Dear colleagues. My name is Thomas Winder. I'm a Medical Oncologist from Austria.
It's an honour and privilege to present to you today the NICHE-2 trial.
The NICHE-2 trial was presented at the presidential session at the ESMO 2022 meeting.
NICHE-2 is a neo-adjuvant immunotherapy trial in locally advanced colorectal cancer patients. So, they included in the intention-to-treat analysis 112 patients.
As you are aware around 10 to 15% of patients with locally advanced colorectal cancer are mismatch repair deficient. The recurrence rate of these patients is around 20 to 40 percent with standard treatment options.
So, in the NICHE-2 trial, they treated the patients in the neo-adjuvant setting with a combined treatment of nivolumab and ipilimumab followed by a single treatment with nivolumab followed by surgery.
The primary endpoint of the study was safety and efficacy defined by pathological response.
So now I want to present you the fascinating results of the study.
The study was safe and around 98% of the patients received surgery timely. And now the intriguing results on the pathological response. 95% of patients had a major pathological response and 67% of the patients had a complete pathological response.
These are intriguing results. They also presented the disease-free survival with the median follow-up of around 13 months, and there were no recurrences.
You need to keep in mind that in this setting around 40-50% of high-risk stage 3 colorectal cancer patients recur with standard treatment options. So, these results are really fascinating and potentially practice changing.
So, for the future they are now going to plan the NICHE-3 study maybe with a different immunotherapy compound and we are looking forward to these results. And we are looking forward to the further information we're going to get on this study, on the three-year disease-free survival, which we will await in 2023.