RE-MIND Comparison Data Review

EP: 1.Phase 2 L-MIND Trial Overview

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EP: 2.RE-MIND Comparison Data Review

EP: 3.L-MIND and RE-MIND Practical Implications

Gilles A. Salles, MD, PhD: We recently had an update of the L-MIND trial regarding the overall response rate, overall survival, and duration of response. And as already mentioned, the overall response rate was confirmed with further follow-up in the range of 60% if we consider all patients, and a complete response rate in the range of 40%, again considering all patients who were recruited in the study. The median overall survival for these patients was close to 36 months, which is remarkable for a population of patients who are relapsed or refractory. And again, the duration of response hasn’t been reached, clearly showing very interesting long-term effect of the activity of this drug combination for our patients.

So we have this new combination, and the question is how can we use the data in the treatment of our patients. The study recruited patients who were either in the first or second failure, and there was an increased response rate in those patients who were in first relapse versus second relapse. However, the duration of response was roughly similar. Based on entry criteria, there were very few patients who had refractory disease or primary refractory disease who entered the study. But we have seen some response in these patients. There were about 40% of the patients who were refractory to the last line of therapy, usually second line, and again, we have seen responses in these patients.

Overall, the other characteristics of the patients were not necessarily predicting the activity of the compound. We have seen responses in GCB [germinal center B-cell type] and non-GCB type in patients with a low and high IPI [International Prognostic Index score], better response in patients with a low IPI, and also in patients with tumor bulk, and different ages, and other characteristics. So it's a treatment regimen that appears, based on the L-MIND data, to be suitable for many patients. I think this regimen offers us a new possibility of treatment for our patients with relapsed/refractory DLBCL [diffuse large B-cell lymphoma].

To further assess the value of this combination, there was a study called RE-MIND presented by my colleague Grzeg Nowakowski, MD, and Pier Luigi Zinzani, MD, PhD, in recent meetings that evaluated the real-life data collected on patients who received lenalidomide as a single agent for relapsed/refractory DLBCL and compared them to the L-MIND combination data of tafasitamab plus lenalidomide. To ensure the solidity of these data, a matched analysis based on patients’ individual characteristics was performed. What was observed with this study is that the overall response rate of the matched population was significantly different, 67% for those patients who received the L-MIND regimen versus 34% for the patients who had received lenalidomide alone. If we consider the complete response rate, this was observed in 39% of the patients of the L-MIND study versus only 13% of the patients who received lenalidomide alone.

The effect on the prolongation of progression-free survival was also assessed in the RE-MIND study, and the hazard ratio was shown to be of 0.49, so close to 0.5, which indicated that the addition of tafasitamab doubled the progression-free survival of what was seen with lenalidomide alone. I will say that we were probably expecting this result, but it further consolidates the data that we have regarding the activity of tafasitamab plus lenalidomide.

Transcript edited for clarity.