ESMO GI 2024 | REGINA: regorafenib, nivolumab, and SCRT in rectal adenocarcinoma

So the REGINA trial was a Phase II trial in rectal cancer, and the investigator tested the combination of short course radiotherapy with the combination of regorafenib, which is a tyrosine kinase inhibitor, a multi tyrosine kinase inhibitor, and immunotherapy, nivolumab, in patients with localized rectal cancer. So they’ve actually included an unselected group of rectal cancer patients. About 44% of those patients had at least one of the rapido high risk groups. And what they have done is they’ve found what they found is they have a high response rate. The primary endpoint of the trial was an unusual combination of pathological CR and clinical complete response at one year. And what they found is that they achieved the primary endpoint of the trial. So they have about a 30% in the whole group achieving a pathological CR. And this is, by the way, an interim analysis. They haven’t completed the trial yet. And there was, I think, about eight patients who actually achieved a clinical complete response. Now we know that immune therapy works very well in patients who are MSI high and they have not selected patients for their MSI status. So when we looked at when they looked at the microsatellite stable patients, they were able to find that there’s about 25% pathologic CR and five patients achieved a clinical complete response.