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POLARIX subgroup analysis: Pola-R-CHP for older patients aged ≥60 years with untreated DLBCL
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Polatuzumab vedotin (Pola) is an anti-CD79b ADC that was approved in 2023 by the FDA in combination with rituximab (R)-CHP for the treatment of patients with untreated DLBCL based on results from the phase III POLARIX trial (NCT03274492).1 The Lymphoma Hub has previously covered the primary results and other analyses from the POLARIX trial. Results from a further subgroup analysis of this trial, focusing on older patients with previously untreated DLBCL aged ≥60 years (Pola-R-CHP, n = 311; R-CHOP, n = 318) were published in Blood Advances by Hu et al.1 The endpoints included PFS, OS, EFS, CRR, DFS, and safety.1 |
| Key learnings |
| Pola-R-CHP improved PFS in patients aged ≥60 years and across all age subgroups analyzed. The greatest benefit was in patients aged ≥70 years (HR, 0.63; 95% CI, 0.41–0.96), for whom the risk of disease progression, relapse, or death was reduced by 37% compared with R-CHOP. |
| In patients with an IPI score of 3–5, a PFS benefit was observed with Pola-R-CHP vs R-CHOP (2-year PFS difference, 13% in patients aged ≥70 years). In patients aged ≥60 years, OS was similar for Pola-R-CHP vs R-CHOP (HR, 0.99; 95% CI, 0.67–1.47). |
| Safety profiles were similar for Pola-R-CHP vs R-CHOP, including Grade 3–4 AEs (62.7% vs 61.5%), Grade 3–5 infections (15.0% vs 12.9%), and Grade 5 AEs (3.6% vs 3.2%). A higher rate of Grade 3–4 febrile neutropenia (16.3% vs 7.6%) was observed with Pola-R-CHP vs R-CHOP, highlighting the importance of G-CSF prophylaxis in this population. |
| Consistent with the POLARIX overall treatment population, Pola-R-CHP showed a favorable benefit-risk profile for patients aged ≥60 years with previously untreated DLBCL, suggesting that elderly patients can benefit from treatment with Pola-R-CHP with manageable toxicities. |
Abbreviations: ADC, antibody−drug conjugate; AE, adverse event; CHOP, cyclophosphamide-doxorubicin-vincristine-prednisone; CHP, cyclophosphamide-doxorubicin-prednisone; CI, confidence interval; CRR, complete response rate; DFS, disease-free survival; DLBCL, diffuse large B-cell lymphoma; EFS, event-free survival; FDA, U.S. Food and Drug Administration; G-CSF, granulocyte-colony stimulating factor; HR, hazard ratio; IPI, International Prognostic Index; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; Pola, polatuzumab vedotin; R, rituximab.
- Hu NL, Reagan PM, Shen LH, et al. Subgroup analysis of elderly patients (≥60 years) with diffuse large B-cell lymphoma in the phase 3 POLARIX study. Blood Adv. 2025. Online ahead of print. DOI: 10.1182/bloodadvances.2024014707
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