GSK plc (LSE/NYSE: GSK) today announced headline results from the FIRST-ENGOT-OV44 phase III trial evaluating Zejula (niraparib) and Jemperli (dostarlimab) in first line advanced ovarian cancer. The trial met its primary endpoint of PFS demonstrating a statistically significant difference with the addition of dostarlimab to both standard of care carboplatin-paclitaxel chemotherapy and niraparib maintenance, with or without bevacizumab..

葛兰素史克股份有限公司（伦敦证交所/纽约证交所：葛兰素史克）今天宣布了第一项ENGOT-OV44 III期临床试验的主要结果，该试验评估了Zejula（niraparib）和Jemperli（dostarlimab）治疗一线晚期卵巢癌。该试验达到了PFS的主要终点，表明在有或没有贝伐单抗的情况下，在卡铂-紫杉醇化疗和尼拉帕利维持治疗的标准治疗中加入dostarlimab有统计学意义上的显着差异。。

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “As part of our focus in gynaecological cancers, we continue to evaluate the potential of this combination and look forward to sharing full results from the trial.”

葛兰素史克公司研发全球肿瘤学负责人高级副总裁Hesham Abdullah表示：“作为我们关注妇科癌症的一部分，我们将继续评估这种组合的潜力，并期待分享试验的全部结果。”

The key secondary endpoint of overall survival (OS) did not meet statistical significance. Further analyses are ongoing and data will be shared with health authorities and presented at an upcoming scientific meeting.

总生存期（OS）的关键次要终点未达到统计学显着性。进一步的分析正在进行中，数据将与卫生部门共享，并在即将举行的科学会议上提交。

The safety and tolerability profile was generally consistent with the known safety profiles of the individual agents.

安全性和耐受性概况通常与个体药物的已知安全性概况一致。

About ovarian cancer

关于卵巢癌

Ovarian cancer is the eighth most common cancer in women worldwide.1 Despite high response rates to platinum-based chemotherapy in the first-line setting, approximately 85% of patients will experience disease recurrence. Once the disease recurs, it is rarely curable, with decreasing time intervals to each subsequent recurrence.2.

卵巢癌是全球女性中第八大最常见的癌症。尽管在一线治疗中铂类化疗的反应率很高，但大约85%的患者会出现疾病复发。一旦疾病复发，它很难治愈，每次复发的时间间隔缩短。

About the FIRST trial

关于第一次审判

The FIRST-ENGOT-OV44 trial is an international, double-blind, randomised phase III ENGOT trial sponsored by GSK and led by GINECO, a French cooperative group dedicated to gynecological oncology. FIRST is investigating the addition of dostarlimab to both, standard of care (SOC) platinum-based chemotherapy and niraparib maintenance, with or without bevacizumab, as a first-line treatment of stage III or IV nonmucinous epithelial ovarian cancer.

FIRST-ENGOT-OV44试验是一项由GSK赞助的国际双盲随机III期ENGOT试验，由法国妇科肿瘤学合作组织GINECO领导。首先是研究在有或没有贝伐单抗的情况下，将dostarlimab添加到标准治疗（SOC）铂类化疗和尼拉帕利维持治疗中，作为III期或IV期非粘液性上皮性卵巢癌的一线治疗。

Originally, participants were randomised 1:1:2 into three groups: Arm 1: SOC chemotherapy followed by placebo maintenance; Arm 2: SOC chemotherapy followed by niraparib maintenance; Arm 3: SOC chemotherapy and dostarlimab followed by niraparib and dostarlimab maintenance. Bevacizumab could be added at the investigator’s discretion across all arms.

最初，参与者以1:1:2的比例随机分为三组：第1组：SOC化疗，然后维持安慰剂；第2组：SOC化疗，然后维持尼拉帕利；第3组：SOC化疗和dostarlimab，然后是niraparib和dostarlimab维持。贝伐单抗可以由研究者自行决定添加到所有武器中。

Due to the approvals of PARP inhibitors in the first-line setting, Arm 1 (n=193) was closed and participants were subsequently randomized 1:2 to Arms 2 (n= 385) and 3 (n= 753) only. The primary endpoint is investigator-assessed PFS in Arms 2 and 3. Secondary endpoints include OS, PFS2, time to first and second subsequent therapy..

由于PARP抑制剂在一线环境中的批准，第1组（n=193）被关闭，参与者随后以1:2的比例随机分配到第2组（n=385）和第3组（n=753）。主要终点是研究者评估的第2组和第3组的PFS。次要终点包括OS，PFS2，第一次和第二次后续治疗的时间。。

ABOUT GINECO3

关于GINECO3

GINECO (Groupe d’Investigateurs National pour l’Etude des Cancers de l’Ovaire et du sein) is the French Cooperative Group in Oncology labelled by INCa (Institut National du Cancer or French NCI) developing and conducting gynecological and metastatic breast cancer clinical trials at the national and international level.

GINECO（国家癌症研究小组）是由INCa（国家癌症研究所或法国NCI）标记的法国肿瘤学合作小组，在国家和国际层面开发和进行妇科和转移性乳腺癌临床试验。

The GINECO group was founded in 1993 and is member of international consortia such as ENGOT and GCIG (Gynecologic Cancer InterGroup)..

