A Phase 1 Study of Mosunetuzumab With Polatuzumab Vedotin and Lenalidomide (M+Pola+Len) in Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)

This phase I trial studies the side effects and best dose of mosunetuzumab when given together with polatuzumab vedotin and lenalidomide in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Mosunetuzumab and polatuzumab vedotin are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Polatuzumab, linked to a toxic agent called vedotin, attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Lenalidomide may stimulate or suppress the immune system in different ways and stop cancer cells from growing and by preventing the growth of new blood vessels that cancer cells need to grow. Giving mosunetuzumab with polatuzumab vedotin and lenalidomide may work better in treating patients with relapsed/refractory DLBCL.

开始日期2024-09-03

申办/合作机构

National Cancer Institute

NCT06071871 / Not yet recruiting临床2期IIT

A Phase II Trial of Polatuzumab Vedotin, Obinutuzumab and Glofitamab as a Peri-CAR-T Cell Treatment Strategy in Large B-cell Lymphoma

The PORTAL study will test a new combination of drugs (glofitamab, polatuzumab vedotin and obinutuzumab) in patients with large B-cell lymphoma (LBCL) that has come back (relapsed) or not responded to previous treatment. It will determine how safe and effective the combination of these cancer drugs is in treating LBCL before and after CAR-T cell therapy.

开始日期2024-04-30

申办/合作机构

University College London

[+1]

NCT06043674 / Recruiting临床2期IIT

A Phase 2 Study of Glofitamab as Monotherapy or in Combination With Polatuzumab Vedotin or Atezolizumab in Richter's Transformation

This research is being done to evaluate Glofitamab by itself or in combination with Polatuzumab Vedotin or Atezolizumab as possible treatments for Chronic Lymphocytic Leukemia (CLL) that has transformed into Richter's Transformation (RT).
The names of the study drugs involved in this research study are:
Glofitamab (a T-cell bispecific humanized monoclonal antibody)
Obinutuzumab (a humanized glycoengineered type II anti-CD20 monoclonal antibody)
Polatuzumab vedotin (an antibody-drug conjugate)
Atezolizumab (a humanized immunoglobulin monoclonal antibody)
Tocilizumab (a recombinant, humanized, anti-human monoclonal antibody)

开始日期2024-04-01

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+1]

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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153

项与维泊妥珠单抗相关的文献（医药）

2024-02-01·The Lancet Haematology

Polatuzumab vedotin plus rituximab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma: a cohort of a multicentre, single-arm, phase 1b/2 study

Article

作者: Panizo, Carlos ; Triguero, Ana ; Sharma, Sunil ; Abrisqueta, Pau ; Banerjee, Lalita ; Bastos-Oreiro, Mariana ; González-Barca, Eva ; Pérez, José María Arguiñano ; Jin, Hyun Yong ; Musick, Lisa ; McMillan, Andrew ; Seymour, Erlene ; Hirata, Jamie ; de Guzman, Jayson ; Miall, Fiona ; Diefenbach, Catherine

BACKGROUND:

Diffuse large B-cell lymphoma comprises nearly 30% of non-Hodgkin lymphoma cases and patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for stem-cell transplantation have few treatment options and poor prognoses. We aimed to determine whether the novel combination of polatuzumab vedotin in combination with rituximab and lenalidomide (Pola+R+Len) would provide a tolerable treatment option with enhanced antitumour response in patients with relapsed or refractory diffuse large B-cell lymphoma.

METHODS:

This completed phase 1b/2, open-label, multicentre, single-arm study (GO29834) evaluated the safety and efficacy of Pola+R+Len in patients with relapsed or refractory diffuse large B-cell lymphoma at 19 sites in three countries (USA, Spain, and UK). Patients (≥18 years old) were eligible for inclusion if they had histologically documented CD20-positive relapsed or refractory diffuse large B-cell lymphoma and Eastern Cooperative Oncology Group performance status of 2 or lower, had received at least one previous line of chemoimmunotherapy, including an anti-CD20 agent, and were ineligible for stem-cell transplantation. The dose-escalation phase (1b) used escalating doses of lenalidomide to find the recommended phase 2 dose. Patients received six 28-day cycles of induction treatment with intravenous rituximab 375 mg/m² and intravenous polatuzumab vedotin 1·8 mg/kg (all cohorts) plus oral lenalidomide at the following doses: 10 mg (cohort A); 15 mg (cohort B); and 20 mg (cohort C). Rituximab and polatuzumab vedotin were administered on day 1 and lenalidomide on days 1-21 of each 28-day cycle. During the dose-expansion phase (2), patients received six 28-day cycles of Pola+R+Len at the recommended phase 2 dose established during dose escalation. In both phases, patients with a complete response or partial response at the end of induction were eligible for post-induction therapy with rituximab 375 mg/m² on day 1 and lenalidomide 10 mg/day on days 1-21 of each 28-day cycle for a maximum of 6 cycles. The primary safety objective of the dose-escalation phase was identification of the maximum tolerated dose through incidence of dose-limiting toxic effects. The primary efficacy outcome of the dose-expansion phase was Independent Review Committee-assessed complete response rate at end of induction, based on PET-CT. Analyses were conducted in the safety population, which included all patients who received at least one dose of any study drug, and the efficacy population, which included all patients who received at least one dose of any study drug at the recommended phase 2 dose. This study is registered with ClinicalTrials.gov, number NCT02600897.

FINDINGS:

Between July 11, 2017 and Feb 3, 2020, 57 patients were enrolled (median age 71 years [IQR 60-75]; 38 [67%] were male and 19 (33%) were female; 47 [82%] were not Hispanic or Latino; and the median previous lines of therapy was 2 [IQR 1-3]). 18 participants were included in phase 1b and 39 were included in phase 2. Phase 1b confirmed a 20 mg recommended phase 2 dose for lenalidomide. After a median follow-up of 11·8 months (IQR 4·7-25·8), the complete response rate, as assessed by the Independent Review Committee, was 31% (90% CI 20-43). The most common grade 3-4 adverse events were neutropenia (35 [61%] of 57) and thrombocytopenia (eight [14%] of 57). Serious adverse events were reported in 23 (40%) of 57 patients and one patient died due to a treatment-related adverse event (neutropenic sepsis).

