Rituximab

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today announced that the European Commission (EC) has approved Minjuvi® (tafasitamab) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy. "The EC approval of Minjuvi addresses a critical need, bringing a new, first-of-its-kind, chemotherapy-free option to patients in Europe with relapsed or refractory FL,” said Bill Meury, President and Chief Executive Officer, Incyte. "The EC approval of Minjuvi addresses a critical need, bringing a new, first-of-its-kind, chemotherapy-free option to patients in Europe with relapsed or refractory FL,” said Bill Meury, President and Chief Executive Officer, Incyte. “Historically, FL patients have had limited treatment options in the second-line setting, and we are proud to drive this important advancement for the lymphoma community as we seek to deliver innovative medicines for patients with cancer.” The EC decision follows the positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in November 2025. This marks the second indication for Minjuvi, which was previously approved by the EC in combination with lenalidomide for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The EC decision is based on data from the Phase 3 inMIND trial evaluating the efficacy and safety of Minjuvi in combination with rituximab and lenalidomide as a treatment for patients with relapsed or refractory FL. Results from the trial showed that Minjuvi combined with rituximab and lenalidomide met its primary endpoint. The data demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in comparison to placebo added to lenalidomide and rituximab. Patients receiving Minjuvi in combination with rituximab and lenalidomide achieved a median PFS by investigator assessment of 22.4 months (95% CI, 19.2-not evaluable [NE]) compared to 13.9 months (95% CI, 11.5-16.4) in the control arm (hazard ratio [HR]: 0.43 [95% CI, 0.32-0.58]; P<0.0001). The PFS assessed by an Independent Review Committee (IRC) was consistent with investigator-based results. Median PFS by IRC was not reached (95% CI, 19.3-NE) in the Minjuvi group versus 16.0 months (95% CI, 13.9-21.1) in the placebo group (HR: 0.41 [95% CI, 0.29-0.56]. Minjuvi was generally well-tolerated, with a manageable safety profile. Safety and tolerability were comparable with the addition of tafasitamab to lenalidomide in combination with rituximab. The most common adverse reactions in the Phase 3 study (≥20%) in recipients of Minjuvi, excluding laboratory abnormalities, were respiratory tract infections (including COVID-19 infection and pneumonia), diarrhea, rash, fatigue, constipation, musculoskeletal pain and cough.2 FL is the most common slow-growing form of B-cell non-Hodgkin lymphoma (NHL), representing about 30% of NHL cases globally. It is considered incurable, with patients frequently relapsing after initial therapy and experiencing a progressively worsening prognosis with each recurrence.3 Despite advances in treatment, there remains a significant unmet need for additional options for relapsed or refractory FL, with approximately 2-4 out of every 100,000 people affected in Western countries.1 “Relapsed or refractory FL is an incurable, complex and persistent cancer,” said Stefano Luminari, M.D., Professor of Oncology, University of Modena and Reggio Emilia, Italy and inMIND study investigator. “The EC