ICML 2023 | Final analysis of the Ro-CHOP trial: romidepsin plus CHOP vs CHOP in previously untreated PTCL

This year at ICML, we presented the results of the final analysis of the Ro-CHOP Phase III trial. It was an international, multicenter, randomized Phase III trial that compared romidepsin plus CHOP versus CHOP in peripheral T-cell lymphoma patients in the first-line setting. The interim analysis was previously reported and had demonstrated that there was no difference in terms of outcome between the two arms. And this year, this is the final analysis, five years after the last patient and we observed that there was still no difference between the two arms, with an exception for patients with a Tfh-like PTCL after central pathologic review. And those patients have a longer duration of response after romidepsin-CHOP, approximately 50 months, as compared to a patients in the CHOP arm that have a median progression free survival of 24 months. So probably patients with a Tfh lymphoma have a benefit from romidepsin addition. We also have a special focus on relapse pattern and outcome after the first disease progression. Disappointingly, we observed that patients have a very poor prognosis after the first progression in a well annotated cohort in the last decade. The treatments used at relapse are very diverse and heterogeneous and led to poor results with a median PFS after the first progression of three months and a median overall survival that did not reach one year and there was no consensus about the best treatment option. There was no advantage of one or another. When we compare the different salvage chemotherapy options, maybe a small benefit for brentuximab vedotin addition in combination with salvage chemotherapy. But it was an exploratory analysis and this finding should now be confirmed in other studies.