Multicenter Phase II Study of Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With Diffuse Large B-Cell Lymphoma

This single-arm, interventional phase 2 study is designed to evaluate whether the inclusion of mosunetuzumab subcutaneous and polatuzumab vedotin (Mosun-Pola) to a split-dose CHP chemotherapy backbone will improve outcomes for elderly patients with a new diagnosis of diffuse large B-cell lymphoma.

开始日期2025-06-01

申办/合作机构

Medical College of Wisconsin

NCT06828991

/ Not yet recruiting临床2期IIT

CtDNA-Guided Mosunetuzumab Consolidation Therapy in Older Patients with Untreated DLBCL

Older patients with diffuse large B- cell lymphoma (DLBCL) do not have the same rates of disease control as younger patients and are at risk for toxicity. Identifying which patients might benefit from more therapy at the end of first-line treatment is important. The ability to measure small amounts of persistent lymphoma (circulating tumor DNA or ctDNA) might allow the investigators to risk stratify patients. If older patients have detectable ctDNA in the blood at the end of six cycles of polatuzumab vedotin, rituximab and dose-attentuated CHP chemotherapy, patients will receive a bispecific antibody called mosunetuzumab. The investigators hypothesize this will result in "clearing" the ctDNA from the blood and result in better disease control and outcomes for patients. The study will also measure the safety of this regimen and the impact on the function of these older patients utilizing a tool called the geriatric assessment.

开始日期2025-04-01

申办/合作机构

University of Rochester

[+3]

NCT06563505

/ Recruiting临床2期IIT

A Phase 2 Trial of Mosunetuzumab and Zanubrutinib for Patients With Relapsed/Refractory Marginal Zone Lymphoma

To assess the efficacy and safety of mosunetuzumab combined with zanubrutinib in patients with relapsed or refractory MZL.

开始日期2024-12-11

申办/合作机构

The University of Texas MD Anderson Cancer Center

100 项与莫妥珠单抗相关的临床结果

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100 项与莫妥珠单抗相关的转化医学

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100 项与莫妥珠单抗相关的专利（医药）

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项与莫妥珠单抗相关的文献（医药）

2025-03-01·Journal of Cancer Policy

Trials that treat what should be observed: SWOG 2308, a study of mosunetuzumab-axgb in asymptomatic low tumor burden follicular lymphoma

Article

作者: Prasad, Vinay ; Kim, Myung Sun

S2308 is a study comparing rituximab, which is not the standard of care, to.mosunetuzumab-axgb, a first-in-class CD20-directed CD3 T-cell engager with.unknown long term side effects, in a heterogeneous patient population in which a fifth.of patients do not need treatment for at least 10 years. The treatment of asymptomatic.low tumor burden follicular lymphoma is watchful waiting and no treatment has.demonstrated improvement in OS after long term follow up. Beyond the limitations of.the study design, this study would be the basis of regulatory approval and cooperative.groups receiving federal funding should not be running this trial. Study sites are USbased.and mostly include community oncology practices, risking inclusion of very low.risk patients that are most likely to be harmed by any treatment.

2025-02-25·Blood Advances

Impact of prior CAR T-cell therapy on mosunetuzumab efficacy in patients with relapsed or refractory B-cell lymphomas

Article

作者: Wu, Mei ; Shadman, Mazyar ; Matasar, Matthew J. ; Bartlett, Nancy L. ; Napier, Ellen B. ; Goy, Andre ; Schuster, Stephen J. ; Flinn, Ian W. ; Kumar, Anita ; Fraietta, Joseph A. ; Budde, Lihua E. ; Bosch, Francesc ; Fay, Keith ; Chong, Emeline R. ; Lundberg, Rachel K. ; Chong, Elise A. ; Yin, Shen ; Wei, Michael C. ; Nastoupil, Loretta J. ; Penuel, Elicia

Abstract:

