Mirvetuximab soravtansine

今年的美国临床肿瘤学会（ASCO）会议聚焦于乳腺癌、胃癌、肺癌和头颈癌领域具有改变临床实践意义的研究成果，并重点关注了大型制药公司研发的新一代抗体药物偶联物（ADC）。以下是对会议内容的报道和分析：口服 SERDs 在 ER + 乳腺癌中的竞争在ASCO全体会议上，阿斯利康（AstraZeneca）展示了其口服选择性雌激素受体降解剂（SERD）camizestrant在ER 阳性 / HER2 阴性乳腺癌中的一线转换策略数据。III期SERENA-6 研究显示，在接受芳香化酶抑制剂和 CDK4/6 抑制剂标准治疗期间出现ESR1突变的患者中，换用 camizestrant 联合相同 CDK4/6 抑制剂后，疾病进展或死亡风险降低56%。然而，并非所有人都认可阿斯利康的连续循环肿瘤DNA（ctDNA）的监测方案。礼来肿瘤（Lilly Oncology）领域总裁Jacob Van Naarden强调了连续液体活检带来的经济、后勤和心理负担，然而其竞品口服 SERD imlunestrant 在III 期 EMBER-3 试验中无需复杂的监测流程即可实现相似的疾病控制持续时间。乳腺癌领域：Enhertu再获突破在乳腺癌领域的另一项突破中，阿斯利康与第一三共（Daiichi Sankyo）的 Enhertu（曲妥珠单抗德鲁替康），在转移性 HER2 阳性乳腺癌治疗领域大显身手。III 期 DESTINY-Breast09 研究结果显示，Enhertu 联合罗氏的 Perjeta（帕妥珠单抗）中位无进展生存期（PFS）达 40.7 个月，较标准治疗 Herceptin（曲妥珠单抗）+ Perjeta 延长超1年。Imfinzi 在胃癌围手术期治疗成功阿斯利康的III期MATTERHORN研究，有望为 Imfinzi（度伐利尤单抗）开辟又一重磅适应症。PD-L1抑制剂Imfinzi（durvalumab）联合FLOT化疗用于早期胃癌/胃食管结合部癌的围手术期治疗中，Imfinzi 改善了早期胃癌和胃食管交界癌患者的无事件生存期，而 Keytruda（帕博利珠单抗）此前在此领域未能成功。未来需聚焦的两个关键问题在于：对于微创或无淋巴结转移患者，该方案的获益风险比如何？以及疾病进展后的后续治疗顺序如何优化？默克 HER3靶向ADC 在非小细胞肺癌（NSCLC）中失利随着 Keytruda 专利到期日益临近，Merck& Co.的 HER3靶向ADC药物 patritumab deruxtecan 在总生存期（OS）上的失败及其撤回的监管申请更是雪上加霜。III 期 HERTHENA-Lung02 验证性研究数据显示，在 EGFR 突变的 NSCLC 患者中，三线治疗使用该 HER3 导向 ADC 的中位OS为16个月，与化疗组的15.9个月相比无显著差异，并导致两例致命性间质性肺病。默克正评估是否可通过生物标志物定义的亚组为 patritumab deruxtecan 在肺癌中寻找出路，并转向乳腺癌领域（计划今年启动III期研究）。Opdivo 挑战 Keytruda，在新诊断头颈鳞癌（HNSCC）中崭露头角ASCO 会前，Keytruda 围手术期治疗的 III 期 KEYNOTE-689 研究阳性结果提高了新诊断头颈鳞癌患者设定了更高标准。并可能挑战Keytruda在该领域的领先地位。礼来、艾伯维和默克展示新一代 ADC尽管 Enhertu 在现有获批 ADC中占据领先地位，但各大药企仍在加速布局：礼来：公布了其领先 ADC 药物 LY4170156 的首次人体试验数据，在晚期卵巢癌患者中总缓解率（ORR）达 55%。该候选药物靶向叶酸受体α（FRα），直接与艾伯维的 Elahere（mirvetuximab soravtansine）和 Genmab 的 rinatabart sesutecan（Rina-S）形成竞争。艾伯维：低调拓展其内部 ADC 平台，在会议上分享了 cMET 靶向 ADC 药物 telisotuzumab adizutecan（Temab-A）的I期数据，其在 EGFR 突变 NSCLC 患者三线治疗中 ORR 达 63%。默克：ASCO 的表现因 patritumab deruxtecan 的生存数据失利而蒙上阴影，但其管线中的其他ADC仍有早期积极数据，包括TROP2靶向ADCsacituzumab tirumotecan（sac-TMT）和 ROR1 靶向 ADC zilovertamab vedotin。信息来源：Pharma Industry News and Analysis | FirstWord Pharma药事纵横投稿须知：稿费已上调，欢迎投稿

LOS ANGELES, June 9, 2025 /PRNewswire/ -- TORL BioTherapeutics LLC (TORL), a clinical-stage biotechnology company discovering and developing new antibody-based immunotherapies to improve and extend the lives of patients with cancer worldwide, today announced the appointment of Anna Berkenblit, MD, MMSc, as Board Member. "We are excited and proud to welcome Anna to TORL's Board. Dr. Berkenblit's contributions as a clinician and an industry leader have made a significant global impact on patients, most recently by leading the clinical development of a new targeted treatment option for a subset of patients with ovarian cancer," said Mark J. Alles, Chairman and Chief Executive Officer at TORL BioTherapeutics. Dr. Berkenblit has more than two decades of experience in clinical development of novel anticancer therapies. Currently, she is the Chief Scientific and Medical Officer of the Pancreatic Cancer Action Network (PanCAN), responsible for the organization's scientific and clinical strategies through sponsored studies, research grants, health data, business development and patient services. Prior to joining PanCAN, Dr. Berkenblit served as Chief Medical Officer at ImmunoGen where she led the development of mirvetuximab soravtansine-gynx, a first-in-class antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα). Under Dr. Berkenblit's leadership, mirvetuximab soravtansine-gynx received FDA approval for the treatment of patients with FRα -positive platinum-resistant ovarian cancer (PROC). "I am thrilled to add my experience and expertise developing novel cancer therapeutics to the TORL Board," said Dr. Berkenblit. "I look forward to working with the Board and Management to build on the Company's current discovery and development progress, and to establish TORL BioTherapeutics as a global leader among oncology-focused biotechnology companies." "Anna's clinical and