{
  "abstract": "Background Bispecific antibodies (bsAbs) have transformed the therapeutic landscape across hematologic and solid malignancies, offering durable remissions in heavily pretreated populations. However, access to these agents is often limited to clinical trials, which frequently use stringent exclusion criteria. While intended to optimize patient safety and standardize study populations, these criteria likely inadvertently exclude patients who could benefit from treatment. We analyzed how current trial criteria may restrict access and assessed clinical outcomes of patients treated with bsAbs outside of clinical trial settings.Methods We reviewed actively recruiting phase 2 and 3 clinical trials involving bsAbs listed on the National Cancer Institute’s website (www.cancer.gov) for the following agents: blinatumomab, tarlatamab, epcoritamab, glofitamab, mosunetuzumab, talquetamab, teclistamab, and elranatamab. Eligibility criteria were abstracted for exclusions based on creatinine clearance (CrCl), age, ECOG status, hemoglobin, platelet count, liver function tests, ejection fraction, autoimmune disease, and prior immune checkpoint inhibitor-related toxicities.In parallel, we conducted a retrospective chart review of patients treated with bsAbs for standard of care therapy at a Brown University Health site from 2018 to 2025. Baseline characteristics relevant to trial criteria were collected.Results Sixty-four clinical trials were analyzed. The most common exclusion criteria were ECOG status (92%, median 2), liver function tests (64%, median AST/ALT > 100), CrCl (53%, median 45), platelet count (50%, median 75), autoimmune disease (47%), hemoglobin (39%, median 8), and age (13%, median 75).At our institution, 64 patients received bsAbs for standard of care therapy. Those most represented were teclistamab (38%), tarlatamab (28%), and talquetamab (23%). Thirty-four patients (53%) would have been excluded based on at least one trial criterion. The most common exclusionary factors were age > 75 (36%), platelet count < 75 (20%), and CrCl < 45 (20%) (table 1). Mean treatment duration was similar between trial-eligible (4.7+4.2 months) and ineligible patients (4.5±5.7 months, p=0.31) (figure 1). Discontinuation rates were also comparable (57% vs 74%, p=0.25).Conclusions A substantial proportion of real-world patients receiving bsAbs would not have qualified for clinical trial enrollment due to common exclusion criteria such as age, cytopenias, and renal dysfunction. Despite this, treatment duration and discontinuation rates were similar between trial-eligible and trial-ineligible groups suggesting that current eligibility criteria may be overly restrictive. These findings highlight the need to reconsider trial design to improve accessibility and better reflect real-world populations.Abstract 979 Table 1Exclusion criteria and bispecific used. Bispecifics and number of patients excluded based on clinical trial criteria describedAbstract 979 Figure 1Treatment duration by eligibility status. Bispecific treatment duration by clinical trial eligibility status",
  "authors": [
    {
      "affiliations": [
        "Brown University Health, Providence, RI, USA"
      ],
      "name": "Sovijja Pou"
    },
    {
      "affiliations": [
        "Brown University Health, Providence, RI, USA"
      ],
      "name": "Chanjun S Park"
    },
    {
      "affiliations": [
        "Brown University Health, Providence, RI, USA"
      ],
      "name": "Charmi Trivedi"
    },
    {
      "affiliations": [
        "Brown University Health, Providence, RI, USA"
      ],
      "name": "Matthew J Hadfield"
    }
  ],
  "title": "979 Reassessing clinical trial eligibility: real-world impact of bispecific antibody exclusion criteria",
  "uid": "e19a4f1e-b63d-53b9-a569-2b0413209d2a"
}