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Polatuzumab vedotin in previously untreated DLBCL: an Asia subpopulation analysis from the phase 3 POLARIX trial

In the phase 3 POLARIX study in previously untreated diffuse large B-cell lymphoma, polatuzumab vedotin combined with rituximab plus cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) significantly improved progression-free survival (PFS) compared with rituximab plus cyclophosphamide, doxoru...

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Autores principales: Song, Yuqin, Tilly, Hervé, Rai, Shinya, Zhang, Huilai, Jin, Jie, Goto, Hideki, Terui, Yasuhito, Shin, Ho-Jin, Kim, Won Seog, Cao, Junning, Feng, Jifeng, Eom, Hyeon Seok, Kim, Tae Min, Tsai, Xavier Cheng-Hong, Gau, Jyh-Pyng, Koh, Hideo, Zhang, Liling, Song, Yongping, Yang, Yu, Li, Wei, Huang, He, Ando, Kiyoshi, Sharman, Jeff P., Sehn, Laurie H., Bu, Lilian, Wang, Xin, Jiang, Yanwen, Hirata, Jamie, Lee, Calvin, Zhu, Jun, Izutsu, Koji
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The American Society of Hematology 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10646777/
https://www.ncbi.nlm.nih.gov/pubmed/36626583
http://dx.doi.org/10.1182/blood.2022017734
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author Song, Yuqin
Tilly, Hervé
Rai, Shinya
Zhang, Huilai
Jin, Jie
Goto, Hideki
Terui, Yasuhito
Shin, Ho-Jin
Kim, Won Seog
Cao, Junning
Feng, Jifeng
Eom, Hyeon Seok
Kim, Tae Min
Tsai, Xavier Cheng-Hong
Gau, Jyh-Pyng
Koh, Hideo
Zhang, Liling
Song, Yongping
Yang, Yu
Li, Wei
Huang, He
Ando, Kiyoshi
Sharman, Jeff P.
Sehn, Laurie H.
Bu, Lilian
Wang, Xin
Jiang, Yanwen
Hirata, Jamie
Lee, Calvin
Zhu, Jun
Izutsu, Koji
author_facet Song, Yuqin
Tilly, Hervé
Rai, Shinya
Zhang, Huilai
Jin, Jie
Goto, Hideki
Terui, Yasuhito
Shin, Ho-Jin
Kim, Won Seog
Cao, Junning
Feng, Jifeng
Eom, Hyeon Seok
Kim, Tae Min
Tsai, Xavier Cheng-Hong
Gau, Jyh-Pyng
Koh, Hideo
Zhang, Liling
Song, Yongping
Yang, Yu
Li, Wei
Huang, He
Ando, Kiyoshi
Sharman, Jeff P.
Sehn, Laurie H.
Bu, Lilian
Wang, Xin
Jiang, Yanwen
Hirata, Jamie
Lee, Calvin
Zhu, Jun
Izutsu, Koji
author_sort Song, Yuqin
collection PubMed
description In the phase 3 POLARIX study in previously untreated diffuse large B-cell lymphoma, polatuzumab vedotin combined with rituximab plus cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) significantly improved progression-free survival (PFS) compared with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) with similar safety. Patients were randomized 1:1 to 6 cycles of Pola-R-CHP or R-CHOP plus 2 cycles of rituximab alone. For registration of POLARIX in China, consistency of PFS in an Asia subpopulation (defined as ≥50% of the risk reduction in PFS expected in the global population) was evaluated. Overall, 281 patients were analyzed: 160 patients from Asia in the intention-to-treat (ITT) population of the global study and 121 from an ITT China extension cohort. Of these, 141 were randomized to Pola-R-CHP and 140 to R-CHOP. At data cutoff (28 June 2021; median follow-up 24.2 months), PFS met the consistency definition with the global population, and was superior with Pola-R-CHP vs R-CHOP (hazard ratio, 0.64; 95% confidence interval [CI], 0.40-1.03). Two-year PFS was 74.2% (95% CI, 65.7-82.7) and 66.5% (95% CI, 57.3-75.6) with Pola-R-CHP and R-CHOP, respectively. Safety was comparable between Pola-R-CHP and R-CHOP, including rates of grade 3 to 4 adverse events (AEs; 72.9% vs 66.2%, respectively), serious AEs (32.9% vs 32.4%), grade 5 AEs (1.4% vs 0.7%), AEs leading to study treatment discontinuation (5.0% vs 7.2%), and any-grade peripheral neuropathy (44.3% vs 50.4%). These findings demonstrate consistent efficacy and safety of Pola-R-CHP vs R-CHOP in the Asia and global populations in POLARIX. This trial was registered at https://clinicaltrials.gov/ct2/home as # NCT03274492.
