Real-World Safety and Efficacy of Pola-R-CHP in Previously Untreated DLBCL: POLASTAR Interim Analysis of 500 Patients.

Authors

Takahiro Kumode, Hitomi Sawa, Kohta Miyawaki, Atsushi Satake, Nobuhiro Kanemura, Ritsuro Suzuki, Yuki Fujiwara, Yasuhiro Nagate, Shuichi Ota, Takahiro Fujino, Hideki Goto, Noriko Fukuhara, Mamiko Sakata-Yanagimoto, Koji Izutsu, Momoko Nishikori, Hirohiko Shibayama, Daisuke Ennishi, Takayuki Shimose, Mai Asai, Itaru Matsumura, Koichi Akashi, Koji Kato

Published in

Cancer science. Jul 24, 2026. Epub Jul 24, 2026.

Abstract

POLASTAR (jRCT1071220082) is a multicenter, prospective observational study evaluating the real-world efficacy and safety of polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisolone (Pola-R-CHP) in Japanese patients with diffuse large B-cell lymphoma (DLBCL), addressing the limited real-world data in this setting. Patients ≥ 18 years, with previously untreated DLBCL, receiving Pola-R-CHP were enrolled. Patients excluded from POLARIX (NCT03274492), including those > 80 years, were included. Overall, 485 patients were included in the full analysis set (FAS; median age, 71 years [range 27-93]; age ≤ 80 years, 87.6%; International Prognostic Index score 2-5, 73.7%). Median relative dose intensity (RDI) for rituximab and polatuzumab vedotin was ≥ 93.0% (both FAS and patients > 80 years), and for the chemotherapy components median RDI was ≥ 87.2% in the FAS and ≥ 49.6% for patients > 80 years. Grade ≥ 3 adverse events (AEs) occurred in 47.4% of patients in the FAS and 56.7% of patients > 80 years; serious AEs occurred in 12.6% and 25.0%, respectively. The most common Grade ≥ 3 AE (FAS/> 80 years) was neutrophil count decreased (25.6%/26.7%). In the FAS, 5 (1.0%) deaths due to AEs were reported and 33 (6.8%) patients discontinued polatuzumab vedotin due to AEs. No new safety signals were observed. In the FAS, overall response rate and complete response rate (95% confidence interval [CI]) were 93.2% (90.5-95.2) and 83.3% (79.6-86.5), respectively, and were 87.3% (76.0-93.7) and 80.0% (67.6-88.4) in patients > 80 years. Safety and efficacy of Pola-R-CHP in Japanese patients, including those > 80 years, were consistent with results from POLARIX. Trial Registration: Japan Registry of Clinical Trials (jRCT1071220082).

PMID:
42495802
Bibliographic data and abstract were imported from PubMed on 24 Jul 2026.

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