Mosunetuzumab and other CD20/CD3 bispecific antibodies (BsAbs) have efficacy in B-cell lymphomas relapsing after or refractory to CD19-directed chimeric antigen receptor (CAR)–modified T cells (CAR-T). The optimal timing of BsAbs and biomarkers of BsAb response after CAR-T are unknown. We addressed these questions using clinical data and blood samples from patients previously treated with CAR-T and subsequently treated on a phase 1/2 study of mosunetuzumab. Thirty patients had paired samples at baseline and after 1 cycle of mosunetuzumab. The median time from CAR-T to mosunetuzumab was significantly longer for responding than for nonresponding patients (P = .006, unadjusted for multiple comparisons). Most patients (20/30) did not receive intervening therapy between CAR-T administration and mosunetuzumab. The remainder of patients received 1 intervening therapy after a protocol-mandated drug washout. After mosunetuzumab, responding patients had higher lymphocytes (995 vs 400 cells per μL; P = .02) and greater increases in CD4 and CD8 cells (median change, 73 vs –90 cells per μL [P = .005] and 243 vs –103 cells per μL [P = .004], respectively). Additionally, responding patients had an increase in activated CD8 cells (median fold change, 1.7; P = .02). Nonresponders had a relative decrease in CAR transgene levels (n = 16; P = .04). This is, to our knowledge, the first study to assess changes in lymphocytes, T cells, and CAR transgene levels in patients treated with BsAbs after CAR-T. These findings suggest an interaction between prior CAR-T and BsAb outcomes and have implications for optimal timing of BsAb after CAR-T. The trial was registered at www.ClinicalTrials.gov as #NCT02500407.

2025-02-13·BLOOD

Long-term 3-year follow-up of mosunetuzumab in relapsed or refractory follicular lymphoma after ≥2 prior therapies

Article

作者: Shadman, Mazyar ; Schuster, Stephen J. ; Assouline, Sarit E. ; Bolen, Christopher R. ; Ku, Matthew ; Bartlett, Nancy L. ; To, Iris ; Kwan, Antonia ; Kuruvilla, John ; Budde, Lihua E. ; Kaufman, Derrick ; Penuel, Elicia ; Dietrich, Sascha ; Cheah, Chan Yoon ; Fay, Keith ; Yin, Shen ; Sehn, Laurie H. ; Wei, Michael C. ; Giri, Pratyush ; Matasar, Matthew J. ; Nastoupil, Loretta J.

Abstract:

Mosunetuzumab, a CD20×CD3 T-cell engaging bispecific antibody, redirects T cells to eliminate malignant B cells. We present updated efficacy and safety data of a pivotal phase 1/2 study after a median follow-up of 37.4 months in 90 patients with relapsed/refractory (R/R) follicular lymphoma (FL) and ≥2 prior lines of therapy treated with fixed-duration mosunetuzumab. Investigator-assessed complete response (CR) rate and objective response rate were 60.0% (95% confidence interval [CI], 49.1-70.2) and 77.8% (95% CI, 67.8-85.9), respectively. Among 70 responders, median duration of response was 35.9 months (95% CI, 20.7 to not estimable [NE]). Among 54 patients who achieved CR, 49 remained in CR at the end of treatment; median duration of CR was not reached (NR; 95% CI, 33.0 to NE); Kaplan-Meier-estimated 30-month remission rate was 72.4% (95% CI, 59.2-85.6). Estimated 36-month overall survival (OS) rate was 82.4% (95% CI, 73.8-91.0); median OS was NR (95% CI, NE to NE). Median progression-free survival was 24.0 months (95% CI, 12.0 to NE). Median time to CD19+ B-cell recovery was 18.4 months (95% CI, 12.8-25.0) after 8 cycles of mosunetuzumab treatment. No new cytokine release syndrome events or fatal, serious, or grade ≥3 adverse events were reported. With extended follow-up, mosunetuzumab demonstrated high response rates, durable remissions, and manageable safety with no long-term concerns. This supports outpatient mosunetuzumab administration as an off-the-shelf, fixed-duration, safe, and effective treatment for patients with R/R FL, including those with high-risk disease. This trial was registered at www.clinicaltrials.gov as #NCT02500407.

