IMS 2025 | Long-term follow-up and subgroup analyses from the LINKER-MM1 trial of linvoseltamab in myeloma

This year’s IMS 2025, meaning updated data from long-term follow-up and subgroup analyses were presented from the pivotal LINKER-MM1 study with linvoseltamab. Linvoseltamab, just as a brief background, is a BCMA bispecific antibody which was recently approved for the treatment of triple class exposed relapse refractory multiple myeloma in patients with at least three prior lines of therapy in the European Union and at least four prior lines of therapy in the United States. As a brief background, LINKER-MM1 was a pivotal study that evaluated linvoseltamab in patients with heavily pretreated relapse refractory multiple myeloma. A total of 117 patients were enrolled at the 200 milligram approved dose of linvoseltamab. And with longer follow-up of 21.3 months median follow-up, the overall response rate was 71% and the complete response rate or better was 52%. Additionally, the median duration of response is approximately 29 months and the median progression-free survival actually has not been reached, again, at a median follow-up of 21.3 months. With this update, additional subgroup analyses were also performed, particularly in difficult to treat subsets of myeloma patients, including those patients with high-risk cytogenetics, older patients over the age of 75, patients with a high baseline disease burden based on soluble IL-6 levels, among other baseline characteristics. And in summary, the overall response rates in these difficult-to-treat patient subsets were over 50%, and many of these subgroups also had deep and durable responses with additional follow-up. With this follow-up, also with this longer follow-up, there was no additional safety signals with linvoseltamab in this patient population. In fact, with longer follow-up, actually the incidence of infection actually decreased with time. And that’s probably correlated with the decrease in the frequency of dosing per protocol that patients experienced if attaining a very good partial response or better. The dosing was decreased every four weeks, which occurred in about half of patients enrolled on the study. So in summary, with this longer follow-up of linvoseltamab and the pivotal LINKER-MM1 study, responses were deep and durable for patients treated with linvoseltamab. Again, linvoseltamab was recently approved for the treatment of relapse refractory multiple myeloma. In addition, high responses were seen in difficult to treat subsets of patients with multiple myeloma. And again, provides a really highly effective off-the-shelf approach for the treatment of patients in this context.

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