INTERPRETATION:

Although the combination of Pola+R+Len did not meet the prespecified activity threshold, some patients derived clinical benefit and the regimen had a tolerable safety profile in patients with relapsed or refractory diffuse large B-cell lymphoma.

FUNDING:

Genentech/F Hoffmann-La Roche.

2024-01-01·Nature medicine1区 · 医学

Mosunetuzumab with polatuzumab vedotin in relapsed or refractory aggressive large B cell lymphoma: a phase 1b/2 trial

1区 · 医学

Article

作者: Batlevi, Connie Lee ; Pham, Song ; Sabry, Waleed ; Ghosh, Nilanjan ; Kamdar, Manali ; Ead, Wahib S ; To, Iris ; Lossos, Izidore S ; Assouline, Sarit ; Diefenbach, Catherine ; Jing, Jing ; Wu, Hao ; Nakhoda, Shazia K ; Modi, Dipenkumar ; Olszewski, Adam J ; Smith, Stephen D ; Dorritie, Kathleen ; Naik, Seema ; Wei, Michael C ; Huw, Ling-Yuh ; Mehta, Amitkumar ; Budde, Lihua E ; Chavez, Julio C ; Jia, Ting

Abstract:

Relapsed/refractory aggressive large B cell lymphoma (LBCL) remains an area of unmet need. Here we report the primary analysis of a phase 1b/2 trial of outpatient mosunetuzumab (a CD20xCD3 T-cell-engaging bispecific antibody) plus polatuzumab vedotin (an anti-CD79B antibody–drug conjugate) in relapsed/refractory LBCL. The phase 2 component is a single arm of an ongoing multi-arm trial. The primary endpoint during dose expansion was independent review committee (IRC)-assessed best overall response rate. Secondary endpoints included investigator-assessed overall response rate, complete response, duration of response, progression-free survival and overall survival. At data cutoff, 120 patients were enrolled (22 dose escalation, 98 dose expansion). The primary endpoint was met during dose expansion, with IRC-assessed best overall response rate and complete response rates of 59.2% (58/98; 95% confidence interval (CI): 48.8–69.0) and 45.9% (45/98; 95% CI: 35.8–56.3), respectively (median follow-up, 23.9 months). Median duration of complete was not reached (95% CI: 20.5–not estimable (NE)). Median progression-free survival was 11.4 months (95% CI: 6.2–18.7). Median overall survival was 23.3 months (95% CI: 14.8–NE). Across dose escalation and expansion, the most common grade 3 or higher adverse events were neutropenia (25.0%, 30/120) and fatigue (6.7%, 8/120). Any-grade cytokine release syndrome occurred in 16.7% of patients. These data demonstrate that mosunetuzumab plus polatuzumab vedotin has a favorable safety profile with highly durable responses suitable as second-line therapy in transplant-ineligible relapsed/refractory LBCL. ClinicalTrials.gov identifier: NCT03671018.

2023-12-31·Journal of Medical Economics

Cost-effectiveness of combination therapy of polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisolone for previously untreated diffuse large B-cell lymphoma in Japan

Article

作者: Saito, Shota ; Oshima, Tomoha ; Yamamoto, Kazuhito ; Mizuoka, Takashi ; Sakamaki, Hiroyuki ; Fuji, Shigeo ; Murata, Tatsunori ; Inubashiri, Naoki ; Ohno, Shinya

AIM:

The POLARIX trial showed that Pola + R-CHP (polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisolone) prolongs progression-free survival (PFS) in patients with previously untreated diffuse large B-cell lymphoma (DLBCL) compared with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone), the conventional standard of care, with a similar safety profile. However, Pola + R-CHP has not been evaluated from the viewpoint of health economics in Japan. This study evaluates the cost-effectiveness of Pola + R-CHP for previously untreated DLBCL from a Japanese public healthcare payer's perspective.

METHODS:

A partitioned survival analysis model was constructed to estimate lifetime costs and effectiveness of Pola + R-CHP and R-CHOP in previously untreated DLBCL who had an International Prognostic Index score (IPI) score of ≥2. A parametric survival model was applied to data analyzed in the POLARIX trial to estimate the lifetime overall survival (OS) and PFS for each treatment. The parameters required for the model were based on the results of a literature search and expert opinion.

RESULTS:

The incremental cost-effectiveness ratio (ICER) of Pola + R-CHP vs. R-CHOP was JPY2,710,238 per quality-adjusted life year (QALY), less than the ICER of JPY7.5 million per QALY that is considered to be cost-effective based on the threshold of the Japanese cost-effectiveness evaluation system. One-way sensitivity analysis showed that the parameters influencing the results of the analysis were median PFS and the total cost per regimen of salvage chemotherapy, patient weight, and patient age. Probabilistic sensitivity analysis showed that the probability of Pola + R-CHP having superior cost-effectiveness was 99.2% when the reference value was JPY7.5 million. The results of scenario analysis suggested that prolongation of PFS was an important factor in the evaluation of cost-effectiveness in previously untreated DLBCL with or without prolongation of OS.

CONCLUSIONS:

This study suggests that Pola + R-CHP is a cost-effective treatment for previously untreated DLBCL in Japan under the public health insurance system.

