A Phase 2, Open-Label, Randomized, Master Protocol Dose Optimization Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Mirvetuximab Soravtansine in Subjects With Ovarian Cancer

Ovarian cancer is a lethal disease with an estimated 310,000 new cases and 200,000 deaths experienced worldwide in 2020. The purpose of this study is to assess the adverse events and change in disease activity of mirvetuximab soravtansine with carboplatin, or bevacizumab (Bev), or bev alone in participants with ovarian cancer (OC). Participants must have confirmation of folate receptor alpha (FRa) positivity by the Ventana folate receptor 1 (FOLR1) Assay.
Mirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC. Participants will be assigned to 1 of 2 substudies and further into groups called treatment arms. In substudy 1, arms A-C, participants will receive 1 of 2 doses of MIRV with Bev, or Bev alone. In substudy 2, arms D and E, participants will receive 1 of 2 doses of MIRV with carboplatin, followed by MIRV alone. Approximately 320 participants will be enrolled in the study at 100 sites around the world.
Participants will receive intravenously (IV) infused MIRV with IV infused carboplatin, or IV infused Bev, or IV infused Bev alone. The total study duration will be approximately 40 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

开始日期2025-09-08

申办/合作机构

AbbVie, Inc.

NCT06890338

/ Not yet recruiting临床2期

A Single-Arm, Phase 2 Study of Neoadjuvant Carboplatin and Mirvetuximab Soravtansine in Subjects With FRα-Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of neoadjuvant carboplatin and mirvetuximab soravtansine in participants with folate receptor alpha (FRα) -expressing advanced-stage serous epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC).
Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). This is a single arm study in adult participants with advanced-stage Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) III-IV FRα-expressing serous EOC. Around 140 participants will be enrolled in the study at approximately 80 sites in the United States.
Participants will receive intravenous infusion of MIRV in combination with carboplatin on day 1 of each cycle, every 21 days for up to 6 - 9 Cycles. The total study duration will be approximately 3 years .
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

开始日期2025-08-20

申办/合作机构

AbbVie, Inc.

NCT06682988

/ Recruiting临床2期

A Randomized Phase 2, Open-label Study of Mirvetuximab Soravtansine in Patients With Platinum-resistant Advanced High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-alpha Expression Testing 2 Schedules of Administration for Dose Optimization, With a Separate Cohort to Determine Starting Dose in Patients With Moderate Hepatic Impairment

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer (platinum-resistant ovarian cancer) (PROC) whose tumors express a high level of folate receptor alpha (FRα).
Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). There are 2 cohorts in this study, the Randomized Phase 2 Cohort and the Hepatic Impairment Cohort. In the Randomized Phase 2 Cohort, participants are placed in 1 of 2 groups, called treatment arms. Each treatment arm receives MIRV on a different schedule (on day 1 every 21 days or on days 1 and 15 every 28 days). The Hepatic Impairment Cohort is designed to determine the starting dose of MIRV in patients with moderately abnormal liver function. Around 110 participants will be enrolled in the study at approximately 75 sites worldwide.
The total study duration will be approximately 24 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

开始日期2025-05-28

申办/合作机构

AbbVie, Inc.

100 项与索米妥昔单抗相关的临床结果

登录后查看更多信息

100 项与索米妥昔单抗相关的转化医学

登录后查看更多信息

100 项与索米妥昔单抗相关的专利（医药）

登录后查看更多信息

127

项与索米妥昔单抗相关的文献（医药）

2025-10-01·INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER

Mirvetuximab soravtansine in the ovarian cancer treatment landscape: influence of prior taxane exposure on outcomes

Article

作者: Smick, Alexandra H ; Salani, Ritu ; Chase, Dana M ; Silverstein, Jordyn ; Konecny, Gottfried ; Brennan, Lindsay

OBJECTIVE:

To evaluate prescribing patterns, toxicities, and outcomes among patients receiving mirvetuximab for platinum-resistant ovarian cancer.

METHODS:

This retrospective study included patients with platinum-resistant ovarian cancer with high folate receptor alpha expression treated with mirvetuximab at a single institution (2018-2023). Patients were categorized based on treatment immediately preceding mirvetuximab: the taxane group received taxane treatment; the non-taxane group received other therapy. An age-matched cohort of platinum-resistant patients not treated with mirvetuximab was included for survival comparison. Statistical analyses included descriptive statistics, Kaplan-Meier curves, log-rank tests, Wilcoxon rank-sum tests, and Cox models.

