June 16, 2024 | Naresh Bumma, Joshua Richter, Sundar Jagannath, Hans C. Lee, James E. Hoffman, Attaya Suvannasankha, Jeffrey A. Zonder, Mansi R. Shah, Suzanne Lentzsch, Rachid Baz, Joseph J. Maly, Swathi Namburi, Matthew J. Pianko, Jing Christine Ye, Ka Lung Wu, Rebecca Silbermann, Chang-Ki Min, Marie-Christiane Vekemans, Markus Munder, Ja Min Byun, Joaquin Martinez-Lopez, Kaniel Cassady, Michelle DeVaux, Dhriti Chokshi, Anita Boyapati, Anasuya Hazra, George D. Yancopoulos, L. Andres Sirulnik, Karen Rodriguez Lorenz, Glenn S. Kroog, Yariv Houvras, Madhav V. Dhodapkar
Linvoseltamab, a B-cell maturation antigen × CD3 bispecific antibody, showed promising results in treating relapsed/refractory multiple myeloma (RRMM). In a phase I/II trial, 117 patients received 200 mg of linvoseltamab, with a median age of 70 years and 39% having high-risk cytogenetics. The overall response rate (ORR) was 71%, with 50% achieving a response of ≥complete response (CR). The median duration of response (DOR) was 29.4 months. In the 50 mg group, the ORR was 48%, with 21% achieving ≥CR. Common adverse events included cytokine release syndrome (CRS), neutropenia, and anemia. The most common severe adverse event was CRS, affecting 46% of patients. Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 7.7% of patients. Infections were reported in 74.4% of patients, with severity decreasing over time. Linvoseltamab demonstrated a favorable safety profile, with a high response rate and durable responses. The 200 mg dose was selected as the optimal dose due to its efficacy and safety. Linvoseltamab showed high efficacy in patients with high disease burden and high-risk features. It was compared to other BCMA-targeted therapies, showing superior ORR and CR rates. Linvoseltamab had a shorter time to onset and resolution of CRS compared to other bispecific antibodies. It also showed a lower rate of CRS and fewer infections. The study highlights linvoseltamab as a promising treatment for RRMM, with a manageable safety profile and durable responses. The results suggest that linvoseltamab offers substantial clinical benefit for patients with RRMM.Linvoseltamab, a B-cell maturation antigen × CD3 bispecific antibody, showed promising results in treating relapsed/refractory multiple myeloma (RRMM). In a phase I/II trial, 117 patients received 200 mg of linvoseltamab, with a median age of 70 years and 39% having high-risk cytogenetics. The overall response rate (ORR) was 71%, with 50% achieving a response of ≥complete response (CR). The median duration of response (DOR) was 29.4 months. In the 50 mg group, the ORR was 48%, with 21% achieving ≥CR. Common adverse events included cytokine release syndrome (CRS), neutropenia, and anemia. The most common severe adverse event was CRS, affecting 46% of patients. Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 7.7% of patients. Infections were reported in 74.4% of patients, with severity decreasing over time. Linvoseltamab demonstrated a favorable safety profile, with a high response rate and durable responses. The 200 mg dose was selected as the optimal dose due to its efficacy and safety. Linvoseltamab showed high efficacy in patients with high disease burden and high-risk features. It was compared to other BCMA-targeted therapies, showing superior ORR and CR rates. Linvoseltamab had a shorter time to onset and resolution of CRS compared to other bispecific antibodies. It also showed a lower rate of CRS and fewer infections. The study highlights linvoseltamab as a promising treatment for RRMM, with a manageable safety profile and durable responses. The results suggest that linvoseltamab offers substantial clinical benefit for patients with RRMM.