373

项与维泊妥珠单抗相关的新闻（医药）

2024-04-25

·药研网

罗氏2024Q1财报|眼科双抗销售亮眼，增长108%

4月24日，罗氏发布2024年第一季度业绩，总收入143.99亿瑞士法郎（约156.95亿美元)，按固定汇率（CER）计算，增长2%。除去COVID-19相关的产品，销售额增长了7%。（本文汇率换算按1瑞士法郎=1.09 美元）展望未来，罗氏表示新冠产品的销售额下降不会对公司业绩产生进一步的影响，预计2024年销售额实现中个位数 (CER) 增长。01Q1业绩详情从具体部门业务来看，第一季度制药业务收入109.21亿瑞士法郎（约119亿美元），不包括与疫情相关的产品，增长了7%，这主要得益于治疗以下药物的销售强劲：Vabysmo（眼科|双抗）：销售额 8.47亿瑞士法郎，同比增长108%Phesgo（乳腺癌|曲妥珠单抗+帕妥珠单抗）: 销售额 3.88亿瑞士法郎, 增长70%Ocrevus（多发性硬化症新药）:销售额16.58亿瑞士法郎，增长8%Polivy（血癌|CD79b ADC）: 销售额2.5亿瑞士法郎，增长81%Hemlibra（A型血友病）: 销售额10.4亿瑞士法郎，增长增长8%以上5款增长强劲的药物合计销售额达42亿瑞士法郎，较 2023 年第一季度增加了 9 亿瑞士法郎（按CER计算）。眼药 Vabysmo 是最大的增长动力，销售额达到8.47亿瑞士法郎（约9.23亿美元），同比增长108%。销售额表现最好的资产是 Ocrevus，它在第一季度获得了16.58亿瑞士法郎（约18.07亿美元），比 2023 年同期增长8%。02眼科双抗VabysmoVabysmo 是第一个也是唯一一个被批准用于眼部的双特异性抗体，经过独特设计，通过中和血管生成素-2 (Ang-2) 和血管内皮生长，靶向并抑制与许多威胁视力的视网膜疾病相关的两条信号通路A 因子 (VEGF-A) 可恢复血管稳定性。Vabysmo目前已获批3项适应症：于2022年2月首次获批在全球90多个国家获批用于治疗新生血管性或“湿性”年龄相关性黄斑变性 (nAMD) 和糖尿病性黄斑水肿 (DME) 患者，并于2023年10月在美国获批用于治疗视网膜静脉阻塞（RVO）。此外，在超过 25 个市场和超过 2.5 个国家获得公共报销全球分发了 100 万剂疫苗。第一季度，罗氏公布了Vabysmo治疗视网膜静脉阻塞 RVO两项全球 III 期研究的详细结果：高达 60% 接受 Vabysmo 的患者能够将治疗间隔延长至三到四个月。此外，研究中的患者在研究的前 24 周内保持了视力增益和强劲的视网膜干燥，持续了一年多。两项研究中，Vabysmo 的耐受性良好，且安全性与之前的研究一致。03放弃5项早期资产对于其产品管线，罗氏表示已停止开发5项早期资产：1. RG6185 Belvarafenib：是一种口服 RAF 激酶抑制剂，目前正在开展两项针对各种癌症的临床研究。罗氏基因泰克于 2016 年以 8000 万美元预付款从 Hanmi Pharmaceutical 获得许可。当时该药物处于第一阶段。Hanmi于 2017 年开始了一项 1b 期研究，测试 belvarafenib 与 cobimetinib 或 cetuximab 联合使用。 Hanmi 保留了韩国资产的权利，于 2019 年公布了1 期试验和扩展研究的数据，并继续跟踪 1b 期研究中的患者，以评估 belvarafenib 与 MEK 或 EGFR 抑制剂联合使用的效果。2. RG6526 camonsertinib：一种潜在的first in class口服小分子共济失调-毛细血管扩张症和Rad3相关蛋白激酶（ATR）抑制剂。I期研究结果显示，单药Camonsertib对实体瘤有温和的治疗效果，99例患者接受治疗后临床获益率（CBR）为13%，分子应答率为43%，其中卵巢癌患者的应答率相对较好，CBR达到了75%。2月12日，Repare宣布罗氏因产品线调整及外部因素，决定自2024年5月7日起与其终止关于Camonsertib（RP-3500）的合作协议3. RG6286：是一种双特异性抗体，可与T细胞上的结直肠癌抗原LY6G6D和CD3结合。基因泰克于 2020 年开始在结直肠癌患者中测试该候选药物（也称为 BLYG8824A）。1期临床试验的主要完成日期预计为2026年初。4. RG6163：新的候选分子药物，用于精神类疾病药物，未公开披露。5. RG6319：LepB 抑制剂，用于复杂的尿路感染。罗氏放弃该药物并将重点转向另一种针对同一靶点的分子 RG6436。此外，由于IL-6单抗3期临床不达预期，罗氏还终止了RG6168萨特利珠单抗（商品名Enspryng）用于治疗重症肌无力的3期临床研究（LUMINESCE）。LUMINESCE主要研究终点达到具有统计学意义的数据，但是临床获益程度不达预期，Enspryng耐受性良好，安全性与其适应症视神经脊髓炎谱系疾病（NMOSD）的安全性一致。罗氏子公司Chugai制药表示该研究结果不影响Enspryng在NMOSD患者中的使用，该公司还在开发Enspryng用于其他神经自身免疫性和炎症性疾病的治疗。自去年三季度以来，罗氏已经从管道中移除了 20% 的新分子。本次部分管线的终止是重新广泛调整的一部分，并表示，移除的重点是那些“成功可能性较低”的资产。Schinecker 表示，罗氏需要终止一些项目，以腾出现金来投资加速“一些很有可能成功并对患者产生巨大影响的项目”。04展望2024展望2024年的剩余时间，罗氏预计销售额将实现中个位数 (CER) 增长。其首席执行官Thomas Schinecker 表示：“我们今年开局强劲，两个部门的基础业务均呈现高个位数增长——不包括 COVID-19 销售额。本季度之后，与 COVID-19 相关的销售影响基本上已经过去。与去年同期相比，瑞士法郎兑大多数货币的升值影响了以瑞士法郎报告的销售额。我们的眼药 Vabysmo 的使用继续保持势头。我们有信心2024 年集团销售额能够实现中位数增长（按固定汇率计算）。”细胞系产品查询投稿丨商务合作转载丨加交流群往期推荐视角 | 纸面之外的药明康德2023年报Claudin18.2ADC赛道群雄逐鹿：3家率先进入III期临床下一个10亿美元重磅炸弹选手"裁员潮”仍在加剧：2月多家药企裁员点击下方“药研网”，关注更多精彩内容

