研究性药物Rinatabart Sesutecan（Rina-S®）在晚期卵巢癌患者中继续显示出令人鼓舞的抗肿瘤活性-动脉网

Investigational Rinatabart Sesutecan (Rina-S®) Continues to Show Encouraging Antitumor Activity in Patients with Advanced Ovarian Cancer

GlobeNewswire 等信源发布 2025-03-17 12:19

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Media Release

新闻稿

COPENHAGEN, Denmark; March 17, 2025

丹麦哥本哈根；2025年3月17日

Results from Phase 2 RAINFOL

RAINFOL第二阶段结果

商标

-01 trial (B1 cohort) showed that with a median on-study follow-up of 48 weeks, Rina-S 120 mg/m

-01试验（B1队列）显示，在中位随访48周的情况下，Rina-S 120 mg/m

led to a confirmed objective response rate (ORR) of 55.6% and median duration of response (mDOR) was not reached

导致确认的客观缓解率（ORR）为55.6%，中位缓解持续时间（mDOR）尚未达到。

Phase 2 RAINFOL

第二阶段 RAINFOL

商标

-01 and Phase 3 RAINFOL

-01 和第三阶段 RAINFOL

商标

-02 trials evaluating the safety and efficacy of Rina-S at 120 mg/m

-02 项评估 Rina-S 在 120 mg/m 剂量下的安全性和有效性试验

in patients with platinum resistant ovarian cancer (PROC) are actively recruiting

在招募对铂类耐药的卵巢癌（PROC）患者方面非常积极。

Genmab A/S

(Nasdaq:

（纳斯达克：

GMAB

)

announced today updated data from cohort B1 of the Phase 1/2 RAINFOL-01 study of rinatabart sesutecan (Rina-S

今天公布了来自1/2期RAINFOL-01研究的B1队列的更新数据，研究药物为利那巴特塞苏替坎（Rina-S）。

), an investigational folate receptor-alpha (FRα)-targeted, TOPO1 antibody-drug conjugate (ADC) that showed Rina-S 120 mg/m

），一种研究性的叶酸受体α（FRα）靶向、TOPO1抗体药物偶联物（ADC），展示了Rina-S 120 mg/m

every 3 weeks (Q3W) resulted in a confirmed objective response rate (ORR) of 55.6% (95% CI: 30.8-78.5) in heavily pre-treated ovarian cancer (OC) patients regardless of FRα expression levels. With a median on-study follow-up of 48 weeks, 1 out of 10 patients experienced disease progression and the median duration of response (mDOR) was not reached (95% CI: 40.14-NR).

每3周一次（Q3W）的治疗在经过多线治疗的卵巢癌（OC）患者中，无论FRα表达水平如何，均获得了55.6%（95% CI：30.8-78.5）的确证客观缓解率（ORR）。在中位随访时间为48周时，10例患者中有1例出现疾病进展，中位缓解持续时间（mDOR）尚未达到（95% CI：40.14-NR）。

The data are from the dose expansion cohort of the multi-part study evaluating the safety and efficacy of Rina-S as a single agent in solid tumors that are known to express FRα and were presented at the 2025 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer.

这些数据来自评估Rina-S单药治疗已知表达FRα的实体瘤的安全性和有效性的多部分研究的剂量扩展队列，并在2025年妇科肿瘤学会女性癌症年会上公布。

(SGO) in Seattle, Washington.

华盛顿州西雅图的（SGO）。

“The antitumor activity observed in the dose expansion cohort continues to demonstrate the potential for a much-needed treatment option for patients with PROC, who have historically had poor prognosis. I am hopeful that further exploration of Rina-S will lead to advancements in the treatment landscape.” said Elizabeth Lee, M.D., a medical oncologist in the gynecologic oncology program at Dana-Farber. .

“剂量扩展队列中观察到的抗肿瘤活性继续表明，对于历史上预后较差的PROC患者而言，这种治疗选择具有巨大的潜力。我希望对Rina-S的进一步探索能够推动治疗领域的进展。”达纳-法伯妇科肿瘤项目中的医学肿瘤学家Elizabeth Lee博士表示。

The B1 cohort is a dose expansion study in patients with histologically or cytologically confirmed advanced OC (epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer). Rina-S 120 mg/m

B1队列是一项针对经组织学或细胞学确认的晚期卵巢癌（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。Rina-S 120 mg/m

Q3W at a median on-study follow-up of 48 weeks showed encouraging antitumor activity; the confirmed ORR was 55.6% (95% CI: 30.8-78.5), the disease control rate (DCR) was 88.9% (95% CI: 65.3-98.6), and the median duration of response (mDOR) was not reached (95% CI: 40.14-NR). In the 18 patients evaluable for response treated with 120 mg/m.

