Elrexfio (elranatamab-bcmm)

P=N/A, N=50, Not yet recruiting, Gruppo Italiano Malattie EMatologiche dell'Adulto

P3, N=944, Recruiting, Pfizer | N=361 --> 944

P2, N=46, Terminated, Pfizer | Active, not recruiting --> Terminated; A business decision was made by Pfizer to terminate the study and not proceed with the Phase 2 expansion of this study. The reason for study termination is not due to any safety concerns or requests from regulatory authorities.

In newly diagnosed MM (NDMM), minimal residual disease (MRD)-adaptive consolidation with linvoseltamab in IMMUNOPLANT converted persistent MRD positivity to MRD negativity in all evaluable patients, supporting biologically guided treatment intensification...In early relapsed/refractory MM (RRMM), the pioneering phase III MajesTEC-3 trial demonstrated significant progression-free survival (PFS) and overall survival (OS) benefits with BsAb teclistamab plus daratumumab compared to other standard triplets, with response rates approaching those historically observed with chimeric antigen receptor (CAR) T cell therapy. A novel rational BsAb combination of BsAb elranatamab anda cereblon E3 ligase modulatory drug (CELMoD) iberdomide in MagnetisMM-30 showed promising synergy despite cytopenias and updates to combination BsAb targeting in RedirecTT-1 demonstrated major activity in difficult to treat extramedullary myeloma (EMM). First-in-human inMMyCAR data showcased the forefront of engineered immune strategies, by introducing an in vivo CAR-T product as a proof-of-concept platform, with tremendous potential to streamline the access to therapy. Collectively, these studies signal a shift toward earlier and adaptive immunotherapy in all phases of MM disease, while underscoring the importance of infection mitigation and long-term safety evaluation.

P2, N=64, Not yet recruiting, Case Comprehensive Cancer Center

P1, N=59, Active, not recruiting, Pfizer | Trial primary completion date: Apr 2026 --> Jul 2025

P2, N=34, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting | Initiation date: Jul 2026 --> Mar 2026

Notably, marked peripheral CD8+ T cell expansion was observed at the onset of response, and counts remained elevated during sustained remission. This case suggests that early sFLC reduction is a useful indicator for treatment continuation, and that peripheral CD8+ T-cell dynamics may serve as an on-treatment response biomarker for elranatamab therapy.

P1, N=59, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | N=90 --> 59

P2, N=32, Recruiting, Massachusetts General Hospital | Trial primary completion date: Dec 2025 --> Aug 2026

P2, N=30, Recruiting, Massachusetts General Hospital | Not yet recruiting --> Recruiting

P2, N=26, Recruiting, Memorial Sloan Kettering Cancer Center