Asia subpopulation analysis from the phase III POLARIX trial.

Authors

null

Yuqin Song

Key Laboratory of Carcinogenesis and Transitional Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital and Institute, Beijing, China

Yuqin Song , Jie Jin , Herve Tilly , Huilai Zhang , Junning Cao , Jifeng Feng , Liling Zhang , Shinya Rai , Hideki Goto , Yasuhito Terui , Won Seog Kim , Ho-Jin Shin , Jyh-Pyng Gau , Cheng-Hong Tsai , Jeff Porter Sharman , Lilian Bu , Jamie Hirata , Calvin Lee , Koji Izutsu , Jun Zhu

Organizations

Key Laboratory of Carcinogenesis and Transitional Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital and Institute, Beijing, China, The First Affiliated Hospital of College of Medicine, Zhejiang University, Zhejiang, China, Department of Hematology and U1245, Centre Henri Becquerel and University of Rouen, Rouen, France, Tianjin's Clinical Research Center for Cancer, Tianjin Medical University, Tianjin, China, Fudan University Shanghai Cancer Center, Shanghai, China, Jiangsu Cancer Hospital, Nanjing, China, Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, China, Kindai University Hospital, Osaka, Japan, Hokkaido University Hospital, Sapporo, Japan, The Cancer Institute Hospital of JFCR, Tokyo, Japan, Samsung Medical Center, Seoul, South Korea, Pusan National University Hospital, Seoul, South Korea, Taipei Veterans General Hospital, Taipei, Taiwan, National Taiwan University Hospital, Taipei, Taiwan, Willamette Valley Cancer Institute/US Oncology, Eugene, OR, Genentech, Inc., South San Francisco, CA, National Cancer Center Hospital, Tokyo, Japan, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital and Institute, Beijing, China

Research Funding

Pharmaceutical/Biotech Company

Background: In the pivotal Phase III POLARIX trial, Pola-R-CHP demonstrated significantly improved progression-free survival (PFS) compared with R-CHOP, with a similar safety profile in patients with previously untreated DLBCL (Tilly et al. 2022). An Asia subpopulation analysis was included as part of the trial design; patients enrolled in Asia were analyzed for the purpose of registration in China of POLARIX (NCT03274492). Methods: Patients from mainland China, Hong Kong, Japan, South Korea, and Taiwan (enrolled during the global phase), and from the China extension cohort were included in the Asia subpopulation. POLARIX methods were previously described (Tilly et al. 2022). Briefly, patients with untreated DLBCL were randomized 1:1 using the same stratification factors to receive six cycles of Pola-R-CHP or R-CHOP, plus two cycles of rituximab alone. The purpose of this analysis was to evaluate consistency of PFS (defined as ≥50% risk reduction in PFS) in the Asia subpopulation with the global population. Results: Overall, 281 patients (intent-to-treat population; 150, 85, 31 and 15 patients in mainland China, Japan, South Korea and Taiwan, respectively) were analyzed (141 received Pola-R-CHP and 140 received R-CHOP); 160 patients from the global population and 121 from the China extension cohort. Median age was 63 (range 19–79) years, and most patients had an International Prognostic Index of 3–5 (61.9%). At the data cut-off of June 28, 2021, (median follow-up of 24.2 months) PFS was superior with Pola-R-CHP vs R-CHOP (hazard ratio [HR] 0.64; 95% confidence interval [CI]: 0.40–1.03) and met the consistency definition with the global population. The 2-year PFS rate was 74.2% (95% CI: 65.7–82.7) with Pola-R-CHP vs 66.5% (95% CI: 57.3–75.6) with R-CHOP. Other key efficacy results were similar to the global study results (Table). The safety profile was generally comparable for Pola-R-CHP vs R-CHOP, including rates of grade 3–4 adverse events (AEs; 72.9% vs 66.2%), serious AEs (32.9% vs 32.4%), grade 5 AEs (1.4% vs 0.7%), AEs leading to discontinuation of any study treatment (5.0% vs 7.2%), and incidence of peripheral neuropathy (all grades, 44.3% vs 50.4%), respectively. Key efficacy results. CR, complete response. Conclusions: The results from the Asia subpopulation of POLARIX were consistent with the global study, with a clinically meaningful improvement in PFS (risk of disease progression, relapse or death reduced by 36%) following treatment with Pola-R-CHP vs R-CHOP, and a comparable safety profile in Asian patients with previously untreated DLBCL. Clinical trial information: NCT03274492.

OutcomePola-R-CHP
(n=141)
R-CHOP
(n=140)
Progression-free survival, number of events (%)30 (21.3)40 (28.6)
HR (95% CI)0.64 (0.40–1.03)
Event-free survival, number of events (%)30 (21.3)41 (29.3)
HR (95% CI)0.62 (0.38–1.00)
PET-CT CR (independent review) at end of treatment, n (%)116 (82.3)109 (77.9)
Overall survival, number of events (%)10 (7.1)15 (10.7)
HR (95% CI)0.64 (0.29–1.42)

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2022 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Track

Hematologic Malignancies

Sub Track

Non-Hodgkin Lymphoma

Clinical Trial Registration Number

NCT03274492

Citation

J Clin Oncol 40, 2022 (suppl 16; abstr 7558)

DOI

10.1200/JCO.2022.40.16_suppl.7558

Abstract #

7558

Poster Bd #

211

Abstract Disclosures

Similar Abstracts

First Author: Bei Hu

Abstract

2022 ASCO Annual Meeting

Efficacy and safety of orelabrutinib in diffuse large B-cell lymphoma: A real-world analysis.

First Author: Peng-Peng Xu

First Author: Michael Dickinson