317

项与莫妥珠单抗相关的新闻（医药）

2025-03-09

·蒲公英Ouryao

谁家抗癌药最畅销？2024全球肿瘤药企TOP3出炉

随着科技的飞速发展和人类对癌症认知的不断深入，2024年的全球制药肿瘤行业迎来了新一轮的洗牌。今天，就让我们一起揭晓2024年全球制药肿瘤行业排名TOP10，看看TOP3的企业是哪些？哪些产品又占据了前三甲？在肿瘤产品市场前三甲的激烈排位争夺战中，默沙东凭借史上最畅销的肿瘤药物K药强势卫冕。与此同时，BMS与罗氏之间的竞争态势愈发白热化。靠着实体瘤和血液瘤两大板块的多元扩张，两者的肿瘤业务收入都增长到了270亿美元量级，在肿瘤市场中形成了强有力的竞争格局，也为整个行业的发展注入了新的活力与变数。图 2024年全球制药巨头肿瘤业务排名TOP10 （来源：医药魔方） PART.01 2024年全球制药肿瘤业务TOP3企业 NO.3 罗氏凭借着实体瘤和血液瘤板块的双轮驱动增长，罗氏作为肿瘤霸主的辉煌再度闪耀，2024年其肿瘤业务收入达237.44亿瑞士法郎（约270.40亿美元），与BMS的肿瘤业绩已相差无几。 Tecentriq（阿替利珠单抗）和Perjeta（帕妥珠单抗）依然是罗氏实体瘤领域的两大拳头产品。在一众实体瘤产品中，治疗乳腺癌的HER2单抗复方制剂Phesgo（帕妥珠单抗曲妥珠单抗皮下注射制剂）的增长表现较为亮眼，同比增长62%至17.40亿瑞士法郎（约19.82亿美元）。此外，PI3Kα抑制剂Itovebi的获批也为罗氏的乳腺癌产品线注入了新的活力。在乳腺癌领域持续领跑的罗氏正通过外部创新巩固其优势。2024年9月，罗氏旗下基因泰克将以8.5亿美元的首付款收购锐格医药的下一代CDK抑制剂，这与罗氏现有的HER2、PI3K等靶向药物形成了更全面的产品矩阵。血液瘤领域，革新弥漫性大B细胞淋巴瘤（DLBCL）一线治疗的CD79b ADC药物Polivy展现不错的产品力，以11.21亿瑞士法郎（约12.77亿美元）的销售额跻身重磅炸弹行列。两款主打适应症差异化的CD3/CD20双抗Columvi和Lunsumio还在起量阶段。通用型CAR-T疗法的开发有望进一步强化罗氏在血液瘤领域的实力。2024年11月，罗氏以15亿美元收购了Poseida Therapeutics。罗氏认为，基于后者的技术平台打造的通用型CAR-T疗法有潜力成为各治疗领域的同类最佳产品。 NO.2 BMS BMS的肿瘤业务十分庞大，实体瘤与血液瘤两大板块齐头并进。Opdivo（纳武利尤单抗）仍是BMS在实体瘤领域的扛大旗者，2024年销售收入93.04亿美元，同比增长3%。 BMS始终跑在免疫联合赛道的前沿。Yervoy（伊匹木单抗）销售额稳健增长，O药+Y药的免疫双子星组合还于2024年在中国迎来了新适应症的全球首批，一线治疗MSI-H/dMMR结直肠癌患者。PD-1+LAG-3组合疗法Opdualag（纳武利尤单抗+瑞拉利单抗）离重磅炸弹只有一步之遥。新一代ROS1/NTRK抑制剂Augtyro（瑞普替尼）和全球第2款KRAS G12C抑制剂Krazati（阿达格拉西）初露头角，2024年的全球销售额分别为0.38亿美元和1.26亿美元。在后期实体瘤管线的储备中，抗岩藻糖GM1神经节苷脂（Fucosyl-GM1）单抗atigotatug（BMS-986012）承载了BMS进击小细胞肺癌的雄心，其与O药一线联合治疗广泛期小细胞肺癌的III期研究已推进至III期阶段。血液瘤领域，CD19 CAR-T疗法Breyanzi因产能扩大释放了销售潜力，翻倍增长至7.47亿美元。BCMA CAR-T疗法Abecma销售有所下滑，为4.06亿美元。全球首个红细胞成熟剂Reblozyl（罗特西普）全年销售额达17.73亿美元，高增长主要由一线骨髓增生异常综合征导致的贫血患者的需求驱动。Revlimid（来那度胺）和Pomalyst/Imnovid（泊马度胺）两代度胺类产品合计贡献93.18亿美元。