Safety of Linvoseltamab in High-Risk Smoldering Myeloma

In an interview with Targeted Oncology, Paula Rodriguez Otero, MD, PhD, consultant and deputy professor at the University of Navarra, discusses the safety of linvoseltamab (Lynozyfic) in high-risk smoldering multiple myeloma (HR-SMM), according to findings from the phase 2 LINKER-SMM1 study.

Based on the safety and efficacy data presented for the first 24 patients involved in the study, the overall safety profile of linvoseltamab in the HR-SMM setting was determined to be manageable and consistent with the known safety profile of the drug. The profile appears more favorable in this smoldering myeloma patient group compared with its profile in patients with relapsed or refractory multiple myeloma.

Linvoseltamab had previously induced deep and durable responses with a generally manageable safety profile in patients with relapsed/refractory multiple myeloma in the phase 1/2 LINKER-MM1 study.

Cytokine release syndrome (CRS) was reported in 42% of patients. The vast majority of these events were low-grade, specifically grade 1 and 2. No immune effector cell-associated neurotoxicity syndrome (ICANS) events were observed in the cohort analyzed.

Infections are noted as the most common nonhematological adverse events associated with BCMA-targeted bispecific antibodies. The incidence of any-grade infection was 79%. Severe infections (grade 3 or 4) remained uncommon. Only 12% (n = 3/24) experienced a grade 3 or 4 infection. The specific grade 3 events reported were 1 case of COVID-19, 1 case of Salmonella gastroenteritis, and 1 case of staphylococcal bacteremia.

The investigators reported no treatment discontinuations due to adverse events. There were no treatment-related deaths reported.The evaluation of adverse events of special interest, including the frequency of grade ≥2 CRS and ICANS, along with the frequency and severity of treatment-emergent adverse events, served as the primary endpoints for the initial safety run-in phase (part 1) of the LINKER-SMM1 study.

Read the full interview with Dr Rodriguez Otero here.