Patients with relapsed/refractory multiple myeloma (RRMM) frequently present with renal impairment (RI), a complication that complicates treatment selection and prognosis. This often leads to their exclusion from pivotal clinical trials, leaving a data gap regarding optimal therapeutic strategies. A recent systematic review, presented at ASCO 2026, addresses this by evaluating the safety and efficacy of bispecific antibodies (BsAbs) in RRMM patients with RI, concluding that these agents maintain comparable outcomes to those with preserved renal function.1
Renal impairment, defined as an estimated glomerular filtration rate less than 60 mL/min, with or without the need for dialysis, is a common and severe complication in patients with relapsed/refractory multiple myeloma.1 This condition can significantly impact patient prognosis, drug metabolism, and available treatment options.1 While bispecific antibodies have received approval for RRMM, their safety and efficacy in patients with RI have remained insufficiently characterized due to the exclusion of individuals with significant renal dysfunction from most clinical trials.1
What the study did
A systematic review, conducted according to PRISMA guidelines, aimed to characterize the safety and efficacy of bispecific antibodies in RRMM patients with renal impairment.1 Researchers searched PubMed, Scopus, and ScienceDirect up to February 2, 2026, for clinical trials and retrospective real-world studies that reported data on BsAbs in RRMM patients with RI.1 Abstracts from major international scientific congresses over the preceding three years, including ASH, IMS, ASCO, EHA, and EMN, were also systematically screened.1
The review identified a total of 11 eligible studies, comprising 3 pivotal trials and 8 real-world cohorts, encompassing 1117 patients.1 The primary outcomes assessed included overall response rate (ORR), progression-free survival (PFS), and overall survival (OS).1 Safety profiles, specifically the incidence of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infections, and hematologic toxicities, were also evaluated.1
Key Findings
The systematic review demonstrated that ORR, PFS, and OS were comparable between patients with and without renal impairment.1 The safety profile, including the incidence of CRS, ICANS, infections, and hematologic toxicities, was also comparable across renal subgroups.1 The only exception was thrombocytopenia, which showed a significantly increased incidence in patients with RI.1 Overall, bispecific antibodies demonstrated substantial efficacy and manageable safety in RRMM patients with renal dysfunction.1 The outcomes observed were similar to those in patients with preserved renal function.1 These findings support the use of bispecific antibodies in this high-risk population in both clinical practice and future clinical trials.1
The persistent exclusion of patients with renal impairment from pivotal trials has long been a clinical frustration, creating a void in evidence-based guidance for a vulnerable population. This systematic review provides a much-needed clarification, confirming that bispecific antibodies are not only efficacious but also manageable in terms of safety for patients with relapsed/refractory multiple myeloma and renal dysfunction. The comparable outcomes for ORR, PFS, and OS across renal subgroups should reassure clinicians, allowing for broader application of these agents without undue concern for diminished efficacy or exacerbated toxicity, save for a noted increase in thrombocytopenia.
For the pharmaceutical industry, this data offers a clear directive: future clinical trials for multiple myeloma therapies must actively include patients with varying degrees of renal impairment. The historical rationale for exclusion, often cited as concerns over drug metabolism and toxicity, appears less tenable for bispecific antibodies based on these findings. This inclusion will not only strengthen the generalizability of trial results but also accelerate the integration of new treatments into routine clinical practice for a significant proportion of the myeloma patient population.
Ultimately, this evidence empowers clinicians to offer a wider range of effective treatment options to patients who previously faced limited choices due to their renal status. It underscores the importance of real-world data and systematic reviews in bridging the gaps left by restrictive trial designs. While the increased incidence of thrombocytopenia in patients with RI warrants careful monitoring, the overall picture supports a more inclusive approach to bispecific antibody therapy, aligning treatment decisions more closely with the complex realities of multiple myeloma patient care.
- The Pivot Bispecific antibodies, previously under-evaluated in patients with renal impairment, are now supported for use in this high-risk population.
- The Data Overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) were comparable between patients with and without renal impairment.1
- The Action Clinicians should consider bispecific antibodies as a viable treatment option for RRMM patients, irrespective of renal function status.
ART-2026-150
Cite This Article
Team TLSFE. Bispecific antibodies efficacious in multiple myeloma with renal impairment. The Life Science Feed. Published May 31, 2026. Updated May 31, 2026. Accessed May 31, 2026. https://thelifesciencefeed.com/haematology/multiple-myeloma/news/bispecific-antibodies-multiple-myeloma-renal-impairment.
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References
1. Ntanasis-Stathopoulos I, Manganas S, Filippatos C. The Role of Bispecific Antibodies in Relapsed/Refractory Multiple Myeloma With Renal Impairment: A Systematic Review. Am J Hematol. 2026;101(5):e200-e203.
