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Next-Generation Therapies Target High-Risk Smoldering Multiple Myeloma: Paula Rodríguez-Otero, MD, PhD
Paula Rodríguez-Otero, MD, PhD, talks about promising phase 3 trials investigating combination treatments that include lenalidomide or daratumumab
Ongoing research is exploring novel regimens for individuals who have high-risk smoldering multiple myeloma, with these patients generally gaining access to treatment only through clinical trials, explains Paula Rodríguez-Otero, MD, PhD. In this conclusion of her recent interview with The American Journal of Managed Care®, she also talks about promising phase 3 trials investigating combination treatments that include lenalidomide or daratumumab.
Rodríguez-Otero is medical coordinator of the Central Unit for Clinical Trials; associate clinical professor, preclinical and hematology seminars; and deputy director of the expert degree in immuno-oncology, School of Medicine, Cancer Center Clínica Universidad de Navarra (University of Navarra) in Pamplona, Spain.
This transcript has been lightly edited for clarity; captions were auto-generated.
Transcript
What are the next steps for the LINKER-SMM1 trial, and what efficacy end points will be most critical in determining linvoseltamab's potential as an early intervention?
The idea is to, after completion of this study and analyzing the trial, to move to a phase 3 randomized study eventually with daratumumab as a comparator, but this is still being defined and discussed. Definitely in that case, the probable end points will change. Delayed disease progression would probably be one of the important end points of the study, but this is still a work in progress.
What treatment needs remain unfulfilled for patients with high-risk smoldering disease?
High-risk smoldering myeloma patients are, in general, not being treated in routine clinical practice. They are normally referred to be enrolled in the context of clinical trials because there is no formal drug that is approved for the treatment of high-risk smoldering multiple myeloma. There are 2 phase 3 randomized studies comparing lenalidomide single agent vs observation, one led by the Spanish Myeloma Group and another one led by the ECOG [Eastern Cooperative Oncology Group] US group. Both trials were positive, demonstrating superiority in progression-free survival, showing that early intervention delayed disease progression into active disease. Particularly, the Spanish trial also showed that early intervention with lenalidomide was able to prolong overall survival in patients with high-risk smoldering.
Recently, we have also seen positive data from the phase 3 study comparing daratumumab monotherapy also vs observation, and this study was also positive both in terms of progression-free survival and also in terms of overall survival. There are other trials ongoing comparing, for example, doublet treatment with isatuximab plus lenalidomide vs lenalidomide alone, also evaluating this combination in this setting. Also, there [are] phase 2 data with BCMA CAR Ts [chimeric antigen receptor T-cell therapies], and the study I am showing, BCMA [B-cell maturation antigen] bispecifics.
Really, the unmet need is to define who are the high-risk smoldering myeloma patients who will benefit from each of these strategies and whether indeed our hypothesis that we may even completely prevent the development of active disease is proven with any of these strategies.
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