approval of Minjuvi in combination with lenalidomide and rituximab represents an important innovation, as it brings the first CD19- and CD20-dual-targeted immunotherapy to eligible patients with FL in Europe, which has demonstrated a meaningful reduction in the risk of disease progression, including among those with high-risk disease.” About inMIND A global, double-blind, randomized, placebo-controlled Phase 3 study, inMIND (NCT04680052) evaluated the efficacy and safety of tafasitamab in combination with rituximab and lenalidomide compared with placebo in combination with rituximab and lenalidomide in patients with relapsed or refractory follicular lymphoma (FL) Grade 1 to 3a or relapsed or refractory nodal, splenic or extranodal marginal zone lymphoma (MZL). The study enrolled a total of 654 adults (age ≥18 years). The primary endpoint of the study is progression-free survival (PFS) by investigator assessment in the FL population, and the key secondary endpoints are PFS in the overall population as well as positron emission tomography complete response (PET-CR) and overall survival (OS) in the FL population. For more information about the study, please visit https://clinicaltrials.gov/study/NCT04680052. About Minjuvi® (tafasitamab) Minjuvi® (tafasitamab) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanisms including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. In the U.S., Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials. Additionally, Monjuvi received accelerated approval in the U.S. in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). In the European Union, Minjuvi also received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. XmAb® is a registered trademark of Xencor, Inc. Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the “triangle” design are registered trademarks of Incyte. Safety Information from the EU Summary of Product Characteristics (SmPC) Minjuvi should be administered to patients with an active infection only if the infection is treated appropriately and well controlled. Patients with a history of recurring or chronic infections may be at increased risk of infection and should be monitored appropriately. Patients should be advised to contact their healthcare professionals if fever or other evidence of potential infection, such as chills, cough or pain on urination, develops. Treatment with Minjuvi in combination with lenalidomide and/or rituximab should not be initiated in female patients unless pregnancy has been excluded. In the inMIND study, the most common adverse reactions were infections (68%), including viral infections (41%) and bacterial infections (27%); neutropenia (57%), rash (36.4%), asthenia (34.9%), pyrexia (19%), thrombocytopenia (17%), anaemia (17%), infusion related reaction (15.9%), pruritus (15.6%), and headache (10.4%). The most common serious adverse reactions were infections (26%), including viral infections (13%) and bacterial infections (6%), febrile neutropenia (2.8%), and pyrexia (1.8%). Treatment with tafasitamab can cause serious or severe myelosuppression including neutropenia, thrombocytopenia, and anaemia. Complete blood counts should be monitored throughout treatment and prior to administration of each treatment cycle. For more information, see the Minjuvi SmPC. About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the potential offered