财报临床3期疫苗抗体药物偶联物

2024-04-24

·生物制品圈

全球上市的ADC药物盘点，看这一篇就够了

20世纪初，Paul Ehrlich首次提出著名的“魔法子弹”理论设想，他认为可以针对病原体特殊的结构特点，寻找和研制只杀伤病原体，不影响正常组织和细胞的药物。随后，抗体-药物偶联的概念被提出，它将单克隆抗体的靶标特异性和细胞毒性分子的抗肿瘤特性结合在一起。历经几十年的尝试，直到2000年靶向CD33的ADC药物Mylotarg（Gemtuzumab Ozogamicin）出现，ADC的发展才取得了实质性的成功。目前全球已有15款ADC药物获批上市，分别是辉瑞的Mylotarg、Besponsa，罗氏的Kadcyla、Polivy，阿斯利康的Lumoxiti、Enhertu，Seagen/武田制药的Adcetris，Seagen/安塞泰来的Padcev，Seagen/Genmab的Tivdak，葛兰素史克的Blenrep，吉利德的Trodelvy，Rakuten Medical的Akalux，ADCTherapeutics的Zynlonta，荣昌生物的爱地希，以及ImmunoGen/华东医药的Elahere。治疗领域涉及淋巴瘤、白血病、乳腺癌、多发性骨髓瘤、乳腺癌、头颈癌、尿路上皮癌等。Mylotarg®（gemtuzumab ozogamicin，吉妥单抗）适应症：急性粒细胞白血病（AML）研发公司：辉瑞靶点：CD33由人源化抗CD33单克隆抗体、卡奇霉素、可切割的连接子组成。抗体与CD33抗原结合后，细胞毒素的内化和释放，从而诱导双链DNA断裂和细胞死亡。全球首款上市的ADC。2000年获FDA加速批准，用于治疗急性粒细胞白血病（AML）。由于由于连接子不稳定、细胞毒素提前释放引起严重毒性反应引发安全性问题，2010年自主撤市。随后，辉瑞补充更新了临床证据（三项临床试验研究：ALFA-0701、AML-19、MyloFrance-1），调整了规格，从原先的5mg/瓶改为4.5 mg/瓶，给药方案也进行了相应调整，推荐剂量从9mg/m2调整为3mg/m2，重新向FDA递交申请。2017年，Mylotarg®获得批准、再次上市，用于用于治疗成人新确诊的髓系细胞分化抗原（CD33）阳性的急性髓系白血病（Acute Myeloid Leukemia，AML），≥2岁儿童和成人的复发难治性髓系细胞分化抗原（CD33）阳性的AML。Adcetris®（brentuximab vedotin，维布妥昔单抗，安适利®）适应症：霍杰金淋巴瘤\系统性间变性大细胞淋巴瘤研发公司：武田和Seattle Genetics靶点：CD30一种靶向CD30的ADC，由嵌合lgG1抗体cAC10、 MMAE和蛋白酶可切割的连接子组成。内化后，蛋白水解释放MMAE，MMAE通过破坏微管系统诱导细胞周期阻滞和凋亡。由于MMAE具有旁观者效应，BV在表达CD30的组织异质性肿瘤中也有效。2011年8月被FDA批准。用于治疗霍奇金淋巴瘤（HL）和间变性大细胞淋巴瘤（sALCL）。在我国于2020年5月被NMPA批准，用于治疗复发或难治性sALCL和CD30阳性HL患者，是第二款国内获批上市的ADC。2021年获欧盟批准，可作为CD30表达的sALCL一线治疗药物，也成为全球第一个用于一线治疗的ADC。Brentuximab vedotin是第二代ADC代表药物，采用人鼠嵌合抗体、或人源化单抗代替鼠源单抗，即降低了免疫原性，又增强了肿瘤靶向性，并且采用的连接子也更加的稳定。其缺点是裸抗较多，这些未结合的单抗与偶联物竞争抗原结合位点，影响疗效。过高的药物/抗体比率（DAR），引起抗体聚集，清除加快，非特异性毒性增加等。Brentuximab平均携带4个MMAE分子，其药物/抗体比率（DAR）为4，分子量约153kDa。Kadcyla®（ado-trastuzumab emtansine，恩美曲妥珠单抗，赫赛莱®）适应症：乳腺癌研发公司：罗氏和ImmunoGen靶点：HER2一种靶向Her2的ADC，由人源化抗Her2 IgG1单抗（曲妥珠单抗）、小分子细胞毒素DM1和不可切割的连接子组成。在体循环和肿瘤微环境中能维持较高的稳定性。2013年2月22日，FDA批准Kadcyla®用于曾接受曲妥珠单抗和紫杉烷治疗的转移性Her2阳性乳腺癌患者治疗。2019年5月3日，FDA批准Kadcyla®作为单一药物用于接受新辅助曲妥珠单抗治疗后残留疾病的Her2阳性乳腺癌患者的辅助治疗。2020年1月，NMPA批准Kadcyla®用于接受了紫杉烷类联合曲妥珠单抗为基础的新辅助治疗后，仍残存侵袭性病灶的HER2阳性早期乳腺癌患者、不可切除局部晚期或转移性乳腺癌患者的辅助治疗。是我国首个上市的抗体药物偶联物（ADC），也是全球首款被批准用于实体瘤的ADC。Kadcyla®是商业化最成功的ADC。2021年全球ADC市场规模超过52亿美元，其中Kadcyla®独占半壁江山，销售额达到21.7亿美元。Kadcyla平均每个抗体上连接3.5个DM1，分子量约148,781Da。Besponsa®（inotuzumab ozogamicin，奥加伊妥珠单抗，贝博萨®）适应症：BCP-ALL研发公司：辉瑞靶点：CD22一种人源化抗CD22单克隆抗体，通过酸不稳定的腙连接子与卡奇霉素偶联。CD22是一种内吞受体，是B细胞急性淋巴细胞白血病(ALL)的特异性标志物，在90%以上的B细胞恶性肿瘤患者中表达。一旦ADC与CD22受体结合，该复合物被内化到靶细胞内，触发卡奇霉素的释放，卡奇霉素通过与DNA双螺旋的小沟结合并引起位点特异性双链DNA切割，从而诱导细胞凋亡。2017年6月获得EMA批准上市，用于治疗患有复发或难治性前体B细胞急性淋巴细胞性白血病（ALL）的成人患者。2017年8月获得美国FDA批准，治疗成人复发或难治性B细胞前体急性淋巴性白血病。这是首款获得FDA批准的靶向CD22的抗体偶联药物。2021年12月在我国上市，成为中国第四款上市的ADC。NMPA的批准基于境外临床试验B1931022数据在中国的递交，豁免中国注册临床试验。上市后，需开展上市后研究（B1931034）。