Mirvetuximab soravtansine

点击蓝字 关注我们 编者按 2026年10月1日至3日，国际妇科肿瘤学会（IGCS）全球年会在加拿大蒙特利尔举行。本届大会上，铂耐药卵巢癌成为学术焦点之一，三项入选Late-Breaking Abstracts（LBA）的研究，分别从靶向CDH6的抗体偶联药物（ADC）、免疫联合化疗的组织学亚型探索，以及靶向FRα的ADC三个维度，为这一预后不佳、治疗选择有限的疾病带来了最新证据。作为全球妇科肿瘤领域最具影响力的学术舞台之一，IGCS年会上的这些进展，正为临床实践勾勒出更清晰的治疗方向。 先读懂困局：铂耐药卵巢癌为何难治 铂耐药卵巢癌（PROC）通常指含铂方案治疗后6个月内发生复发的卵巢癌，历来是卵巢癌治疗中最棘手的困局之一。此类患者传统化疗疗效有限，多数难以获得持久缓解，且随着治疗线数增加，可用的有效策略越来越少。 在此背景下，抗体偶联药物（ADC）凭借精准递送细胞毒载荷的优势，正成为铂耐药卵巢癌最受瞩目的新治疗方向之一；免疫联合化疗也在探索通过组织学亚型筛选实现更精准的获益。本次IGCS大会上的三项LBA，正是这些探索的集中体现。 CUSP06：CDH6靶向ADC，重度经治患者中的持久活性 研究概览 CUSP06是一种靶向钙黏蛋白6（CDH6）的ADC，携带拓扑异构酶I抑制剂载荷（依喜替康）。此前的Ph1a阶段研究显示，CUSP06已展现出初步抗肿瘤活性和可管理的安全性。 研究设计 CUSP06-1001是一项正在进行的Ph1a/1b开放标签、多中心剂量递增与扩展研究，纳入PROC及其他CDH6阳性肿瘤患者。在Ph1b剂量优化阶段，既往接受过1~4线治疗的PROC患者按1:1随机分入两对队列：3.6 mg/kg与4.4 mg/kg＋G-CSF，以及4.0 mg/kg与4.0 mg/kg＋G-CSF（每队列约20例）。研究终点包括客观缓解率（ORR）、缓解持续时间（DOR）、无进展生存期（PFS）以及安全性和药代动力学参数。 初步数据 截至2026年6月15日，共181例患者接受治疗，其中82例为Ph1b期PROC患者；所有Ph1b PROC队列入组均已完成。4.0 mg/kg及4.0 mg/kg＋G-CSF队列随访尚不成熟。 安全性与此前Ph1a结果一致，未观察到新的安全信号；预防性使用G-CSF降低了高级别中性粒细胞减少的发生。 虽然疗效数据仍在成熟中，但各队列均观察到令人鼓舞的临床活性：3.6 mg/kg队列ORR为50.0%（10/20），4.4 mg/kg＋G-CSF队列为40.0%（8/20）；既往接受过索米妥昔单抗治疗人群的ORR为45.0%（9/20）。在缓解者中，4例Ph1b患者达到完全缓解（CR），其中1例在部分缓解（PR）7个月后达到CR；9例患者治疗时间≥12个月，1例持续缓解接近2年。 意义与影响 CUSP06在重度经治的PROC患者中展现出持久的抗肿瘤活性和可管理的安全性，支持其在未按CDH6和FRα表达筛选的患者中持续推进开发。 KEYNOTE-B96：免疫联合化疗，各组织学亚型一致获益 研究概览 某些卵巢癌组织学亚型（如透明细胞癌，CCC）与较差的预后和生存结局相关。在Ⅲ期ENGOT-ov65/KEYNOTE-B96研究（NCT05116189）中，帕博利珠单抗（对比安慰剂）联合周疗紫杉醇±贝伐珠单抗，在铂耐药复发卵巢癌患者中显著改善了PFS和OS，无论是总人群还是PD-L1联合阳性评分（CPS）≥1人群均如此。本次分析进一步评估了不同PROC组织学亚型中的获益。 研究方法 入组患者为组织学确认、铂耐药的上皮性卵巢癌、输卵管癌或原发性腹膜癌，涵盖多种组织学亚型，包括高级别浆液性或以浆液性为主、透明细胞癌、低级别浆液性、任意级别子宫内膜样癌及癌肉瘤。患者按1:1随机分配接受帕博利珠单抗400 mg静脉注射或安慰剂Q6W，均联合周疗紫杉醇（每个3周周期的第1、8、15天，80 mg/m2）±贝伐珠单抗（10 mg/kg Q2W），直至疾病进展或出现不可耐受毒性。主要终点为PD-L1 CPS≥1人群及总人群中研究者评估的RECIST v1.1 PFS；OS为两个人群的关键次要终点。按组织学亚型的疗效结局为预设的探索性终点。 初步数据 最终分析中，按组织学亚型展示的疗效结局显示，帕博利珠单抗（对比安慰剂）联合周疗紫杉醇±贝伐珠单抗，在PD-L1 CPS≥1人群和总人群中，各组织学亚型的PFS和OS获益均一致。 意义与影响 帕博利珠单抗（对比安慰剂）联合周疗紫杉醇±贝伐珠单抗在PD-L1 CPS≥1人群及总人群中，各组织学亚型的PFS和OS获益均与总人群结果一致。 Rina-S：FRα靶向ADC单药，Ⅱ期结果显著且持久 研究概览 Rinatabart sesutecan（Rina-S）是一种研究性FRα靶向ADC，携带拓扑异构酶I抑制剂载荷和亲水性蛋白酶可裂解连接子。剂量优化已确定120 mg/m2为Rina-S在PROC中的Ⅱ期推荐剂量（RP2D）。本报告为RAINFOL-01研究（NCT05579366）中评估Rina-S 120 mg/m2 Q3W单药治疗PROC患者的单臂Ⅱ期结果。 研究方法 入组患者为转移性或不可切除PROC，既往接受过1~3线治疗（pLOT）；若患者FRα表达≥75%且最近一次治疗为米妥昔单抗（MIRV），允许接受最多4线治疗。入组不受FRα表达水平限制。主要终点为ORR，次要终点包括DOR、PFS、OS和安全性。 初步数据 共109例患者接受治疗，中位随访13.6个月。超过半数（53%）患者既往接受过3或4线治疗；所有患者均接受过贝伐珠单抗和紫杉类药物，33%接受过MIRV。研究者评估的确认ORR为45.9%（95%CI：36.3~55.7），其中包括5例CR；疾病控制率（DCR）为94.5%（95%CI：88.4~98.0）。中位DOR为12.1个月（95%CI：6.5~15.4），截至数据截止时42%的缓解仍在持续，其中包括全部CR。中位PFS为9.5个月（95%CI：7.6~11.3）。 安全性方面，≥3级治疗期间出现的不良事件（TEAEs）主要为中性粒细胞减少（33.9%）、贫血（30.3%）和血小板减少（23.9%）。未发生致死性TEAEs；7例（6.4%）患者因TEAEs停用Rina-S。 意义与影响 Rina-S 120 mg/m2 Q3W在需求尚未获得满足的PROC患者人群中带来了显著而持久的抗肿瘤活性，并转化为有意义的PFS获益，且安全性可耐受。 国际视角：ADC浪潮下的治疗新图景 本届IGCS大会上，三项LBA共同指向一个清晰趋势：抗体偶联药物正成为铂耐药卵巢癌最受瞩目的新治疗支柱之一。无论是CDH6靶向的CUSP06、FRα靶向的Rina-S，还是在既往接受过米妥昔单抗人群中的探索，均在重度经治患者中展现出实现持久缓解的潜力。KEYNOTE-B96则从组织学亚型角度，进一步夯实了免疫联合化疗在PROC中的价值。 一个值得关注的细节是，CUSP06和Rina-S在索米妥昔单抗经治人群中均观察到抗肿瘤活性。这提示，围绕FRα及相关ADC，未来可能形成序贯或互补的治疗策略——这将是后续临床研究值得持续关注的方向。 同时也要看到数据仍在成熟：CUSP06的4.0 mg/kg剂量队列随访尚不成熟，其成熟随访结果，以及三项策略的Ⅲ期确证性研究数据，将决定这些方向能否真正改变临床实践。 摘要来源：International Journal of Gynecologic Cancer，DOI分别为10.1016/j.ijgc.2026.105617、105618、105619 （来源：《肿瘤瞭望》编辑部） 声 明 凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