RESULTS:

Forty-one patients received mirvetuximab, with a median of 8 cycles (range; 1-47). Grade ≥3 adverse events included ocular (n = 6; 15%), hematologic (n = 1; 2%), neuropathy (n = 1; 2%), and pneumonitis (n = 1; 2%). Dose reductions and delays occurred in 26 (63%) and 21 (51%) patients, respectively. Mirvetuximab was discontinued in 40 patients (98%), most commonly due to disease progression (n = 35; 88%). Mirvetuximab-treated patients had longer median overall survival from diagnosis compared to the age-matched cohort without mirvetuximab exposure (83.12 vs 52.14 months; HR 0.34, 95% CI 0.18 to 0.64, p < .001). Among patients who received taxane therapy immediately before mirvetuximab (n = 9), average treatment duration was 5 months (9 cycles), with no grade ≥3 neuropathy. In those who received a non-taxane regimen immediately before mirvetuximab (n = 32), average treatment duration was 6 months (8 cycles), with 1 patient (3%) experiencing grade ≥3 neuropathy. Median progression-free survival was similar between groups (5.49 vs 6.28 months; HR 1.30, 95% CI 0.61 to 2.78, p = .50), but overall survival was shorter in the taxane group (11.28 vs 21.02 months; HR 2.47, 95% CI 1.01 to 6.04, p = .048).

CONCLUSIONS:

Real-world experience with mirvetuximab demonstrated a favorable safety profile and clinical benefit in platinum-resistant ovarian cancer. Taxane therapy immediately preceding mirvetuximab was associated with shorter overall survival but not increased neurotoxicity.

2025-09-01·INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER

Antibody-drug conjugates in gynecologic cancer: current landscape, clinical data, and emerging targets

Review

作者: Wang, Ying ; Jia, Li ; Chen, Mi ; He, Jinhui

Antibody-drug conjugates (ADCs) are an emerging class of targeted therapies that combine monoclonal antibodies with potent cytotoxic payloads, demonstrating significant potential in the treatment of gynecologic malignancies. By selectively targeting tumor-associated antigens, ADCs enable precise drug delivery while minimizing off-target toxicity. Currently, mirvetuximab soravtansine and tisotumab vedotin have been approved by the Food and Drug Administration for the treatment of folate receptor-alpha-positive, platinum-resistant ovarian cancer and recurrent cervical cancer, respectively, exhibiting promising objective response rates and manageable toxicity profiles in pivotal clinical trials. However, ADC therapy faces challenges, including ocular toxicity, pulmonary toxicity, peripheral neuropathy, tumor antigen heterogeneity, and acquired resistance. Additionally, multiple investigational ADCs, such as upifitamab rilsodotin (targeting NaPi2b), trastuzumab deruxtecan (targeting HER2), and sacituzumab govitecan (targeting trophoblast cell surface antigen 2), have demonstrated preliminary efficacy in ongoing clinical trials, offering new therapeutic opportunities for gynecologic malignancies. This review comprehensively summarizes the current clinical applications and research progress of ADCs in gynecologic cancers, including key clinical trials, therapeutic efficacy, safety profiles, and associated challenges. Furthermore, we discuss future optimization strategies, including the identification of novel targets, rational combination therapies, and molecular design improvements to advance ADC-based precision treatment in gynecologic oncology.

2025-09-01·GYNECOLOGIC ONCOLOGY

Safety and efficacy of mirvetuximab soravtansine, a folate receptor alpha (FRα)–targeting antibody-drug conjugate (ADC), in combination with pembrolizumab in patients with platinum-resistant ovarian cancer

Article

作者: Xia, Yu ; Moore, Kathleen N ; Method, Michael ; Martin, Lainie P ; Matulonis, Ursula A ; Vergote, Ignace ; O'Malley, David M ; Birrer, Michael J ; Gilbert, Lucy ; Castro, Cesar M ; Stec, James

OBJECTIVE:

Evaluate the efficacy and safety of mirvetuximab soravtansine-gynx (MIRV) plus pembrolizumab in dose escalation and expansion cohorts of heavily pretreated patients with platinum-resistant ovarian cancer (PROC).

METHODS:

Participants with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease relapsed ≤6 months from last platinum-based treatment received MIRV (6 mg/kg adjusted ideal body weight) and pembrolizumab (200 mg) intravenously once every 3 weeks. Tumor FRα expression thresholds were ≥25 % (dose escalation cohort) and ≥50 % (dose expansion cohort) of cells with ≥2+ membrane staining intensity. The primary efficacy endpoint was objective response rate (ORR). Secondary endpoints included duration of response (DOR), progression-free survival (PFS), and safety.

RESULTS:

Fifty-six participants received the doublet. Median age was 62 years (range, 40-78). Twenty percent of participants had 3 prior lines of systemic treatment, 43 % had ≥4 prior lines, 43 % had prior bevacizumab exposure, and 41 % had prior PARP inhibitor exposure. Among 55 response-evaluable participants, ORR was 31 % (95 % CI, 19-45), median DOR was 8.0 months (95 % CI, 4.2-NR), and median PFS was 4.2 months (95 % CI, 2.8-5.6). Efficacy persisted in patients with multiple prior lines of treatment. Treatment-emergent adverse events were consistent with the profiles of each agent; the most common were diarrhea (all grades, 57 %; grade 3, 4 %), nausea (55 %; 5 %), and fatigue (50 %; 2 %). Treatment-emergent pneumonitis occurred in 25 % of participants, with grade ≥3 events occurring in 2 (4 %) participants.

