REGN5458

Overview

REGN5458 is a bispecific BCMA/CD3 T cell engaging antibody.

SparkCures ID 351
Developed By Regeneron Pharmaceuticals
Generic Name REGN5458
Additional Names linvoseltamab
Treatment Classifications
Treatment Targets

Clinical Trials

Published Results

REGN5458 Elicits Early, Sustainable Responses in Heavily Pretreated Multiple Myeloma

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.

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