未来BMS在血液瘤领域将重点攻坚多发性骨髓瘤，其精准布局的GPRC5D CAR-T疗法arlo-cel、两款分子胶iberdomide和mezigdomide均已推进至III期阶段。 NO.1 默沙东全球肿瘤免疫标杆产品Keytruda（帕博利珠单抗）再度展现“药王”的实力，2024年以18%的增长速度创收294.82亿美元，不仅贡献了默沙东全年总营收46%的份额，更助力其坐稳了肿瘤领域NO.1的位置。默沙东从晚期适应症的覆盖到早中期的前移探索，从单药到联合，以及皮下制剂的开发。就以早期肿瘤的治疗来说，K药是唯一在4项研究中显示出显著OS获益的肿瘤免疫疗法，并获得了9项适应症批准。其他肿瘤产品也均处于增长之中。全球首创HIF-2α抑制剂Welireg于2021年上市，如今似乎进入了快速放量阶段，2024年取得5.09亿美元的销售额，同比增长133%。Lynparza（奥拉帕利）和Lenvima（仑伐替尼）则分别带来了13.11亿美元和10.10亿美元的收入分成。基于现有的业务布局，默沙东认为在肿瘤领域还有250亿美元的潜在市场机会。要将这250亿美元的潜在价值转化为实际收益，ADC药物将打出关键组合拳。通过与第一三共和科伦博泰等ADC龙头企业的合作，默沙东快速收获了一系列管线，覆盖HER3、B7-H3、CDH6和TROP2诸多潜力靶点。其中，HER3-DXd已申报上市。 PART.02 2024年肿瘤产品销售额TOP3 No.3 / Opdivo（纳武利尤单抗） 2024年，BMS的Opdivo（纳武利尤单抗）销售收入93.04亿美元，加上来自小野制药的8.40亿美元，总销售额达到101.44亿美元。纳武利尤单抗目前已在包括美国、欧盟、日本和中国在内的超过65个国家和地区获得批准上市，涵盖12个瘤种，包括肺癌、头颈癌、胃癌、食管癌、肝癌、肾癌、结直肠癌、尿路上皮癌、黑色素瘤、霍奇金淋巴瘤、胸膜肿瘤、不明原发部位肿瘤。纳武利尤单抗的专利将于2028年到期，BMS正通过推出皮下制剂等方式延长产品生命周期。2024年12月28日，FDA批准了Opdivo皮下注射剂Opdivo Qvantig（nivolumab加透明质酸酶）上市，用于所有已批准的Opdivo适应症，意味着Opdivo成为全球首款获批上市的PD-1皮下制剂。 No.2 / Darzalex（达雷妥尤单抗）强生的达雷妥尤单抗（Darzalex）作为治疗多发性骨髓瘤的靶向CD38单抗，2024年全球销售额达116.70亿美元，同比增长19.8%，首次突破百亿美元大关。达雷妥尤单抗的组合物专利将于2026年3月到期，国内药企中，正大天晴、复宏汉霖、九源基因都有在研的生物类似药。 No.1 / Keytruda（帕博利珠单抗） 2023年的药王Keytruda（帕博利珠单抗）营收高达294.82亿美元，同比增长18%，其销售额约占默沙东全年总营收的46%，成功卫冕2024年的全球药王。2024其增长主要源于全球范围内对转移适应症的需求持续强劲，包括新增膀胱癌、子宫内膜癌适应症以及包括三阴性乳腺癌和非小细胞肺癌等在内的早期适应症。不过，K药的部分关键专利将在2028年到期，生物类似药的涌入和国产PD-1的“出海”都将蚕食其市场份额。 2024年全球制药肿瘤行业排名TOP10的出炉，不仅展现了各家药企在肿瘤领域的实力，也为未来肿瘤治疗的发展指明了方向。免疫治疗发展迅速，联合治疗方式因其显著疗效而逐渐成为研究热点。此外，部分药企借助AI技术辅助药物研发，加速了药物研发的速度，也提升了治疗方案的精准性。 END 参考来源：1、2024年全球制药巨头肿瘤业务排名TOP10 https://mp.weixin.qq.com/s/MKFoIGw04PieE5A8Jzn2bQ 2、谁是肿瘤药之王?2024年全球肿瘤药品TOP3https://mp.weixin.qq.com/s/BTaHwf13fUWJBhEaBedbSw 声明：本文仅代表作者个人观点，不代表任何组织及本公众号立场，如有不当之处，敬请指正。如需转载，请注明作者及来源：蒲公英Biopharma。