Besponsa®作为辉瑞的第二款ADC、第三代ADC产品，抗体免疫原性更低，靶向性更强，细胞活性更高，连接子更稳定，小分子毒性药物的稳定性和亲水性有了进一步改善，ADC的稳定性、均一性也更好。Besponsa分子量约为160kDa，与每个抗体平均结合的6个卡奇霉素，分布范围为2~8。Lumoxiti®(Moxetumomab pasudotox，帕西妥莫单抗)适应症：复发性或难治性毛细胞白血病（HCL）的成年患者研发公司：阿斯利康靶点：CD22由抗CD22单克隆抗体共价连接到假单胞菌外毒素a(PE38)的38kDa片段上。免疫毒素的Fv部分与CD22结合，内化后，通过催化延伸因子-2(EF-2)中二苯二胺残基的ADP核糖基化诱导凋亡。2018年9月获得FDA批准上市，用于治疗复发性或难治性毛细胞白血病(HCL)成人患者。2021年2月，获EMA批准。但五个月后，同年7月EMA发布公告，撤销了它在欧盟的上市许可。然而由于临床使用非常低，阿斯利康在2023年7月将Lumoxiti永久撤出美国市场。两个撤市均为商业考量，并非安全性问题。Polivy®（polatuzumab vedotin，泊洛妥珠单抗，优罗华®）适应症：弥漫性大B细胞淋巴瘤研发公司：罗氏靶点：CD79b一种由抗CD79b单克隆抗体、蛋白酶可切割的连接子和MMAE偶联。CD79b是B细胞特异性表面蛋白，它在超过90%的B细胞非霍奇金淋巴瘤中高表达，例如：弥漫性大B细胞淋巴瘤、滤泡性淋巴瘤等，CD79b与抗体结合后被迅速内吞并递送至溶酶体内。因此，CD79b成为治疗这类淋巴瘤的理想靶点。2019年6月11日首次获得FDA加速批准上市，联合苯达莫司汀和利妥昔单抗，用于治疗至少两次以上的复发或难治性（R/R）弥漫性大B细胞淋巴瘤（DLBCL）的成年患者。随后，于2021年1月和3月，分别在欧盟、日本批准上市。2023年1月，Polivy®获得中国国家药品监督管理局（NMPA）正式批准。适应症为：联合利妥昔单抗、环磷酰胺、多柔比星和泼尼松适用于治疗既往未经治疗的弥漫性大B细胞淋巴瘤（DLBCL）成人患者；以及联合苯达莫司汀和利妥昔单抗用于不适合接受造血干细胞移植的复发或难治性弥漫性大B细胞淋巴瘤成人患者。Polivy®是20多年来国内唯一获批用于 DLBCL 一线治疗的创新靶向药物。与传统治疗方案相比，Polivy®可显著改善患者的临床结局，是20年来首个显著改善复发或难治性弥漫性大B细胞淋巴瘤的新治疗方案。因此，在美国、欧盟和日本，Polivy®被授予“孤儿药资格”，在美国还被FDA授予“突破性药物资格”，欧盟EMA则被授予“优先药物资格”。Polivy®药物/抗体比率（DAR）为3-4，分子量约150kDa。Enhertu®(fam-trastuzumab deruxtecan-nxki，德喜曲妥珠单抗，优赫得®）适应症：胃食管交界处癌，转移性胃癌，转移性乳腺癌研发公司：阿斯利康；第一三制药靶点：HER2Enhertu®是第三代ADC的代表，由靶向Her2的曲妥珠单抗、可切割的四肽连接子和细胞毒性拓扑异构酶I抑制剂组成。研究表明T-DXd对Her2高或低表达的肿瘤细胞或Her2突变的肿瘤细胞都有效，其原因可能包括：1）T-DXd的DAR值高达8，因此具有高效的有效载荷；2）释放的有效载荷具有较高的膜透性，使其能够进入邻近的肿瘤细胞，产生旁观者效应；3）新型基于四肽的连接子在血浆中具有很高的稳定性。2019年12月，Enhertu获得FDA加速批准，用于既往接受过HER2治疗的、不可切除，或转移性HER2阳性乳腺癌成年患者。2022年3月正式递交国内上市申请，并于5月被正式纳入优先审评目录，首个适应症为：治疗既往接受过一种或一种以上抗HER2药物治疗的不可切除或转移性HER2阳性成人乳腺癌患者。Enhertu®在治疗HER2阳性转移性乳腺癌等方面表现出的惊人疗效，是ADC药物研发近年来罕见的重大进展，也令HER2成为目前热度最高的ADC药物靶点。Enhertu®是全球首个且目前唯一在HER2阳性晚期乳腺癌二线治疗中，头对头对比的ADC药物，并取得了阳性结果。据Natrue子刊市场预测，Enhertu有望在2026年达到62亿美元的销售额，占据全球40%的ADC市场份额。或将取代Kadcyla，成为新一代的ADC “药王”。Padcev®（enfortumab vedotin，恩诺单抗）适应症：尿路上皮癌研发公司：Seagen；安斯泰来靶点：Nectin-4一种靶向nectin-4的ADC，由一种靶向nectin-4的人单克隆抗体、蛋白酶可切割的连接子、MMAE偶联。Nectin-4是一种细胞粘附分子，在97%的尿路上皮癌中过表达，并与肿瘤生长和增殖有关。Nectin-4在成人健康组织中表达量很低，但在多种肿瘤细胞中高表达，如：在尿路上皮癌、膀胱癌、乳腺癌、卵巢癌、胃癌、肝细胞癌和胰腺癌等组织中，具有特异性的高表达，与肿瘤的发生和转移具有密切的关系，可通过激活PI3K/AKT途径促进肿瘤细胞增殖、分化、迁移、侵袭等。因此，Nectin-4已成为许多实体瘤诊断和治疗的重要靶点。2019年12月，FDA加速批准了Padcev®用于局部晚期或转移性尿路上皮癌的成年患者，这些患者先前接受过程序性死亡受体-1(PD-1)抑制剂或程序性死亡配体受体-1(PD-L1)抑制剂以及含铂化疗药物的治疗。Padcev®是首个获批治疗尿路上皮癌的ADC，也是首个以Nectin-4为靶点的获批药物Trodelvy®（sacituzumab govitecan，戈沙妥珠单抗，拓达维®）适应症：三阴性乳腺癌研发公司：吉利德靶点：Trop-2一种靶向Trop-2的单抗，通过酸不稳定的腙可切割连接子与SN-38偶联组成。SN-38是一种拓扑异构酶-1抑制剂，是化疗药物伊立替康的活性代谢物。给药后，ADC与肿瘤细胞上的Trop-2结合，并促使SN-38释放，引发DNA损伤，随后导致细胞周期阻滞。由于SN-38的膜透性，它可以在不被内化的情况下刺激附近细胞的抗肿瘤作用，发挥旁观者效应。TROP-2，一种跨膜糖蛋白，它在乳腺癌、胃癌、非小细胞肺癌、小细胞肺癌、结肠癌、胰腺癌等多种肿瘤组织中过表达，尤其是三阴乳腺癌，表达率高达90%以上。