Abstract
BACKGROUND
DLBCL is the most common B-cell non-Hodgkin lymphoma in adults, with first-line therapy curing approximately 60% of patients. For patients with relapsed/refractory disease, a subset may have durable remission with autologous stem cell transplant or CAR-T therapy, but most are ineligible or lack access to these, with poor outcomes. Bispecific T cell engager antibodies offer promising and more accessible immune therapy options (epcoritimab and glofitimab were approved by the US FDA in May and June 2023, respectively). This retrospective real-world study evaluated the early adoption of BsAbs in the US community oncology setting.
METHODS
This retrospective observational cohort study used structured data from iKnowMed, an oncology-specific electronic health records (EHR) system that documents outpatient encounters within The US Oncology Network and non-Network practices. Adult patients with DLBCL who initiated third-line or later therapy (3L+) between May 1, 2023, and June 30, 2025, were included. Two cohorts were defined: those receiving BsAbs and those who did not. The start date of the first 3L+ treatment served as the index date. Patient characteristics at index (or within three months for Eastern Cooperative Oncology Group [ECOG] performance status) were compared across cohorts, and BsAb treatment patterns were described. Overall survival (OS) in the BsAb cohort was estimated using unadjusted Kaplan-Meier methods.
RESULTS
A total of 332 adult DLBCL patients initiating 3L+ were identified. Patient and clinical characteristics were similar between the BsAb and non-BsAb cohorts. The median age was 75 in the BsAb group and 73 in the non-BsAb group;13.0% of patients among BsAb recipients were treated in rural practices and 12.1% among non-recipients. Most patients were White (78.3% BsAb; 67.5% non-BsAb), and ECOG >1 was observed in ~20% of both cohorts. Advanced-stage disease (stage III/IV) was present in 71.7% of BsAb and 69.2% of non-BsAb patients. Among BsAb recipients, 65.2% received therapy in 3L, 27.2% in 4L, and 7.6% in 5L+. The proportion of patients receiving BsAb increased over time: 10.1% (May–Dec 2023), 32.7% (Jan–Jun 2024), 40.3% (Jul–Dec 2024), and 46.3% (Jan–Jun 2025). Median OS in the BsAb cohort was 9.1 months (95% CI: 5.2-14.2). Survival probabilities at 3, 6, and 12 months were 74.6% (95% CI: 63.7-82.7), 55.1% (42.9-65.8), and 39.8% (26.3-52.9), respectively.
CONCLUSION
This real-world study showed an early and growing adoption of BsAb therapies for patients with relapsed/refractory DLBCL in US community oncology settings following FDA approvals. Most patients received BsAbs after only two prior lines of therapy, and baseline characteristics were similar to those receiving other 3L+ treatments. The median OS of 9.1 months for the BsAb-treated patients was lower than that reported in clinical trials, likely reflecting an older and less fit population. The main limitation of this study is its reliance on structured EHR data, which may not capture key clinical details such as treatment response, adverse events, and disease progression. Future research incorporating abstracted unstructured data and longer follow-up will be essential to deepen this analysis and inform real-world experience.
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