COPENHAGEN, Denmark--(BUSINESS WIRE)--Genmab A/S (Nasdaq: GMAB) announced today new data from the Phase 1/2 study of rinatabart sesutecan (Rina-S), an investigational folate receptor-alpha (FRα)-targeted, Topo1 antibody-drug conjugate (ADC), demonstrated a confirmed objective response rate (ORR) of 50.0% (95% CI) in ovarian cancer patients treated with Rina-S 120 mg/m2 once every 3 weeks (Q3W), regardless of FRα expression levels.

丹麦哥本哈根--（商业新闻短讯）--Genmab A/S（纳斯达克：GMAB）今天宣布了来自rinatabart sesutecan（Rina-S）的1/2期研究的新数据，Rina-S是一种研究性叶酸受体α（FRα）靶向的Topo1抗体-药物偶联物（ADC），无论FRα表达水平如何，在每3周一次（Q3W）用Rina-S 120 mg/m2治疗的卵巢癌患者中，证实的客观缓解率（ORR）为50.0%（95%CI）。

These data were from the dose expansion part of a multi-part study evaluating the safety and efficacy of single-agent Rina-S in ovarian cancer (OC) and endometrial cancer (EC). These results, and additional findings from the study, were presented at the European Society of Medical Oncology Congress 2024 (ESMO) in Barcelona, Spain..

这些数据来自一项多部分研究的剂量扩展部分，该研究评估了单药Rina-S在卵巢癌（OC）和子宫内膜癌（EC）中的安全性和有效性。这些结果以及该研究的其他发现已在西班牙巴塞罗那举行的2024年欧洲医学肿瘤学会大会（ESMO）上发表。。

Part B of the study randomized 42 previously-treated patients with histologically or cytologically confirmed advanced OC (epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer) to Rina-S 100 mg/m2 (n=22) or Rina-S 120 mg/m2 (n=20). Ninety-five percent of patients in the 120 mg/m2 group were identified as platinum-resistant ovarian cancer (PROC) as were 90.9% of patients in the 100 mg/m2 group.

该研究的B部分将42名先前接受过组织学或细胞学证实的晚期OC（上皮性卵巢癌，原发性腹膜癌或输卵管癌）患者随机分为Rina-S 100 mg/m2（n=22）或Rina-S 120 mg/m2（n=20）。120 mg/m2组中95%的患者被确定为铂类耐药卵巢癌（PROC），100 mg/m2组中90.9%的患者被确定为铂类耐药卵巢癌。

In patients receiving Rina-S 100 mg/m2, results showed a confirmed ORR of 18.2% compared with 50.0% among patients receiving 120 mg/m2. Results for 100 mg/m2 and 120 mg/m2 respectively also included: complete response: 0 (0%) and 1 (5.6%); partial response in 4 (18.2%) and 8 patients (44.4%); stable disease in 15 (68.2%) and 7 patients (38.9%); disease progression in 3 patients (13.6%) and 1 patient (5.6%).

在接受Rina-S 100 mg/m2的患者中，结果显示确诊的ORR为18.2%，而接受120 mg/m2的患者为50.0%。100 mg/m2和120 mg/m2的结果还包括：完全缓解：0（0%）和1（5.6%）；部分缓解4例（18.2%）和8例（44.4%）；15例（68.2%）和7例（38.9%）病情稳定；3例患者（13.6%）和1例患者（5.6%）的疾病进展。

Only one patient in the 120 mg/m2 treatment arm was not evaluable. With a median on study follow-up of 24 weeks, all confirmed responses with the 120 mg/m2 dose were ongoing at the time of data cutoff. The disease control rate (DCR) was 86.4% and 88.9% (95% CI: 65.3-98.6), respectively. Based on these results, Rina-S 120 mg/m2 has been selected for further evaluation in a Phase 3 trial for patients with advanced ovarian cancer, which is expected to start in 2024..

120 mg/m2治疗组中只有一名患者无法评估。研究中位随访时间为24周，所有120 mg/m2剂量的确诊反应均在数据截止时进行。疾病控制率（DCR）分别为86.4%和88.9%（95%CI:65.3-98.6）。基于这些结果，Rina-S 120 mg/m2已被选择用于晚期卵巢癌患者的3期临床试验的进一步评估，该试验预计于2024年开始。。

'Ovarian cancer presents a significant challenge, especially for those with advanced or recurrent cases, where treatment options and prognosis are often limited,' said Elizabeth Lee, MD, a medical oncologist in the gynecologic oncology program at Dana-Farber. 'The encouraging Phase 1/2 data for Rina-S demonstrates the potential for future treatment options for patients.

