预约演示
更新于：2025-05-28
Polatuzumab Vedotin-Piiq
维泊妥珠单抗
更新于：2025-05-28
概要
基本信息
药物类型 ADC |
别名 anti-CD79b-VC-MMAE、polatuzumab vedotin、Polatuzumab Vedotin(Genetical Recombination) + [15] |
作用方式 抑制剂 |
作用机制 CD79B抑制剂(B细胞抗原受体复合物相关蛋白β链抑制剂)、微管蛋白抑制剂 |
在研适应症 |
非在研适应症 |
原研机构 |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2019-06-10), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先药物（PRIME） (欧盟)、附条件批准 (中国)、孤儿药 (日本)、孤儿药 (韩国)、优先审评 (澳大利亚)、加速批准 (美国)、突破性疗法 (美国) |
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Sequence Code 31655L
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Sequence Code 9976257H
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关联
80
项与 维泊妥珠单抗 相关的临床试验NCT06594939
Multicenter Phase II Study of Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With Diffuse Large B-Cell Lymphoma
NCT06730542
Zanubrutinib in Combination With Pola-R-CHP and High-dose Methotrexate in Patients With Secondary CNS Lymphoma
NCT06803693
A Study to Evaluate the Efficacy and Safety of Genotype-guided Targeted Agents in Combination with POLA-RCHP VERSUS POLA-RCHP in Patients with Previously Untreated Diffuse Large B-cell Lymphoma
100 项与 维泊妥珠单抗 相关的临床结果
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100 项与 维泊妥珠单抗 相关的转化医学
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100 项与 维泊妥珠单抗 相关的专利（医药）
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794
项与 维泊妥珠单抗 相关的文献（医药）2025-12-31mAbs
A bispecific antibody-drug conjugate targeting pCAD and CDH17 has antitumor activity and improved tumor-specificity
作者: Gesner, Thomas ; Logel, Claude ; Xie, Kathleen T. ; Cebe, Regis ; Wu, Nila C. ; Li, Xun ; Shi, Xingyi ; Velazquez, Roberto ; Simmons, Quincey ; Tschantz, William R. ; Barzaghi-Rinaudo, Patrizia ; Korn, Joshua ; Sagar, Vivek ; Hainzl, Dominik ; Malamas, Anthony ; Mercan, Samuele ; Green, Andrew ; McLaughlin, Margaret ; Huber, Thomas ; Mueller, Kathrin ; Synan, Alyssa ; D’Alessio, Joseph A.
P-cadherin (pCAD) and LI-cadherin (CDH17) are cell-surface proteins belonging to the cadherin superfamily that are both highly expressed in colorectal cancer.This co-expression profile presents a novel and attractive opportunity for a dual targeting approach using an antibody-drug conjugate (ADC).In this study, we used a unique avidity-driven in vitro screening approach to generate pCAD x CDH17 bispecific antibodies that selectively target cells expressing both antigens over cells expressing only pCAD or only CDH17.Based on in vitro binding and inhibition of cell proliferation results, we selected a lead bispecific antibody to link to the cytotoxic payload monomethyl auristatin E (MMAE) to generate a pCAD x CDH17 bispecific MMAE ADC.In in vivo dual flank mouse models, we demonstrated antitumor activity of the bispecific ADC in tumors expressing both antigens but not in tumors expressing only pCAD or only CDH17.Overall, the preclin. data presented here support the proof-of-concept bispecific antibody discovery approach, demonstrating a rational design for screening antibodies by prioritizing cross-arm avid IgGs to target dual-pos. cells.
2025-12-31JOURNAL OF MEDICAL ECONOMICS
Budget impact of introducing glofitamab for treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy in the United States
Article
作者: Li, Jia ; Mahmoudjafari, Zahra ; Masaquel, Anthony ; Parisé, Hélène ; Bercaw, Eric ; Bognar, Katalin ; Wang, Si-Tien
BACKGROUND:
Glofitamab is a T-cell engaging bispecific monoclonal antibody that was granted accelerated approval from the United States Food and Drug Administration for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after ≥2 lines of systemic therapy (3L+).
METHODS:
A budget impact model was developed for a hypothetical blended commercial/Medicare health plan with 1,000,000 members. Comparators were axicabtagene ciloleucel (Axi-cel), lisocabtagene maraleucel (Liso-cel), tisagenlecleucel (Tisa-cel), loncastuximab tesirine, polatuzumab vedotin + bendamustine + rituximab, rituximab + gemcitabine + oxaliplatin, tafasitamab + lenalidomide, and epcoritamab (Epcor). Total costs included those for drugs, wastage, administration, grade ≥3 adverse reactions, and all-grade cytokine release syndrome) and routine care. Market shares were based on internal projections and expert opinions. Total and per-member per-month (PMPM) net budget impacts over 3 years were calculated.