在中位随访 48 周时，Q3W 显示出令人鼓舞的抗肿瘤活性；确认的客观缓解率（ORR）为 55.6%（95% 置信区间：30.8-78.5），疾病控制率（DCR）为 88.9%（95% 置信区间：65.3-98.6），中位缓解持续时间（mDOR）未达到（95% 置信区间：40.14-未达到）。在 18 例可评估疗效且接受 120 mg/m 治疗的患者中。

Q3W, complete responses were observed in 4 patients (2 confirmed; 2 unconfirmed) and 8 patients experienced confirmed partial responses (44.4%). Most responses with Rina-S 120 mg/m

Q3W，4名患者出现完全缓解（2名确认；2名未确认），8名患者出现确认的部分缓解（44.4%）。大多数使用Rina-S 120 mg/m的反应

were observed early (at week 6). Only one patient in the 120 mg/m

早期（第6周）被观察到。120 mg/m剂量组中只有一名患者

treatment arm was not evaluable. In the Rina-S 100 mg/m

治疗组无法评估。在Rina-S 100 mg/m中

Q3W treatment arm (N=22), at a median on study follow-up of 46 weeks, the confirmed ORR was 22.7% (95% CI: 7.8-45.4), the DCR was 86.4% (95% CI: 65.1-97.1), and the mDOR was not reached (95% CI, 16.3-NR). Partial responses were observed in 4 patients (18.2%) and 1 patient (4.5%) experienced a complete response.

Q3W治疗组（N=22），在中位随访时间为46周时，确认的客观缓解率（ORR）为22.7%（95%置信区间：7.8-45.4），疾病控制率（DCR）为86.4%（95%置信区间：65.1-97.1），中位缓解持续时间（mDOR）未达到（95%置信区间：16.3-未达到）。4例患者（18.2%）出现部分缓解，1例患者（4.5%）出现完全缓解。

Rina-S 120 mg/m.

利纳-S 120 毫克/米。

has been selected for further evaluation in the RAINFOL-01 and Phase 3 RAINFOL-02 trials for patients with platinum resistant ovarian cancer (PROC).

已被选中在RAINFOR-01和第三阶段的RAINFOR-02试验中进行进一步评估，用于治疗铂类耐药性卵巢癌（PROC）患者。

In this Phase 1/2 study, common treatment-emergent adverse events (TEAEs) included anemia, nausea, neutropenia, leukopenia, fatigue, thrombocytopenia, vomiting, diarrhea, alopecia, and hypokalemia. Dose reductions and treatment discontinuations were infrequent and no new safety signals were observed..

在这一 I/II 期研究中，常见的治疗中出现的不良事件 (TEAE) 包括贫血、恶心、中性粒细胞减少、白细胞减少、疲劳、血小板减少、呕吐、腹泻、脱发和低钾血症。剂量减少和治疗中断的情况很少见，且未观察到新的安全性信号。

“The updated results reinforce the potential of Rina-S and further validate our development approach in advanced ovarian cancer,” said Judith Klimovsky, M.D., Executive Vice President and Chief Development Officer of Genmab. “We are excited to keep moving forward with the ongoing Phase 3 trial, to evaluate the potential of Rina-S as a treatment option for patients facing this challenging disease.”.

“更新的结果进一步证实了Rina-S的潜力，并进一步验证了我们在晚期卵巢癌中的开发方法，”Genmab执行副总裁兼首席开发官Judith Klimovsky博士表示。“我们很高兴继续推进正在进行的III期试验，以评估Rina-S作为治疗这种具有挑战性疾病的患者的一种选择的潜力。”

The safety and efficacy of rinatabart sesutecan has not been established for these investigational uses.

Rinatabart sesutecan 的安全性和有效性在这些研究性用途中尚未得到证实。

About the RAINFOL

关于RAINFOL

商标符号（™）

-01 Trial

-01 试验

RAINFOL-01 (

NCT05579366

) is an open-label, multicenter Phase 1/2 study, 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..