CONCLUSIONS:

MIRV plus pembrolizumab demonstrated anti-cancer efficacy and a tolerable safety profile in heavily pretreated patients with PROC. However, the efficacy benefit may be mainly attributable to MIRV alone.

588

项与索米妥昔单抗相关的新闻（医药）

2025-09-17

·医药经济报

PTK7靶点再蒙阴影，艾伯维、辉瑞接连折戟，礼来、科伦博泰接棒攻坚

丹麦制药巨头Genmab斥资18亿美元押注的“核心资产”骤然搁浅，ADC赛道的GEN1107黯然退场。近日，全球临床试验收录网站clinicaltrials显示，Genmab已终止GEN1107（PRO-1107）用于实体瘤的一项I/II期研究（NCT06171789），原因是“因为其总体获益-风险特征不再支持继续研发。” 据悉，Genmab斥资18亿美元，于2024年5月收购了普方生物，GEN1107是Genmab通过收购获得的3款临床阶段候选药物之一。值得关注的是，GEN1107还深陷法律纠纷漩涡。今年3月，艾伯维对Genmab提起诉讼，指控普方生物利用其前科学家掌握的专有信息开发ADC药物，此番临床折戟也为这场知识产权纠纷增添了新的讨论点和猜测空间。在ADC领域，PTK7靶点备受礼来、科伦博泰、Day One生物制药等的关注。但PTK7靶向药大多处于早期阶段，且辉瑞和艾伯维已研发终止的先例。随着GEN1107的开发终止，该靶点的未来发展前景更添不确定性。核心ADC项目遭终止艾伯维狙击“命中”？ GEN1107拟用于治疗多种实体瘤，包括卵巢癌、子宫内膜癌和尿路上皮癌。此前，GEN1107与艾伯维/辉瑞的Cofetuzumab pelidotin临床前头对头研究数据显示，该药在抗肿瘤活性和耐受性上优于Cofetuzumab pelidotin，并且还具有旁观者效应。然而，基于“总体获益-风险特征不再支持继续研发”临床评估结果，Genmab已决定终止GEN1107用于实体瘤的I/II期研究（NCT06171789），这一决定凸显出从临床前研究成功过渡到临床阶段的挑战，也为PTK7靶点药物的开发增添了新的不确定性。回看Genmab收购普方生物的交易，除了GEN1107外，最核心的ADC资产是一款以叶酸受体α（FRα）为靶点的候选药物Rina-S，该药已获得突破性疗法认定，目前正处于卵巢癌的Ⅲ期临床试验阶段。对于Genmab来说，Rina-S的销售峰值也预计超过20亿美元，可以算是近两年的重中之重。GEN1107的失败使得Rina-S的重要性进一步凸显。然而，Rina-S也陷入法律诉讼。2025年3月，Genmab发布公告表示，艾伯维在美国华盛顿西区地方法院（西雅图）对Genmab、普方生物美国分部公司、普方生物苏州研发创新中心及艾伯维前员工提起诉讼，指控盗用其商业秘密。艾伯维声称，被告旗下在研ADC药物Rina-S及其他普方生物的ADC管线产品，未经授权使用了一项旨在增强ADC亲水性的基于二糖的连接技术。有分析认为，艾伯维发起诉讼的可能动机之一，是出于对Rina-S未来上市后可能对其现有产品Elahere构成竞争威胁的担忧。Elahere是艾伯维在2024年3月获美国FDA完全批准，用于治疗叶酸受体α（FRα）阳性、铂类耐药的上皮性卵巢癌、输卵管癌或原发性腹膜癌患者的ADC药物。作为首款在铂类耐药卵巢癌患者上显示带来总生存期（OS）改善的疗法，Elahere在2024年实现收入4.79亿美元，在艾伯维全年总收入中仅占比0.85%。而Rina-S与Elahere靶点相同，存在直接竞争关系。因此才通过这种方式拖延其上市进度。 ADC领域已成为近年来制药行业最热门的赛道之一，众多药企通过并购或合作进入该领域。艾伯维发起诉讼不仅反映了商业机密保护在行业竞争中的重要性，也凸显了ADC技术在肿瘤治疗领域的巨大潜力和商业价值。 PTK7靶点前途未卜 ADC领域“高风险赌局”？ PTK7被认为是肿瘤药研发的潜力靶点，最初在结肠癌细胞中被发现，是一种受体蛋白酪氨酸激酶（RPTK）样分子，是催化缺陷的受体蛋白酪氨酸激酶家族的成员，在多种肿瘤类型中呈现显著上调的态势。然而，PTK7靶点的研发之路却并非坦途，而是布满了重重未知与挑战。在GEN1107临床终止之前，辉瑞与艾伯维也有过类似的折戟经历。Cofetuzumab Pelidotin是一款靶向PTK7的ADC药物，最初由Stemcentrx研发，该公司与辉瑞在2015年达成合作开发，该药物命名为PF-06647020。2016年，艾伯维豪掷58亿美元收购了Stemcentrx，这一举动在当时被视为对PTK7靶点潜力的高度认可。然而，希望的曙光并未如预期般闪耀。辉瑞和艾伯维于2020年2月开启了临床Ib期试验，评估其在表达PTK7的复发性NSCLC患者中的抗肿瘤活性和安全性。但结果却不尽如人意，患者的客观缓解率（ORR）较低（19.6%）。 2023年8月，Cofetuzumab Pelidotin的管线从艾伯维的官网上悄然消失。同年10月，辉瑞也正式宣布终止该药物的后续开发。Cofetuzumab Pelidotin，这款曾被寄予厚望的ADC药物，最终成了一枚弃子。如今，随着Genmab的GEN1107也因“收益风险状况不佳”而终止开发，PTK7靶点的成药性再次受到关注。目前，全球范围内仍有不少企业在这一领域布局，国内生物科技公司在全球PTK7 ADC研发中扮演着主力军的角色。其中科伦博泰的SKB518进展最快，已启动II期临床。礼来作为新入局的跨国大药企，其PTK7 ADC药物LY4175408也已于2025年7月登记了I期临床试验，探索用于非小细胞肺癌、肺癌、子宫内膜癌以及三阴性乳腺癌的治疗。全球部分在研PTK7靶向药 PTK7作为肿瘤治疗领域的潜力靶点，其研发征程仍处于探索阶段。目前，多数PTK7靶向药物尚处于早期研究，且已有项目因疗效或安全性等问题终止研发，为该靶点的成药性带来更多不确定性。尽管前路挑战重重，PTK7的未来仍取决于未来一至两年内更多临床数据的披露，届时或可为其能否成功“破茧”提供明确答案。编辑：张洁莹版式编辑：余远泽审校：马飞、张松十大商业龙头中报净利润分化，透露哪些趋势？从触底到暴涨20倍，歌礼制药手握“季度针”，直面GLP-1红海厮杀？第11批国采规则六大调整！申报资质、锚点价、中选名额等有变 www.yyjjb.com.cn 洞悉行业趋势长按关注医药经济报《中国处方药》学术公众号聚焦药学学术和循证研究长按关注中国处方药《医药经济报》终端公众号记录药品终端产经大事件长按关注21世纪药店