达纳法伯妇科肿瘤学项目的医学肿瘤学家伊丽莎白·李（ElizabethLee）说：“卵巢癌是一个巨大的挑战，尤其是对于那些晚期或复发病例，治疗选择和预后往往有限的患者。”Rina-S令人鼓舞的1/2期数据显示了患者未来治疗选择的潜力。

We are looking forward to additional data from tumor-specific dose expansion cohorts.”.

我们期待着来自肿瘤特异性剂量扩展队列的更多数据。”。

In this Phase 1/2 study, common treatment-emergent adverse events (TEAEs) included anemia, neutropenia, nausea, thrombocytopenia, leukopenia, fatigue, vomiting, alopecia, and diarrhea. Dose reductions and treatment discontinuations were infrequent. No signals of ocular toxicities, neuropathy or interstitial lung disease (ILD) were observed..

在这项1/2期研究中，常见的治疗紧急不良事件（TEAE）包括贫血，中性粒细胞减少，恶心，血小板减少，白细胞减少，疲劳，呕吐，脱发和腹泻。剂量减少和治疗中断很少。没有观察到眼部毒性，神经病或间质性肺病（ILD）的信号。。

“We are encouraged by the data from this ongoing Phase 1/2 trial evaluating Rina-S in a patient population that is in need of new therapeutic options and believe the data support the potential for Rina-S to demonstrate anti-tumor activity beyond first-generation folate receptor-alpha based therapies,” said Jan van de Winkel, Ph.D., President and Chief Executive Officer of Genmab.

Genmab总裁兼首席执行官Jan van de Winkel博士说：“我们对正在进行的1/2期试验的数据感到鼓舞，该试验评估了需要新治疗选择的患者群体中的Rina-S，并相信这些数据支持Rina-S在第一代叶酸受体α疗法之外表现出抗肿瘤活性的潜力。”。

“Genmab is pioneering technologies that aim to transform the treatment of cancer and other serious diseases. We are committed to evaluating the full potential utility of Rina-S in patients with ovarian, endometrial and other solid tumor cancers.”.

“Genmab是旨在改变癌症和其他严重疾病治疗的开创性技术。我们致力于评估Rina-S在卵巢癌，子宫内膜癌和其他实体瘤癌症患者中的全部潜在效用。”。

About Rina-S Phase 1/2 Clinical Trial (NCT05579366)

关于Rina-S 1/2期临床试验（NCT05579366）

This open-label, multicenter Phase 1/2 study is designed to evaluate the safety and efficacy of rinatabart sesutecan (Rina-S) as a single agent Q3W at various doses in solid tumors that are known to express FRα. The study consists of multiple parts including Part A dose-escalation cohorts; Part B tumor-specific monotherapy dose-expansion cohorts; Part C platinum-resistant ovarian cancer (PROC) cohort; and Part D combination therapy cohorts..

这项开放标签的多中心1/2期研究旨在评估rinatabart sesutecan（Rina-S）作为单一药物Q3W在已知表达FRα的实体瘤中的安全性和有效性。该研究由多个部分组成，包括A部分剂量递增队列；B部分肿瘤特异性单药治疗剂量扩展队列；；和D部分联合治疗队列。。

Part A looked at dose escalation in patients with locally advanced and/or metastatic solid tumors, including epithelial ovarian cancer, endometrial cancer, breast cancer, non-small cell lung cancer, and mesothelioma. In patients with OC (n=32) and EC (n=11), treatment with Rina-S 100-120 mg/m2 (n=23 and n=5, respectively) demonstrated a confirmed Objective Response Rate (ORR) of 30.8% (95% CI: 14.3-51.8) with Partial Responses (PR) in 8 patients (30.8%), Stable Disease (SD) in 15 patients (57.7%), and Progressive Disease (PD) in 3 patients (11.5%).

A部分研究了局部晚期和/或转移性实体瘤患者的剂量递增，包括上皮性卵巢癌，子宫内膜癌，乳腺癌，非小细胞肺癌和间皮瘤。在OC（n=32）和EC（n=11）患者中，Rina-S 100-120 mg/m2（分别为n=23和n=5）治疗显示确诊客观缓解率（ORR）为30.8%（95%CI:14.3-51.8），部分缓解（PR）8例（30.8%），稳定疾病（SD）15例（57.7%），进展性疾病（PD）3例（11.5%）。

The Disease Control Rate (DCR) was 88.5% (95% CI: 69.8-97.6), and the median Duration of Response (DOR) was 35.3 weeks (95% CI: 20.14-NE)..

