Our CONCEPT trial is a Phase II academic trial which is or is and was exclusively for high-risk newly diagnosed myeloma patients, both transplant eligible and non-eligible, and it investigates the ISA-KRd quadruplet, so isatuximab, carfilzomib, lenalidomide and dexamethasone in an intensified regimen induction, high dose consolidation and also triplet maintenance, and we have been able to before to show this high efficacy with high rates of MRD negativity and also with regards to PFS and overall survival...
Our CONCEPT trial is a Phase II academic trial which is or is and was exclusively for high-risk newly diagnosed myeloma patients, both transplant eligible and non-eligible, and it investigates the ISA-KRd quadruplet, so isatuximab, carfilzomib, lenalidomide and dexamethasone in an intensified regimen induction, high dose consolidation and also triplet maintenance, and we have been able to before to show this high efficacy with high rates of MRD negativity and also with regards to PFS and overall survival. And today or yesterday actually we looked at the subgroups, the cytogenetic subgroups and how they do with this treatment, and the sort of overall answer is that basically all subgroups really benefit and achieve high rates of MRD negativity. But it was also one aspect we looked at the patients with two or more high-risk cytogenetic aberrations, because those are the patients who are also called ultra-high-risk patients. And these were actually more than one-third of our patients. And even of those, many patients showed the same results as the others. So really great results except for one smaller subgroup, patients who have at least two high-risk aberrations and one of those being the deletion 17p. So they still have lower outcomes and are therefore now the group with the highest unmet need which we definitely need to address even better.
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