2025-09-16

·FierceBiotech

Genmab discards clinical ADC picked up in last year\'s $1.8B ProfoundBio buy

Genmab has dropped one of three clinical-stage antibody-drug conjugates picked up in last year\'s $1.8 billion ProfoundBio buy.\n Genmab has dropped an antibody-drug conjugate picked up as part of its $1.8 billion ProfoundBio buyout, citing an inadequate benefit-risk profile.A spokesperson confirmed the discontinuation to Fierce Biotech and said Genmab continues to develop other investigational treatments obtained in last year’s acquisition.The discarded candidate, dubbed GEN1107, is a protein tyrosine K 7 (PTK7)-targeted ADC that was being studied in a phase 1/2 cancer trial. The study enrolled 33 patients with advanced solid tumors, including ovarian cancer, endometrial cancer, triple negative breast cancer, non-small cell lung cancer, gastroesophageal cancer and urothelial cancer.The trial stopped Aug. 18 of this year after launching in January 2024, according to ClinicalTrials.gov.GEN1107 is one of three clinical candidates picked up in the deal, alongside ProfoundBio’s star rinatabart sesutecan (Rina-S). The investigational ADC is designed to deliver topoisomerase-1 (Topo1) inhibitor to cells that express folate receptor alpha (FRα).FRα is overexpressed in ovarian cancer and other solid tumors, and numerous other biopharmas—such as AbbVie with its $10 billion Immunogen buy for the FRα drug Elahere—are targeting the receptor. While Genmab has entered the scene later than the rest, the company’s ProfoundBio purchase reflects a belief that Rina-S has best-in-class potential.Genmab is continuing the development of Rina-S, which is currently being studied in platinum-resistant ovarian cancer and endometrial cancer, the spokesperson confirmed. The big biotech is also still holding onto GEN1160, a CD70-targeted ADC being tested out in advanced renal cell carcinoma, nasopharyngeal carcinoma and non-Hodgkin lymphoma, the spokesperson said. Genmab continues to work on preclinical assets picked up from ProfoundBio, as well.The dropped program, GEN1107, and Rina-S are both listed in a lawsuit against Genmab that was filed by AbbVie in March. The big pharma claims that ProfoundBio used proprietary information from a former AbbVie scientist to develop its ADCs, and that Genmab was “intentionally and willfully blind” to the theft of trade secrets.Genmab has refuted the claims and vowed to “vigorously defend” itself.

