A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Subjects With Low CA125 Platinum-Sensitive Ovarian Cancer

MORAb-003-011 is a global, multicenter, double-blind, randomized placebo-controlled study to assess the safety and efficacy of farletuzumab in combination with standard chemotherapy in subjects with low cancer antigen 125 (CA125) platinum-sensitive ovarian cancer in first relapse.

开始日期2015-03-19

申办/合作机构

Eisai, Inc.

NCT01218516 / Completed临床2期

A Randomized, Double-Blind, Placebo-Controlled, Study of the Safety and Efficacy of Farletuzumab in Combination With a Platinum-Containing Doublet in Chemotherapy-Naive Subjects With Stage IV Adenocarcinoma of the Lung (FLAIR)

The primary objective of this study is to compare the effect of farletuzumab versus placebo in combination with either a platinum agent (carboplatin) with paclitaxel or a platinum agent (carboplatin or cisplatin) with pemetrexed followed by farletuzumab or placebo on investigator-assessed progression free survival (PFS) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 or definitive clinical disease progression (eg, new occurrence of positive fluid cytology) in chemotherapy naive participants with folate receptoralpha (FRA)-expressing Stage IV adenocarcinoma of the lung.

开始日期2011-06-27

申办/合作机构

Morphotek, Inc.

EUCTR2008-005449-43-BE / Not yet recruiting临床3期

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of MORAb-003 (farletuzumab) in Combination with Paclitaxel Therapy in Subjects with Platinum-Resistant or Refractory Relapsed Ovarian Cancer

开始日期2011-02-04

申办/合作机构

Morphotek, Inc.

100 项与 Farletuzumab 相关的临床结果

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100 项与 Farletuzumab 相关的转化医学

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100 项与 Farletuzumab 相关的专利（医药）

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项与 Farletuzumab 相关的文献（医药）

2023-03-01·International journal of gynecological cancer : official journal of the International Gynecological Cancer Society

Integrating antibody drug conjugates in the management of gynecologic cancers

Review

作者: Mahner, Sven ; Coleman, Robert L ; Lorusso, Domenica ; Moore, Kathleen Nadine ; Chelariu-Raicu, Anca

The clinical development of antibody drug conjugates (ADCs) in ovarian cancer began in 2008 with farletuzumab, a humanized monoclonal antibody, and vintafolide, an antigen drug conjugate, both targeting alpha folate receptor. Over the years, this novel class of drugs expanded to agents with a more sophisticated design and structure, targeting tissue factor (TF) in cervical cancer or human epidermal growth factor receptor 2 (HER2) in endometrial cancer. Despite the impressive number of patients included in clinical trials investigating different ADCs across gynecological cancers, it was only recently that the Food and Drug Administration (FDA) granted accelerated approvals to the first ADCs in gynecologic cancer. In September 2021, the FDA approved tisotumab vedotin (TV) in recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This was followed in November 2022, by the approval of mirvetuximab soravtansine (MIRV) for adult patients with folate receptor alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Currently, the field of ADCs is rapidly expanding and more than 20 ADC formulations are in clinical trials for the treatment of ovarian, cervical and endometrial tumors. This review summarizes key evidence supporting their use and therapeutic indications, including results from late-stage development trials investigating MIRV in ovarian cancer and TV in cervical cancer. We also outline new concepts in the field of ADCs, including promising targets such as NaPi2 and novel drug delivery platforms such as dolaflexin with a scaffold-linker. Finally, we briefly present challenges in the clinical management of ADC toxicities and the emerging role of ADC combination therapies, including chemotherapy, anti-angiogenic and immunotherapeutic agents.

2023-03-01·Gynecologic oncology

Randomized phase II trial of farletuzumab plus chemotherapy versus placebo plus chemotherapy in low CA-125 platinum-sensitive ovarian cancer

Article

作者: González-Martín, Antionio ; Rubio, Maria-Jesús ; Vulsteke, Christof ; Ushijima, Kimio ; Monk, Bradley J ; Gabra, Hani ; Arranz, José A ; Fujiwara, Keiichi ; Wenham, Robert M ; Ramsay, Lisa ; Hanna, Rabbie ; Armstrong, Deborah K ; Jia, Yan ; Zamagni, Claudio ; Tewari, Krishnansu S ; Sehouli, Jalid ; Scambia, Giovanni ; Slomovitz, Brian ; Ghamande, Sharad A ; Weil, Susan C ; Herzog, Thomas J ; Pignata, Sandro ; Vergote, Ignace B ; Coleman, Robert L

OBJECTIVE:

The primary purpose of this study was to determine if farletuzumab, an antifolate receptor-α monoclonal antibody, improved progression-free survival (PFS) versus placebo when added to standard chemotherapy regimens in patients with platinum-sensitive recurrent ovarian cancer (OC) in first relapse (platinum-free interval: 6-36 months) with low cancer antigen 125 (CA-125) levels.