疾病控制率（DCR）为88.5%（95%CI:69.8-97.6），中位缓解期（DOR）为35.3周（95%CI:20.14-NE）。。

Part B includes the B1 cohort, which is a dose expansion study in patients with histologically or cytologically confirmed advanced OC (epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer). Patients were randomized 1:1 to 100 mg/m2 and 120 mg/m2 dose groups with a median age ranging from 62.5 to 64.5 years across both groups.

B部分包括B1队列，这是一项针对组织学或细胞学证实的晚期OC（上皮性卵巢癌，原发性腹膜癌或输卵管癌）患者的剂量扩展研究。患者被随机分为1:1至100 mg/m2和120 mg/m2剂量组，两组的中位年龄为62.5至64.5岁。

Ninety-point nine percent of patients in the 100 mg/m2 group were identified as platinum-resistant ovarian cancer (PROC) as were 95% of patients in the 120 mg/m2 group. Study participants were previously treated with a median of 3 prior lines of therapy (range 1-4) including bevacizumab (90.9% in the 100 mg/m2 group and 90.0% in the 120 mg/m2 group respectively), PARP inhibitors (68.2%; 65%) and mirvetuximab soravtansin (18.2%; 19%).

100 mg/m2组中有99.9%的患者被确定为铂类耐药卵巢癌（PROC），120 mg/m2组中有95%的患者被确定为铂类耐药卵巢癌（PROC）。研究参与者之前接受过3种治疗方案（范围1-4）的中位数治疗，包括贝伐单抗（100 mg/m2组为90.9%，120 mg/m2组为90.0%），PARP抑制剂（68.2%；65%）和mirvetuximab-soravtansin（18.2%；19%）。

Responses in patients with OC were observed across FRα expression levels..

。。

About Ovarian Cancer

关于卵巢癌

Ovarian cancer is a major global health issue, with over 320,000 new cases diagnosed annually worldwide.i It ranks as the eighth most common cancer and the eighth leading cause of cancer-related deaths among women globally.ii The disease is often diagnosed at an advanced stage due to its subtle and non-specific symptoms, such as abdominal bloating, pelvic pain and difficulty eating.iii Platinum-based chemotherapy, often in combination with targeted therapies and surgery, has been the standard treatment in ovarian cancer across all stages.iv,v Approximately 70-90% of women with advanced-stage ovarian cancer worldwide experience a recurrence after initial treatment.vi Ovarian cancer has a low five-year survival rate, which varies significantly by region, but generally hovers around 30-50%.vii,viii.

卵巢癌是一个重大的全球健康问题，全世界每年诊断出32万多例新病例。i它是全球女性中第八大最常见的癌症，也是导致癌症相关死亡的第八大主要原因。ii由于其微妙且非特异性的症状，例如腹胀，骨盆疼痛和进食困难，该疾病通常被诊断为晚期。iii铂类化疗通常与靶向治疗和手术相结合，已成为卵巢癌各个阶段的标准治疗方法。iv，v全世界约70-90%的晚期卵巢癌女性在初次治疗后复发。vi卵巢癌的五年生存率较低，因地区而异，但通常徘徊在30-50左右七、八。

About Rinatabart Sesutecan (Rina-S; GEN1184)

关于Rinatabart Sesutecan（Rina-S；GEN1184）

Rinatabart Sesutecan (Rina-S; GEN1184) is a clinical-stage, FRα-targeted, Topo1 ADC, currently in Phase 2 development for the treatment of ovarian cancer and other FRα-expressing solid tumors. Based on the data from the ongoing clinical trials, Genmab intends to broaden the development plans for Rina-S within ovarian cancer and other FRα-expressing solid tumors.

Rinatabart Sesutecan（Rina-S；GEN1184）是一个临床阶段，以FRα为靶点的Topo1 ADC，目前处于第二阶段，用于治疗卵巢癌和其他表达FRα的实体瘤。根据正在进行的临床试验的数据，Genmab打算扩大卵巢癌和其他表达FRα的实体瘤中Rina-S的开发计划。

In January 2024, the U.S. Food and Drug Administration granted Fast Track designation to Rina-S for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer..

。。

About Genmab

关于Genmab

Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies.

Genmab是一家国际生物技术公司，其核心目的是指导其不可阻挡的团队努力改善创新和分化抗体治疗患者的生活。25年来，其充满激情，创新和合作的团队发明了下一代抗体技术平台，并利用了翻译，定量和数据科学，形成了一条专有的管道，包括双特异性T细胞参与者，抗体-药物偶联物，下一代免疫检查点调节剂和效应功能增强的抗体。

By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO®) antibody medicines..