industry perspectives come at a critical time for TORL, advancing the portfolio of novel potential first- and best-in-class antibody-based therapies, starting with our Claudin 6-targeted ADC TORL-1-23. We are very excited that she has joined the TORL Board," commented Board Member and Scientific Co-founder Dennis Slamon, MD, PhD, Professor of Medicine, and Chief of the Division of Hematology/Oncology at UCLA's David Geffen School of Medicine. Prior to her leadership role at ImmunoGen, Dr. Berkenblit was Senior Vice President, Clinical Development at H3 Biomedicine, and Vice President, Head of Clinical Research at Aveo Oncology. She also held positions of increasing responsibility at Wyeth/Pfizer including Vice President, Asset Team Leader. Throughout her career, Anna has led clinical development and oncology trials spanning early testing through large registration programs. "Dr. Berkenblit's experience successfully developing mirvetuximab soravtansine-gynx, a first-in-class targeted ADC in PROC, will directly benefit the TORL team as we continue our registrational Phase 2 CATALINA-2 trial of TORL-1-23 ADC for Claudin 6-positive PROC patients, currently TORL's top priority in 2025," said Dave Licata, Co-founder, Board Member, President and Chief Financial Officer of TORL BioTherapeutics. Dr. Berkenblit earned an MD from Harvard Medical School and a Master of Medical Sciences (MMSc) at Harvard/MIT Health Sciences & Technology. Her internship and residency were at Brigham and Women's Hospital and hematology/oncology fellowship at Beth Israel Deaconess Medical Center (BIDMC) where she continued as staff to focus on clinical research in gynecological and gastrointestinal malignancies. Subsequently, Anna led the BIDMC/Dana-Farber Harvard Cancer Center Phase 1 oncology clinical trial program prior to entering the biopharmaceutical industry. About Claudin 6 Claudin 6 (CLDN6) is overexpressed in multiple cancers with limited to no detectable expression observed in normal tissues, thus an ideal target for ADC development. CLDN6 is a transmembrane protein important for cell-to-cell connectivity in normal tissues during development but not in adult tissues. Overexpression of CLDN6 occurs in certain malignancies and is implicated in the initiation, progression, and metastasis of certain cancers, which include ovarian, non-small cell lung, endometrial, testicular and others. High expression correlates with shortened survival outcomes for patients with ovarian cancer. About TORL-1-23 TORL-1-23 is a first- and potentially best-in-class clinical-stage ADC for the treatment of CLDN6+ solid tumors. TORL-1-23 has received Fast Track Designation from the U.S. Food and Drug Administration. TORL BioTherapeutics is currently enrolling the pivotal Phase 2 CATALINA-2 study of TORL-1-23 in women with CLDN6+ PROC. Further details can be found at . About CATALINA-2 CATALINA-2 is a global, randomized, open-label Phase 2 study of novel CLDN6-targeted ADC TORL-1-23 in women with CLDN6+ PROC who have received one to three prior lines of therapy. The primary endpoint is objective response rate (ORR) per RECIST v1.1 by blinded independent central review. Secondary endpoints consist of duration of response, ORR by investigator assessment, progression-free survival, overall survival and safety. Further details can be found at . About TORL BioTherapeutics LLC TORL is a clinical-stage biopharmaceutical company developing new antibodies, both monoclonal antibodies and ADCs, with the goal of transforming the lives of patients challenged with a variety of human malignancies. Through a strategic partnership with the Slamon Research Lab at UCLA, TORL has exclusive development and commercial rights to a large program of biologics-based drugs for new, promising and novel cancer targets. SOURCE TORL Biotherapeutics LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED