GSK plc (LSE/NYSE: GSK) today announced the European Medicines Agency (EMA) has accepted its application to expand the use of Jemperli (dostarlimab) in combination with standard-of-care chemotherapy (carboplatin and paclitaxel) to all adult patients with primary advanced or recurrent endometrial cancer.

葛兰素史克股份有限公司（LSE/NYSE:GSK）今天宣布，欧洲药品管理局（EMA）已接受其申请，将Jemperli（dostarlimab）与标准化疗（卡铂和紫杉醇）联合应用于所有成年原发性晚期或复发性子宫内膜癌患者。

The EMA’s Committee for Medicinal Products for Human Use will begin the formal review process to make a recommendation to the European Commission, with approval expected in H1 2025..

欧洲药品管理局（EMA）的人用医药产品委员会将启动正式审查程序，向欧盟委员会提出建议，预计将于 2025 年上半年获得批准。

Currently, in the EU, Jemperli in combination with carboplatin and paclitaxel is approved for the treatment of adult patients who are candidates for systemic therapy with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H).

目前，在欧盟，Jemperli联合卡铂和紫杉醇被批准用于治疗成人患者，这些患者是系统治疗失配修复缺陷（dMMR）或微卫星不稳定性高（MSI-H）的原发性晚期或复发性子宫内膜癌的候选者。

If this new application is approved, dostarlimab would be expanded to all patients with primary advanced or recurrent endometrial cancer, regardless of their biomarker type, including those with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours where currently there are no approved frontline immuno-therapy-based treatments in the EU..

如果这项新应用获得批准，dostarlimab将扩展到所有原发性晚期或复发性子宫内膜癌患者，无论其生物标志物类型如何，包括那些错配修复熟练（MMRp）/微卫星稳定（MSS）肿瘤的患者，目前欧盟还没有批准的基于一线免疫治疗的治疗方法。。

The application is based on results from Part 1 of the RUBY phase III trial. The trial met its primary endpoints of investigator-assessed progression-free survival (PFS) and overall survival (OS), demonstrating a statistically significant and clinically meaningful benefit in the overall population of patients treated with dostarlimab plus carboplatin-paclitaxel versus chemotherapy alone.

该应用程序基于RUBY III期试验第1部分的结果。该试验达到了研究者评估的无进展生存期（PFS）和总生存期（OS）的主要终点，证明了与单独化疗相比，用dostarlimab加卡铂-紫杉醇治疗的患者总体人群具有统计学意义和临床意义。

RUBY Part 1 is the only clinical trial to show a statistically significant overall survival benefit in this patient population. The safety and tolerability analyses from RUBY showed a safety profile for dostarlimab plus carboplatin-paclitaxel that was generally consistent with the known safety profiles of the individual agents..

。RUBY的安全性和耐受性分析显示，dostarlimab加卡铂-紫杉醇的安全性与个体药物的已知安全性基本一致。。

OS data were presented at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer on 16 March 2024, and were published in Annals of Oncology on 9 June 2024.

OS数据于2024年3月16日在妇科肿瘤学会女性癌症年会上发表，并于2024年6月9日发表在《肿瘤学年鉴》上。

About endometrial cancer

关于子宫内膜癌

Endometrial cancer is found in the inner lining of the uterus, known as the endometrium. Endometrial cancer is the most common gynaecologic cancer in developed countries, with approximately 417,000 new cases reported each year worldwide1, and incidence rates are expected to rise by almost 40% between 2020 and 2040.2,3 In Europe, approximately 121,000 people are estimated to be diagnosed with primary advanced or recurrent endometrial cancer each year.4 Approximately 15-20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis.5 Among patients with primary advanced or recurrent endometrial cancer, approximately 70-75% have MMRp/MSS tumours.6.