$Genmab discards clinical ADC picked up in last year\'s $1.8B ProfoundBio buy$

抗体药物偶联物并购免疫疗法

2025-09-15

·Biotech前瞻

卵巢癌迎来黄金时代，口服激素受体拮抗剂、免疫、ADC，破局妇瘤之王

点击蓝字关注我们本期看点卵巢癌被誉为“妇瘤之王”，病情凶险、治疗选择有限。既往主要以化疗为主，ADC作为精准化疗的迭代，在多个潜力新靶点上进展迅速：世界卵巢癌日丨妇瘤之王迎来ADC“黄金时代”，破局有望！而近日，帕博利珠单抗治疗铂耐药复发性卵巢癌的三期成功，免疫终于实现了卵巢癌后线的突围。未来的卵巢癌治疗格局有望成为ADC、免疫双线并进的格局，先看中门对狙的疗效和安全性结果，也有可能免疫+ADC实现组合探索。本期内容 01 卵巢癌丨relacorilant 02 卵巢癌丨ICIs 03 卵巢癌丨ADC 04 总结与展望【01 卵巢癌丨relacorilant】近日，FDA已受理 relacorilant（口服选择性糖皮质激素受体〔GR〕拮抗剂）联合白蛋白紫杉醇用于铂耐药卵巢癌（PROC）的NDA，并确定 PDUFA 日期为 2026年7月11日； III期 ROSELLA 及多项II期结果显示，无需生物标志物筛选的情况下，联用方案将 PFS 从 5.52 提至 6.54 个月（HR 0.70, P = 0.0076），OS 从 11.50 提至 15.97 个月（HR 0.69, P = 0.0121），安全性在类型/频率/严重度上与纳米紫杉醇单药相近；给药多采用在化疗前一日/当日/次日短程口服relacorilant以覆盖化疗关键窗口。其机制为阻断皮质醇-GR信号（该通路可诱导肿瘤抗凋亡、降低化疗敏感性），从而逆转应激驱动的化疗耐受、增强税烷诱导的凋亡，实现“化疗增敏”。 02 卵巢癌丨ICIs 2025年5月15日，默沙东宣布其基于PD-1抑制剂KEYTRUDA®（帕博利珠单抗）的Ⅲ期KEYNOTE-B96（ENGOT-ov65）试验达成主要研究终点。该随机、双盲、多中心研究纳入约643例含铂耐药复发性卵巢癌患者，比较了KEYTRUDA联合紫杉醇（加/不加贝伐珠单抗）与安慰剂联合同一化疗方案在无进展生存期（PFS）方面的疗效。主要终点达成：不论PD-L1表达状态如何，K药方案均显著延长PFS，并达临床意义标准。次要终点（OS）突破：在PD-L1阳性（CPS≥1）亚组中，KEYTRUDA组合同样显著改善总生存期（OS），首次在含铂耐药卵巢癌中展现免疫检查点抑制剂的OS获益。安全性可控：研究期间未观察到新的安全信号，安全性与先前研究数据一致。这是首个基于免疫检查点抑制剂的治疗方案，在含铂耐药卵巢癌患者中同时实现PFS和OS获益。详细数据有待进一步公布。对于卵巢癌的治疗，免疫联合方案的突破，意义非凡。作为全球第三大妇科恶性肿瘤、女性第七大常见癌症。2022年，全球新发病例约32.5万，死亡病例约20.7万。虽然相较于高发病种，如此小的市场，既往在各个企业布局中都属于冷门领域。但随着肿瘤赛道内卷激烈，近年来，宫颈癌、卵巢癌、子宫内膜癌的创新药布局逐步增多，如：子宫内膜癌成为免疫竞逐新瘤种，PD-1/L1先后获批，默沙东也逐步开始加速妇科肿瘤领域的研究布局。默沙东正全力推动一系列旨在拓展乳腺癌及妇科肿瘤（卵巢癌、宫颈癌和子宫内膜癌）治疗选择的临床研究，期望改善更多患者的预后。乳腺癌和妇科肿瘤分别是全球女性中最常见和第二常见的癌症类型，默沙东凭借逾20项在研临床试验、覆盖全球超过1.8万名受试者，系统性地探索新药在不同疾病阶段的应用。 K药已开展7项妇科肿瘤关键III期试验，其中卵巢癌研究占比达45%。本次KEYNOTE-B96的成功标志着K药首次突破"免疫冷肿瘤"壁垒。除此之外，宫颈癌（KEYNOTE-826）、子宫内膜癌（KEYNOTE-C93）研究，也陆续报道利好消息。如：K药在华获批局晚期宫颈癌，免疫+同步放化疗3项3期研究，争议前行更大的野望在于默沙东通过与科伦博泰、第一三共的合作，已布局TROP2、CDH6等7个ADC靶点。