The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant.

欧洲药品管理局人用药品委员会（CHMP）已采纳积极意见，推荐批准Sarclisa联合硼替佐米、来那度胺和地塞米松（VRd）用于适合自体干细胞移植的新诊断多发性骨髓瘤（NDMM）成人患者的诱导治疗。

A final decision is expected in the coming months..

预计将在未来几个月内做出最终决定。

Olivier Nataf

奥利维尔·纳塔夫

Global Head, Oncology

全球肿瘤学主管

“The CHMP’s recommendation represents significant progress toward our ambition for Sarclisa, addressing unmet patient needs in multiple myeloma care and making a meaningful difference in treatment outcomes at every stage of the disease across regions. If approved, this regimen would represent a new, important induction option for transplant-eligible patients, with the potential to improve long-term outcomes and deepen responses at a critical juncture in treatment.”.

“CHMP的推荐代表了我们在Sarclisa方面的雄心取得了重要进展，解决了多发性骨髓瘤护理中未满足的患者需求，并在各个地区的疾病每个阶段对治疗结果产生有意义的影响。如果获得批准，该方案将为适合移植的患者提供一个新的、重要的诱导治疗选择，有可能改善长期疗效并在治疗的关键时刻加深反应。”

The positive CHMP opinion is based on part one results from the two-part, double-randomized, German-speaking Myeloma Multicenter Group (GMMG)-HD7 study (clinical study identifier:

CHMP的积极意见基于两部分、双随机、德语区骨髓瘤多中心小组（GMMG）-HD7研究的第一部分结果（临床研究标识符：

NCT03617731

NCT03617731

at the 2024 American Society of Hematology Annual Meeting & Exposition and published in the

在2024年美国血液学会年会暨博览会上发表并出版于

Journal of Clinical Oncology

临床肿瘤学杂志

GMMG-HD7 is the first phase 3 study to demonstrate a deep and rapid response with an anti-CD38-based induction regimen in transplant-eligible (TE) NDMM patients, with a higher proportion of patients with minimal residual disease (MRD) negativity benefit post-induction, alongside a significant progression-free survival (PFS) benefit from first randomization, regardless of maintenance therapy and without consolidation..

GMMG-HD7 是首个在适合移植（TE）的新诊断多发性骨髓瘤（NDMM）患者中证明基于抗CD38诱导方案可带来深度且快速响应的III期研究，无论是否进行巩固治疗，更多患者在诱导治疗后达到微小残留病（MRD）阴性，并在首次随机化后显示出显著的无进展生存期（PFS）获益，且与维持治疗无关。

Additionally, the data showed the highest post-induction and post-transplant MRD negativity rates of any CD38 monoclonal antibody using VRd as a backbone in TE NDMM. The results are part of the growing body of clinical evidence supporting the use of Sarclisa in the front-line setting and reinforce the potential of Sarclisa-VRd when used prior to transplant..

此外，数据显示，在TE NDMM中使用VRd作为基础方案的任何CD38单克隆抗体中，诱导后和移植后的MRD阴性率最高。这些结果构成了支持在前线治疗中使用Sarclisa的越来越多临床证据的一部分，并进一步证实了在移植前使用Sarclisa-VRd的潜力。

Sarclisa is currently approved in three indications in the EU, across different lines of therapy in adult patients with relapsed and/or refractory (R/R) MM and with NDMM who are not eligible for transplant.

Sarclisa目前在欧盟已获批用于三个适应症，涵盖复发和/或难治性（R/R）多发性骨髓瘤（MM）成年患者的不同治疗阶段，以及不符合移植条件的新诊断多发性骨髓瘤（NDMM）患者。

About the GMMG-HD7 study

关于GMMG-HD7研究

GMMG-HD7 is an investigational pivotal, randomized, open-label, multicenter, two-part phase 3 study evaluating Sarclisa in combination with VRd, also referred to as RVd (lenalidomide, bortezomib, and dexamethasone), versus VRd induction followed by post-transplant re-randomization to Sarclisa plus lenalidomide versus lenalidomide maintenance in TE NDMM patients.

