FDA grants fast track designation to IBI3003 for the treatment of RRMM

On January 26, 2026, the U.S. Food and Drug Administration (FDA) granted fast track designation to IBI3003, a trispecific antibody targeting B-cell maturation antigen (BCMA) and G protein-coupled receptor class C group 5 member D (GPRC5D) on myeloma cells and CD3 on T cells, for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) who have received ≥4 prior lines of therapy (LoT). IBI3003 is currently being evaluated as part of a phase I/II clinical trial in China and Australia (NCT06083207), with plans to initiate a phase I/II clinical trial in the United States.

Results from the phase I/II trial (NCT06083207) evaluating IBI3003 in 39 patients with RRMM were presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, December 6–9, 2025, Orlando, US. In patients receiving ≥120 μg/kg (n = 24), the overall response rate (ORR) was 83.3%, with 4 patients experiencing a stringent complete response (sCR). All patients achieving complete response or better (≥CR) were MRD-negative by next-generation sequencing (NGS). All cases of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were Grade 1–2. Treatment-emergent adverse events (TEAEs) associated with GPRC5D were predominantly Grade 1–2, with two cases of Grade 3 rash.