EHA 2025 | The real-world efficacy and safety of teclistamab in RRMM: the REALiTEC study

We’ve all been seeing a lot of real-world data with the bispecific antibodies, but what’s very important with real-world data is firstly to have a wide geographical spread and secondly to have adequate follow-up to have meaningful results. So this was the premise of the REALITEC study, which was a pan-European study that recruited over a hundred patients across eight different countries within Europe, and this was essentially looking at the use of teclistamab outside of clinical trials. What we found was that almost two-thirds of these patients would not have been eligible for the initial pivotal Majestic 1 clinical trial. So this was quite a heavily pre-treated population. Many of these patients actually had prior BCMA exposure, and so it’s in effect were retreats, and a large proportion of extramedullary disease. What we found was that the overall response rate was 55%, but if you look at the non-BCMA exposed patient, it rises to about 65%, which is very much in keeping with what we saw in the clinical trial. So that’s very reassuring because I’ve already told you that two-thirds of the patients would not have been eligible for the study. To see that response rate in the real world was very heartening. The toxicity profile was very similar. There were no real surprises there. Again, what was interesting was the durability of response. So what we see is that the durability of response was over 20 months and the overall survival is in excess of two years. So I think essentially what we’re seeing with this real-world data is that the toxicity profile is as expected. Indeed, with the use of IVIG, it’s going to be improving, but the efficacy signal is very strong and in fact is probably looking marginally better than the initial clinical trials, which I think demonstrates that we are learning how better to use these drugs.

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