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POLARIX: 5-year follow-up of Pola-R-CHP in patients with intermediate- or high-risk DLBCL
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Pola, an antibody–drug conjugate targeting CD79b, was approved by the FDA in combination with R-CHP for the treatment of patients with untreated DLBCL based on results from the POLARIX trial (NCT03274492). POLARIX is a phase III, randomized trial that investigated the efficacy and safety of Pola in combination with R-CHP (Pola-R-CHP; ITT, n = 500; safety evaluable, n = 495) vs standard of care (R-CHOP; ITT, n = 500; safety evaluable, n = 498) as first-line treatment for patients with DLBCL. The Lymphoma Hub has previously covered the primary results, descriptive analysis outcomes, safety and efficacy in elderly patients, Asian population analysis, and Pola-R-CHP vs R-CHOEP outcomes from the trial. Here, we summarize the 5-years results presented at the 66th ASH Annual Meeting and Exposition by Gilles Salles.1 |
| Key learnings |
| At the 5-year follow-up, PFS remained significantly improved with Pola-R-CHP vs R-CHOP (64.9% vs 59.1%). |
| The 5-year DFS and OS rates were also higher with Pola-R-CHP vs R-CHOP at 71.8 vs 66.5% and 82.3% vs 79.5%, respectively. |
| The safety profiles of Pola-R-CHP and R-CHOP were comparable, with similar rates of any grade and Grade 3–5 AEs, including any grade peripheral neuropathy (50.3% vs 52.4%) and infections (47.9% vs 44.0%). The difference in hematologic toxicities was <5% between arms. |
| Long-term data from the POLARIX trial demonstrate deep and durable efficacy of Pola-R-CHP, with sustained and significant PFS and DFS benefits vs R-CHOP and a comparable safety profile, supporting its use in patients with intermediate- or high-risk untreated DLBCL. |
Abbreviations: AE, adverse event; DLBCL, diffuse large B-cell lymphoma; DFS, disease-free survival; FDA, U.S. Food and Drug Administration; ITT, intention to treat; OS, overall survival; PFS, progression-free survival; Pola-R-CHP, polatuzumab vedotin-rituximab-cyclophosphamide-doxorubicin-prednisone; R-CHOP, rituximab-cyclophosphamide-doxorubicin-vincristine-and prednisone.
- Gilles Salles. Five-year analysis of the POLARIX study: Prolonged follow-up confirms positive impact of polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) on outcomes. Oral abstract #469. 66th American Society of Hematology (ASH) Annual Meeting and Exposition; Dec 10, 2024; San Deigo, US.
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