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Randomized Controlled Trial
. 2023 Apr 20;141(16):1971-1981.
doi: 10.1182/blood.2022017734.

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

Yuqin Song  1 , Hervé Tilly  2 , Shinya Rai  3 , Huilai Zhang  4 , Jie Jin  5 , Hideki Goto  6 , Yasuhito Terui  7 , Ho-Jin Shin  8 , Won Seog Kim  9 , Junning Cao  10 , Jifeng Feng  11 , Hyeon Seok Eom  12 , Tae Min Kim  13 , Xavier Cheng-Hong Tsai  14 , Jyh-Pyng Gau  15 , Hideo Koh  16 , Liling Zhang  17 , Yongping Song  18 , Yu Yang  19 , Wei Li  20 , He Huang  21 , Kiyoshi Ando  22 , Jeff P Sharman  23 , Laurie H Sehn  24 , Lilian Bu  25 , Xin Wang  25 , Yanwen Jiang  26 , Jamie Hirata  26 , Calvin Lee  26 , Jun Zhu  1 , Koji Izutsu  27
Affiliations
Randomized Controlled Trial

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

Yuqin Song et al. Blood. .

Abstract

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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Conflict of interest statement

Conflict-of-interest disclosure: H.T. reports honoraria from Bristol Myers Squibb and Roche, consulting or an advisory role for Celgene/Bristol Myers Squibb, Incyte, and Roche, research funding from Roche/Genentech (institutional), and travel, accommodations, and expenses from Roche. S.R. reports speakers’ bureau fees from Chugai Pharma, Janssen, and Ono Pharmaceutical. H.G. reports speakers’ bureau fees from Chugai Pharma, Janssen, Kyowa Kirin, Novartis, MSD, and Daiichi Sankyo, and research funding from Bristol Myers Squibb. Y.T. reports speakers’ bureau fees from AbbVie, Celgene, Chugai Pharma, Eisai, Janssen, and Ono Pharmaceutical. T.M.K. reports consulting or advisory roles from AstraZeneca, Hanmi, Janssen, Novartis, Regeneron, Roche/Genentech, and Takeda, and research funding from AstraZeneca, Korea Health Industry Development Institute. X.C.-H.T. reports honoraria from Kirin Pharmaceuticals, Novartis, and Takeda, consulting or advisory role for Astellas Pharma, Chugai Pharma, Novartis, Pfizer, and Roche, and speakers’ bureau fees from Astellas Pharma, Bristol Myers Squibb, Celgene, Harvester Trading Co, Janssen, Kirin Pharmaceuticals, Novartis, Pfizer, Roche, and Takeda. H.K. reports research funding from Chugai Pharmaceutical and Takeda Pharmaceutical, and honoraria from Novartis and Takeda Pharmaceutical. K.A. reports research funding from Solasia, Novartis, Janssen, Otsuka, IQVIA, Zenyaku, Chugai, and Astellas, and honoraria from Kyowa Kirin, Takeda, Chugai, Meiji Seika, Eisai, and Mochida. J.P.S. reports consulting or advisory role for AbbVie, Acerta Pharma/AstraZeneca, BeiGene, Bristol Myers Squibb, Genentech, Merck, and TG Therapeutics, and research funding from Acerta Pharma (institutional), Celgene (institutional), Genentech (institutional), Gilead Sciences (institutional), Merck (institutional), Pharmacyclics (institutional), Seattle Genetics (institutional), Takeda (institutional), and TG Therapeutics (institutional). L.H.S. reports consulting for Novartis, Genmab, Debiopharm, Teva, Roche/Genentech, AbbVie, Acerta, Amgen, Apobiologix, AstraZeneca, Celgene, Gilead, Incyte, Janssen, Kite, Karyopharm, Lundbeck, Merck, Morphosys, Sandoz, Seattle Genetics, Takeda, TG Therapeutics, and Verastem, and research funding from Teva and Roche/Genentech. L.B. is an employee of F. Hoffmann La Roche Ltd. X.W. is an employee of F. Hoffmann La Roche Ltd, and receives F. Hoffmann-La Roche Ltd stocks/stock options. Y.J., J.H., and C.L. are employees of Genentech, Inc, and receive F. Hoffmann-La Roche Ltd stocks/stock options. K.I. reports honoraria from AbbVie, Allergan, AstraZeneca, Bayer, Bristol Myers Squibb, Celgene, Chugai Pharma, Daiichi Sankyo, Dainippon Sumitomo Pharma, Eisai, Fujifilm, HUYA Bioscience International, Janssen, Kyowa Kirin, MSD, Mundipharma, Novartis, Ono Pharmaceutical, and Takeda, consulting or advisory role for AbbVie, AstraZeneca, Bayer, Celgene, Kyowa Kiri, and Ono Pharmaceutical, and research funding for Chugai Pharma and Eisai. The remaining authors declare no competing financial interests.

Figures

None
Graphical abstract
Figure 1.
Figure 1.
Patient disposition (intention-to-treat population).
Figure 2.
Figure 2.
Kaplan–Meier estimates of efficacy end points. (A) Investigator-assessed PFS. (B) Investigator-assessed EFS. (C) OS. (D) DFS (intention-to-treat population). Data cutoff: 28 June, 2021. EFS, EFS for efficacy purposes.
See this image and copyright information in PMC

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