Yesterday I presented the results of the ERMES trial. ERMES is a phase III trial investigating the efficacy of the maintenance therapy with cetuximab alone after induction with FOLFIRI plus cetuximab in the RAS and BRAF wildtype metastatic colorectal cancer patients. The ERMES trial is a phase III trial, the first phase III trial, in a setting where we have the controversial results from three phase II trials such as the VALENTINO trial, the PANAMA trial and then the MACRO-2 trial. So we have, for the first time, a phase III trial in this setting.
For the ERMES trial we had two co-primary endpoints. The first one was the non-inferiority in terms of progression free survival of the experimental arm versus the standard arm. The experimental arm was cetuximab in maintenance with a lone therapy and the standard arm was FOLFIRI plus cetuximab until disease progression. The second co-primary endpoint was a better profile of safety in terms of lower incidence of grades or 4 adverse events for the experimental arm than the standard arm.
The ERMES trial did not meet the first primary endpoint but we have some interesting results that we can bring into our clinical practice. In fact, for the de-escalation arm with cetuximab alone, the experimental arm achieves an interesting performance in progression free survival with 10 months in median progression free survival. These results are quite similar with other studies with more intensive treatment in this setting. At the same time, we didn’t observe any difference in overall response rate between the two arms. More and more interesting, in the overall survival results the experimental arm achieved a median overall survival of over [inaudible] months. Those results were consistent with other phase III trials in this setting with more intensive therapy such as the doublet or triplet plus anti-EGFR.
So despite a negative primary endpoint, the ERMES could allow to preserve the hypothesis that we can ultra-select in the RAS and wild type population some patients that can benefit from these de-escalation strategies. That ultra-selection could be made possible with the use of NGS in the tissue sample and liquid biopsy. The NGS analysis of tissue sample or liquid biopsy are ongoing in our study and we hope to present these results in our next meeting.