We have presented at the EHA the phase II study focused on the peripheral T-cell lymphoma. We know that this a heterogenous group of diseases, the outcome has been improved for the CD30-positive peripheral T-cell lymphomas, especially anaplastic large-cell lymphoma, but it’s still not a great satisfaction with some of the subgroups.

So what the aim was is to add to the BV-CHEP etoposide like CHOEP versus CHOP. So it means we ran the phase II study, it consisted of the brentuximab vedotin anti-CD30 antibody-drug conjugate plus cyclophosphamide, Adriamycin, etoposide and prednisone. It was for young patients, it has been intended for young patients, stem-cell transplant eligible. In this phase II study we recruited 33 patients, the primary endpoint is the complete metabolic remission rate which was 76%. It has been translated into promising progression free survival – with a median follow-up of 30 months we have observed two years progression free survival of 78% and overall survival 90%.

What could be the clinical significance of these results?

This is definitely not the ultimate answer if it is worthwhile to intensify the regimen. But in the light that some patients are progressing and at the end of the treatment all patients acceded to undergo all six cycles of the CHEPA protocol but we have been facing 10% PD at the end of the therapy and there are some early relapses. So during the follow-up we have observed eight progressions, relapses, and five deaths. So it means that it needs to be improved but this is a good step, like the previous CHOEP versus CHOP, that we could use for younger patients, BV-CHEP, the CHEPA regimen, and hopefully it could improve the outcome. But definitely this is not the final, final answer for those patients.

What’s next for the study?

It’s important because it’s a very low number phase III randomised study. So, for instance, up to now we do not have any randomised study which is able to compare the stem cell transplant consolidation versus just observation. We have limited phase III studies, ECHELON-2 is one of them.

This study gave us some evidence that we can safely use for young patients a more intensive regimen together with brentuximab vedotin, which I think is a very important message.

Part of this study, and we haven’t shown the results because the work is under progress, is that we are aiming to focus on the MRD in the peripheral T-cell lymphoma which is so far an area which we do not have any, or very little, data. So we are able up to now the data is showing that we will be able to follow 100% of the patients, either TCR-based MRD or specific mutation, specific clonal mutation for particular T-cell lymphoma, and we will be able to follow. So we are hoping that the data is going to be submitted to ASH this year.