METHODS:

Eligibility included CA-125 ≤ 3 x upper limit of normal (ULN, 105 U/mL), high-grade serous, platinum-sensitive recurrent OC, previous treatment with debulking surgery, and first-line platinum-based chemotherapy with 1st recurrence between 6 and 36 months since frontline platinum-based treatment. Patients received investigator's choice of either carboplatin (CARBO)/paclitaxel (PTX) every 3 weeks or CARBO/pegylated liposomal doxorubicin (PLD) every 4 weeks x6 cycles in combination with either farletuzumab [5 mg/kg weekly] or placebo randomized in a 2:1 ratio. Maintenance treatment with farletuzumab (5 mg/kg weekly) or placebo was given until disease progression or intolerance.

RESULTS:

214 patients were randomly assigned to farletuzumab+chemotherapy (142 patients) versus placebo+chemotherapy (72 patients). The primary efficacy endpoint, PFS, was not significantly different between treatment groups (1-sided α = 0.10; p-value = 0.25; hazard ratio [HR] = 0.89, 80% confidence interval [CI]: 0.71, 1.11), a median of 11.7 months (95% CI: 10.2, 13.6) versus 10.8 months (95% CI: 9.5, 13.2) for farletuzumab+chemotherapy and placebo+chemotherapy, respectively. No new safety concerns were identified with the combination of farletuzumab+chemotherapy.

CONCLUSIONS:

Adding farletuzumab to standard chemotherapy does not improve PFS in patients with OC who were platinum-sensitive in first relapse with low CA-125 levels. Folate receptor-α expression was not measured in this study. (Clinical Trial Registry NCT02289950).

2021-07-15·Clinical cancer research : an official journal of the American Association for Cancer Research1区 · 医学

First-in-Human Phase 1 Study of MORAb-202, an Antibody–Drug Conjugate Comprising Farletuzumab Linked to Eribulin Mesylate, in Patients with Folate Receptor-α–Positive Advanced Solid Tumors

1区 · 医学

Article

作者: Koyama, Takafumi ; Shimizu, Toshio ; Furuuchi, Keiji ; Yamamoto, Noboru ; Fujiwara, Yutaka ; Miura, Takuma ; Tamura, Kenji ; Yonemori, Kan ; Ikezawa, Hiroki ; Shimomura, Akihiko ; Sato, Jun ; Nomoto, Maiko ; Nakajima, Ryo

Abstract:

Purpose::

MORAb-202, an antibody–drug conjugate containing farletuzumab and eribulin with a cathepsin-B cleavable linker, targets folate receptor α (FRα)–expressing tumor cells. The primary objective of this first-in-human study was to evaluate the safety and tolerability of MORAb-202 in patients with solid tumors.

Patients and Methods::

Patients ≥20 years with adequate organ function and FRα-positive solid tumors who failed to respond to standard therapy were eligible. Patients received MORAb-202 intravenously at doses of 0.3 to 1.2 mg/kg once every three weeks. Endpoints included dose-limiting toxicities, safety, tumor responses, pharmacokinetics, and pharmacodynamics. Trial registration number: NCT03386942 (ClinicalTrials.gov).

Results::

Between November 28, 2017 and June 4, 2019, 22 patients (median age, 58.0 years) with advanced solid tumors were enrolled. Treatment-emergent adverse events occurred in 21 (95%) patients, with leukopenia and neutropenia in 10 (45%) patients each. One patient (0.9 mg/kg cohort) experienced two grade 3 dose-limiting toxicities: serum alanine aminotransferase and γ-glutamyl transferase increases. Following review by an independent adjudication committee, grade 1/2 interstitial lung disease thought to be related to MORAb-202 was identified in five (23%) patients. Complete response, partial response, and stable disease were observed in one, nine, and eight patients, respectively. The normalized predose serum FRα tended to be positively correlated with the maximum tumor shrinkage (R2 = 0.2379; P = 0.0291).

Conclusions::

The MTD of MORAb-202 was not reached. MORAb-202 demonstrated promising antitumor activity in FRα-positive solid tumors and was generally well-tolerated at the tested doses. Further investigations are required to establish appropriate dosage and clinical utility of MORAb-202.