免疫疗法细胞疗法抗体药物偶联物并购

2025-03-03

·生物制药小编

罗氏的one asset team策略

如果研究罗氏的研发管线不难发现某些靶点罗氏针对不同适应症开发了不同药物，这种研发策略被其称为“one asset team"（图1）。这种研发策略使罗氏在这些靶点上具有相较于其它公司更深的理解及更广泛的布局，从而在长期的积累中获得竞争优势。本文将以CD20为例分析解读罗氏one asset team研发策略的发展史。利妥昔单抗（Rituximab，商品名：美罗华 MabThera）是由斯坦福大学淋巴瘤治疗专家Ronald Levy教授与美国基因泰克公司（2009年被罗氏收购）共同研发的一款用于治疗B细胞相关疾病的药物，于1997年上市并成为第一款用于肿瘤治疗的单抗药物。它是一种人鼠嵌合型单克隆抗体，能够高度特异性地识别并结合B细胞表面的CD20抗原。 CD20是一种跨膜糖基化磷蛋白，在B细胞来源的淋巴瘤、白血病等肿瘤细胞表面高表达（图2）。虽然它也在正常的B细胞表面表达，但是它只在特定时期的B细胞表面表达。B淋巴细胞是由骨髓内多能干细胞分化而成，发育过程包括祖B细胞、前B细胞、不成熟B细胞以及成熟B细胞4个阶段。成熟B细胞可继续分化为浆细胞。CD20只出现在前B细胞和成熟B细胞上，而不表达在造血干细胞、祖B细胞和成熟的浆细胞上。图2. CD20结构及不同单抗的结合域因此抗CD20抗体虽然会在攻击肿瘤细胞误杀正常成熟B细胞，但是祖B细胞可以随后补充成熟的B细胞，已有浆细胞也可以支撑免疫系统正常运行。利妥昔单抗凭借其优异的药效很快成为了一款重磅炸弹级别的药物并一直持续了十余年，最高年销售超百亿美元。不管是疾病进展特别快的侵袭性的 DLBCL（弥漫大 B 细胞淋巴瘤）类型，还是进展比较慢的FL（滤泡淋巴瘤）类型，以及其他一些淋巴瘤小分型，利妥昔单抗联合化疗方案都能有效的杀死癌细胞。尽管作为第一代CD20单抗的利妥昔单抗的疗效很好，但由于它是人鼠嵌合抗体，使用时存在一定的排斥反应，副作用有待改善。于是罗氏/基因泰克进而开发了第二代CD20单抗人源化单抗奥瑞珠（商品名：Ocrevus）。但是第二代CD20单抗在淋巴瘤适应症的疗效方面均无法超越利妥昔单抗，于是罗氏尝试了拓展适应症。奥瑞珠是首个在多发性硬化症领域获得突破性疗法的产品，于2017年3月被FDA批准用于治疗复发型多发性硬化症（RRMS）和原发进展型多发性硬化症（PPMS），是目前销售额最高的一款MS药物，2024年销售达70亿美元。为了寻找利妥昔单抗的下一代产品，罗氏筛选不同的Epitope并通过糖工程改造调节抗体Fc功能开发了第三代产品人源化单抗奥妥珠单抗（商品名：Gazyva）并于2013年获FDA批准上市（图3）。适应症包括：1）使用苯丁酸氮芥用于以前未经治疗的慢性淋巴细胞白血病患者的治疗；2）联合苯达莫司汀，二线治疗复发性滤泡性淋巴瘤。图3. 三代CD20抗体Fc功能比较 2016年，罗氏公布了Gazyva和利妥昔在滤泡性淋巴瘤领域的头对头3期临床试验结果，试验结果表明对于之前未接受过治疗的滤泡性淋巴瘤患者，奥妥珠显著提高患者的PFS（无进展生存期），达到了试验的主要临床终点。但是在另一项3期临床试验中，在弥漫性大B细胞淋巴瘤领域，奥妥珠和利妥昔的头对头比较中，其主要临床终点（奥妥珠显著延长先前未经治疗的DLBCL患者的PFS）并没有达到。近日，罗氏/基因泰克宣布，其奥妥珠单抗治疗活动性狼疮性肾炎患者的3期临床试验REGENCY的详细分析已发表于NEJM。数据显示，奥妥珠单抗与标准治疗联用，达到试验的主要终点，显著提高患者的完全肾脏缓解（CRR）率（图4）。图4. 临床试验REGENCY结果从作用机制来看，不同CD20单抗可分为I型及II型，其中I型CD20单抗可诱导CD20二聚化进而内吞，而II型CD20单抗不诱导CD20内吞（图5）。利妥昔属于I型CD20单抗而奥妥珠属于II型CD20单抗。图5. I型及II型CD20单抗作用机制的区别与此同时，罗氏/基因泰克还利用其强大的双抗研发能力开发出两款CD3/CD20双抗（Mosunetuzumab及Glofitamab）并先后获批上市。从结构设计来看，Mosunetuzumab采用1:1型非对称双抗结构而Glofitamab采用2:1型非对称双抗结构（图6）。图6. Mosunetuzumab及Glofitamab结构示意图 Glofitamab的特点是药效更强，可以在安全耐受的前提条件下加强杀伤肿瘤细胞的能力，对侵袭性和难治淋巴瘤行之有效。而Mosunetuzumab的疗效则相对温和，细胞因子释放综合征（CRS）发生概率相对较低，更适用于治疗滤泡性淋巴瘤等惰性淋巴瘤。值得注意的是罗氏正在开展Mosunetuzumab用于SLE的临床1期试验。此外，由于多发性硬化症是一种脑部疾病，为了增强抗体穿透血脑屏障从而提高脑部药物浓度，罗氏开发了Brainshuttle技术并将其应用于奥瑞珠单抗成为其临床开发的下一代产品RG6035（图7）。图7. RG6035结构（A）及作用机制（B）示意图 2024年11月，罗氏与Poseida Therapeutics达成并购协议，前者将以每股现金9美元（总价约10亿美元）收购后者。而Poseida是一家专注于同种异体CAR-T疗法的公司，双方早在2022年8月就开始合作进行开发包括P-CD19CD20-ALLO1在内的四款产品。由此可见，在CD20这个靶点上罗氏对细胞治疗产品也抱有期望。综上所述，在过去的30多年时间里，罗氏/基因泰克对CD20靶点进行了持续深入的布局，开发出多款产品并成功上市，涉及血液瘤、神经系统疾病以及自免疾病。所谓的one asset team是将某个靶点当作公司的宝贵财产而围绕其展开深入并广泛的研发，不断拓展新适应症以及开发新一代产品从而在激烈的竞争中立于不败之地。

