Regeneron Pharmaceuticals, Inc. announced that the European Commission (EC) has approved Ordspono (odronextamab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy

Regeneron Pharmaceuticals，Inc.宣布，欧盟委员会（EC）已批准Ordspono（odronextamab）用于治疗两种或两种以上全身治疗后复发或难治（R/R）滤泡性淋巴瘤（FL）或R/R弥漫性大B细胞淋巴瘤（DLBCL）的成年患者

This marks the first regulatory approval of Ordspono in the world for these patients. Ordspono is a bispecific antibody that acts by linking the lymphoma cell to a killer T cell.

这标志着Ordspono在世界上首次获得这些患者的监管批准。Ordspono是一种双特异性抗体，通过将淋巴瘤细胞与杀伤性T细胞连接起作用。

“The EC approval of Ordspono is a meaningful advancement for EU patients and their physicians as a new option to treat both indolent and aggressive lymphomas,” said Stefano Luminari, M.D., Professor of Oncology at the University of Modena and Reggio Emilia, hematologist at the Hematology Unit of Arcispedale Santa Maria Nuova in Reggio Emilia, and a trial investigator.

摩德纳大学肿瘤学教授Stefano Luminari医学博士和雷吉奥·埃米利亚（Reggio Emilia）说：“欧共体批准Ordspono对欧盟患者及其医生来说是一项有意义的进步，它是治疗惰性和侵袭性淋巴瘤的新选择。”雷吉奥·埃米利亚（Reggio Emilia）的Arcispedale Santa Maria Nuova血液科血液学家，也是一名试验研究者。

“In clinical trials, Ordspono demonstrated remarkable complete response rates in follicular lymphoma, as well as compelling efficacy results in diffuse large B-cell lymphoma, including in the post-CAR-T setting. Physicians, especially in the community setting, will have an off-the-shelf option that can be administered out-patient – offering the chance for complete remission.”.

“在临床试验中，Ordspono在滤泡性淋巴瘤中表现出显着的完全缓解率，以及在弥漫性大B细胞淋巴瘤中令人信服的疗效，包括在CAR-T后环境中。医生，特别是在社区环境中，将有一个现成的选择，可以在门诊给药-提供完全缓解的机会。”。

The approval is based on results from the Phase 1 ELM-1 and pivotal Phase II ELM-2 trials, which demonstrated robust, durable response rates in adults with R/R FL or R/R DLBCL: In R/R FL:, results from ELM-2 (N=128) as assessed by an independent review committee (IRC) showed an objective response rate (ORR) of 80%, with 73% achieving a complete response (CR).

批准是基于第一阶段ELM-1和关键的II期ELM-2试验的结果，这些试验证明了R/R FL或R/R DLBCL成人的稳健，持久的反应率：在R/R FL中：，由独立审查委员会（IRC）评估的ELM-2（N=128）的结果显示客观反应率（ORR）为80%，其中73%达到完全反应（CR）。

Among complete responders, the median duration of response (DoR) was 25 months (95% confidence interval [CI]: 20 months to not estimable [NE]).  In R/R DLBCL: results from ELM-2 (N=127) in patients who were CAR-T therapy naive, as assessed by an IRC showed 52% ORR, with 31% achieving a CR. Among complete responders the median DoR was 18 months (95% CI: 10 months to NE) results from ELM-1 (N=60) in patients who had progressed after CAR-T therapy, as assessed by an IRC showed 48% ORR, with 32% achieving a CR.

在完全缓解者中，中位缓解时间（DoR）为25个月（95%置信区间[CI]:20个月至不可估计[NE]）。在R/R DLBCL中：通过IRC评估，未接受CAR-T治疗的患者的ELM-2（N=127）结果显示ORR为52%，CR为31%。在完全缓解者中，中位DoR为18个月（95%可信区间：10个月至NE），IRC评估的CAR-T治疗后进展患者的ELM-1（N=60）结果显示ORR为48%，CR为32%。

Among responders (n=29), the median DoR was 15 months (95% CI: 3 months to NE)..

在应答者（n=29）中，中位DoR为15个月（95%CI:3个月至NE）。。

The most common adverse reactions were cytokine release syndrome (CRS; 54%), neutropenia (41%), pyrexia (39%), anemia (38%), thrombocytopenia (27%), diarrhea (24%) and COVID-19 (22%). The most common serious adverse reactions were CRS (14%), pneumonia (9%), COVID-19 (9%) and pyrexia (6%). Ordspono can cause serious or fatal infections, and CRS, which may be serious or life-threatening..