）是一项开放标签、多中心的1/2期研究，旨在评估Rinatabart Sesutecan（Rina-S）作为单一药物每三周一次在不同剂量下对已知表达FRα的实体瘤的安全性和有效性。该研究包括多个部分：A部分为剂量递增队列；B部分为针对特定肿瘤的单药治疗剂量扩展队列；C部分为铂类耐药卵巢癌（PROC）队列；D部分为联合治疗队列。

Part B of the trial includes the B1 cohort, 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/m

试验的B部分包括B1队列，这是一项针对经组织学或细胞学确认的晚期卵巢癌（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。患者以1:1的比例随机分配至100 mg/m组。

and 120 mg/m

和 120 毫克/米

dose cohorts. Median age was 62.5 and 64.5 years in the 100 mg/m

剂量组。100 mg/m组的中位年龄为62.5岁和64.5岁，

and 120 mg/m

和 120 毫克/米

cohorts, respectively. Study participants were previously treated with a median of 3 prior lines of therapy (range 1-4). Patients received prior treatment with bevacizumab (90.9% in the 100 mg/m

队列，分别。研究参与者先前接受过中位数为3线的治疗（范围1-4）。患者之前接受过贝伐单抗治疗（100 mg/m²剂量组中占90.9%）。

group and 90.0% in the 120 mg/m

组和 90.0% 在 120 mg/m

group respectively), PARP inhibitors (68.2%; 65%), and mirvetuximab soravtansin (18.2%; 19%). Initial results from Part B of this trial were presented during a mini-oral session at the European Society of Medical Oncology Congress 2024 (ESMO).

分别为PARP抑制剂（68.2%；65%）和mirvetuximab soravtansin（18.2%；19%）。该试验B部分的初步结果在2024年欧洲医学肿瘤学会大会（ESMO）的一个小型口头会议上公布。

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.

卵巢癌是一个主要的全球健康问题，全世界每年诊断出超过320,000个新病例。

我

It ranks as the eighth most common cancer and the eighth leading cause of cancer-related deaths among women globally.

它在全球女性中排名第八，是最常见的癌症之一，也是第八位导致癌症相关死亡的主要原因。

二

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.

由于症状隐匿且不具特异性，如腹胀、盆腔疼痛和进食困难，该疾病常在晚期才被诊断出来。

iii

Standard of care for platinum resistant ovarian cancer typically involves single agent chemotherapy (pegylated liposomal doxorubicin (PLD), topotecan, gemcitabine or paclitaxel).

铂类耐药卵巢癌的护理标准通常涉及单药化疗（聚乙二醇化脂质体多柔比星 (PLD)、拓扑替康、吉西他滨或紫杉醇）。

四

Approximately 70-90% of women with advanced-stage ovarian cancer worldwide experience a recurrence after initial treatment.

全世界大约70%-90%的晚期卵巢癌女性在初次治疗后会经历复发。

Ovarian cancer has a low five-year survival rate, which varies significantly by region, but generally hovers around 30-50%.

卵巢癌的五年生存率较低，这一比率因地区而异，但通常在30%-50%左右波动。

，

vii

七

About Rinatabart Sesutecan (Rina-S

关于Rinatabart Sesutecan（Rina-S）

; GEN1184)

Rinatabart sesutecan (Rina-S; GEN1184) is a FRα-targeted, TOPO1 ADC, currently being evaluated for the potential treatment of ovarian cancer and other FRα-expressing cancers. A Phase 3 trial (RAINFOL-02,

Rinatabart sesutecan（Rina-S；GEN1184）是一种靶向FRα的TOPO1抗体药物偶联物（ADC），目前正被评估用于治疗卵巢癌和其他表达FRα的癌症的潜力。一项三期临床试验（RAINFOL-02，

NCT06619236

) evaluating Rina-S in patients with platinum resistant ovarian cancer compared to treatment of investigator's choice is ongoing. 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..

）正在评估Rina-S与研究者选择的治疗方案在铂类耐药卵巢癌患者中的疗效。2024年1月，美国食品药品监督管理局授予Rina-S快速通道资格，用于治疗表达FRα的高级别浆液性或子宫内膜样铂类耐药卵巢癌患者。

Please visit

请访问

www.clinicaltrials.gov

for more information.