其中TROP2 ADC药物Sacituzumab Tirumotecan在全球启动13项III期研究，覆盖卵巢癌（Trofuse-022）、子宫内膜癌（Trofuse-033）等适应症，有望进一步提升疗效，占据更多先发优势地位。而卵巢癌领域，ADC创新产品迭出。【03 卵巢癌丨ADC】 FDA数据库显示，2024年前三季度，全球卵巢癌ADC临床试验启动数量同比增长227%，其中翰森制药的HS-20089（B7H4 ADC）、华东医药的Soboblzautamab（FRα ADC）、恒瑞医药的SHR-A1921（HER2 ADC）构成第一梯队。翰森制药丨B7H4 ADC 2025年4月24日，CDE官网显示，翰森制药注射用HS-20089拟纳入突破性治疗品种，用于治疗铂耐药复发上皮性卵巢癌、输卵管癌或原发性腹膜癌患者。前不久，翰森制药在clinical trials网站上注册了一项B7H4 ADC药物HS-20089，在铂类不耐受的复发卵巢癌患者中，启动一项3期临床试验NCT06855069，该临床预计于2025年3月启动，入组人数为468例，这也是全球首个B7H4 ADC药物启动三期临床。早前，翰森制药的B7H4 ADC药物HS-20089已授权给葛兰素史克（GSK），并正在进行国际临床试验。恒瑞医药—Her2 ADC 2024年12月13日，CDE官网最新公示，恒瑞医药 HER2 ADC 创新药注射用瑞康曲妥珠单抗（SHR- A1811）拟纳入突破性治疗品种，用于治疗HER2表达的铂耐药复发上皮性卵巢癌、输卵管癌或原发性腹膜癌。截止到目前为止，SHR-A1811至少已经有6项适应症已被纳入突破性治疗品种，适应症覆盖乳腺癌、非小细胞肺癌、结直肠癌、胃癌或胃食管结合部腺癌以及胆道癌等。基于Her2 单抗/ADC在胃癌和乳腺癌领域已经有多款产品上市，对于后来者，如何弯道超车，瘤种的选择极为重要。Her2阳性非小细胞肺癌患者人群很少，但如若有不错的疗效数据，极容易被CDE纳入突破性疗法认定或快速审评。 Her2(人表皮生长因子受体2)是重要的癌症驱动基因，在多个癌种当中高度表达，其中肺癌检出率约2.5%，乳腺癌检出率约15%~25%，胃癌检出率约20%，胆管癌检出率约20%，卵巢癌检出率约27%，子宫内膜癌中检出率可以达到18%~80%。妇科肿瘤领域，潜力巨大。华东医药—FRα ADC 2024年11月27日，中美华东收到NMPA核准签发的《药品注册证书》，索米妥昔单抗注射液（爱拉赫®/ELAHERE®）用于既往接受过1-3线系统性治疗的叶酸受体α阳性的铂类耐药卵巢癌（PROC）适应症的上市许可申请获得批准。该产品为艾伯维于2023年11月30日花费总价101亿美元收购ImmunoGen公司所得核心产品。早前在 2020 年 10 月，ImmunoGen 已将索米妥昔单抗大中华区的权益授权给华东医药，获得 4000 万美元的首付款以及最高可能达 2.65 亿美元的里程碑付款。Elahere 2024 年 3 月 22 日，艾伯维宣布，FDA已完全批准Elahere（mirvetuximab soravtansine）用于治疗叶酸受体α（FRα）阳性、铂类耐药的上皮性卵巢癌、输卵管癌或原发性腹膜癌患者，既往接受过至多3种全身治疗方案。ELAHERE 是美国批准用于治疗这种难以治疗的恶性肿瘤的第一个也是唯一一个抗体药物偶联物 (ADC) 。该产品为艾伯维于2023年11月30日花费总价101亿美元收购ImmunoGen公司所得核心产品。及其标志性产品。毫无疑问的是，卵巢癌正迎来ADC大爆发的黄金时代。 04 总结与展望从治疗前景看，市场研究认为靶向疗法将继续主导卵巢癌用药结构：2024年统计中，靶向疗法占卵巢癌药物市场最大份额，显示ADC等精准治疗正成为增长驱动力。此外，亚太地区尤其是中国市场增速显著。相关报告显示，亚太地区卵巢癌用药市场将以最快速度扩张，中国庞大人口基数和增长的发病率为市场带来广阔前景。此次，K药三期研究的成功，将进一步改写卵巢癌治疗格局。有望在未来五年迎来更多产品获批上市。行文不易，欢迎关注，为中国的Biotech行业保驾护航，也是人生幸事。用通俗的语言，讲清晰医药专业知识，关爱自己，关爱家人。 ★

