Linvoseltamab in HR-SMM: LINKER-SMM1 Study Design

In an interview with Targeted Oncology, Paula Rodriguez Otero, MD, PhD, consultant and deputy professor at the University of Navarra, discusses the study design of the phase 2 LINKER-SMM1 trial evaluating linvoseltamab (Lynozyfic) in high-risk smoldering multiple myeloma.

This is a phase 2 study with a safety run-in phase that enrolls patients with high-risk smoldering myeloma defined as a smoldering diagnosis within 5 years of study entry and high-risk features, either using the 2/20/20 risk criteria or the PETHEMA risk criteria. These patients would receive treatment with linvoseltamab, which is a BCMA/CD3 bispecific antibody, for a duration of 2 years.

In the safety run-in phase, 6 patients were enrolled, and the primary end point of that part was safety. In the expansion part, 34 patients will be enrolled. The primary end point of the expansion phase is the complete response rate and [minimal residual disease (MRD)] negativity at 1 year and 2 years.

The study is ongoing and continues to recruit patients.

Read the full interview with Dr Rodriguez Otero here.