2020年4月，Trodelvy®获得FDA加速批准用于对既往接受过两种或两种以上转移性疾病治疗的成人转移性三阴性乳腺癌的治疗。2022年6月，NMPA批准Trodelvy®用于既往至少接受过2种系统治疗，其中至少一种治疗针对转移性疾病的不可切除的局部晚期或转移性三阴乳腺癌成人患者。Blenrep®（belantamab mafodotin，玛贝妥单抗）适应症：多发性骨髓瘤研发公司：GSK靶点：BCMA一种靶向B细胞成熟抗原(BCMA)的lgG抗体，通过不可切割的马来酰亚胺基己酰(MC)连接子与MMAF偶联。BCMA是一种在恶性浆细胞上大量表达的细胞表面蛋白，是治疗多发性骨髓瘤的一个很重要的靶点。一旦belantamab maodotin与BCMA结合，该复合物内化并在溶酶体中降解，MMAF释放，诱导生长阻滞和细胞凋亡。2020年8月，FDA加速批准Blenrep®用于复发或难治性多发性骨髓瘤的成人患者，这些患者之前接受过至少四种治疗，其必须包括抗CD38单克隆抗体、免疫调节剂和蛋白酶体抑制剂。2022年11月，Blenrep®的验证性临床III期DREAMM-3试验宣告失败，这是一项“头对头”的优效性试验，研究对比了Blenrep单药与泊马度胺联合低剂量地塞米松（PomDex）的疗效。同年12月，Blenrep®撤出美国市场，也成为FDA“加速批准”来，最快退市的药物。然而，这不代表GSK停止了这款药物的开发，DREAMM系列的临床研究没有暂停，GSK正通过联合用药寻找其他获益可能。Akalux®（Cetuximab Sarotalocan Sodium，沙西妥昔单抗）适应症：头颈癌研发公司：Rakuten靶点：EGFR由靶向EGFR的抗体cetuximab与光敏物质IR700偶联而成。2020年9月，获得日本厚生劳动省正式批准，用于治疗手术无法切除的头颈部恶性肿瘤，也是全球首个光免疫疗法ADC，治疗时需要与BioBlade激光系统联合使用。Akalux®与癌细胞表面的EGFR抗体结合后，利用近红外线照射肿瘤病灶，红外线可以局部激活偶联染料并破坏已经与化学物质结合的肿瘤细胞膜，从而达到灭杀癌细胞的目的。Zynlonta®（Loncastuximab tesirine，朗妥昔单抗）适应症：LBCB研发公司：ADCTherapeutics靶点：CD19一种靶向CD19的抗体，通过可切割的酶型连接子与细胞毒性烷基化剂SG3199偶联而成。SG3199是一种合成的PBD二聚体，通过促进DNA链间交联的形成阻止细胞分裂，具有强大的细胞毒性作用。2021年4月23日，Zynlonta®获得FDA加速批准，用于弥漫性大B细胞淋巴瘤(DLBCL)患者。2022 年 12 月，Zynlonta®得到欧洲药品管理局（EMA）的附条件批准。并且CDE 官网显示，2023年7月，瓴路药业注射用泰朗妥昔单抗申报上市（受理号：JXSS2300057）。这也是国内首款申报上市的 CD19 ADC。爱地希®（Disitamab Vedotin，维迪西妥单抗）适应症：胃癌，尿路上皮癌研发公司：荣昌靶点：HER2由亲和力更高的新型人源化抗HER2抗体、可裂解连接子和微管抑制剂MMAE组成，作用机制包括抑制HER2信号通路和MMAE的细胞毒性。2021年6月和2021年12月，爱地希®获NMPA批准上市，适用于至少接受过2种系统化疗的HER2过表达局部晚期或转移性胃癌（包括胃食管结合部腺癌）患者的治疗，以及2+或3+的局部晚期或转移性尿路上皮癌的治疗。爱地希®为首家获批上市的国产ADC品种。除已获批2项适应症外，荣昌生物还开展了多项针对实体瘤的临床研究，包括乳腺癌（BC），同时还在探索对于其他HER2过表达的常见癌种的治疗，如非小细胞肺癌（NSCLC）、胆道癌（BTC）、黑色素瘤等。Tivdak®（tisotumab vedotin-tftv，替索单抗）适应症：宫颈癌研发公司：Genmab靶点：TF一种靶向组织因子(TF-011)的单克隆抗体、一种可切割的mc-VC-PABC连接子和MMAE组成。研究显示，相对正常宫颈组织，TF在宫颈癌组织中大量表达。一旦vedotin与TF结合，MMAE就会被传递到细胞中，从而阻断微管蛋白聚合并终止细胞分裂。2021年9月，美国FDA授予Tivdak加速批准，用于化疗期间或化疗后疾病进展的复发性或转移性宫颈癌成人患者。Tivdak®是首个获批用于治疗化疗期间或化疗后疾病进展的复发性或转移性宫颈癌患者的ADC。Elahere（mirvetuximab soravtansine-gynx，索米妥昔单抗）适应症：卵巢癌研发公司：ImmunoGen、华东医药靶点：FEα一款FRα靶向ADC，由IgG1亚型抗FRα人源化单抗M9346A、抗微管蛋白剂DM4（一种美登素衍生物）和连接子三部分组成。FRɑ在72%-100%的间皮瘤、35%-68%的三阴性乳腺癌、76%-89%的卵巢癌和14%-74%的非小细胞肺癌患者样本中高表达2022年11月获FDA作为一种单药疗法加速批准，用于治疗先前已接受过1-3种全身治疗方案、FRα阳性、铂耐药的上皮性卵巢癌、输卵管癌、原发性腹膜癌成人患者。结语以上就是全球上市的15款ADC药物，从原研地区来看，尽管其中只有爱地希®来自中国，确能说明中国创新药企不再是门外汉、看客，而是参与者和座上宾。虽然全球生物医药行业的寒冬还未结束，许多在原始创新道路上坚持的中国企业依旧踽踽独行。不过，最艰难的时刻已经过去，属于中国原创新药的春天已悄然来临。资料来源：1.BiG生物创新社：上市ADC系列2.全球已批准上市的15款ADC药物的包装外观图.抗体圈.2024-04-13.盘点：国内已上市ADC&双抗全景图.药渡.2023-08-174.已获批上市的ADC药物的开发回顾及未来展望.生物药搬运工.2024-04-115.2023年终盘点：ADC药物推进肿瘤治疗进程飞跃！全球上市的ADC药物概览来了.咚咚癌友圈.2023-12-236.国内上市的ADC药物(抗体药物偶联物)汇总盘点.利多卡vivi.2024-02-26识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

