Linvoseltamab (REGN5458) is a bispecific BCMA/CD3 T cell engaging antibody.
SparkCures ID | 351 |
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Developed By | Regeneron Pharmaceuticals |
Generic Name | Linvoseltamab (REGN5458) |
Treatment Classifications | |
Treatment Targets |
View all active clinical trials around the US.
The following is a listing of clinical trials for patients with multiple myeloma who have been newly diagnosed or have not yet received treatment.
June 13, 2022
The overall response rate (ORR) was 51% among all enrolled patients (n = 73). Among all responders, 86% achieved a very good partial response (VGPR) or better and 43% achieved a complete response (CR) or better.
All-grade treatment-emergent adverse effects (TEAEs) occurred in 100% of patients (grade 3, 42%; grade 4, 33%).
Hematologic TEAEs occurring in at least 20% of patients included anemia (all grade, 32%; grade 3, 23%), lymphopenia (all grade, 23%; grade 3, 10%; grade 4, 10%), neutropenia (all grade, 23%; grade 3, 7%; grade 4, 15%), and thrombocytopenia (all grade, 21%; grade 3, 8%; grade 4, 5%).
Nonhematologic TEAEs occurring in at least 20% of patients included fatigue (all grade, 45%; grade 3, 3%), CRS (all grade, 38%), pyrexia (all grade, 36%; grade 3, 4%), nausea (all grade, 33%), dyspnea (all grade, 26%), diarrhea (all grade, 25%; grade 3, 3%), back pain (all grade, 25%; grade 3, 5%), vomiting (all grade, 25%), pneumonia (all grade, 23%, grade 3, 11%), chills (all grade, 22%; grade 3, 1%), cough (all grade 22%), and headache (all grade, 21%; grade 3, 3%).
Three patients (4%) experienced grade 2 immune effector cell–associated neurotoxicity syndrome (ICANS); notably, no grade 3 ICANS events were reported.
Five (7%) grade 5 AEs occurred due to sepsis (n = 3), COVID-19 (n = 1), and pneumonia (n = 1); all deaths were determined to be unrelated to study treatment.
Across the study population, 38% of patients developed CRS. Most CRS events were grade 1 (n = 25), and only 3 patients (4%) experienced grade 2 CRS; no grade 3 or greater CRS events occurred.