The SKylaRK trial

Dr Betsy O’Donnell, a haematologist at the Dana-Farber Cancer Institute (US), presents the findings from the SKylaRK trial, a phase 2 study in NDMM patients eligible for transplantation, who received a four-drug combination comprising isotuximab, carfilzomib, lenalidomide, and dexamethasone.

The trial enrolled patients with all-risk cytogenetics, and participants underwent four cycles of the quadruplet regimen. Subsequently, after stem cell collection, patients had the option to defer transplant or proceed with transplantation. A majority of patients opted to defer transplant and underwent an additional four cycles of therapy.

Results indicate a noteworthy OR of 100%, with a PFS of 92% and an OS of 95% at the two-year mark. Post-consolidation, an excellent MRD negativity rate was achieved. Noteworthy, maintenance therapy was stratified by risk, posing a critical question in NDMM patients, especially those achieving deep responses. Additional insights into the optimal duration of maintenance therapy will be gained as the study matures.

High-risk patients, defined by del(17p), 1q gains, t(4:14), t(14:20), t(14:16), received a triplet maintenance combination comprising both the proteasome inhibitor and the monoclonal antibody, in contrast to the standard lenalidomide alone for standard-risk patients. Both arms exhibited outstanding results, underscoring the importance of addressing this question.

An essential endpoint in this study is the QoL, which demonstrated significant improvement across most metrics for MM after a temporary decline post-transplant. This study underscores the overall efficacy and tolerability of the quadruplet regimen in NDMM patients eligible for transplantation.

Reference:

O’Donnell E, ASH2023. #4671

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