抗体药物偶联物上市批准临床结果多肽偶联药物

2024-04-24

·BioSpace

Roche Trims Four Early Assets as Q1 Sales Slip 6% on Currency, COVID Headwinds

Pictured: Roche's building in Shanghai, China/iStock, Robert Way Roche released its first-quarter 2024 earnings results on Wednesday posting a 6% decline in sales compared to the same prior year period, as the company continued to be weighed down by weak demand for COVID-19 products and currency headwinds while narrowly beating analysts’ expectations. In the first quarter of 2024, the pharma group’s sales brought in around $15.79 billion, down from its Q1 2023 earnings of approximately $16.78 billion. The performance of Roche’s pharmaceuticals division likewise slowed by 6% in the quarter, with its sales falling to $11.96 billion from $12.71 billion in the same period last year. CEO Thomas Schinecker in a statement attributed the decline to the ongoing contraction of the COVID-19 market and to the “appreciation of the Swiss franc versus most currencies,” which in turn had a significant adverse impact on the group’s sales reported in Swiss francs. At constant exchange rates, Roche’s earnings grew by 2%. Excluding pandemic-related products, sales increased by 7%. “After this quarter, the COVID-19-related impact on sales is largely behind us,” Schinecker added. The eye treatment Vabysmo (faricimab-svoa) emerged as Roche’s strongest growth driver, bringing in $927.4 million in Q1, a 108% increase compared with the same period in 2023 while beating the analyst consensus. Vabysmo was first approved in February 2022 for wet age-related macular degeneration and diabetic macular edema. The drug picked up another approval in October 2023 for retinal vein occlusion. The blood cancer therapy Polivy (polatuzumab vedotin-piiq) and breast cancer medicine Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzfx) were also strong growth contributors in Q1. These assets brought in $424 million and $273 million, respectively, representing sales increases of 70% and 81%. Roche’s top-performing asset was Ocrevus which secured $1.82 billion in Q1, representing 8% growth from the same time period in 2023. As for its pipeline, the pharma group disclosed in Wednesday’s earnings presentation that it had discontinued the development of four early-stage assets including camonsertinib—which was being trialed in solid tumors—and belvarafenib, which was likewise being assessed for solid tumors in combination with Genentech’s Cotellic (cobimetinib). Roche also terminated two new molecular candidates—one for colorectal cancer and one for psychiatric disorders. Looking forward to the rest of the year, Roche reaffirmed its 2024 outlook and noted in its statement that the company expects a sales increase in the mid-single digit range at constant exchange rates. To meet its forecast, Roche has several milestones lined up including a potential U.S. and European Union approval for crovalimab in paroxysmal nocturnal hemoglobinuria and for subcutaneous Ocrevus in relapsing or primary progressive multiple sclerosis. The pharma group is also preparing for key readouts for the Phase III VERONA study of Venclexta plus azacitidine in first-line myelodysplastic syndrome, as well as the Phase IIb PADOVA trial of prasinezumab in Parkinson’s disease. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

上市批准临床2期财报临床3期临床1期

100 项与维泊妥珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	维泊妥珠单抗	L01XC	DB12240

研发状态

适应症	最高研发状态	国家/地区	公司
弥漫性大B细胞淋巴瘤	批准上市	日本更多	Chugai Pharmaceutical Co., Ltd. 更多
难治性B细胞淋巴瘤	临床3期	韩国更多	Hoffmann-La Roche, Inc. 更多
复发性弥漫性大B细胞淋巴瘤	临床3期	英国更多	Hoffmann-La Roche, Inc. 更多
滤泡性淋巴瘤	临床2期	美国更多	Genentech, Inc. 更多
非霍奇金淋巴瘤	临床2期	意大利更多	Hoffmann-La Roche, Inc. 更多