GMMG-HD7 是一项关键的三期研究，评估 Sarclisa 联合 VRd（也称为 RVd，即来那度胺、硼替佐米和地塞米松）对比 VRd 诱导治疗后移植后重新随机分配至 Sarclisa 加来那度胺或来那度胺维持治疗在适合移植的新诊断多发性骨髓瘤患者中的效果。该研究为实验性、随机、开放标签、多中心、分为两部分的三期临床试验。

The GMMG-initiated study is being conducted in close collaboration with Sanofi based on jointly defined research. Sanofi provided financial support to GMMG for this study. In December 2021, Sanofi and GMMG shared results from part one, which met the primary endpoint of MRD negativity after induction therapy and before transplant in NDMM patients..

由GMMG发起的这项研究是在与赛诺菲紧密合作的基础上，基于共同定义的研究进行的。赛诺菲为这项研究向GMMG提供了资金支持。2021年12月，赛诺菲和GMMG分享了第一部分的结果，该结果达到了在新诊断多发性骨髓瘤（NDMM）患者中诱导治疗后和移植前微小残留病（MRD）阴性的主要终点。

The study enrolled 662 patients with TE NDMM across 67 sites in Germany. In the first part of the study, all participants were equally randomized to receive three 42-day cycles of VRd in both arms of the study, while Sarclisa was added to only one study arm. In the second part of the study, patients were re-randomized post-transplant to receive Sarclisa plus lenalidomide or lenalidomide alone as maintenance therapy.

该研究在德国67个研究中心招募了662名TE NDMM患者。在研究的第一部分，所有参与者被随机平均分配到两组，接受三个42天周期的VRd治疗，但仅在其中一个研究组中添加了Sarclisa。在研究的第二部分，患者在移植后重新随机分组，接受Sarclisa联合来那度胺或单独使用来那度胺作为维持治疗。

During the study, Sarclisa was administered through an intravenous infusion at a dose of 10 mg/kg once weekly for the first four weeks of cycle one, then every other week for the rest of the induction period..

在研究期间，Sarclisa 在第一个周期的前四周以 10 mg/kg 的剂量每周一次通过静脉输注给药，然后在诱导期的其余时间内每两周给药一次。

The GMMG-HD7 protocol defined two primary endpoints: MRD negativity following induction therapy in the first part of the study, and PFS after the second randomization post-transplant in the second part, where Sarclisa was added to lenalidomide maintenance. The latter endpoint is expected to be available at a later time.

GMMG-HD7 协议定义了两个主要终点：研究第一部分中诱导治疗后的 MRD 阴性，以及研究第二部分中移植后第二次随机化加入 Sarclisa 到来那度胺维持治疗后的 PFS。后一终点预计将在稍后时间获得。

The key secondary endpoint for the first part of the study was PFS from first randomization. Additional secondary endpoints included rates of complete response after induction, and intensification, overall survival, and safety..

研究第一部分的关键次要终点是从第一次随机化开始的无进展生存期（PFS）。其他次要终点包括诱导和强化后的完全缓解率、总生存期和安全性。

MRD negativity was assessed by next-generation flow cytometry (sensitivity of 1x10-5) after induction. In the latest results, PFS for both arms, regardless of maintenance therapy, were measured from the first randomization.

诱导治疗后，通过下一代流式细胞术（敏感性为1x10-5）评估了MRD阴性。在最新的结果中，无论是否进行维持治疗，两组的PFS均从第一次随机分组开始测量。

About Sarclisa

关于Sarclisa

Sarclisa (isatuximab) is approved in more than 50 countries, including in the US, EU, Japan, and China, across multiple treatment lines for MM. Based on the ICARIA-MM phase 3 study, Sarclisa is approved in the US, EU and Japan in combination with pomalidomide and dexamethasone for the treatment of patients with R/R MM who have received ≥two prior therapies, including lenalidomide and a proteasome inhibitor and have relapsed on the last therapy; this combination is also approved in China for patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.