项与 Farletuzumab 相关的新闻（医药）

2024-08-30

·生物制品圈

经历重重挫折，FRα 曲折的“靶生”

FRα一直被视为一种有潜力的靶点，但其成药之路经历了起起伏伏：卫材公司开发的人源化单抗farletuzumab，及默沙东与Endocyte公司合作开发的叶酸偶联药物Vintafolide等，都未能如预期般成功 2022年11月，FRα靶向ADC药物ELAHERE首次获得FDA加速批准，历经两年后获得正式批准。 2024年4月，Genmab公司以高达18亿美金的现金收购了普方生物，获得其核心首发管线ADC药物rinatabart sesutecan（Rina-S）。 BMS退回卫材的FRα靶向ADC farletuzumab ecteribulin（FZEC），该交易里程碑金额高达24.5亿美元。叶酸受体（FRα）靶点叶酸，这个在妊娠期预防出生缺陷中广为人知的营养素，其背后蕴含着FRα在胚胎发育中的巨大作用。叶酸受体α（FRα）由FOLR1编码，是分子量38-40KD的细胞表面糖蛋白，发现其除了运送叶酸外还参与调控肿瘤细胞的增殖和转移。叶酸是维持细胞生长和代谢所必需的重要营养物质，它在DNA和RNA的合成中起着关键作用。在某些快速增殖的癌细胞中，其对叶酸的需求更高（如乳腺癌、卵巢癌、肺癌等），叶酸受体α表达水平明显增加。FRα在实体瘤中有广泛高表达，比如间皮瘤（72-100%），三阴性乳腺癌（35-68%），卵巢癌（76-89%），非小细胞肺癌（14-74%）；而在正常组织中表达率很低或仅在特定局限区域表达。在癌症中过表达FRα和正常组织中FRα表达水平除了肿瘤组织过表达，正常组织中表达受限以外，与非生理性叶酸高度的亲和力、参与癌细胞信号转导与促生存信号通路也是FRα被广泛应用于临床的重要原因。在FRα靶点开发上，有单抗、ADC、小分子偶联药物，CART等多种机制，其中ADC是当前研发的热点。上市及在研FRα ADC（来源：德邦证券）唯一上市FRα ADC：Elahere Elahere（mirvetuximab soravtansine）是首款上市FRa ADC药物，毒素为DM4，linker为可裂解连接子。 2022 年 11 月，FDA 加速批准使用 Elahere 治疗既往接受过 1 至 3 次全身治疗方案的 FRα 阳性、铂类耐药上皮性卵巢癌、输卵管癌或原发性腹膜癌成人。自上市后放量迅速：根据ImmunoGen公司财报， 2023年一季度的销售额为2950万美元，二季度为7740万美元，第三季度美国净销售额为1.052亿美元，前九个月销售额达到2.12亿美元。2023年11月30日，艾伯维（AbbVie）与ImmunoGen宣布达成最终协议，艾伯维将以总额达约101亿美元收购ImmunoGen。 2024 年3月22日，FDA完全批准Elahere用于治疗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ADC。完全批准是基于确证性3期MIRASOL试验的数据。该试验在铂耐药的卵巢癌（PROC）患者中将ELAHERE治疗与研究者选择（IC）的化疗进行了比较。结果显示：中位PFS结果 AE结果 Elahere组患者的中位OS为16.46个月，IC化疗组为12.75个月。总生存期风险比（HR）为0.67（95%置信区间[CI]：0.50，0.88；p=0.0046），与IC化疗组相比，ELAHERE组的死亡风险降低了33%。无进展生存期风险比为0.65（95% CI：0.52，0.81；p<0.0001），与IC化疗组相比，ELAHERE组肿瘤或癌症进展的风险降低了35%。 Elahere组的中位PFS为5.62个月，而IC化疗组为3.98个月。 Elahere组患者的ORR为42.3%，包括12例完全缓解（CR），而IC化疗组为15.9%，无患者获得CR。与IC化疗对照组相比，ELAHERE组3级以上不良事件更少，不良事件导致的停药率更低。 FRα吸引了大量的药企入局。只是，过去理想很丰满，现实很骨感。从90年代发现至今，FRα经历重重挫折仍未成药，单抗、小分子偶联药物研发纷纷折戟。 Elahere的出现拯救了FRα靶点，但是Elahere也有一些缺憾，患者群体较窄，只对高度表达FRα的患者有效。而这类患者只占据卵巢癌人群的35-40%，对于更多的FRα中低表达患者，Elahere束手无策。另一方面是绕不开的安全问题，一名患者因视力障碍而终止治疗。