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Prashant Kapoor, MD, FACP


ASH 2022: Dose-Escalation Study Evaluates T-Cell–Engaging Bispecific Antibody in Resistant Myeloma

By: Vanessa A. Carter, BS
Posted: Thursday, January 5, 2023

A phase I dose-escalation study performed by Carmelo Carlo-Stella, MD, PhD, of Humanitas University and IRCCS Humanitas Research Hospital, Milan, Italy, and colleagues suggests that the GPRC5D x CD3 T-cell engaging–bispecific antibody RG6234 is active in patients with relapsed or refractory multiple myeloma, regardless of administration method. These findings were presented during the 2022 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 161).

The study authors focused on 105 patients with relapsed or refractory multiple myeloma who had received at least one prior immunomodulatory drug and proteasome inhibitor. Participants received RG6234 intravenously (n = 51) or subcutaneously (n = 54) for up to 1 year or until unacceptable toxicity or disease progression.

With a median number of five prior therapy lines, 63.3% and 73.1% of patients given intravenous and subcutaneous treatment had triple-class–refractory disease, respectively; 30.6% and 42.3% had penta-class–refractory disease. The median follow-up was longer in the intravenous group (7.1 months) than the subcutaneous group (3.9 months). Overall response rates were 71.4% in the intravenous group and 60.4% in the subcutaneous group.

The most common adverse event was cytokine-release syndrome, although events of grade 3 or higher were not commonly observed. Of note, most adverse events were confined to cycle 1. Other commonly reported adverse events related to on-target, off-tumor effects included hair and nail changes, dermal conditions, and events impacting the tongue or gastrointestinal mucosal epithelium.

Although infrequent, grade 3 or higher hematologic adverse events such as thrombocytopenia, neutropenia, and anemia did occur. Infections were also common, affecting 56.9% of the intravenous group and 37.0% of the subcutaneous group. Treatment-related adverse events led to treatment discontinuation in two patients from each group, and one patient died of grade 5 acute respiratory failure.

Disclosure: For full disclosures of the study authors, visit

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