DALLAS, Oct. 13, 2026 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON) today announced the appointment of Isabel Kalofonos as Chief Commercial Officer. A highly accomplished biopharmaceutical executive with more than 20 years of commercial leadership experience, Ms. Kalofonos will lead the Company's commercial strategy and execution as CG Oncology advances toward the potential launch of cretostimogene grenadenorepvec and continues to establish itself as a leader in bladder cancer. "Isabel’s appointment reflects our commitment to ensuring we are well positioned to bring cretostimogene to as many patients as possible upon approval," said Arthur Kuan, Chairman and Chief Executive Officer of CG Oncology. "As we prepare for a potential first commercial launch, we are making deliberate investments in experienced leaders who have successfully built commercial organizations, developed differentiated strategies, and delivered product launches at scale. Isabel brings an outstanding track record of commercial execution across multiple therapeutic areas and stages of growth, and we are confident her expertise will be instrumental as we prepare to deliver on the full potential of cretostimogene." Ms. Kalofonos brings more than 20 years of experience driving successful launches and commercial execution, helping bring innovative therapies to patients at scale across the biotechnology and pharmaceutical industries. Most recently, she served as Chief Commercial Officer of Crinetics Pharmaceuticals (acquired by Vertex Pharmaceuticals), where she played a key role in the company’s transition to the commercial stage, helping to drive the successful launch of PALSONIFY™ (paltusotine) and advance commercial planning across the pipeline. Prior to Crinetics, Ms. Kalofonos served as Chief Commercial Officer at ImmunoGen (acquired by AbbVie), where she led the successful launch of ELAHERE® (mirvetuximab soravtansine) in ovarian cancer. Earlier in her career, Ms. Kalofonos served as Senior Vice President and Global Head of the Prescription Business Unit at Galderma, where she oversaw the build-out of the business unit and pre-launch preparations for NEMLUVIO® (nemolizumab). She also served as Vice President and Head of the Hereditary Angioedema Franchise at Takeda Pharmaceuticals (formerly Shire), leading a multi-billion-dollar business and the successful global launch of TAKHZYRO® (lanadelumab‑flyo). Throughout her career, she has built and led high-performing global commercial organizations across oncology, immunology, rare diseases, and neurology. Ms. Kalofonos holds an M.B.A. in Entrepreneurship and Marketing from Babson College and a bachelor's degree in Industrial Engineering from Pontificia Universidad Javeriana. "CG Oncology is entering an exciting and transformative period, and I am thrilled to join the company at such a pivotal time," said Isabel Kalofonos. "The clinical data generated to