为了提醒人们注意这一副作用，FDA直接给Elahere打上了黑框警告。前赴后继的FRα玩家百奥泰BAT8006 BAT8006由重组人源化抗 FRα 抗体与毒性小分子拓扑异构酶 I 抑制剂通过自主研发的可剪切连接子连接而成，DAR为8，为高DAR搭配中等毒性的毒素的第四代ADC药物。 BAT8006 Ⅰ期临床研究数据发布。截至2023年7月6日，29名晚期实体瘤患者被纳入到了1.2mg/kg、1.8mg/kg、2.1mg/kg、2.4mg/kg剂量组进行剂量爬坡研究。纳入的受试者无FRα表达水平的要求，囊括了卵巢癌、乳腺癌、非小细胞肺癌和宫颈癌等多个瘤种，其中卵巢癌受试者占比约60%。结果显示：总体客观缓解率（ORR）为31%，疾病控制率（DCR）为86.2%。对于卵巢癌：在2.1 mg/kg和2.4mg/kg剂量水平下，共纳入了15例受试者，在TPS>25%的12例受试者中，ORR达到58.3%，DCR为91.7%。安全性方面，无观察到间质性肺疾病、眼毒性以及显著的肝毒性等不良事件。 2024年3月，BAT8006的2期临床试验申请获美国FDA许可，拟在铂耐药上皮性卵巢癌、输卵管癌或原发性腹膜癌患者中评估其疗效及安全性。 BAT8006的Ib/IIa期临床研究结果 2024年ASCO年会上，百奥泰以壁报形式汇报了BAT8006的Ib/IIa期临床研究结果。研究显示，不论FRα表达水平如何，ORR为37.0%（包含5例未确认的部分缓解），中位缓解持续时间为6.3个月，中位无进展生存期（PFS）为7.47个月，6个月、1年总生存（OS）率均为83.0%。 Genmab/普方生物Rina-S Rina-S（PRO1184）是一款以FRα为靶点、以拓扑异构酶1抑制剂依喜替康作为有效载荷，采用普方生物自主研发的新型亲水性连接子的在研ADC药物，目前正处于针对多种实体肿瘤的临床1/2期开发阶段，预计将于2027年首次获批。 Rina-S（PRO1184）结构在SITC 2023上公布了Rina-S1/2期试验数据，结果显示：各剂量的卵巢/子宫内膜癌的 ORR为 38%（21例）；在 FRα 表达>1%的卵巢癌和子宫内膜癌患者中，ORR67%；安全性良好，大多数TRAE为1级或2级。阿斯利康AZD5335 AZD5335由由FRα靶向抗体与AstraZeneca专有的拓扑异构酶1抑制剂（TOP1i）有效载荷（AZ14170132）偶联而成，其DAR值为8。目前全球最高研发状态为临床 I/IIa 期（NCT05797168）。在2023年AACR上，阿斯利康公布了AZD5335临床前数据。数据显示，相同或更高剂量下，在FRα低-中表达的两种卵巢癌患者的异种移植模型（PDX）中，AZD5335比基于微管抑制剂（MTI）有效载荷的靶向FRα ADC具有更优秀的临床前活性。 Sutro/天士力STRO-002 STRO-002由Sutro Biopharma开发的一种新型的FOLR1/FRα靶向ADC。该药由IgG1亚型抗FRα单抗、SC209（一种具有抗微管活性的半阿斯特林衍生物）和可裂解连接子三部分组成，其DAR值为4。目前最高研发状态为临床II/III期（NCT05870748），该项临床研究旨在对比luveltamab tazevibulin和IC化疗对FOLR1表达的卵巢癌(包括输卵管癌或原发性腹膜癌)的疗效和安全性。 2021年12月，天士力与Sutro Biopharma达成总金额为$3.85亿美元的合作协议。根据协议内容，天力士将获得其靶向FRα的ADC药物，Luveltamab Tazevibulin在中国大陆及港澳台的独家开发和商业化权益。 2023 ASCO上公布的I期剂量扩展研究（NCT03748186）结果显示：在总人群中ORR为37.5%，mPFS为6.1个月；5.2 mg/kg亚组的ORR（6.1 vs 6.6个月）和mPFS（31.3% vs 43.8%）稍优于4.3 mg/kg亚组。在FRa高表达（>25%）患者中疗效显著优于FRa低表达（≤25%）患者（ORR：11.1% vs 37.5%）。 STRO-002的1期剂量扩展研究资料来源： 1.各公司官网 2.德邦证券：大交易频频, 叶酸受体（FRα）ADC有什么魅力？ 3.Antibody Research：首款FRα ADC获完全批准上市，国内头部管线竞争格局分析识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