by Minjuvi, contain predictions, estimates, and other forward-looking statements. These statements are based on Incyte’s current expectations and are subject to risks and uncertainties that may cause actual results to differ materially. These forward-looking statements are based on Incyte's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the EC, FDA and other regulatory authorities; the efficacy or safety of Incyte and its partners' products; the acceptance of Incyte and its partners' products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte's reports filed with the Securities and Exchange Commission, including its annual report on Form 10-K and its report on Form 10-Q for the quarter ended September 30, 2025. Incyte disclaims any intent or obligation to update these forward-looking statements. 1 Zinzani P.L., Muñoz J., Trotman J. (2024) Current and future therapies for follicular lymphoma. Exp Hematol Oncol, 13(1):87. Link to source (https://pmc.ncbi.nlm.nih.gov/articles/PMC11340193/) 2 Sehn L.H., et al. ASH Annual Meeting 2024; Late breaking abstract tafasitamab plus lenalidomide and rituximab for relapsed or refractory follicular lymphoma: results from a phase 3 study (inMIND). Link to source (https://ash.confex.com/ash/2024/webprogram/Paper212970.html) 3 Dreyling M., Ghielmini M., Rule S., et al. (2021) Newly diagnosed and relapsed follicular lymphoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol, 32(3):298-308. Link to source (https://pubmed.ncbi.nlm.nih.gov/33249059/)

↑↑↑ 点击上方蓝色字关注“中华风湿” 在风湿免疫科，生物制剂和靶向合成药物（b/tsDMARDs）的出现，曾让无数患者看到了曙光。然而，仍有相当一部分患者，即便换用不同机制的药物，病情依然难以控制。这时，医生手中是否还有“牌”可打？近年来，“双重生物制剂疗法”（DBT）——即同时使用两种生物制剂或靶向药——开始进入临床视线。它像是一场“双线作战”，试图同时阻断多条炎症通路，为那些“难治型”风湿病患者提供新的可能。但这条路，到底安不安全？有没有效果？ 一、为什么单用一种药有时会“失灵”？ 风湿病不是单一通路疾病，免疫系统如同一张复杂交织的网络。当医生用药物阻断其中一条通路（如TNF），其他通路（如IL-6、IL-17）可能会被激活或代偿，导致治疗失败。此外，患者体内可能产生抗药抗体、存在特定基因差异、或伴有肥胖等因素，都会影响药物效果。 二、“双药联用”真的有用吗？数据来说话 目前，DBT仍属于超说明书用药，缺乏大规模临床试验支持。现有证据主要来自小规模研究、个案报告和真实世界数据，结论并不统一。 类风湿关节炎（RA）：效果有限，感染风险明确 早期尝试（如依那西普+阿那白滞素）显示，疗效提升不大，但严重感染风险显著增加。 利妥昔单抗（CD20单抗）与TNF抑制剂联用，感染率也明显高于单药。 近年来，JAK抑制剂（如托法替布）与生物制剂联用在难治性RA中显示出一定前景，但带状疱疹发生率较高，尤其在老年患者中需警惕。 银屑病关节炎（PsA）：多靶点控制或具优势 PsA 累及关节、皮肤、指甲等多个部位，单一药物常难以全面控制。 阿普米司特（PDE4抑制剂）因免疫抑制相对较弱，与TNF或IL-23抑制剂联用，可能提升疗效且不显著增加感染风险，是较有潜力的组合。 乌司奴单抗（IL-12/23抑制剂）+TNF抑制剂：部分难治患者有效，但已有报告出现带状疱疹、肺炎等感染事件。 IL-17/IL-23抑制剂与其他生物制剂联用：在个案中显示协同作用，但数据极少，安全性待观察。 中轴型脊柱关节炎（axSpA）：个案有效，证据稀缺 少数报告显示，在传统生物制剂全部失效后，联用两种生物制剂（如英夫利西单抗+依那西普、维多珠单抗+戈利木单抗）可使患者重获缓解。 肠道选择性药物维多珠单抗与TNF抑制剂联用，在合并肠病的axSpA患者中显示出较好的肠道与关节双重控制潜力，且感染风险较低。 三、最大的担忧：安全吗？ 感染风险是DBT最受关注的焦点。 多项研究一致显示，联合治疗（尤其是全剂量组合）的严重感染发生率高于单药治疗。此外，联合使用可能增加机会性感染、注射反应等不良事件。 四、未来方向：更精准，更智能 盲目联用不可取，未来的趋势是“精准打击”： 生物标志物指导治疗：通过血液代谢组、基因分型（如HLA-C*06:02）、蛋白质组等预测患者对哪种药更敏感，避免无效治疗。 诱导免疫耐受：通过调节T细胞、树突状细胞或肠道菌群，从根源上重建免疫平衡，仍处于实验阶段。 CAR-T细胞疗法：目前已用于系统性红斑狼疮等风湿病的研究性治疗，未来可能为重症患者提供全新选择。 总结：给患者与医生的核心建议 DBT不是一线选择，而是“救援策略”：仅适用于多种生物制剂单药治疗均失败、病情仍高度活动、严重影响生活的难治性患者。 决策必须权衡利弊：由经验丰富的风湿免疫科医生全面评估，确保潜在获益远大于感染及其他风险。 优选“低免疫抑制组合”：尽可能选择一种系统免疫抑制较弱的药物（如阿普米司特、维多珠单抗）进行组合，以降低感染风险。 严密监测：治疗期间需密切随访，警惕感染迹象，并做好疫苗接种等预防措施。 参考文献 Hassan, Fadi, et al. "Beyond Monotherapy: Exploring the Efficacy and Safety of Dual Biologic Strategies in Rheumatic Diseases." Biologics: Targets and Therapy (2025): 665-680. END ↑↑↑ 点击关注“中华风湿”与大家共成长 版权声明：本站所有注明“来源：中华风湿”的文字、图片和音视频资料，版权均属于中华风湿所有，非经授权，任何媒体、网站或个人不得转载，授权转载时须注明“来源：中华风湿微信公众号”。本网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，我们将立即进行删除处理。