date for cretostimogene, the significant unmet need that remains for patients with bladder cancer, and the passion of the CG Oncology team make this a truly compelling opportunity. Having spent much of my career preparing companies for launch and building commercial organizations, I look forward to hitting the ground running, partnering across the organization, and helping ensure we are ready to successfully bring cretostimogene to patients." About Cretostimogene Grenadenorepvec Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 400 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. Cretostimogene has received FDA Fast Track and Breakthrough Therapy designations. CG Oncology also has a Phase 2 trial, CORE-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority. About CG Oncology CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: . Forward-Looking Statements CG Oncology cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding the potential approval and commercial launch of cretostimogene, the timing, progress and success of our commercial launch preparations and commercialization activities, our ability to build and execute our commercial strategy and establish the infrastructure necessary to support a potential commercial launch, the anticipated contributions of our Chief Commercial Officer, our ability to bring cretostimogene to patients, if approved, the potential therapeutic and commercial benefits of cretostimogene, and our ability to advance our position in the treatment of bladder cancer. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: the timing and outcome of regulatory review of cretostimogene and the possibility that regulatory approval may be delayed, limited or not obtained, uncertainties regarding the timing and success of our commercial launch preparations and commercialization activities, our ability to establish, scale and maintain an effective commercial infrastructure, the scope of any approved indication or labeling for cretostimogene, the rate and degree of market acceptance of cretostimogene, if approved, by patients, healthcare providers and payors, our ability to obtain and maintain adequate pricing, coverage and reimbursement, our ability and the ability of our third-party manufacturers and suppliers to manufacture and supply sufficient quantities of cretostimogene for commercial use, competition from existing and future therapies, unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval or commercialization, our dependence on third parties in connection with manufacturing, shipping, clinical testing and commercialization activities, our ability to attract and retain key personnel, and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K and other filings that we make with the SEC from time to time (which are available at ). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contacts: Media Sarah Connors Vice President, Communications and Patient Advocacy, CG Oncology sarah.connors@cgoncology.com Investor Relations Megan Knight Vice President, Investor Relations, CG Oncology megan.knight@cgoncology.com