临床3期抗体药物偶联物临床结果临床2期

100 项与索米妥昔单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D10954	索米妥昔单抗	-	DB12489

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
输卵管癌	英国	AbbVie Ltd.	2025-07-24
卵巢癌	英国	AbbVie Ltd.	2025-07-24
原发性腹膜癌	英国	AbbVie Ltd.	2025-07-24
叶酸受体α 阳性铂类耐药的卵巢上皮癌	美国	ImmunoGen, Inc.	2022-11-14
叶酸受体α阳性铂类耐药的输卵管癌	美国	ImmunoGen, Inc.	2022-11-14
叶酸受体α阳性铂类耐药的原发性腹膜癌	美国	ImmunoGen, Inc.	2022-11-14
铂耐药上皮性卵巢癌	美国	ImmunoGen, Inc.	2022-11-14
铂耐药性输卵管癌	美国	ImmunoGen, Inc.	2022-11-14
铂类耐药性原发性腹膜癌	美国	ImmunoGen, Inc.	2022-11-14

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
肿瘤	申请上市	加拿大	AbbVie, Inc.	2025-03-01
铂敏感性卵巢上皮癌	临床3期	美国	AbbVie, Inc.	2022-12-27
铂敏感性卵巢上皮癌	临床3期	中国	AbbVie, Inc.	2022-12-27
铂敏感性卵巢上皮癌	临床3期	日本	AbbVie, Inc.	2022-12-27
铂敏感性卵巢上皮癌	临床3期	阿根廷	AbbVie, Inc.	2022-12-27
铂敏感性卵巢上皮癌	临床3期	澳大利亚	AbbVie, Inc.	2022-12-27
铂敏感性卵巢上皮癌	临床3期	比利时	AbbVie, Inc.	2022-12-27
铂敏感性卵巢上皮癌	临床3期	保加利亚	AbbVie, Inc.	2022-12-27
铂敏感性卵巢上皮癌	临床3期	加拿大	AbbVie, Inc.	2022-12-27
铂敏感性卵巢上皮癌	临床3期	捷克	AbbVie, Inc.	2022-12-27

