Manageable safety profile with early efficacy of Tec-DR in NDMM
Prof Salomon Manier - Hospital Center University De Lille, Lille, France
We presented the safety run-in of MajesTEC-7. So MajesTEC-7 is a phase III trial assessing the role of bispecific antibodies in frontline treatment for elderly patients in multiple myeloma. The trial started with a different safety run-in and we reported the safety run-in cohort 1 before the randomised part in the trial. So 26 patients were included, they were all newly diagnosed multiple myeloma patients who are not intended or not transplant eligible. The median age was 72 years old, some patients were fit but also intermediate or frail based on the IMWG frailty score.
We observed a favourable safety profile in the trial. The most frequent side effect was haematological side effects. 61% of the patients had a CRS but only grade 1 and 2, no grade 3 or more CRS was observed. In terms of infections it’s 30% of the patients who developed a grade 3 or 4 infection in the trial, mostly COVID-19. One patient actually died from infection, the flu, at cycle 3. All the patients for the rest didn’t have much side effects so the safety profile is quite expected and there is no new safety signal in the trial compared to what we know from monotherapies.
For the efficacy we observed a remarkable efficacy in this early data with an overall response rate of 92%. All the patients achieved a VGPR or better and 80% of the patients achieved a complete remission. The median PFS is not reached but the PFS rate at one year is 96% which is, of course, remarkable.
So the trial is moving forward from this safety run-in cohort to the randomised phase, that is ongoing.
What could be the impact of this research?
This early data which is the first data that we have for bispecific antibodies in frontline treatment in multiple myeloma will potentially be the future of the treatment in multiple myeloma. Of course we need now to do the randomised phase III trial with the comparison to DRd, the current standard of care, to assess if it’s truly improving the outcome of those patients and then perhaps can become the next standard of treatment.