抗体药物偶联物引进/卖出免疫疗法上市批准并购

2024-07-19

·九洲药业

【速递】FRα ADC遭受退货，BMS/卫材超30亿美元战略合作终止

2024年7月2日，卫材株式会社（Eisai）宣布，由于百时美施贵宝内部正在进行产品组合优先排序工作，公司已同意终止与百时美施贵宝关于 farletuzumab ecteribulin（FZEC，原称MORAb-202，一种针对叶酸受体α （FRα）的抗体药物偶联物）共同开发和商业化的全球战略合作。根据协议，卫材现在拥有FZEC的所有权利，并将全权负责该药物的全球开发和商业化。卫材将加快FZEC的开发，并将其作为高优先级任务，希望尽早将其交付给患者。卫材将退还合作协议中由百时美施贵宝支付的2亿美元研发费中未使用金额的一部分，并将剩余部分记为其他收入。 FZEC目前正在进行三项临床研究：卫材针对实体瘤的1/2期研究（NCT04300556）和百时美施贵宝针对卵巢癌、腹膜癌和输卵管癌（NCT05613088）和非小细胞肺癌（NCT05577715）的2期研究。关于Farletuzumab ecteribulin Farletuzumab ecteribulin是卫材的首个抗体药物偶联物（ADC)，由卫材内部开发的farletuzumab（一款靶向结合叶酸受体α(FRα）的人源化IgG1单克隆抗体），和内部开发的抗癌药物eribulin通过可酶切的连接体偶联而成。FZEC进入FRα阳性目标癌细胞，连接体被酶切后从抗体中释放出eribulin，从而发挥其抗肿瘤活性。当ADC的药物荷载和抗体成分在靶向抗原阳性癌细胞内分离时，理论上，释放的抗癌药物也会对邻近的抗原阴性癌细胞和肿瘤微环境的组成细胞产生旁观者效应。在临床前研究中，FZEC表现出旁观者效应，对FRα阳性癌细胞周围的FRα阴性癌细胞具有抗肿瘤活性。有效载荷eribulin是软海绵素类微管蛋白抑制剂中的第一种。从结构上看，eribulin是软海绵素B的简化合成版本，软海绵素B是从冈田软海绵（Halichondria okadai）中分离出来的天然产物，通过抑制微管动力学的生长期来阻止细胞分裂。Eribulin已在日本、美国、中国、欧洲和亚洲等国家获批用于治疗晚期乳腺癌和脂肪肉瘤（或称软组织肉瘤）。小结 2021年，BMS与Eisai达成全球性合作协议，共同开发和商业化靶向叶酸受体α（FRα）在研的抗体偶联药物MORAb-202，卫材获得6.5亿美元的前期付款和最高24.5亿美元的里程碑付款。在达成合作时，MORAb-202已有在22名FRα阳性实体瘤患者中开展的I期临床数据（包括乳腺癌、子宫内膜癌、非小细胞肺癌、卵巢癌和输卵管癌）。22例患者中，CR 1例（5%)，PR 9例（41%)，病情稳定8例（36%)。临床总受益率82%。 ▲MORAb-202 I期临床安全性结果 2022年，BMS开展了MORAb-202两项II期试验，一项针对卵巢癌、腹膜癌和输卵管癌，另一项针对非小细胞肺癌。两项研究都已超过预计的完成日期，但仍在ClinicalTrials.gov上显示患者招募中，BMS削减了招募患者数量，并在两项试验中降低了药物剂量。 BMS退还FRα ADC的开发权益，不仅仅是出于对MORAb-202临床毒性过大的担忧，还因为FRα ADC的市场竞争逐渐激烈。在BMS与卫材达成合作之后，BMS已经看到竞争对手 ImmunoGen研发的Elahere获得FDA 的完全批准，后被艾伯维以 101 亿美元收购后接手Elahere市场商业化。以及今年早些时候，Genmab以18亿美元收购普方生物，获得后者一款新型的、下一代的、潜在的同类最佳ADC产品Rina-S，加入FRα ADC的市场竞争。 FRα在实体瘤中有广泛的高表达，当前核心适应症包括卵巢癌、子宫内膜癌等妇科肿瘤传统治疗方法疗效有限，急需创新疗法，有较大的临床需求与市场空间。FRα ADC领域已经诞生3笔金额不低并购/授权交易，首款上市产品Elahere在3Q2023销售额突破2亿美元。全球范围内，亦有多款FRα ADC来自国内Biotech，除普方生物外还包括同宜医药、百奥泰、天力士、普众/联宁生物。 ▲FRα ADC临床研发格局此外，围绕FRα靶点除了主流的ADC之外，小分子、CAR-T、单抗、BiTE等多种药物形式的候选产品处于新药研发阶段。免责申明本公众号注明原创的内容权利均属九洲药业所有，未经授权，不得擅自使用或许可他人使用。如需获得授权，请和九洲药业提前联系。已获得授权的，应在授权范围内使用，并注明来源且不得再全部或部分转授权他人。本公众号对转载、分享的内容、陈述、观点判断保持中立，不对所包含内容的合法性、准确性、可靠性或完善性提供任何明示或暗示的保证，该等内容版权归原作者所有，仅供学习参考之用，若对转载、分享的内容有任何权利疑问，烦请联系九洲药业。