子宫内膜癌发现于子宫内膜，称为子宫内膜。子宫内膜癌是发达国家最常见的妇科癌症，全球每年报告约417000例新病例1，2020年至2040年发病率预计将上升近40%.2,3在欧洲，估计约有121000人每年被诊断为原发性晚期或复发性子宫内膜癌[4]。大约15-20%的子宫内膜癌患者在诊断时将被诊断为晚期疾病[5]。在原发性晚期或复发性子宫内膜癌患者中，约70-75%患有MMRp/MSS肿瘤[6]。

About RUBY

关于RUBY

RUBY is a two-part global, randomised, double-blind, multicentre phase III trial of patients with primary advanced or recurrent endometrial cancer. Part 1 is evaluating dostarlimab plus carboplatin-paclitaxel followed by dostarlimab versus carboplatin-paclitaxel plus placebo followed by placebo. Part 2 is evaluating dostarlimab plus carboplatin-paclitaxel followed by dostarlimab plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo.

RUBY是一项针对原发性晚期或复发性子宫内膜癌患者的两部分全球，随机，双盲，多中心III期临床试验。第1部分是评估dostarlimab加卡铂-紫杉醇，然后是dostarlimab与卡铂-紫杉醇加安慰剂，然后是安慰剂。第2部分是评估dostarlimab加卡铂-紫杉醇，然后是dostarlimab加niraparib与安慰剂加卡铂-紫杉醇，然后是安慰剂。

In Part 1, the dual-primary endpoints are investigator-assessed PFS based on the Response Evaluation Criteria in Solid Tumours v1.1 and OS. The statistical analysis plan included pre-specified analyses of PFS in the dMMR/MSI-H and overall populations and OS in the overall population. Pre-specified exploratory analyses of PFS and OS in the MMRp/MSS population and OS in the dMMR/MSI-H populations were also performed.

在第1部分中，双重主要终点是基于实体瘤v1.1和OS中的反应评估标准的研究者评估的PFS。统计分析计划包括对dMMR/MSI-H中PFS以及总体人群和总体人群中OS的预先指定分析。还对MMRp/MSS人群中的PFS和OS以及dMMR/MSI-H人群中的OS进行了预先指定的探索性分析。

RUBY Part 1 included a broad population, including histologies often excluded from clinical trials and had approximately 10% of patients with carcinosarcoma and 20% with serous carcinoma. .

RUBY第1部分包括广泛的人群，包括通常被排除在临床试验之外的组织学，大约有10%的癌肉瘤患者和20%的浆液性癌患者。

In Part 2, the primary endpoint is investigator-assessed PFS in the overall population, followed by PFS in the MMRp/MSS population, and OS in the overall population is a key secondary endpoint. Additional secondary endpoints in Part 1 and Part 2 include PFS per blinded independent central review, PFS2, overall response rate, duration of response, disease control rate, patient-reported outcomes, and safety and tolerability.

在第2部分中，主要终点是总体人群中研究者评估的PFS，其次是MMRp/MSS人群中的PFS，总体人群中的OS是关键的次要终点。第1部分和第2部分的其他次要终点包括每个盲法独立中央审查的PFS，PFS2，总体缓解率，缓解持续时间，疾病控制率，患者报告的结果以及安全性和耐受性。

RUBY is part of an international collaboration between the European Network of Gynaecological Oncological Trial groups (ENGOT), a research network of the European Society of Gynaecological Oncology (ESGO) that consists of 22 trial groups from 31 European countries that perform cooperative clinical trials, and the GOG Foundation, a non-profit organisation dedicated to transforming the standard of care in gynaecologic oncology..

RUBY是欧洲妇科肿瘤试验小组网络（ENGOT）和GOG基金会（一个致力于改变妇科肿瘤护理标准的非营利组织）之间国际合作的一部分。ENGOT是欧洲妇科肿瘤学会（ESGO）的一个研究网络，由来自31个欧洲国家的22个进行合作临床试验的试验小组组成。。

About Jemperli (dostarlimab)

关于[UNK][UNK]Jemperli[UNK]（dostallimab）

Jemperli, a programmed death receptor-1 (PD-1)-blocking antibody, is the backbone of GSK’s ongoing immuno-oncology-based research and development programme. A robust clinical trial programme includes studies of Jemperli alone and in combination with other therapies in gynaecologic, colorectal and lung cancers, as well as where there are other opportunities for transformational outcomes.

