ASH 2024 | MajesTEC-5: Phase II study of Tec-based induction in transplant-eligible newly diagnosed myeloma

The GMMG-HD10/DSMM-XX MajesTEC-5, which is the full name, to acknowledge all the study groups involved, is a Phase II trial, as you said, that evaluates for the first time actually a bi-specific, a BCMA-directed bi-specific, in this case, teclistamab, in combination with standard of care in transplant-eligible patients. And we presented here the first data on the induction therapy, which consists of six cycles, a combination TEC plus Dara-Rd or TEC plus Dara-VRd, three cohorts. One cohort had a weekly teclistamab dosing. The other two were four weekly teclistamab dosing. And out of the four weekly ones, there was one with Dara-Rd and one with Dara-VRd. So that’s basically the treatment lineup. 

And so what we found is that it is very efficacious. So it’s really, really active. We found not only a really high response rate, but we saw that all patients already after three cycles, so half of the induction therapy, achieved a MRD negativity, at least for those where we had samples, which was almost all patients so I think the two samples or three samples left missing out of 49 patients so the MRD negativity was really high all of the measured ones technically probably 96 92 percent around and with the first cohort having the longest follow-up we also saw that after six cycles so where all patients already had finished the six cycle induction therapy that all of these patients in the first cohort actually achieved a MRD negative CR at end of induction. So this is I think something to build on of course. 

But if you talk about BCMA and bispecifics of course, especially in combination, you have to look at the side effects, the adverse events, especially infections and so what we saw with a, I have to say quite stringent prophylactic measures set in place, like immune globulin replacement IVIgs as well as prophylactic antibiotics and antivirals we saw that overall so far we had a 30 34 35 percent rate of infections grade three and four, no grade five thankfully, all resolved. But of course it has to be taken with caution and also in terms of dose delays in terms of if a patient sees some you know sign shows some signs of infection and having this, so certainly if you have an experienced myeloma center it was very well manageable as we say, but of course you need to keep in mind that it is not just Dara-Rd right but it’s very very effective and this is certainly something that has not been seen before in this extent in this patient population after three cycles already.

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