ipilimumab across all lines of treatment. What we saw is that nivolumab/ipilimumab was shown to be superior as well in terms of progression free survival.
The question is that to date we still don’t know if all patients require a doublet and it’s important to stress that when we are treating patients with two drugs the impact in terms of toxicity could be higher. That’s why it was very important to check the quality of life of these particular patients. As mentioned, these are the results that were presented this year at ESMO GI.
What is the significance of these results?
What we see is that although it was previously presented that patients treated with nivolumab/ipilimumab have a higher rate of grade 3/4 events, that’s not translated in the treatment in terms of quality of life. So, first, those patients that are treated with a doublet present as well an improvement in terms of quality of life and what we see is that for particular outcomes there is a numerically higher superiority in terms of a benefit in terms of quality of life for those patients treated with a doublet compared with monotherapy.