引进/卖出临床2期抗体药物偶联物临床1期并购

2024-07-12

·FiercePharma

Fierce Pharma Asia—BMS, Eisai's ADC divorce; Takeda's US layoffs; House Speaker's BIOSECURE pledge

Bristol Myers Squibb and Eisai's ADC deal termination, Takeda's planned layoffs in Massachusetts and the U.S. House Speaker's pledge for a vote on the BIOSECURE Act made our news in the past two weeks. After a break for the Fourth of July holiday in the U.S., we're back with two weeks' worth of biopharma news from Asia. During that time, Bristol Myers Squibb returned Eisai's FRα-targeted antibody-drug conjugate. In addition, Takeda telegraphed plans to lay off 220 employees in Massachusetts, while U.S. House Speaker Mike Johnson pledged a full floor vote on the BIOSECURE Act this year. 1. BMS axes Eisai ADC pact 3 years after paying $650M for would-be Elahere rival Bristol Myers Squibb has ended its bet on Eisai’s FRα-targeted antibody-drug conjugate, farletuzumab ecteribulin (MORAb-202), which is a potential competitor to AbbVie’s newly bought Elahere. The deal included $460 million upfront, $200 million in R&D support and up to $2.5 billion in milestones, giving BMS joint rights in the U.S. and Europe plus exclusive rights in other countries. Eisai now aims to “accelerate the development of the agent as a high priority.” 2. Takeda to cut another 220 jobs in Massachusetts, as Merck KGaA plots office move Takeda continues to reduce staffing levels in the U.S. amid a restructuring campaign. In Massachusetts, the Japanese pharma said it will cut 190 employees at its Cambridge headquarters and 31 people at its Lexington site, beginning in August. A previous round of 641 cuts was set to begin in early July. 3. House Speaker Mike Johnson pledges vote for BIOSECURE as China-targeting bill hangs in limbo U.S. House Speaker Mike Johnson pledged to advance several China-targeting bills in the remaining term of this Congress. Among them, the House will vote this year on the BIOSECURE Act, Johnson said at an event held by conservative think tank the Hudson Institute. 4. BIOSECURE Act hurts US biopharma industry's confidence in Chinese partners: survey Meanwhile, a L.E.K. survey found that U.S.-based life sciences companies experienced a sharp decline in confidence in working with Chinese partners. Already, 26% of 73 firms surveyed by the consulting firm said they’re looking to shift away from their Chinese partners, even tough only 2% have started the unwinding process. 5. China's share of trials jumps, along with enrollment times: IQVIA report Amid geopolitical turmoil, China’s share of the world’s clinical trials has surpassed Eastern Europe, an IQVIA report shows. The country’s proportion of world trials grew to 15% at the end of 2023, while Eastern Europe’s share declined to 11%. North American trials now make up 23% of the total, a 17% increase from five years ago, while Western Europe’s share fell to 25% of the global total. 6. J&J, Legend's Carvykti shows CAR-T can extend lives in multiple myeloma Johnson & Johnson and Legend Biotech said their Carvykti has shown a statistically significant overall survival benefit in the CARTITUDE-4 trial. Compared with two standard combination therapies, the BCMA CAR-T drug was better at extending the lives of multiple myeloma patients who had tried one to three prior lines of therapy. The latest win puts Carvykti further ahead of Bristol Myers Squibb’s rival, Abecma. 7. Ipsen scores 2nd preclinical ADC via $1B biobucks pact with Foreseen Ipsen has got its hand on a second antibody-drug conjugate this year. In a deal totaling $1.03 billion, the French pharma has obtained exclusive global rights to a preclinical solid tumor candidate by China’s Foreseen Biotechnology. The drug, coded FS001, targets an undisclosed tumor-associated antigen and uses a Topo1 inhibitor as its payload. The target was identified with Foreseen’s AI-powered screening platform. 8. High-flying Samsung Biologics inks $1B production pact with unnamed US pharma Samsung Biologics said it has signed a new manufacturing contract with a large, unnamed U.S. drugmaker worth 1.46 trillion Korean won (about $1.05 billion). The deal represents more than 39% of Samsung Biologics’ total sales from last year and is expected to run through the end of 2030. Other News of Note: 9. Elevar, Hengrui eye quick refile for PD-1 liver cancer combo after surprise FDA rejection 10. China-made injectable PD-L1 drug flunks pivotal trial, forcing US partner to seek strategic options 11. Without Pfizer appeal, Daiichi Sankyo closes long-running ADC patent arbitration with $47M win 12. Ensho emerges with inflammatory disease portfolio from Eisai's EA Pharm 13. CDMO Lotte breaks ground on $3.3B production plant in Korea, touts growth goals 14. Rexulti reclaims TV drug ad spending top spot as Otsuka, Lundbeck eat away at AbbVie’s dominance