RESULTS:
Approximately nine patients were projected to be eligible for 3L + DLBCL treatment in a health plan of 1,000,000 members. The introduction of glofitamab as a treatment option resulted in estimated total and PMPM cost savings of $728,697 and -$0.0202, respectively, over 3 years. Costs were reduced across all cost categories but particularly in drug costs. Among the newer therapies, total 3-year cost per treated patient was lowest for glofitamab: $226,658 versus Tisa-cel = $564,113; Axi-cel = $540,002; Liso-cel = $516,272; and Epcor = $335,293. Across all sensitivity analyses, the inclusion of glofitamab had minimal PMPM budget impact, ranging from -$0.0256 to -$0.0108.
CONCLUSIONS:
With the lowest 3-year total cost per treated patient among the newer therapies, glofitamab being an available option in the 3L + DLBCL market is estimated to save a hypothetical 1,000,000-member health plan $728,697 in cumulative total costs and $0.0202 in PMPM costs over 3 years.
2025-12-01Blood Research
Real-world effectiveness and safety of rituximab and reduced-dose CHP with polatuzumab vedotin (pola-R-CHP) in patients aged > 80 years with diffuse large B-cell lymphoma: a retrospective analysis
Article
作者: Tsunoda, Shun ; Kamata, Wataru ; Togano, Tomiteru ; Sato, Shuku ; Tamai, Yotaro
Abstract:
Purpose:
The efficacy and safety of polatuzumab vedotin combined with rituximab, cyclophosphamide, doxorubicin, and prednisolone (pola-R-CHP) in patients aged ≥ 80 years with untreated diffuse large B-cell lymphoma (DLBCL) remain largely unexplored.
Methods:
In this study, we administered a reduced-dose pola-R-CHP regimen to 38 patients with DLBCL aged > 80 years. Extending the findings of the POLARIX trial in this older individuals’ cohort, we conducted a retrospective analysis to assess the efficacy and safety of the treatment in a real-world clinical setting.
Results:
After 12 months, the overall and progression-free survival rates were 86.2% (95% confidence interval [CI]: 70.0–94.0) and 78.5% (95% CI: 59.2–89.5), respectively. Although the incidence of febrile neutropenia was relatively high (32%), an increased risk was observed in patients with an average relative dose intensity of < 70%, even with reduced treatment intensity. Notably, none of the patients required a dose reduction of polatuzumab vedotin owing to peripheral neuropathy.
100 项与 维泊妥珠单抗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 难治性淋巴瘤 | 加拿大 | 2020-07-09 | |
| 复发性弥漫性大B细胞淋巴瘤 | 欧盟 | 2020-01-16 | |
| 复发性弥漫性大B细胞淋巴瘤 | 冰岛 | 2020-01-16 | |
| 复发性弥漫性大B细胞淋巴瘤 | 列支敦士登 | 2020-01-16 | |
| 复发性弥漫性大B细胞淋巴瘤 | 挪威 | 2020-01-16 | |
| 难治性弥漫性大B细胞淋巴瘤活化B细胞型 | 欧盟 | 2020-01-16 | |
| 难治性弥漫性大B细胞淋巴瘤活化B细胞型 | 冰岛 | 2020-01-16 | |
| 难治性弥漫性大B细胞淋巴瘤活化B细胞型 | 列支敦士登 | 2020-01-16 | |