到2030年，Genmab的愿景是通过脱胎换骨（KYSO®）抗体药物改变癌症和其他严重疾病患者的生活。。

Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

Genmab成立于1999年，总部位于丹麦哥本哈根，国际业务遍及北美、欧洲和亚太地区。有关更多信息，请访问Genmab.com，并在LinkedIn和X上关注我们。

This Media Release contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements.

本媒体发布包含前瞻性声明。“相信”、“期望”、“预期”、“打算”和“计划”等词语以及类似的表达方式代表了前瞻性陈述。实际结果或表现可能与此类声明明示或暗示的任何未来结果或表现存在重大差异。

The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors.

可能导致我们的实际结果或表现产生重大差异的重要因素包括，与产品的临床前和临床开发相关的风险，与临床试验结果和进行相关的不确定性，包括不可预见的安全问题，与产品制造相关的不确定性，我们的产品缺乏市场接受度，我们无法管理增长，与我们的业务领域和市场相关的竞争环境，我们无法吸引和留住合适的合格人员，我们的专利和专有权利不可执行或缺乏保护，我们与附属实体的关系，可能导致我们的产品或技术过时的技术变化和发展，以及其他因素。

For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov.

有关这些风险的进一步讨论，请参阅Genmab最新财务报告中的风险管理部分（可在www.Genmab.com上找到），以及Genmab最新年度报告（表20-F）中包含的风险因素以及向美国证券交易委员会（SEC）提交的其他文件（可在www.SEC.gov上找到）。

Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law..

除非法律要求，否则Genmab没有义务更新或修改本媒体发布中的前瞻性声明，也没有义务确认这些声明以反映制定日期后的后续事件或情况或与实际结果相关的情况。。

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO®.

Genmab A/S和/或其子公司拥有以下商标：Genmab®；Y形Genmab徽标®；Genmab结合Y形Genmab徽标®；HuMax®；；HexaBody®；DuoHexaBody®、HexElect®和KYSO®。

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i World Cancer Research Fund International. https://www.wcrf.org/cancer-trends/ovarian-cancer-statistics/. Accessed August 2024.

i世界癌症研究基金会国际。https://www.wcrf.org/cancer-trends/ovarian-cancer-statistics/.2024年8月访问。

ii World Ovarian Cancer Coalition. https://worldovariancancercoalition.org/about-ovarian-cancer/key-stats/. Accessed August 2024.

ii世界卵巢癌联盟。https://worldovariancancercoalition.org/about-ovarian-cancer/key-stats/.2024年8月访问。

iii Dilley, James et al. Ovarian cancer symptoms, routes to diagnosis and survival - Population cohort study in the 'no screen' arm of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Gynecologic oncology vol. 158,2 (2020): 316-322. doi:10.1016/j.ygyno.2020.05.002.

iii Dilley，James等人，《卵巢癌症状，诊断和生存途径-英国卵巢癌筛查合作试验（UKCTOCS）“无筛查”部门的人群队列研究》。妇科肿瘤学第158,2卷（2020）：316-322。doi:10.1016/j.ygyno.2020.05.002。

iv Ovarian Cancer Research Alliance. https://ocrahope.org/patients/diagnosis-and-treatment/treatment-options/chemotherapy/. Accessed August 2024.

iv卵巢癌研究联盟。https://ocrahope.org/patients/diagnosis-and-treatment/treatment-options/chemotherapy/.2024年8月访问。

v American Cancer Society. https://www.cancer.org/cancer/types/ovarian-cancer/treating.html. Accessed August 2024.

v美国癌症协会。https://www.cancer.org/cancer/types/ovarian-cancer/treating.html.2024年8月访问。

vi Ovarian Cancer Research Alliance. https://ocrahope.org/patients/diagnosis-and-treatment/recurrence/.

vi卵巢癌研究联盟。https://ocrahope.org/patients/diagnosis-and-treatment/recurrence/.

vii European Institute of Women's Health. https://eurohealth.ie/policy‐brief‐women‐and‐ovarian‐cancer‐in‐the‐eu‐2018/. Accessed August 2024.

欧洲妇女健康研究所。https://eurohealth.ie/policy-妇女和卵巢癌简报2018年4月。2024年8月访问。

viii American Cancer Society. Stages of Ovarian Cancer. https://www.cancer.org/cancer/types/ovarian-cancer/detection-diagnosis-staging/survival-rates.html. Accessed August 2024.

viii美国癌症协会。卵巢癌的阶段。https://www.cancer.org/cancer/types/ovarian-cancer/detection-diagnosis-staging/survival-rates.html.2024年8月访问。