Opinion
Video
The IsKia trial findings presented at ASH 2023 are highlighted by Dr Fonseca.
This is a video synopsis/summary of a Post Conference Perspectives featuring Rafael Fonseca, MD.
The IsKia trial, presented for the first time, randomly assigned newly diagnosed multiple myeloma patients to 3 drugs (carfilzomib, lenalidomide, and dexamethasone) vs 4 drugs including the anti-CD38 antibody isatuximab. After 4 induction cycles, mobilization, transplant, and 4 consolidation cycles at the induction dose, minimal residual disease (MRD) was measured at various timepoints. The primary end point was post-consolidation MRD negativity by next generation sequencing (NGS).
With 151 patients per arm, baseline characteristics were balanced. Safety and study completion rates were similar between arms. The post-consolidation MRD negativity rate at 10-5 was 77% with isatuximab arm vs 67% without, meeting the primary end point. The more sensitive threshold of 10-6 showed lower rates of 67% vs 48%. Improvements in MRD were seen with continued therapy. Across subgroups, patients benefited, especially at 10-6. However, MRD negativity differences were most pronounced for high-risk cytogenetics patients, 77% vs 27%, indicating a continued need to improve outcomes in this population.
With good safety and increased MRD negativity rates favoring the 4-drug arm, the IsKia trial shows promise for adding isatuximab. Next steps are determining long-term survival data and potentially moving to the 10-6 MRD threshold. Currently, the choice between isatuximab vs daratumumab with these quadruplets is unclear. Both are reasonable options, pending drug access and approval considerations.
Video synopsis is AI-generated and reviewed by AJMC® editorial staff.
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