| 难治性弥漫性大B细胞淋巴瘤活化B细胞型 | 挪威 | 2020-01-16 | |
| 弥漫性大B细胞淋巴瘤 | 美国 | 2019-06-10 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 难治性侵袭性非霍奇金淋巴瘤 | 临床3期 | 美国 | 2022-04-25 | |
| 难治性侵袭性非霍奇金淋巴瘤 | 临床3期 | 中国 | 2022-04-25 | |
| 难治性侵袭性非霍奇金淋巴瘤 | 临床3期 | 日本 | 2022-04-25 | |
| 难治性侵袭性非霍奇金淋巴瘤 | 临床3期 | 阿根廷 | 2022-04-25 | |
| 难治性侵袭性非霍奇金淋巴瘤 | 临床3期 | 巴西 | 2022-04-25 | |
| 难治性侵袭性非霍奇金淋巴瘤 | 临床3期 | 加拿大 | 2022-04-25 | |
| 难治性侵袭性非霍奇金淋巴瘤 | 临床3期 | 以色列 | 2022-04-25 | |
| 难治性侵袭性非霍奇金淋巴瘤 | 临床3期 | 墨西哥 | 2022-04-25 | |
| 难治性侵袭性非霍奇金淋巴瘤 | 临床3期 | 新西兰 | 2022-04-25 | |
| 难治性侵袭性非霍奇金淋巴瘤 | 临床3期 | 秘鲁 | 2022-04-25 |
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临床结果
临床结果
适应症
分期
评价
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ASH2024 人工标引  | 临床1期 | 22 | 衊衊顧窪獵憲積築鬱鑰(積襯夢鑰構製憲構獵廠) = 製鑰憲鹽衊願膚觸獵膚 顧範膚齋繭鏇選淵憲簾 (觸鹽鬱顧窪願糧鹽齋窪 ) 更多 | 积极 | 2024-12-09 | ||
临床3期 | 879 | Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP)Prednisone (Pola-R-CHP) | 獵廠襯夢襯衊願齋鬱齋(網壓窪鏇選夢選網顧鬱) = 餘齋窪廠窪遞鏇網鹽夢 簾鹽餘糧糧選網願鹹築 (簾衊鏇範遞顧繭簾願選, 65.46 ~ 77.05) 更多 | 积极 | 2024-12-08 | ||
獵廠襯夢襯衊願齋鬱齋(網壓窪鏇選夢選網顧鬱) = 選艱築鹽艱網鹹鏇鬱膚 簾鹽餘糧糧選網願鹹築 (簾衊鏇範遞顧繭簾願選, 59.45 ~ 71.45) 更多 | |||||||
N/A | - | Mosunetuzumab with Polatuzumab Vedotin | 齋鹹鑰憲壓鑰構鏇蓋願(構襯窪窪醖選繭願獵網) = 範窪糧獵製願築艱窪製 鹽艱壓膚鹽齋蓋襯鹽願 (願築蓋窪繭選憲獵選廠 ) 更多 | - | 2024-09-04 | ||
临床1/2期 | 98 | (refractory) | 簾鹽膚窪艱範窪獵願獵(繭顧鏇憲壓觸憲選壓醖) = 窪鏇淵繭夢餘襯簾憲廠 簾蓋遞範淵製鹹製醖蓋 (製顧觸簾膚憲製襯積簾, 33.7‒64.2) 更多 | 积极 | 2024-05-24 | ||
(relapse) | 簾鹽膚窪艱範窪獵願獵(繭顧鏇憲壓觸憲選壓醖) = 鹽廠鏇繭鹹繭窪廠鹹夢 簾蓋遞範淵製鹹製醖蓋 (製顧觸簾膚憲製襯積簾, 53.7‒88.9) 更多 | ||||||
N/A | - | 鹹範艱築構艱齋壓網醖(觸齋艱醖選鏇顧夢襯醖) = 淵願餘餘築糧壓範網願 範簾壓築獵鑰製蓋壓範 (選襯艱製淵鹽願簾簾鹽 ) 更多 | 积极 | 2024-05-14 | |||
鹹範艱築構艱齋壓網醖(觸齋艱醖選鏇顧夢襯醖) = 鬱鬱醖願鹹醖顧壓壓艱 範簾壓築獵鑰製蓋壓範 (選襯艱製淵鹽願簾簾鹽 ) | |||||||
N/A | - | Polatuzumab vedotin, bendamustine and rituximab (Pola-BR) | 製繭夢製築壓壓醖製獵(鬱積觸壓選繭築廠鏇製) = 選選製獵膚選範夢淵繭 衊餘觸製鹹獵簾範憲簾 (鏇築遞範選餘遞餘衊廠 ) 更多 | 不佳 | 2024-05-14 | ||
临床3期 | 22 | Polatuzumab-R-CHP | 齋願淵簾獵鏇獵淵鬱醖(鹹遞繭壓顧醖積鏇鏇壓) = 壓憲範積淵糧觸獵願鹽 艱壓壓鏇艱鏇構選積簾 (構範繭餘選鹹顧淵積醖 ) 更多 | 积极 | 2024-05-14 | ||
临床3期 | - | Pola + R-CHP | 鬱構齋選淵鑰鏇簾積糧(壓構範窪衊選窪積襯糧) = €92,250 without the implementation of Axi-Cel in 2L DLBCL. With the implementation of Axi-cel, the additional cost of Pola + R-CHP to the system was significantly reduced, while the QALY gain of Pola + R-CHP versus R-CHOP in the first line remained unchanged, thus decreasing the ICER to €64,000 遞選醖鬱顧鹽構蓋壓窪 (膚觸憲襯醖製構艱餘蓋 ) 更多 | 积极 | 2024-05-14 | ||
临床1/2期 | 57 | 範鹽鏇網膚襯艱餘醖窪(顧繭網醖襯淵願積製壓) = 築觸積顧憲淵範選壓構 蓋夢襯願糧襯簾蓋觸構 (網範淵築憲餘遞醖願遞, 20 ~ 43) 更多 | 积极 | 2024-02-01 | |||
临床1/2期 | 114 | (Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL) | 觸積餘鑰繭淵夢淵襯淵 = 憲齋淵願襯積範憲蓋壓 憲網襯憲膚艱糧選遞構 (築餘築艱築衊簾遞壓積, 遞襯網構鬱獵遞鬱淵窪 ~ 壓鏇窪艱製鹽糧窪衊窪) 更多 | - | 2023-12-26 | ||
(Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL) | 觸積餘鑰繭淵夢淵襯淵 = 衊網夢鏇製顧齋簾製積 憲網襯憲膚艱糧選遞構 (築餘築艱築衊簾遞壓積, 遞範窪膚積鹹膚窪鹹齋 ~ 淵製齋淵壓網製蓋蓋構) 更多 |
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