ASCO 2024 | Results of the first SRI of MajesTEC-7: safety of tec-DR in transplant-ineligible newly diagnosed MM

So in the MajesTEC-7 study, we enrolled newly diagnosed myeloma patients who are not eligible for stem cell transplantation. And we have now, with a median follow up of more than one year, the first results from the safety run in cohort one. So in safety run in cohort one, patients started with teclistamab daratumumab and dexamethasone, and in cycle two lenalidomide was added. And, with the current follow up there was a very low discontinuation rate. There was a approximately 30% of patients that developed grade three or higher infections. But most of these infections occurred early after initiation of treatment, indicating that we have to be more careful in the beginning and probably have to start IgG supplementation therapy either before or early after step up dosing of teclistamab. And of course with teclistamab we see cytokine release syndrome. But the MajesTEC-7 safety run in one, all the CRS events were grade 1 or 2.

The efficacy results are promising, and most patients responded. 92.3% of the patients responded, and already 80% of the patients had a complete remission or better. And there were no disease progressions. And I think this rate of CR, in this early period after treatment initiation is better than what we see with MAYA. So I think this is a very interesting new avenue for patients with transplant ineligible, newly diagnosed multiple myeloma. And of course, based on these results from safety run in one the phase three part of the MajesTEC-7 has now started in which patients are randomized to three arms: tec-dara plus len, talquetamab dara plus len, or the control arm dara, len, dex.