So just a little bit of background here. Patients with renal impairment were excluded from the pivotal Majestic 1 trial that led to the approval of teclistamab for commercial use. So the clinical outcomes of teclistamab in this population were basically unclear. So as we know, many patients with relapsed/refractory multiple myeloma often have renal impairment, which actually might be multifactorial and related to the myeloma itself, the myeloma treatments, or other causes...
So just a little bit of background here. Patients with renal impairment were excluded from the pivotal Majestic 1 trial that led to the approval of teclistamab for commercial use. So the clinical outcomes of teclistamab in this population were basically unclear. So as we know, many patients with relapsed/refractory multiple myeloma often have renal impairment, which actually might be multifactorial and related to the myeloma itself, the myeloma treatments, or other causes. So for this reason, it’s critical to know if teclistamab is effective and safe in these patients. So with the U.S. Multiple Myeloma Immunotherapy Consortium, we performed a large multicenter retrospective analysis that included patients from 14 academic institutions, where we compared the clinical outcomes of patients with and without renal impairment treated with standard of care teclistamab. So we found that the administration of teclistamab is feasible in patients with renal impairment, with efficacy and safety comparable to patients with normal renal function. With regard to safety, the incidence and severity of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome were comparable in patients with and without renal impairment, including patients with severe renal impairment. In terms of efficacy, the response rates and survival outcomes with teclistamab were similar in patients with and without renal impairment, including patients that had also severe renal impairment. Also, it was encouraging that we did not observe increased non-relapse mortality in the renal impairment group. Moreover, we saw that some patients experienced an improvement in renal function following teclistamab initiation, and overall, renal function did not deteriorate outside of the context of disease progression. So I would say overall, it appears that treatment with teclistamab is feasible, safe, and effective in patients with relapse, refractory, multiple myeloma, and renal impairment. So for this reason, the presence of renal impairment should not be a barrier towards receiving BCMA-targeted b9specific antibodies as standard of care interventions.
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