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spelling pubmed-106467772023-01-12 Polatuzumab vedotin in previously untreated DLBCL: an Asia subpopulation analysis from the phase 3 POLARIX trial Song, Yuqin Tilly, Hervé Rai, Shinya Zhang, Huilai Jin, Jie Goto, Hideki Terui, Yasuhito Shin, Ho-Jin Kim, Won Seog Cao, Junning Feng, Jifeng Eom, Hyeon Seok Kim, Tae Min Tsai, Xavier Cheng-Hong Gau, Jyh-Pyng Koh, Hideo Zhang, Liling Song, Yongping Yang, Yu Li, Wei Huang, He Ando, Kiyoshi Sharman, Jeff P. Sehn, Laurie H. Bu, Lilian Wang, Xin Jiang, Yanwen Hirata, Jamie Lee, Calvin Zhu, Jun Izutsu, Koji Blood Clinical Trials and Observations In the phase 3 POLARIX study in previously untreated diffuse large B-cell lymphoma, polatuzumab vedotin combined with rituximab plus cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) significantly improved progression-free survival (PFS) compared with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) with similar safety. Patients were randomized 1:1 to 6 cycles of Pola-R-CHP or R-CHOP plus 2 cycles of rituximab alone. For registration of POLARIX in China, consistency of PFS in an Asia subpopulation (defined as ≥50% of the risk reduction in PFS expected in the global population) was evaluated. Overall, 281 patients were analyzed: 160 patients from Asia in the intention-to-treat (ITT) population of the global study and 121 from an ITT China extension cohort. Of these, 141 were randomized to Pola-R-CHP and 140 to R-CHOP. At data cutoff (28 June 2021; median follow-up 24.2 months), PFS met the consistency definition with the global population, and was superior with Pola-R-CHP vs R-CHOP (hazard ratio, 0.64; 95% confidence interval [CI], 0.40-1.03). Two-year PFS was 74.2% (95% CI, 65.7-82.7) and 66.5% (95% CI, 57.3-75.6) with Pola-R-CHP and R-CHOP, respectively. Safety was comparable between Pola-R-CHP and R-CHOP, including rates of grade 3 to 4 adverse events (AEs; 72.9% vs 66.2%, respectively), serious AEs (32.9% vs 32.4%), grade 5 AEs (1.4% vs 0.7%), AEs leading to study treatment discontinuation (5.0% vs 7.2%), and any-grade peripheral neuropathy (44.3% vs 50.4%). These findings demonstrate consistent efficacy and safety of Pola-R-CHP vs R-CHOP in the Asia and global populations in POLARIX. This trial was registered at https://clinicaltrials.gov/ct2/home as # NCT03274492. The American Society of Hematology 2023-04-20 2023-01-12 /pmc/articles/PMC10646777/ /pubmed/36626583 http://dx.doi.org/10.1182/blood.2022017734 Text en © 2023 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Clinical Trials and Observations
Song, Yuqin
Tilly, Hervé
Rai, Shinya
Zhang, Huilai
Jin, Jie
Goto, Hideki
Terui, Yasuhito
Shin, Ho-Jin
Kim, Won Seog
Cao, Junning
Feng, Jifeng
Eom, Hyeon Seok
Kim, Tae Min
Tsai, Xavier Cheng-Hong
Gau, Jyh-Pyng
Koh, Hideo
Zhang, Liling
Song, Yongping
Yang, Yu
Li, Wei
Huang, He
Ando, Kiyoshi
Sharman, Jeff P.
Sehn, Laurie H.
Bu, Lilian
Wang, Xin
Jiang, Yanwen
Hirata, Jamie
Lee, Calvin
Zhu, Jun
Izutsu, Koji
Polatuzumab vedotin in previously untreated DLBCL: an Asia subpopulation analysis from the phase 3 POLARIX trial
title Polatuzumab vedotin in previously untreated DLBCL: an Asia subpopulation analysis from the phase 3 POLARIX trial
title_full Polatuzumab vedotin in previously untreated DLBCL: an Asia subpopulation analysis from the phase 3 POLARIX trial
title_fullStr Polatuzumab vedotin in previously untreated DLBCL: an Asia subpopulation analysis from the phase 3 POLARIX trial
title_full_unstemmed Polatuzumab vedotin in previously untreated DLBCL: an Asia subpopulation analysis from the phase 3 POLARIX trial
title_short Polatuzumab vedotin in previously untreated DLBCL: an Asia subpopulation analysis from the phase 3 POLARIX trial
title_sort polatuzumab vedotin in previously untreated dlbcl: an asia subpopulation analysis from the phase 3 polarix trial
topic Clinical Trials and Observations
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10646777/
https://www.ncbi.nlm.nih.gov/pubmed/36626583
http://dx.doi.org/10.1182/blood.2022017734
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