Elrexfio (elranatamab-bcmm)

P1/2, N=49, Recruiting, Brigham and Women's Hospital | Not yet recruiting --> Recruiting

Currently, two BCMA-targeting BsAbs (teclistamab and elranatamab) and one GPRC5D-targeting BsAb (talquetamab) have regulatory approval for the treatment of patients (pts) with RRMM. CMMC counts through serial peripheral blood sampling can be used to assess disease burden and early kinetics of response to BsAb therapy. Further follow-up and additional cohorts are planned to confirm performance of this assay as a biomarker in predicting response and long-term outcomes in patients receiving BsAb and other therapies, as well as interrogating mechanisms of resistance through targeted sequencing and analysis of tumor-associated antigens of enumerated cells.

B-cell maturation antigen (BCMA)-targeting bispecific T-cell engagers (BiTEs), Teclistimab and Elranatamab have shown rapid and durable responses in RRMM with a lower incidence and severity of cytokine release syndrome (CRS) compared to chimeric antigen receptor T-cell therapies...CRS occurred within 24 hours of the first priming dose, lasted two days, and resolved with IV fluids, tocilizumab, and dexamethasone without recurrence... In this case series of heavily pre-treated Daratumumab relapsed/ refractory AL amyloidosis patients with advanced cardiac involvement, Elranatamab elicited rapid and deep hematological responses with all patients achieving a hematological complete response with deep suppression of iFLC within two weeks of treatment initiation, including MRD negative disease and cardiac responses in all tested patients after 3-5 cycles. Elranatamab was well-tolerated with no added toxicity and acceptable safety profile. These data support Elranatamab’s use in relapsed/refractory AL amyloidosis and prospective studies using BCMA-targeting BiTEs in this high-risk, high-need population.

P2, N=65, Not yet recruiting, Washington University School of Medicine | Trial completion date: Sep 2031 --> Dec 2031 | Initiation date: Sep 2024 --> Dec 2024 | Trial primary completion date: Sep 2031 --> Dec 2031

P2, N=40, Not yet recruiting, Ontario Clinical Oncology Group (OCOG) | Initiation date: Jul 2024 --> Nov 2024

P3, N=761, Recruiting, Pfizer | Active, not recruiting --> Recruiting

P=N/A, N=1, Active, not recruiting, Pfizer | N=700 --> 1

P=N/A, N=1, Active, not recruiting, Pfizer | Not yet recruiting --> Active, not recruiting | N=430 --> 1

P1, N=4, Completed, Pfizer | Active, not recruiting --> Completed

P1/2, N=38, Active, not recruiting, Pfizer | Phase classification: P2 --> P1/2

P3, N=761, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting

P=N/A, N=700, Active, not recruiting, Pfizer

P=N/A, N=150, Not yet recruiting, Pfizer

P1/2, N=49, Not yet recruiting, Brigham and Women's Hospital

P1, N=90, Recruiting, Pfizer | Trial completion date: Mar 2028 --> Nov 2027 | Trial primary completion date: May 2026 --> Dec 2025

P2, N=40, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting

P=N/A, N=2, Completed, Pfizer

P2, N=65, Not yet recruiting, Washington University School of Medicine

P=N/A, N=430, Not yet recruiting, Pfizer

P1, N=100, Recruiting, Pfizer | Trial completion date: Mar 2028 --> Jul 2028 | Trial primary completion date: Apr 2027 --> Aug 2027

P1, N=90, Recruiting, Pfizer | Trial primary completion date: Feb 2026 --> May 2026

P3, N=761, Recruiting, Pfizer | Trial completion date: Sep 2026 --> May 2027 | Trial primary completion date: Dec 2024 --> Aug 2025

P2, N=40, Not yet recruiting, Ontario Clinical Oncology Group (OCOG)

P2, N=50, Recruiting, Stichting European Myeloma Network | Not yet recruiting --> Recruiting

P2, N=50, Not yet recruiting, Stichting European Myeloma Network | Initiation date: Jan 2024 --> May 2024

P1, N=90, Recruiting, Pfizer | Trial primary completion date: Aug 2025 --> Feb 2026

P2, N=32, Recruiting, Massachusetts General Hospital | Not yet recruiting --> Recruiting

P2, N=120, Recruiting, Pfizer | N=92 --> 120

P1, N=90, Recruiting, Pfizer | N=14 --> 90

P2, N=50, Recruiting, PETHEMA Foundation | Not yet recruiting --> Recruiting | Initiation date: Mar 2024 --> Nov 2023

P2, N=187, Active, not recruiting, Pfizer | Trial completion date: Apr 2024 --> Dec 2025

P1, N=100, Recruiting, Pfizer | Not yet recruiting --> Recruiting | Trial completion date: Jun 2028 --> Mar 2028 | Trial primary completion date: Aug 2026 --> Apr 2027

P2, N=50, Not yet recruiting, PETHEMA Foundation

P1, N=101, Completed, Pfizer | Active, not recruiting --> Completed

P2, N=20, Not yet recruiting, Odense University Hospital | Initiation date: Jan 2024 --> May 2024

P3, N=492, Recruiting, Pfizer | Not yet recruiting --> Recruiting

P1, N=100, Not yet recruiting, Pfizer

P2, N=40, Not yet recruiting, M.D. Anderson Cancer Center

P2, N=92, Recruiting, Pfizer | Phase classification: P1b/2 --> P2 | Trial completion date: Sep 2027 --> Jun 2027 | Trial primary completion date: Mar 2025 --> Jul 2025

P2, N=50, Not yet recruiting, European Myeloma Network

P2, N=39, Active, not recruiting, Pfizer | Phase classification: P1b/2 --> P2

P=N/A, N=1, Completed, Pfizer | N=646 --> 1