Elrexfio (elranatamab-bcmm)

Based on the results of this systematic review, BCMA-directed therapies such as CAR-T cell therapy and bispecific antibodies demonstrate promising efficacy among patients with anti-CD38 refractory disease. However, additional evidence from randomized clinical trials is necessary to establish best practice guidelines.

P2, N=40, Not yet recruiting, Ontario Clinical Oncology Group (OCOG) | Initiation date: Nov 2024 --> May 2025 | Trial primary completion date: Dec 2025 --> Dec 2026

P=N/A, N=400, Recruiting, St. Olavs Hospital

P3, N=492, Recruiting, Pfizer | Trial primary completion date: Dec 2025 --> Aug 2026

P2, N=30, Not yet recruiting, Massachusetts General Hospital

This is the first reported application of a Markov model to describe the probability of CRS following BsAb therapy, and it successfully explained differences between different dose-priming regimens via clinically relevant covariates. This approach may be useful for the future clinical development of BsAbs.

P2, N=33, Recruiting, University of California, San Diego | Not yet recruiting --> Recruiting

P1/2, N=39, Active, not recruiting, Pfizer | Trial completion date: Feb 2025 --> Aug 2025

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

BiTe therapy is linked to a higher risk of severe COVID-19 due to an inflammatory cytokine storm, with LIF and the JAK-STAT pathway playing key roles. Targeting LIF and JAK-STAT pathway may help reduce severe COVID-19 in MM patients treated with BiTe.

P4, N=80, Recruiting, Pfizer | Trial completion date: Feb 2031 --> Feb 2032 | Trial primary completion date: Feb 2031 --> Feb 2032

P2; Not yet recruiting --> Recruiting

P2, N=33, Not yet recruiting, University of California, San Diego

P=N/A, N=150, Not yet recruiting, Pfizer | Trial completion date: Jan 2030 --> May 2030 | Initiation date: Oct 2024 --> Mar 2025 | Trial primary completion date: Jan 2030 --> May 2030

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. Conclusions : 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...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; 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