Sarclisa（isatuximab）已在包括美国、欧盟、日本和中国在内的50多个国家获得批准，适用于多发性骨髓瘤（MM）的多线治疗。基于ICARIA-MM的三期研究，Sarclisa在美国、欧盟和日本被批准与泊马度胺和地塞米松联合使用，用于治疗已接受过至少两种先前疗法（包括来那度胺和蛋白酶体抑制剂）并在最后一次治疗中复发的复发/难治性多发性骨髓瘤（R/R MM）患者；该组合也在中国获批，用于至少接受过一线先前治疗（包括来那度胺和蛋白酶体抑制剂）的患者。

Based on the IKEMA phase 3 study, Sarclisa is also approved in more than 50 countries in combination with carfilzomib and dexamethasone, including in the US for the treatment of patients with R/R MM who have received one to three prior lines of therapy and in the EU for patients with MM who have received at least one prior therapy.

基于IKEMA的三期研究，Sarclisa已在全球50多个国家获批与卡非佐米和地塞米松联合使用，包括在美国用于治疗接受过一到三种先前治疗的复发/难治性多发性骨髓瘤（R/R MM）患者，以及在欧盟用于至少接受过一种先前治疗的多发性骨髓瘤（MM）患者。

In the US, EU, UK, and China, Sarclisa is approved in combination with VRd as a front-line treatment option in transplant-ineligible NDMM patients, based on the IMROZ phase 3 study. In Japan, Sarclisa is approved in combination with VRd as a front-line treatment option regardless of transplant eligibility..

在美国、欧盟、英国和中国，基于IMROZ三期研究，Sarclisa联合VRd被批准作为不适合移植的新诊断多发性骨髓瘤（NDMM）患者的一线治疗选择。在日本，Sarclisa联合VRd被批准作为一线治疗选择，无论是否适合移植。

At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need..

在赛诺菲，我们一直致力于肿瘤学领域，不断追求科学奇迹，以改善癌症患者的生活。我们致力于通过开发创新的、首屈一指的免疫疗法和靶向治疗，来改变癌症护理，特别是针对那些罕见且难以治疗的、具有高度未满足需求的癌症。

For more information on Sarclisa clinical studies, please visit

有关Sarclisa临床研究的更多信息，请访问

www.clinicaltrials.gov

www.clinicaltrials.gov

.

。

About the German-speaking Myeloma Multicenter Group

关于德语多发性骨髓瘤多中心小组

GMMG is the largest study group focusing on MM in Germany, with headquarters based in Heidelberg. Within the last 20+ years, the GMMG study group has performed numerous studies including five randomized, multicenter phase 3 studies with 4,000 patients enrolled from about 90 participating and cotreating centers throughout Germany.

GMMG是德国最大的专注于骨髓瘤（MM）的研究组，总部位于海德堡。在过去的20多年里，GMMG研究组开展了众多研究，其中包括五项随机、多中心的III期临床研究，共有来自德国约90个参与和共同治疗中心的4000名患者入组。

The overall goal of GMMG is to generate improved therapies for myeloma patients through the development and testing of novel and personalized, genome- and signaling driven treatment strategies. The GMMG has set itself the goal of achieving further approvals for effective antibody-based drug combinations for the first-line treatment of myeloma patients, in which antibody-based treatment regimens have been integrated into seven GMMG study concepts (CONCEPT, DANTE, DADA, HD6, HD7, HD8, HD9 and HD10)..

GMMG 的总体目标是通过开发和测试新颖且个性化的、基于基因组和信号传导的治疗策略，为骨髓瘤患者提供更有效的治疗方法。GMMG 为自己设定的目标是进一步获得针对骨髓瘤患者一线治疗的有效抗体药物组合的批准，其中抗体治疗方案已整合到七个 GMMG 研究概念中（CONCEPT、DANTE、DADA、HD6、HD7、HD8、HD9 和 HD10）。

About Sanofi

关于赛诺菲

Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time..

赛诺菲是一家以研发为驱动、以人工智能为助力的生物制药公司，致力于改善人们的生活并实现引人注目的增长。我们凭借对免疫系统的深刻理解，研发能够治疗和保护全球数百万人的药物与疫苗，并通过创新的研发管线造福更多人群。我们的团队秉持一个使命：追逐科学奇迹以改善人们的生活；这激励我们不断推动进步，通过应对当今最紧迫的医疗、环境和社会挑战，为我们服务的员工和社区带来积极影响。

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

赛诺菲在 EURONEXT（欧洲证券交易所）上市，代码为 SAN；并在 NASDAQ（纳斯达克）上市，代码为 SNY。