并购上市批准细胞疗法突破性疗法

2025-02-26

·EndPoints

After rejection, Regeneron seeks accelerated approval of bispecific for only one of two types of lymphoma

Regeneron is now expecting an accelerated approval decision this summer on its T cell engager for one form of lymphoma, while it’s giving up on accelerated approval for a different form of the disease. The FDA last March rejected the biotech’s application for odronextamab over its confirmatory trial enrollment status in both follicular lymphoma and diffuse large B cell lymphoma (DLBCL). Regeneron said Wednesday that the FDA set a decision deadline of July 30 for odronextamab in follicular lymphoma that has returned or is not responding to treatment. The drug would be for patients who have tried at least two previous lines of systemic therapy. However, Regeneron is no longer asking for accelerated approval in DLBCL. “Due to competitor developments, we no longer believe odronextamab in R/R DLBCL has an accelerated approval path and therefore, we plan to seek full approval pending data from ongoing Phase 3 studies,” a Regeneron spokesperson told Endpoints News via email. In DLBCL, Roche announced in December that a Phase 3 study showed its T cell engager Columvi plus chemotherapy led to a statistically significant improvement in overall survival, and it’s expecting an FDA decision to update the drug’s label in July. In order to ask for approval now, Regeneron would likely also need to show a survival benefit in a late-stage study. That’s likely to delay Regeneron’s US expansion of odronextamab into DLBCL, the more common form of lymphoma between the two, by years. Regeneron’s Phase 3 trial in DLBCL is expected to wrap up in 2028, according to a federal clinical trials database . Odronextamab is a bispecific antibody that targets two proteins found on cells: CD20 on malignant B cells, and CD3 on T cells. By bridging the two, the hope is that the therapy will lead the immune system to kill the cancer cells. If approved, odronextamab would be the fourth CD20xCD3 bispecific to make it to market in the US. AbbVie and Genmab market Epkinly, while Roche subsidiary Genentech markets two CD20xCD3 bispecifics in Lunsumio and Columvi. Regeneron said Wednesday that the FDA accepted its application for follicular lymphoma after achieving “an FDA-mandated enrollment target” for its confirmatory trial, though it declined to specify what that target was. The biotech noted that was the “sole approvability issue” raised by the FDA in its last submission . Regeneron said in February that the study was over 40% enrolled, and according to a federal clinical trials database, the Phase 3 confirmatory study is expected to enroll 478 patients. The FDA has been calling for faster confirmatory trials, suggesting they should be “well underway” at the time of an accelerated approval. Regeneron is asking for approval for follicular lymphoma based on clinical trial data that showed 80% of patients responded to treatment, with 74% seeing all signs of their cancer disappear. In the EU, odronextamab was approved in August and is marketed as Ordspono for both indications after two-plus lines of systemic therapy. The FDA last week set a July 10 decision deadline for Regeneron’s multiple myeloma bispecific linvoseltamab, which it previously rejected over manufacturing issues . Editor’s note: This story was corrected to reflect that the PDUFA date for linvoseltamab is July 10, not August 22.

