Real-World Efficacy and Safety Protocols for Bispecific Antibodies

EP: 1.Treatment Decision-Making in Multiple Myeloma at First and Subsequent Relapses

EP: 2.Navigating Novel Therapies: ADCs, BsAbs, and CAR T in RRMM

EP: 3.Sequencing Strategies and Patient Selection for Bispecific Antibodies in RRMM

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EP: 4.Real-World Efficacy and Safety Protocols for Bispecific Antibodies

Real-world experience with bispecific antibodies has consistently demonstrated efficacy comparable to clinical trial results, even in patient populations typically excluded from studies. These patients often present with more advanced age, high-risk cytogenetics, and significant comorbidities, yet multiple academic and community centers have reported similar response rates across different bispecific agents including teclistamab, talquetamab, and elranatamab. This consistency suggests that the benefits observed in carefully selected trial populations translate effectively to broader patient cohorts encountered in routine clinical practice.

The implementation of bispecific therapies in community settings has been limited by concerns about Risk Evaluation and Mitigation Strategy (REMS) programs and management of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). However, the risk of severe toxicities decreases significantly after the initial step-up dosing period, and prophylactic measures including tocilizumab and dexamethasone have substantially reduced the incidence and severity of complications. The development of standardized protocols and growing clinical experience have made these therapies increasingly manageable for patients receiving care outside academic centers.

Most patients can successfully complete step-up dosing and continue maintenance therapy in community settings once appropriate safety infrastructure is established. The key requirements include clear protocols for managing fevers and toxicities, access to emergency medications like tocilizumab, and coordination between academic centers for initial dosing and community providers for ongoing care. REMS certification should not deter community physicians from managing patients who have completed step-up dosing, as the risk of significant CRS or ICANS becomes minimal after the first few weeks of treatment.