抗体药物偶联物并购专利侵权引进/卖出

100 项与 Farletuzumab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09343	Farletuzumab	-	DB05595

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
铂敏感性卵巢癌	临床3期	美国	Morphotek, Inc.	2009-04-16
铂敏感性卵巢癌	临床3期	美国	Eisai Europe Ltd.	2009-04-16
铂敏感性卵巢癌	临床3期	日本	Eisai Europe Ltd.	2009-04-16
铂敏感性卵巢癌	临床3期	日本	Morphotek, Inc.	2009-04-16
铂敏感性卵巢癌	临床3期	阿根廷	Morphotek, Inc.	2009-04-16
铂敏感性卵巢癌	临床3期	阿根廷	Eisai Europe Ltd.	2009-04-16
铂敏感性卵巢癌	临床3期	澳大利亚	Eisai Europe Ltd.	2009-04-16
铂敏感性卵巢癌	临床3期	澳大利亚	Morphotek, Inc.	2009-04-16
铂敏感性卵巢癌	临床3期	奥地利	Eisai Europe Ltd.	2009-04-16
铂敏感性卵巢癌	临床3期	奥地利	Morphotek, Inc.	2009-04-16

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02289950 (Pubmed)	临床2期	铂敏感性卵巢癌	214	Farletuzumab+Chemotherapy	獵鑰鹹獵範壓膚襯願憲(範鑰簾範夢鏇鏇構簾遞) = 窪鹽遞選願積鹹構醖範醖築築壓淵願鏇壓廠繭 (鬱簾糧繭淵壓構簾範製 )	不佳	2023-02-07
				Placebo+Chemotherapy	獵鑰鹹獵範壓膚襯願憲(範鑰簾範夢鏇鏇構簾遞) = 願願築鏇艱艱範獵網艱醖築築壓淵願鏇壓廠繭 (鬱簾糧繭淵壓構簾範製 )
NCT00849667 (CTgov)	临床3期	铂敏感性卵巢癌	1,100	Carboplatin+Farletuzumab+Taxane (1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin)	積顧願簾網鬱淵網鏇觸(鬱鬱遞夢顧遞遞獵襯觸) = 獵衊製鏇願構鏇觸簾餘鑰顧糧構鹽膚範鹹選艱 (淵壓餘廠鹹艱範選網壓, 憲憲餘壓積鏇齋築醖築 ~ 範襯襯範憲獵繭製衊窪) 更多	-	2022-12-30
				Carboplatin+Farletuzumab+Taxane (2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin)	積顧願簾網鬱淵網鏇觸(鬱鬱遞夢顧遞遞獵襯觸) = 廠積顧齋顧遞鑰窪鏇襯鑰顧糧構鹽膚範鹹選艱 (淵壓餘廠鹹艱範選網壓, 鬱範構築鬱鬱簾網簾廠 ~ 艱醖餘範繭蓋艱繭膚網) 更多
NCT01018563 (CTgov)	临床2期	铂敏感性卵巢上皮癌 \| 卵巢上皮癌	3	Farletuzumab (Farletuzumab 62.5 mg/m^2)	遞積蓋壓淵鏇鹽襯鏇遞(廠範構範選淵膚選壓範) = 糧鬱遞鹹鏇獵鹽簾築夢構鬱糧衊襯觸遞衊積蓋 (鑰繭鹽製蓋齋艱衊鹹觸, 鏇襯獵衊夢鏇窪鏇鹽蓋 ~ 壓鏇蓋齋遞齋獵餘壓鑰) 更多	-	2021-12-08
				Farletuzumab (Farletuzumab 100 mg/m^2)	獵鏇襯窪製鏇鏇壓蓋鹹(艱淵窪選鬱憲積觸鹽襯) = 蓋餘淵築願製鏇鹹鏇淵衊糧觸壓簾淵鏇蓋構願 (窪艱範蓋簾積築鬱顧膚, 遞構鑰鹹網範糧夢範鏇 ~ 選襯選壓鹽簾築艱醖範) 更多