更多信息，请参阅。

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 more than 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，其核心目标是引导其不懈努力的团队通过创新和差异化的抗体疗法改善患者的生活。在过去的25年多时间里，其充满热情、创新和协作的团队发明了下一代抗体技术平台，并利用转化、定量和数据科学，构建了一个包含双特异性T细胞接合器、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型抗体的自主知识产权管线。

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的愿景是通过令人惊叹（KYSO）的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成立于1999年，总部位于丹麦哥本哈根，在北美、欧洲和亚太地区均有业务。欲了解更多信息，请访问

Genmab.com

and follow us on

并关注我们

领英

and

和

。

Contact:

联系人：

David Freundel, Senior Director, Global Communications & Corporate Affairs

大卫·弗伦德尔，全球传播与企业事务高级总监

T: +1 609 430 2481; E:

电话：+1 609 430 2481；电子邮件：

dafr@genmab.com

Andrew Carlsen, Vice President, Head of Investor Relations

安德鲁·卡森，副总裁，投资者关系主管

T: +45 3377 9558; E:

电话：+45 3377 9558；电子邮件：

acn@genmab.com

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”等词语及其类似表达用于识别前瞻性声明。实际结果或表现可能与这些声明所表达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但不限于：与产品临床前和临床开发相关的风险、与临床试验结果和实施相关的不确定性（包括不可预见的安全问题）、与产品生产相关的不确定性、市场对我们产品的接受度不足、我们无法管理增长、与我们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人员、我们的专利和专有权利无法执行或缺乏保护、我们与关联实体的关系、技术的变化和发展可能使我们的产品或技术过时，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 .

有关这些风险的进一步讨论，请参阅Genmab最近的财务报告中的风险管理部分，这些报告可在以下位置查阅。

www.genmab.com

and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings

以及Genmab最近的20-F表格年度报告和其他文件中包含的风险因素

with the U.S. Securities and Exchange Commission (SEC), which are available at

提交给美国证券交易委员会 (SEC)，可从以下网址获取

www.sec.gov

. 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.

Genmab 不承担任何更新或修改本新闻稿中前瞻性声明的义务，也不确认这些声明以反映在作出声明之后发生的事件或情况或与实际结果相关的情况，除非法律要求。

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab

Genmab A/S 及其子公司拥有以下商标：Genmab

; the Y-shaped Genmab logo

；Y形的Genmab标志

; Genmab in combination with the Y-shaped Genmab logo

；Genmab与Y形Genmab标志组合

; HuMax

胡马克斯

; DuoBody

; 双体

; HexaBody

; 六边形体

; DuoHexaBody

; 双六边形体

, HexElect

，HexElect

, Rina-S

，里娜-S

and KYSO

和KYSO

。

i World Cancer Research Fund International.

世界癌症研究基金会国际组织。

https://www.wcrf.org/cancer-trends/ovarian-cancer-statistics/

. Accessed August 2024.

访问于2024年8月。

ii World Ovarian Cancer Coalition.

世界卵巢癌联盟。

https://worldovariancancercoalition.org/about-ovarian-cancer/key-stats/

. Accessed August 2024.

. 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).

iii Dilley，詹姆斯等人。卵巢癌症状、诊断途径和生存率——英国卵巢癌筛查协作试验（UKCTOCS）“无筛查”组中的人群队列研究。

Gynecologic oncology

妇科肿瘤学

vol. 158,2 (2020): 316-322. doi:10.1016/j.ygyno.2020.05.002.

第158卷，第2期（2020年）：316-322页。doi:10.1016/j.ygyno.2020.05.002。

iv Eskander RN, Moore KN, Monk BJ, Herzog TJ, Annunziata CM, O’Malley DM and Coleman RL (2023) Overcoming the challenges of drug development in platinum-resistant ovarian cancer. Front. Oncol. 13:1258228

Eskander RN, Moore KN, Monk BJ, Herzog TJ, Annunziata CM, O’Malley DM 和 Coleman RL (2023) 克服铂耐药卵巢癌药物开发的挑战。《肿瘤学前沿》13:1258228。

Ovarian Cancer Research Alliance.

卵巢癌研究联盟。

https://ocrahope.org/patients/diagnosis-and-treatment/recurrence/

。

v Ovarian Cancer Research Alliance.

卵巢癌研究联盟。

https://ocrahope.org/patients/diagnosis-and-treatment/recurrence/

。

vi European Institute of Women's Health.

欧洲妇女健康研究所

https://eurohealth.ie/policy‐brief‐women‐and‐ovarian‐cancer‐in‐the‐eu‐2018/