临床3期加速审批上市批准

100 项与莫妥珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11463	-	-	DB15434

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
滤泡性淋巴瘤	欧盟	Roche Registration GmbH	2022-06-03
滤泡性淋巴瘤	冰岛	Roche Registration GmbH	2022-06-03
滤泡性淋巴瘤	列支敦士登	Roche Registration GmbH	2022-06-03
滤泡性淋巴瘤	挪威	Roche Registration GmbH	2022-06-03

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
大B细胞淋巴瘤	临床3期	瑞士	Roche Holding AG	2023-05-23
难治性侵袭性非霍奇金淋巴瘤	临床3期	美国	Hoffmann-La Roche, Inc.	2022-04-25
难治性侵袭性非霍奇金淋巴瘤	临床3期	中国	Hoffmann-La Roche, Inc.	2022-04-25
难治性侵袭性非霍奇金淋巴瘤	临床3期	日本	Hoffmann-La Roche, Inc.	2022-04-25
难治性侵袭性非霍奇金淋巴瘤	临床3期	阿根廷	Hoffmann-La Roche, Inc.	2022-04-25
难治性侵袭性非霍奇金淋巴瘤	临床3期	巴西	Hoffmann-La Roche, Inc.	2022-04-25
难治性侵袭性非霍奇金淋巴瘤	临床3期	加拿大	Hoffmann-La Roche, Inc.	2022-04-25
难治性侵袭性非霍奇金淋巴瘤	临床3期	以色列	Hoffmann-La Roche, Inc.	2022-04-25
难治性侵袭性非霍奇金淋巴瘤	临床3期	墨西哥	Hoffmann-La Roche, Inc.	2022-04-25
难治性侵袭性非霍奇金淋巴瘤	临床3期	新西兰	Hoffmann-La Roche, Inc.	2022-04-25

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临床结果

适应症

分期

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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