NCT02289950 (CTgov)	临床2期	铂敏感性卵巢癌 \| 卵巢上皮癌	332	PLD+Carboplatin+Paclitaxel+Farletuzumab (Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD)	廠簾獵鬱鏇鏇淵築鹽艱(鹹齋鹽鹽蓋淵糧網窪憲) = 獵鏇糧築襯襯遞築糧壓鬱鬱淵憲鹽觸觸夢壓顧 (醖網衊蓋顧積選蓋餘壓, 鹽觸廠鑰膚壓遞廠膚範 ~ 範鹽淵齋製廠艱鹽壓鏇) 更多	-	2021-09-02
				PLD+Carboplatin+Paclitaxel (Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD)	廠簾獵鬱鏇鏇淵築鹽艱(鹹齋鹽鹽蓋淵糧網窪憲) = 餘鹽繭鑰構餘廠網艱範鬱鬱淵憲鹽觸觸夢壓顧 (醖網衊蓋顧積選蓋餘壓, 選醖餘願壓醖積夢醖製 ~ 獵鹽鏇憲繭夢簾鏇糧製) 更多
NCT01218516 (CTgov)	临床2期	肺腺癌	130	Placebo (Combination Therapy: Placebo + Chemotherapy)	獵鏇築蓋夢積願壓顧築(蓋鬱夢鬱淵製築選窪醖) = 齋顧構構遞繭醖蓋齋構願鬱餘壓餘壓糧遞窪構 (顧糧襯願夢鑰選襯夢鏇, 製淵積醖觸製憲壓膚襯 ~ 艱製鬱廠鏇獵繭醖蓋構) 更多	-	2020-08-20
				Farletuzumab (Combination Therapy: Farletuzumab + Chemotherapy)	獵鏇築蓋夢積願壓顧築(蓋鬱夢鬱淵製築選窪醖) = 網積築餘餘遞鹽簾餘觸願鬱餘壓餘壓糧遞窪構 (顧糧襯願夢鑰選襯夢鏇, 鏇製遞構選築夢鏇壓鏇 ~ 襯構廠艱遞廠網夢獵選) 更多
NCT01004380 (Pubmed \| Obstet Gynecol Surv) 人工标引	临床1期	铂敏感性卵巢上皮癌	15	farletuzumab+carboplatin+pegylated liposomal doxorubicin	獵觸鏇糧鏇鹽窪餘窪網(鹽廠衊簾構廠鏇獵窪衊) = 廠襯選願夢鬱鹹築膚鏇蓋壓觸襯繭鏇選夢蓋選 (艱糧鬱積願鹹蓋壓膚艱 ) 更多	积极	2016-02-01
NCT01049061 (Pubmed \| Invest New Drugs) 人工标引	临床1期	实体瘤	16	farletuzumab	壓蓋觸鑰築鹽觸鏇艱遞(願醖製餘窪艱鏇蓋壓鬱) = Neither DLTs nor grade 3/4 toxicities were reported in all cohorts 範糧窪齋築構製觸網糧 (廠淵構廠鏇顧壓壓艱簾 ) 更多	积极	2015-04-01
WCLC2013	N/A	非小细胞肺癌	130	Farletuzumab 7.5 mg/kg	齋齋鬱遞壓獵簾醖範範(醖廠鑰夢糧醖選鹽顧鹽) = 簾夢簾齋鏇廠齋簾網構艱簾蓋艱憲觸廠艱膚艱 (鏇壓餘醖築顧艱鹽糧願 )	不佳	2013-10-28
				Placebo	齋齋鬱遞壓獵簾醖範範(醖廠鑰夢糧醖選鹽顧鹽) = 襯選衊廠鏇鹽觸鏇範鬱艱簾蓋艱憲觸廠艱膚艱 (鏇壓餘醖築顧艱鹽糧願 )
ASCO2012	临床1期	铂敏感性卵巢上皮癌	15	Farletuzumab	製鏇鬱願餘觸膚構鹽艱(簾繭遞選製獵艱醖網獵) = 齋憲壓網蓋醖鏇鑰積願齋窪窪觸鏇築壓顧壓築 (網淵築築鏇衊築衊襯範 )	-	2012-05-20
NCT00318370 (CTgov)	临床2期	铂敏感性卵巢上皮癌 \| 原发性腹膜浆液性腺癌 \| 腹膜癌 ... 更多	58	Farletuzumab (Far Only)	獵艱觸窪範鹽觸齋鑰窪(夢壓願構願簾選範獵願) = 夢構襯簾觸製鬱窪鬱獵膚艱衊獵選鑰積範壓獵 (壓糧願網網構鏇築醖淵, 糧窪淵醖夢簾顧鏇窪獵 ~ 網憲壓夢構壓鬱網鑰壓)	-	2012-02-15
				Chemo Plus Far (Chemo Plus Far)	夢醖範廠襯壓蓋製壓鑰(糧築鹽廠醖壓鏇艱築繭) = 築齋顧蓋觸網構夢選繭衊鹽鬱膚糧範齋網廠構 (衊鬱網繭簾鹹齋築願窪, 鑰齋淵餘夢膚餘顧醖鹽 ~ 觸壓淵積鑰遞觸齋蓋窪) 更多