最常见的不良反应是细胞因子释放综合征（CRS；54%），中性粒细胞减少症（41%），发热（39%），贫血（38%），血小板减少症（27%），腹泻（24%）和COVID-19（22%）。最常见的严重不良反应是CRS（14%），肺炎（9%），COVID-19（9%）和发热（6%）。Ordspono可导致严重或致命的感染，以及可能严重或危及生命的CRS。。

“Ordspono marks the first approval from our bispecific antibody platform, which we hope will increasingly contribute to our growing portfolio of practice-changing medicines for oncology and other diseases,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer of Regeneron.

“Ordspono标志着我们的双特异性抗体平台首次获得批准，我们希望它将越来越多地为我们不断增长的用于肿瘤和其他疾病的改变实践的药物组合做出贡献，”Regeneron董事会联合主席、总裁兼首席科学官George D.Yancopoulos博士说。

“Building upon this approval, we are excited about our OLYMPIA program, which includes multiple Phase III trials investigating Ordspono as a monotherapy and in various combinations, in earlier lines of therapy. We’re also excited to be advancing our broader pipeline of CD3 and other bispecific therapies, both to additional hematologic cancers such as myeloma, as well as to solid tumors.”.

“在获得批准的基础上，我们对我们的奥林匹亚项目感到兴奋，该项目包括多项III期临床试验，研究Ordspono作为单一疗法以及早期治疗中的各种组合。我们也很兴奋能够推进CD3和其他双特异性治疗的更广泛渠道，既可以治疗骨髓瘤等其他血液癌症，也可以治疗实体瘤。”。

About the Ordspono (odronextamab) Clinical Trial Program: Ordspono is a CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing. Ordspono as monotherapy is indicated for the treatment of adult patients with R/R FL or R/R DLBCL, after two or more lines of systemic therapy.

关于Ordspono（odronextamab）临床试验计划：Ordspono是一种CD20xCD3双特异性抗体，旨在将CD20与表达CD3的T细胞桥接在癌细胞上，以促进局部T细胞活化和癌细胞杀伤。Ordspono作为单一疗法适用于在两种或更多种全身治疗后治疗R/R FL或R/R DLBCL的成年患者。

ELM-1 is an ongoing, open-label, multicenter Phase 1 trial to investigate the safety and tolerability of odronextamab in patients with CD20+ B-cell malignancies previously treated with CD20-directed antibody therapy, including a cohort of patients who had progressed after CAR-T therapy. ELM-2 is an ongoing, open-label, multicenter Phase II trial investigating odronextamab across five independent disease-specific cohorts, including DLBCL, FL, mantle cell lymphoma, marginal zone lymphoma and other subtypes of B-NHL.

ELM-1是一项正在进行的开放标签多中心1期临床试验，旨在研究odronextamab在先前接受CD20定向抗体治疗的CD20+B细胞恶性肿瘤患者中的安全性和耐受性，包括CAR-T治疗后进展的患者队列。ELM-2是一项正在进行的开放标签多中心II期临床试验，研究了五个独立的疾病特异性队列中的odronextamab，包括DLBCL，FL，套细胞淋巴瘤，边缘区淋巴瘤和其他B-NHL亚型。

The primary endpoint is ORR according to the Lugano Classification as assessed by IRC, and secondary endpoints include CR, progression-free survival, overall survival and DoR..

根据IRC评估的卢加诺分类，主要终点是ORR，次要终点包括CR，无进展生存期，总生存期和DoR。。

Regeneron is conducting a broad Phase III development program, known as OLYMPIA, investigating odronextamab in earlier lines of therapy and other B-NHLs. In addition, Regeneron is investigating odronextamab in combination with a costimulatory bispecific antibody, REGN5837 (CD22xCD28), and Regeneron’s PD-1 inhibitor cemiplimab for R/R aggressive B-NHL through the ATHENA-1 and CLIO-1 studies, respectively.

。此外，Regeneron正在通过ATHENA-1和CLIO-1研究分别研究odronextamab与共刺激双特异性抗体REGN5837（CD22xCD28）和Regeneron的PD-1抑制剂cemiplimab联合用于R/R侵袭性B-NHL。

These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority. For more information, visit the Regeneron clinical trials website, or contact via clinicaltrials@regeneron.com or +1 844-734-6643..

这些潜在用途是研究性的，其安全性和有效性尚未得到任何监管机构的评估。有关更多信息，请访问Regeneron临床试验网站，或通过clinicaltrials@regeneron.com或+1 844-734-6643。。

Condition: Diffuse Large B Cell /Folicular Lymphoma

病情：弥漫性大B细胞/叶状淋巴瘤

Type: drug

类型：药物