Real-world effectiveness of polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP) compared with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) among elderly Medicare beneficiaries with diffuse large B-cell lymphoma (DLBCL) in the United States

Abstract

Abstract Background: Polatuzumab vedotin (Pola) plus R-CHP (Pola-R-CHP) has shown a sustained progression-free survival (PFS) benefit over R-CHOP in patients with previously untreated DLBCL in the 5-year follow-up of the POLARIX trial (Salles et al. ASH 2024). Real-world evidence of the use and comparative effectiveness of Pola-R-CHP in the United States (US) is emerging, with studies demonstrating that Pola-R-CHP had a manageable safety profile and robust response rates and high survival rates in patients with previously untreated DLBCL (Iyengar et al. ASH 2024; Thiruvengadam et al. EHA 2025; Thiruvengadam et al. ICML 2025). Here, we investigate the real-world effectiveness of first-line treatment with Pola-R-CHP vs R-CHOP in Medicare beneficiaries with DLBCL, comparing patient characteristics, treatment characteristics and patient outcomes. Methods: In this retrospective study, data were sourced from the 100% Medicare fee-for-service claims database (April 2022–December 2024). Patients included had DLBCL based on International Classification of Diseases (10th revision) codes, were aged ≥66 years, and had received no systemic treatment for DLBCL 12 months prior to the index treatment date (defined as the first administration of Pola-R-CHP/R-CHOP on or after the Food and Drug Administration's approval date of Pola-R-CHP [April 19, 2023]). Patients had continuous Medicare coverage for Parts A/B 12 months prior to and 3 months after the index date. Patients with other lymphomas during the 12 months prior to the index date were excluded. Patients were split into two cohorts (Pola-R-CHP vs R-CHOP), with cohort definitions adapted from Burke et al. (CLML 2023). The primary outcome was time to next treatment or death (TTNT-D), as a proxy for PFS. The secondary outcome was overall survival (OS). The number of events during the study period and the percentage of patients with outcomes of interest at 6 and 12 months were examined. For patient characteristics, continuous variables were compared using Mann Whitney U tests, and categorical variables were analyzed using Chi-square tests. Time-to-event analyses were examined using Kaplan–Meier (KM) curves and Cox proportional hazards models were conducted to control for index treatment, age, race/ethnicity, sex, dual eligibility status, urban vs rural residence, Charlson comorbidity index, and Social Deprivation Index. Results: A total of 1,064 patients treated with Pola-R-CHP and 3,642 patients treated with R-CHOP were identified. The median follow-up was 9.3 months for Pola-R-CHP vs 10.3 months for R-CHOP. Patients in the Pola-R-CHP and R-CHOP groups both received a mean number of 4.8 cycles (median: 5 cycles) of Pola or rituximab, respectively. Beneficiaries who received Pola-R-CHP were more likely to be male compared with those who received R-CHOP (58% vs 54%; p-value: 0.0326); were younger, with a mean age of 75.0 vs 77.5 years (p-value: <0.0001); and had a lower Charlson comorbidity score (2.6 vs 2.8; p-value: 0.0006). A similar proportion of beneficiaries who received Pola-R-CHP vs R-CHOP were White (86% vs 88%), had dual Medicare/Medicaid eligibility (5% vs 7%), and lived in an urban setting (both 78%). Improved TTNT-D was observed for patients receiving Pola-R-CHP vs R-CHOP at 6 months (88% vs 83%) and 12 months (81% vs 73%). Significantly fewer patients who received Pola-R-CHP had second-line treatment or died compared with patients who received R-CHOP (17% vs 25%, respectively; adjusted hazard ratio [HR]: 0.79, 95% confidence interval [CI]: 0.67–0.93). A non-significant trend towards improved OS was observed in the unadjusted KM curves with Pola-R-CHP vs R-CHOP, with a higher percentage of patients surviving at 6 months (92% vs 89%) and 12 months (86% vs 82%). After adjusting for baseline characteristics, the adjusted HR for OS was 0.88 (95% CI: 0.72–1.07). Conclusions: To our knowledge, this is the first study examining treatment patterns and comparative outcomes of Pola-R-CHP vs R-CHOP among Medicare beneficiaries with DLBCL. Patients treated with Pola-R-CHP were more often male and younger, with a lower Charlson comorbidity score, compared with patients treated with R-CHOP. After adjusting for these characteristics, significant improvements in TTNT-D and a trend towards improved OS were observed with Pola-R-CHP. Overall, these data provide additional evidence for the effectiveness of Pola-R-CHP as a first-line treatment in an older Medicare population with DLBCL in the US.