Clinical Trials
Regeneron Pharmaceuticals has announced positive data from its pivotal LINKER-MM1 trial, which evaluated linvoseltamab as a treatment for adult patients with relapsed/ refractory (R/R) multiple myeloma (MM).
The trial demonstrated that the drug had a 71% objective response rate, with 46% achieving a complete response or better after 11 months of median follow-up.
All patients treated with the 200mg dose of linvoseltamab experienced adverse events, with 85% experiencing Grade ≥3 events, the most common being cytokine release syndrome.
L Andres Sirulnik MD PhD, senior vice president, Translational and Clinical Sciences, Haematology at Regeneron, commented: “MM remains an incurable disease, in which patients endure cycles of relapse and remission, resulting in a critical need for innovative medicines. With longer follow-up data on linvoseltamab, we’re seeing deep and durable responses with a complete response rate nearing 50% in a difficult-to-treat patient population who had received a median of five prior lines of therapy. Furthermore, in our trial, the regimen had a short monitoring time and a convenient, response-adapted administration schedule that enabled deep responders to go from every two-week to every four-week dosing. This regimen saved time for clinicians and patients, underscoring the potential for linvoseltamab as a patient-centric option in R/R MM.”
This data is expected to be submitted to the relevant regulatory authorities, including the US Food and Drug Administration (FDA) this year.