GINECO集团成立于1993年，是ENGOT和GCIG（妇科癌症集团）等国际财团的成员。。

About ENGOT4

关于ENGOT4

The European Network for Gynaecological Oncological Trial (ENGOT) groups is a research network of the European Society of Gynaecological Oncology and was founded in Berlin in October 2007. Currently, ENGOT consists of 21 trial groups from 31 European countries that perform cooperative clinical trials.

欧洲妇科肿瘤试验网络（ENGOT）小组是欧洲妇科肿瘤学会的一个研究网络，于2007年10月在柏林成立。目前，ENGOT由来自31个欧洲国家的21个试验组组成，这些试验组进行合作临床试验。

ENGOT’s ultimate goal is to bring the best treatment to gynaecological cancer patients through the best science and enabling every patient in every European country to access a clinical trial..

ENGOT的最终目标是通过最好的科学为妇科癌症患者带来最好的治疗，并使每个欧洲国家的每位患者都能获得临床试验。。

About Jemperli (dostarlimab)

关于詹培利（陀思妥利单抗）

Jemperli, a programmed death receptor-1 (PD-1)-blocking antibody, is the backbone of GSK’s ongoing immuno-oncology-based research and development prgramme. A robust clinical trial programme includes studies of Jemperli alone and in combination with other therapies for gynaecologic, colorectal and lung cancers, as well as where there are 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。一个强大的临床试验计划包括单独研究Jemperli，并与其他治疗妇科，结直肠癌和肺癌的疗法相结合，以及有机会取得变革性结果的研究。。

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. This includes patients with mismatch repair proficient/microsatellite stable (MMRp/MSS) and dMMR/MSI-H tumours.

在美国，Jemperli与卡铂和紫杉醇联合使用，其次是Jemperli作为单一药物治疗成人原发性晚期或复发性子宫内膜癌患者。这包括错配修复熟练/微卫星稳定（MMRp/MSS）和dMMR/MSI-H肿瘤的患者。

Jemperli is also approved 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.

Jemperli也被批准作为dMMR复发或晚期子宫内膜癌成年患者的单一药物，这是由美国FDA批准的测试确定的，该药物在任何情况下都在先前的含铂方案上或之后取得了进展，并且不适合进行根治性手术或放疗。

Additionally, Jemperli is 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. The latter indication is approved in the US under accelerated approval based on tumour response rate and durability of response.

此外，根据美国FDA批准的测试，Jemperli在美国适用于dMMR复发或晚期实体瘤患者，这些患者在之前的治疗或之后取得了进展，并且没有令人满意的替代治疗选择。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。

Continued approval for this indication in solid tumours may be contingent upon verification and description of clinical benefit in a confirmatory trial(s)..

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是由AnaptysBio，Inc.发现的，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。。

Important Information for Jemperli in the EU

关于欧盟境内 Jemperli 的重要信息

Indications

适应症

Jemperli is indicated:

指示 Jemperli：

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

与卡铂-紫杉醇联合用于治疗错配修复缺陷型（dMMR）/微卫星不稳定性高（MSI-H）原发性晚期或复发性子宫内膜癌的成年患者，这些患者是全身治疗的候选者；

as monotherapy for treating adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.

作为单一疗法，用于治疗错配修复缺陷型（dMMR）/微卫星不稳定性高（MSI-H）复发或晚期子宫内膜癌的成年患者，这些患者在先前使用含铂方案治疗时或之后已经进展。

About Zejula (niraparib)

关于Zejula（niraparib）

Zejula is an oral, once-daily Poly (ADP-ribose) polymerase (PARP) inhibitor indicated in the US for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy; and for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy and who have been selected based on a US FDA-approved companion diagnostic for Zejula..

Zejula是一种口服，每日一次的聚（ADP-核糖）聚合酶（PARP）抑制剂，在美国用于维持治疗晚期上皮性卵巢癌，输卵管癌或原发性腹膜癌的成年患者，这些患者对一线铂类化疗有完全或部分反应；以及对患有有害或疑似有害生殖系BRCA突变的复发性上皮性卵巢癌，输卵管癌或原发性腹膜癌的成年患者进行维持治疗，这些患者对铂类化疗完全或部分有反应，并且是根据美国FDA批准的Zejula伴随诊断选择的。。

Zejula is indicated:

Zejula表示：

as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

作为维持治疗晚期上皮性（FIGO III期和IV期）高级卵巢癌，输卵管癌或原发性腹膜癌的成年患者的单一疗法，这些患者在完成一线铂类化疗后有反应（完全或部分）。

as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

作为维持治疗铂类敏感复发的高级浆液性上皮性卵巢癌，输卵管癌或原发性腹膜癌的成年患者的单一疗法，这些患者对铂类化疗有反应（完全或部分）。

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 in immuno-oncology and tumour-cell targeting therapies.

肿瘤学是GSK的一个新兴治疗领域，我们致力于通过免疫肿瘤学和肿瘤细胞靶向治疗的突破，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。更多信息请访问gsk.com。