In an interview with Pharmacy Times, Paula Rodríguez-Otero, MD, PhD, discusses patient selection for LINKER-SMM1 and weighs the potential benefits of early linvoseltamab treatment against infection risk in high-risk smoldering multiple myeloma.
In an interview with Pharmacy Times, Paula Rodríguez-Otero, MD, PhD, a hematologist at the University of Navarra Clinic in Pamplona, Spain, discusses how the LINKER-SMM1 study approaches patient selection and infection risk when evaluating linvoseltamab for high-risk smoldering multiple myeloma.
Rodríguez-Otero emphasizes that smoldering myeloma encompasses patients with substantially different risks of progression. Identifying those at high risk is essential when considering treatment before symptomatic disease develops. LINKER-SMM1 used the 20/2/20 and PETHEMA criteria to identify eligible patients. The former considers bone marrow plasma cell percentage, monoclonal protein concentration, and the serum free light chain ratio. PETHEMA incorporates the proportion of aberrant bone marrow plasma cells and the presence of immunoparesis. She explains that these approaches identify a population with an approximately 50% risk of progression to active myeloma within 2 years.
The discussion then turns to the burden of treating an asymptomatic population. Infections occurred in 92% of patients despite intravenous immunoglobulin replacement, Pneumocystis jirovecii pneumonia prophylaxis, and antiviral prophylaxis. Rodríguez-Otero notes that most infections were low grade, approximately 20% of patients experienced grade 3 infections, and no grade 4 or 5 infections occurred. She also emphasizes that smoldering myeloma itself carries an increased infection risk.
For Rodríguez-Otero, the severity of infections is central to assessing whether the potential benefits justify early intervention. She highlights the study’s fixed treatment duration of 2 years and progressively less frequent administration as features that reduce treatment burden over time.
For pharmacists, the interview underscores the importance of understanding risk classification and maintaining comprehensive infection prevention throughout treatment. Rodríguez-Otero views preventing progression as a compelling goal, while emphasizing that phase 3 evidence is needed to clarify the value of bispecific therapy in this setting. The findings support continued investigation rather than establishing linvoseltamab as routine treatment for patients with high-risk smoldering myeloma before active disease develops.