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02600897 (GO29834, Pubmed)	临床1/2期	复发性弥漫性大B细胞淋巴瘤 CD20-positive	57	Polatuzumab vedotin + rituximab + lenalidomide	範網選鹹淵獵鏇齋觸壓(衊鬱蓋鏇範衊構齋範鬱) = 壓齋獵艱簾鹽膚蓋獵膚襯鹽窪廠衊餘醖鑰繭簾 (積顧餘憲簾鹽蓋製簾淵, 20 ~ 43)	不佳	2024-02-01
NCT02600897 (CTgov)	临床1/2期	弥漫性大B细胞淋巴瘤 \| 复发性弥漫性大B细胞淋巴瘤 \| 难治性滤泡性淋巴瘤	114	Pola (Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL)	鬱製築鬱選鏇製艱餘願(憲鬱衊顧餘壓獵窪網壓) = 艱簾鏇顧醖鏇襯獵顧觸壓窪醖顧夢網獵網餘餘 (鑰製醖衊憲鬱夢鏇鬱蓋, 襯積範鹹選繭願顧選鹽 ~ 鹹鹹構膚窪窪遞觸鹽製) 更多	-	2023-12-26
NCT02600897 (CTgov)	临床1/2期	弥漫性大B细胞淋巴瘤 \| 复发性弥漫性大B细胞淋巴瘤 \| 难治性滤泡性淋巴瘤	114	Pola (Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL)	鬱製築鬱選鏇製艱餘願(憲鬱衊顧餘壓獵窪網壓) = 鹹鹽選餘遞齋淵簾網壓壓窪醖顧夢網獵網餘餘 (鑰製醖衊憲鬱夢鏇鬱蓋, 鬱襯鑰簾鏇網糧蓋積構 ~ 鑰鹽獵艱艱鏇願夢醖積) 更多	-	2023-12-26
NCT05940064 (ASH2023)	临床2期	弥漫性大B细胞淋巴瘤一线	12	Polatuzumab vedotin + Zanubrutinib + Rituximab	壓顧糧醖製憲鹽憲遞鑰(醖襯構廠襯夢廠遞鏇繭) = 膚鬱膚襯遞製鏇範遞廠觸醖艱遞醖壓齋鏇衊襯 (鏇艱築醖膚鏇繭淵獵壓 )	-	2023-12-09
EHA2023	N/A	弥漫性大B细胞淋巴瘤	28	Polatuzumab vedotin	鏇壓醖鬱壓構艱齋範醖(遞簾簾製遞壓選廠壓餘) = CMV infection was frequently observed (25%) with a wide range of durations of onset 廠淵襯壓鏇構糧積選餘 (構艱醖蓋艱築襯壓顧繭 )	-	2023-06-08
EHA2023	N/A	B细胞淋巴瘤	94	Pola-based salvage therapy	襯蓋艱淵壓簾願鹹膚壓(壓願襯顧簾鹽憲衊蓋醖) = 鏇鹹製淵齋顧網鑰鹹鹹鬱夢夢醖築築鏇網鏇觸 (鏇襯膚膚鬱觸鏇顧網廠 ) 更多	-	2023-06-08
EHA2023	N/A	B细胞淋巴瘤	94	Pola-based therapy as bridging CAR-T-cell therapy	襯蓋艱淵壓簾願鹹膚壓(壓願襯顧簾鹽憲衊蓋醖) = 淵膚衊網淵鹽衊醖鏇膚鬱夢夢醖築築鏇網鏇觸 (鏇襯膚膚鬱觸鏇顧網廠 ) 更多	-	2023-06-08
COALITION (EHA2023)	临床1/2期	高级别B细胞淋巴瘤 \| 弥漫性大B细胞淋巴瘤	-	Glofitamab + R-CHOP	窪願膚衊鬱顧積願廠繭(繭憲遞範蓋網壓鑰製醖) = Grade (Gr) ¡Ý3 AEs were seen in 10/25 (40%) (Arm A) and 11/21 (52%) (Arm B). There were no Gr 5 AEs. Febrile neutropenia was observed in 1/25 (4%) and 6/21 (29%) and CRS Gr 1 in 5/25 (20%) and 5/21 (24%), respectively. There was 1 episode of Gr 2 CRS in Arm A after 10 mg glofitamab and no Gr 3-4 events. Peripheral neuropathy was limited to Gr 1-2 and occurred in 11/25 (44%) and 5/21 (24%) respectively. No ICANS was observed. 構選鹹繭製築襯網遞簾 (選鹹顧鏇鬱積淵鬱蓋製 )	-	2023-06-08
NCT03274492 (POLARIX \| GO39942, FDA) 人工标引	临床3期	弥漫性大B细胞淋巴瘤	879	POLIVY+rituximab+cyclophosphamide+doxorubicin+prednisone	築構淵膚艱構鬱網顧廠(醖構壓壓壓窪蓋繭築壓) = 憲願範網願積夢襯鏇鬱憲膚蓋齋鹽餘構製窪壓 (淵淵鬱窪簾鹽鏇簾淵鏇 ) 更多	优效	2023-04-19
NCT03274492 (POLARIX \| GO39942, FDA) 人工标引	临床3期	弥漫性大B细胞淋巴瘤	879	rituximab+cyclophosphamide+doxorubicin+vincristine+prednisone	築構淵膚艱構鬱網顧廠(醖構壓壓壓窪蓋繭築壓) = 積廠餘繭淵衊簾衊遞遞憲膚蓋齋鹽餘構製窪壓 (淵淵鬱窪簾鹽鏇簾淵鏇 ) 更多	优效	2023-04-19
NCT03274492 (POLARIX, Pubmed)	临床3期	弥漫性大B细胞淋巴瘤	281	Polatuzumab vedotin combined with rituximab plus cyclophosphamide, doxorubicin and prednisone (Pola-R-CHP)	獵繭顧遞積觸壓蓋鏇獵(壓構廠膚簾網遞壓膚簾): hazard ratio = 0.64 (95% CI, 0.4 ~ 1.03)	积极	2023-01-10
NCT03274492 (POLARIX, Pubmed)	临床3期	弥漫性大B细胞淋巴瘤	281	Rituximab plus cyclophosphamide, doxorubicin, vincristine,Rituximab plus cyclophosphamide, doxorubicin, vincristine,Rituximab plus cyclophosphamide, doxorubicin, vincristine,Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)		积极	2023-01-10
POLARIX (Pubmed)	N/A	侵袭性 B 细胞非霍奇金淋巴瘤	18	Polatuzumab vedotin	遞襯鹹鹽鏇膚壓淵鹹築(鬱糧醖積選壓積衊壓壓) = 鑰糧願遞齋願網簾窪憲鹹糧簾餘膚遞製衊窪夢 (積壓製膚齋艱齋廠夢積, 54 ~ 96) 更多	积极	2022-12-15
NCT04665765 (ASH2022) 人工标引	临床2期	复发性弥漫性大B细胞淋巴瘤二线	37	polatuzumab vedotin+rituximab+etoposide+carboplatin+ifosfamide	遞淵繭襯壓窪鏇窪壓醖(齋鑰鑰鏇顧網製衊獵膚) = 壓齋衊鹹廠齋遞鹹網壓鹽蓋襯蓋窪鏇鹽鬱觸廠 (繭憲築醖選齋鏇範蓋築 ) 更多	积极	2022-11-15