Jemperli是一种程序性死亡受体-1（PD-1）阻断抗体，是GSK正在进行的基于免疫肿瘤学的研究和开发计划的骨干。一项强有力的临床试验计划包括单独研究Jemperli，并与妇科，结直肠癌和肺癌的其他疗法相结合，以及在有其他机会取得变革性结果的地方。

It was the first immuno-oncology treatment approved, in combination with chemotherapy, in the frontline setting for primary advanced or recurrent dMMR/MSI-H endometrial cancer..

这是在原发性晚期或复发性dMMR/MSI-H子宫内膜癌的一线治疗中，首次批准与化疗联合使用的免疫肿瘤学治疗。。

In the US, Jemperli is indicated in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is dMMR, as determined by a US FDA-approved test, or MSI-H, and as a single agent for adult patients with dMMR recurrent or advanced endometrial cancer, as determined by a US FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.

在美国，Jemperli与卡铂和紫杉醇联合使用，其次是Jemperli作为单一药物，用于治疗成人原发性晚期或复发性子宫内膜癌，即dMMR，由美国FDA批准的测试或MSI-H确定，并且作为dMMR复发或晚期子宫内膜癌成人患者的单一药物，由美国FDA批准的测试确定，在任何情况下都已经在先前的含铂方案上或之后取得进展，并且不适合进行根治性手术或放疗。

The sBLA supporting this indication in combination with carboplatin and paclitaxel for dMMR/MSI-H primary advanced or recurrent endometrial cancer received Breakthrough Therapy designation and Priority Review from the US FDA. Jemperli is also indicated in the US for patients with dMMR recurrent or advanced solid tumours, as determined by a US FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.

支持该适应症的sBLA联合卡铂和紫杉醇治疗dMMR/MSI-H原发性晚期或复发性子宫内膜癌，获得了美国FDA的突破性治疗指定和优先审查。Jemperli在美国也适用于dMMR复发或晚期实体瘤患者，这是由美国FDA批准的测试确定的，这些患者在之前的治疗或之后已经取得进展，并且没有令人满意的替代治疗选择。

The latter indication is approved in the US under accelerated approval based on tumour response rate and durability of response. Continued approval for this indication in solid tumours may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). .

后一种适应症在美国根据肿瘤反应率和反应持久性加速批准。在实体瘤中继续批准这种适应症可能取决于验证性试验中临床益处的验证和描述。。

Jemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., under a collaboration and exclusive license agreement signed in March 2014. Under this agreement, GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of Jemperli, and cobolimab (GSK4069889), a TIM-3 antagonist. .

Jemperli‡由AnaptysBio，Inc.发现，并根据2014年3月签署的合作和独家许可协议授权给TESARO，Inc。根据该协议，GSK负责Jemperli和TIM-3拮抗剂cobolimab（GSK4069889）的持续研究，开发，商业化和制造。。

GSK in oncology

葛兰素史克与肿瘤学

Oncology is an emerging therapeutic area for GSK where we are committed to maximising patient survival with a current focus on haematologic malignancies, gynaecologic cancers and other solid tumours through breakthroughs immune-oncology and tumour-cell targeting therapies.

肿瘤学是GSK的一个新兴治疗领域，我们致力于通过突破免疫肿瘤学和肿瘤细胞靶向疗法，最大限度地提高患者的生存率，目前专注于血液系统恶性肿瘤，妇科癌症和其他实体瘤。

About GSK

GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

葛兰素史克是一家全球性生物制药公司，旨在将科学、技术和人才团结起来，共同战胜疾病。。