So this is a prospective Phase II trial evaluating the utility of consolidated therapy with elrantamab, the BCMA T-cell engager, post-ide-cel for patients with relapsed or refractory multiple myeloma who received ide-cel as standard of care. And so the importance of the study is to evaluate the feasibility of consolidating with a BCMA TCE after a BCMA CAR T-cell as in ide-cell...
So this is a prospective Phase II trial evaluating the utility of consolidated therapy with elrantamab, the BCMA T-cell engager, post-ide-cel for patients with relapsed or refractory multiple myeloma who received ide-cel as standard of care. And so the importance of the study is to evaluate the feasibility of consolidating with a BCMA TCE after a BCMA CAR T-cell as in ide-cell. And the reason why we wanted to evaluate in this fashion was we know that from KARMMA and KARMMA-3, the median PFS with ide-cel is a little over approximately a year. And so the intent is to deepen responses and therefore prolong progression-free survival. and that was the intent of the study. With our interim results, we have a target population for enrollment of 32 patients. We’ve enrolled at data cutoff, 16 patients. And this patient population was quite elderly, approximately a third of patients were older than 75 years of age. About a third of patients were ISS stage three. And nearly all patients were triple class exposed and about three quarters of patients were triple class refractory. For these patients, we have partial disease response data from that 16 patients, but what generally found was that patients who were post-ide-cel must have not had progressive disease. And so we observed that three of those patients had a stringent complete response, two patients had a CR. We also had a number of patients with VGPR, PR, and one patient with stable disease. And so what we observed with post-consolidation with elranatamab was that we were able to observe an increase in stringent CR for more than half of the patient population. and patients also deepened from PR and stable disease to VGPR. And in terms of MRD data, we did observe that about approximately a half of patients were UMRD6 while the other half were not. And of all the evaluable patients post consolidation, all were UMRD6. And so we did see a deepening in disease response and also deepening in UMRD6 rates, although this is quite early in terms of follow-up with only 14 of 16 patients evaluable for response post-ide-cel and also approximately six to seven patients post-consolidation with evaluable MRD. I think that with the importance of infection prophylaxis, with any sort of approach that combines consolidated TCE strategies post-CAR-T, And I know that the recent updates in NCCN guidelines also has recommendations for patients receiving T-cell engagers to recommend primary prophylaxis with IVIG. And so we are seeing a change in practice, but do recommend this for patients if they were to be on trials that are evaluating on T-cell engagers post-CAR-T, just given the increased risk of infection for this patient population.
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