NCT03677141 (CTgov)	临床1/2期	B细胞淋巴瘤 \| 弥漫性大B细胞淋巴瘤	117	CHP-Pola+Mosunetuzumab (Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized))	淵遞壓鏇壓製艱簾願醖(構廠醖鹹構憲製壓積願) = 淵鹽製遞簾繭積襯鹽繭構艱淵淵網鹹鬱選簾網 (淵窪鏇顧膚鹽觸簾衊夢, 遞糧簾願淵選餘憲網獵 ~ 鏇顧製遞壓齋蓋餘顧膚) 更多	-	2024-12-18
NCT03677141 (CTgov)	临床1/2期	B细胞淋巴瘤 \| 弥漫性大B细胞淋巴瘤	117	CHP-Pola+Rituximab (Arm 2: Phase II Rituximab + CHP-Pola (Randomized))	淵遞壓鏇壓製艱簾願醖(構廠醖鹹構憲製壓積願) = 願繭鹹觸醖簾膚築糧糧構艱淵淵網鹹鬱選簾網 (淵窪鏇顧膚鹽觸簾衊夢, 簾鏇襯製顧廠膚憲廠繭 ~ 餘窪襯淵艱襯繭鏇淵遞) 更多	-	2024-12-18
ASH2024	N/A	难治性滤泡性淋巴瘤	-	Mosunetuzumab	鑰獵築衊選網顧簾鏇範(範壓醖襯廠艱願齋窪顧) = B-cell recovery to detectable levels was observed after a median of 19.0 months (95% CI: 12.8-25.1); immunoglobulin M recovery to the lower limit of normal was observed after a median of 40.7 months (95% CI: 36.1-NE) 夢築鹹顧顧獵艱醖鏇簾 (鑰醖鹹遞構醖網壓憲遞 ) 更多	-	2024-12-09
NCT05207670 (Morningsun, ASH2024)	临床2期	滤泡性淋巴瘤一线 CD20 \| CD3	65	Mosunetuzumab SC	夢餘獵鹽艱淵夢簾繭繭(窪構範鑰顧製糧鬱糧蓋) = CRS by ASTCT occurred in 30 pts (46.9%; Gr 1, 39.1%; Gr 2, 7.8%) 製糧壓鹹糧積繭夢選糧 (鑰範餘築窪糧選餘醖積 ) 更多	积极	2024-12-08
ASH2024 人工标引	临床2期	套细胞淋巴瘤	25	Mosunetuzumab	選蓋夢繭糧衊顧簾膚醖(糧獵願憲網遞艱網繭願) = The most common adverse events (AEs) were CRS (52%), fatigue (36%), and pyrexia (36%). CRS events were predominantly Grade (Gr) 1/2 (48%); Gr 3 CRS occurred in 1 pt; no Gr ≥4 CRS events were reported. 鬱鏇淵遞餘糧範艱壓齋 (簾膚繭淵壓顧衊鬱積築 ) 更多	积极	2024-12-07
ASH2024	N/A	滤泡性淋巴瘤	-	Mosunetuzumab SC	齋鑰製鏇鏇構積鬱壓選(憲網範築憲鬱醖艱鏇艱) = cytokine release syndrome (CRS; 30%) 衊膚簾網鹽繭蓋築鏇獵 (築積憲襯夢鹽遞窪願製 ) 更多	-	2024-12-07
NCT05315713 (CTgov)	临床1/2期	滤泡性淋巴瘤 \| 难治性B细胞淋巴瘤	8	Mosunetuzumab SC+tocilizumab+Tiragolumab	糧願憲觸網糧築夢願製(鏇觸鏇壓遞觸壓憲糧築) = 選壓獵襯廠積築醖艱衊範醖獵鹽鏇窪膚製鬱製 (廠襯顧壓鹹觸淵觸壓窪, 餘繭鏇範壓積憲築夢鑰 ~ 鑰餘鏇積糧襯構糧觸膚) 更多	-	2024-10-04
SOHO2024	N/A	大B细胞淋巴瘤	-	Mosunetuzumab with Polatuzumab Vedotin	鏇憲鑰蓋蓋鹽製餘憲願(齋蓋繭糧簾鹽壓夢範壓) = 憲遞窪鑰繭艱醖鹽積網繭願膚鏇膚糧鏇構夢選 (壓鏇襯壓鏇淵糧膚築選 ) 更多	-	2024-09-04
SOHO2024	N/A	难治性滤泡性淋巴瘤	-	Mosunetuzumab	糧齋鹽積廠憲網構築願(鹹廠簾淵艱鏇製糧餘壓) = CRS events occurred in 44.4% of patients (Grade 3/4, 2.2%); all resolved 餘醖鏇糧積壓鏇鹽網獵 (築壓鏇憲遞艱鹽窪壓壓 ) 更多	-	2024-09-04
NCT03671018 (ASCO2024) 人工标引	临床1/2期	大B细胞淋巴瘤	98	Mosunetuzumab with polatuzumab vedotin (refractory)	餘鑰膚願蓋蓋蓋選築鹹(製顧網鑰鏇築繭鏇壓鬱) = 鬱遞繭艱蓋積繭齋簾獵鑰鹹艱衊鹽積網鬱積構 (醖築鹹壓獵淵鏇獵願簾, 33.7‒64.2) 更多	积极	2024-05-24
NCT03671018 (ASCO2024) 人工标引	临床1/2期	大B细胞淋巴瘤	98	Mosunetuzumab with polatuzumab vedotin (relapse)	餘鑰膚願蓋蓋蓋選築鹹(製顧網鑰鏇築繭鏇壓鬱) = 鬱鹹積遞繭襯獵願襯壓鑰鹹艱衊鹽積網鬱積構 (醖築鹹壓獵淵鏇獵願簾, 53.7‒88.9) 更多	积极	2024-05-24
ASCO2024	N/A	非霍奇金淋巴瘤一线 CD20 \| CD3	124	Mosunetuzumab monotherapy	構艱鹹鏇襯積鬱顧選淵(願遞構積壓醖遞餘積醖) = common adverse effects given in the table 築鹽艱鏇顧夢選夢憲憲 (構遞鹽鹽範鏇衊鬱鹽製 ) 更多	积极	2024-05-24
ASCO2024	N/A	非霍奇金淋巴瘤一线 CD20 \| CD3	124	Mosunetuzumab + CHOP		积极	2024-05-24