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05041257 (PICCOLO, ESMO_TAT Asia2025) 人工标引	临床2期	铂敏感性卵巢癌 FRα-positive	38	Mirvetuximab soravtansine-gynx (MIRV) 6 mg/kg (HRD-positive)	網壓衊壓壓顧艱憲遞鏇(積網遞膚艱鑰願遞壓醖) = 觸齋範鹹襯觸構顧夢衊夢遞鏇夢蓋繭築獵遞鹹 (鏇齋衊壓構觸遞憲蓋製 ) 更多	积极	2025-06-01
				Mirvetuximab soravtansine-gynx (MIRV) 6 mg/kg (HRD-negative)	網壓衊壓壓顧艱憲遞鏇(積網遞膚艱鑰願遞壓醖) = 鹹憲艱憲艱遞鹽遞構範夢遞鏇夢蓋繭築獵遞鹹 (鏇齋衊壓構觸遞憲蓋製 ) 更多
NEWS \| Literature 人工标引	N/A	铂耐药性卵巢癌	18	索米妥昔单抗	網鹹鹽遞醖齋鹽鑰襯網(窪蓋網製廠衊夢蓋顧簾) = 糧餘簾築膚積襯襯範製廠夢膚蓋鹹憲網襯蓋範 (顧糧鑰願襯觸觸網憲膚 ) 更多	积极	2025-03-31
NCT04209855 (MIRASOL, PRNewswire \| NEWS) 人工标引	临床3期	叶酸受体α 阳性铂类耐药的卵巢上皮癌 FRα expression	453	ELAHERE (mirvetuximab soravtansine-gynx)	糧齋構艱範膚膚餘壓餘(淵選獵鏇齋繭鬱膚繭鹽) = 艱窪壓齋鑰襯蓋觸繭構範觸窪積夢糧糧鬱淵選 (廠範窪製獵膚網壓積夢, 4.34 ~ 5.88) 更多	积极	2025-03-15
				Chemotherapy	糧齋構艱範膚膚餘壓餘(淵選獵鏇齋繭鬱膚繭鹽) = 廠蓋遞範餘製築蓋遞鹹範觸窪積夢糧糧鬱淵選 (廠範窪製獵膚網壓積夢, 2.86 ~ 4.47) 更多
NCT05041257 (PICCOLO, Pubmed \| Ann Oncol \| ESMO_TAT Asia2024 \| NEWS) 人工标引	临床2期	卵巢癌三线 FRα expression	79	Mirvetuximab Soravtansine	壓觸鬱積選觸淵淵繭廠(願鏇淵壓艱選餘簾艱窪) = 製鹽構製夢構夢艱築製遞網製觸範襯遞衊鏇選 (淵憲夢鑰鹽餘鑰範範網, 40.4 ~ 63.3) 达到更多	积极	2024-11-01
				Mirvetuximab Soravtansine (PARPi naïve)	壓觸鬱積選觸淵淵繭廠(願鏇淵壓艱選餘簾艱窪) = 鹽窪簾觸繭淵夢夢齋餘遞網製觸範襯遞衊鏇選 (淵憲夢鑰鹽餘鑰範範網, 42.8 ~ 94.5) 达到更多
SGO2024	N/A	毒性 high folate-receptor alpha expression (FOLR)	-	Mirvetuximab soravtansine	鹽鹹積醖窪廠壓壓夢網(遞淵範積壓簾淵鏇願遞) = 9 % experienced grade 3 ocular adverse reactions 網糧獵選願鹽淵餘範鏇 (鏇鹹廠鬱遞顧願遞簾廠 ) 更多	-	2024-11-01
NCT05041257 (PICCOLO, ESMO2024) 人工标引	临床2期	原发性腹膜癌 \| 铂敏感性卵巢癌 \| 输卵管癌三线 FRα expression	79	Mirvetuximab soravtansine (MIRV) 6 mg/kg	廠壓餘積壓壓窪繭選醖(鑰窪淵壓簾襯夢鏇顧窪) = 鹽遞蓋顧餘鏇鬱獵獵繭簾製築網網齋願鹽膚簾 (觸餘憲鹹製繭糧網範廠, 40.4 ~ 63.3) 更多	积极	2024-09-15
NCT04209855 (MIRASOL, ESMO2024) 人工标引	临床3期	铂耐药性卵巢癌 FRα expression	453	Mirvetuximab soravtansine (MIRV) 6 mg/kg	襯糧鑰醖廠鬱顧遞鑰顧(築製窪廠網襯遞廠築築) = 夢製糧鹹蓋壓網鬱願醖網襯衊獵範製獵選範築 (齋積齋鹽選鏇網衊蓋製, 4.3 ~ 6.0) 更多	积极	2024-09-14
				Investigator’s choice chemotherapy (ICC): paclitaxel (PAC), pegylated liposomal doxorubicin (PLD), or topotecan (Topo)	襯糧鑰醖廠鬱顧遞鑰顧(築製窪廠網襯遞廠築築) = 願獵膚遞廠鹽範簾積齋網襯衊獵範製獵選範築 (齋積齋鹽選鏇網衊蓋製, 2.9 ~ 4.5) 更多
NCT04296890 (SORAYA \| Study 0417 (SORAYA), CTgov)	临床3期	铂耐药性输卵管癌 \| 铂类耐药性原发性腹膜癌 \| 腹膜癌 ... 更多	106	Mirvetuximab Soravtansine	網獵醖醖夢築築鏇鏇遞 = 製遞網積膚繭壓鹽窪齋襯範襯齋憲範選餘繭鹹 (膚築範觸簾衊選糧廠壓, 鹽鑰淵衊蓋衊遞選醖窪 ~ 獵艱鑰蓋鑰遞膚構齋襯) 更多	-	2024-08-07
NCT04209855 (SORAYA \| MIRASOL \| SORAYA study (002) \| MIRASOL (GOG 3045/ENGOT-ov55), CTgov)	临床3期	铂耐药性输卵管癌 \| 铂类耐药性原发性腹膜癌 \| 腹膜癌 ... 更多	453	Mirvetuximab Soravtansine (Mirvetuximab Soravtansine)	獵築襯齋製淵積觸網淵(糧構齋築構鬱鹽襯憲網) = 鬱蓋膚壓鑰觸糧繭觸憲廠襯簾膚糧選蓋獵窪膚 (積鏇糧鹽觸鏇製窪積願, 膚鹽鬱選蓋鹽襯築襯艱 ~ 壓簾壓淵蓋淵蓋遞醖鹽) 更多	-	2024-08-01
				Pegylated liposomal doxorubicin+Paclitaxel+Topotecan (Investigator's Choice (IC) Chemotherapy)	獵築襯齋製淵積觸網淵(糧構齋築構鬱鹽襯憲網) = 餘選廠願憲鑰鹽構選網廠襯簾膚糧選蓋獵窪膚 (積鏇糧鹽觸鏇製窪積願, 餘積壓簾鹽淵願網築淵 ~ 廠製壓廠糧憲糧壓膚壓) 更多
NCT05445778 (GLORIOSA, Pubmed \| Future Oncol) 人工标引	临床3期	铂敏感性卵巢癌维持 FRα-high	-	Mirvetuximab soravtansine plus bevacizumab	餘繭齋積襯願鏇積製鏇(範願醖憲製鹽築鏇簾網) = 糧淵構鏇觸願蓋襯遞構醖顧築鏇顧顧獵簾膚製 (餘構齋觸構廠襯衊遞積, 41 ~ 89) 更多	积极	2024-07-31