奥拉单抗(Olaratumab) - 药物靶点：PDGFRα_在研适应症：X联锁鱼鳞病，软组织肉瘤，转移性软组织肉瘤_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Olaratumab (genetical recombination) (JAN)、Olaratumab (USAN/INN)、奥拉木单抗

+ [6]

靶点

PDGFRα

作用机制

PDGFRα抑制剂(血小板衍生生长因子受体α抑制剂)

治疗领域

肿瘤遗传病与畸形内分泌与代谢疾病+ [2]

在研适应症

X联锁鱼鳞病软组织肉瘤转移性软组织肉瘤+ [1]

非在研适应症

晚期癌症晚期恶性实体瘤多形性胶质母细胞瘤+ [3]

原研机构

Eli Lilly & Co.

在研机构

Telix Pharmaceuticals Ltd.

Eli Lilly & Co.

非在研机构

Eli Lilly Nederland BV

最高研发阶段批准上市

首次获批日期

美国 (2016-10-19),

X联锁鱼鳞病软组织肉瘤

最高研发阶段(中国)-

特殊审评突破性疗法 (美国)、快速通道 (美国)、孤儿药 (美国)、孤儿药 (澳大利亚)、临床急需境外新药 (中国)

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序列信息

Sequence Code 13007203H

来源: *****

Sequence Code 13007633L

来源: *****

关联

28

项与奥拉单抗相关的临床试验

NCT03437070 / Withdrawn临床1期IIT

A Phase I Study of Trabectedin in Combination With Fixed Doses of Doxorubicin and Olaratumab in Patients With Metastatic or Recurrent Leiomyosarcoma

This study seeks to determine if addition of trabectedin (T) to combination doxorubicin (D) and olaratumab (O), is feasible and tolerable with antitumor activity in metastatic or recurrent Leiomyosarcomas (LMS) patients who have limited therapeutic options.

开始日期2019-06-01

申办/合作机构

University of Miami

[+1]

NCT03698227 / Terminated临床2期IIT

Efficacy of Olaratumab and Rechallenge With Doxorubicin in Anthracycline Pretreated, Advanced Soft Tissue Sarcoma Patients. An Exploratory Phase-II Study

This is an exploratory, prospective, open label, single arm, phase II-study for the evaluation of efficacy and feasibility (as determined by safety and tolerability) of olaratumab and doxorubicin rechallenge in anthracycline pretreated locally advanced (unresectable) or metastatic soft tissue sarcoma patients.

开始日期2018-11-12

申办/合作机构-

NCT03985722 / Active, not recruiting临床1期

Phase I Clinical Trial of Olaratumab Plus Trabectedin in Advanced Soft-tissue Sarcoma Patients

Phase I, multicentre clinical trial of olaratumab plus trabectedin in patients with advanced soft-tissue sarcoma.
Olaratumab plus trabectedin could be synergistic and with a manageable toxicity profile in advanced STS.
The study is a phase I, non-randomised, one-armed, multicenter trial, open-label.
The dose escalation rules include patients in blocks of 3 o 6 patient. Treatment is a combination of unlimited cycles of oralatumab and trabectedin.
Primary clinical study endpoint of phase I:
- Determine the maximum tolerated dose (MTD) or the recommended dose of olaratumab combined with trabectedin in advanced soft tissue sarcoma
Secondary clinical study endpoints:
Objective Response Rate (ORR): ORR is defined as the number of subjects with a Best Overall Response (BOR) according to RECIST 1.1.
Progression free survival (PFS): time to progression or death from treatment initiation.
Overall survival (OS): Time from treatment initiation until death. Efficacy measured through tumor response according to Choi criteria. The evaluation criteria will be based on the identification of target lesions in baseline and their follow-up until tumor progression.
Correlation of clinical outcome with translational biomarkers.
Quality of life (QoL) measured per QLQ-C30 questionnaire of EORTC

开始日期2018-09-21

申办/合作机构

Grupo Español de Investigación en Sarcomas

100 项与奥拉单抗相关的临床结果

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100 项与奥拉单抗相关的转化医学

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100 项与奥拉单抗相关的专利（医药）

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104

项与奥拉单抗相关的文献（医药）

2023-10-06·Cancers

Randomized Phase 2 Clinical Trial of Olaratumab in Combination with Gemcitabine and Docetaxel in Advanced Soft Tissue Sarcomas.

Article

作者: Dickson, Mark A ; Jones, Robin L ; Ceccarelli, Matteo ; Peterson, Patrick M ; Chmielowski, Bartosz ; Wagner, Andrew J ; Hindi, Nadia ; Villalobos, Victor ; Attia, Steven ; Oakley, Gerard J

Gemcitabine plus docetaxel is an effective treatment regimen for advanced soft tissue sarcomas (STSs). However, the prognosis for patients remains poor, and thus there is an urgent medical need for novel and effective therapies to improve long-term outcomes. The aim of the ANNOUNCE 2 trial was to explore the addition of olaratumab (O) to gemcitabine (G) and docetaxel (D) for advanced STS. Adults with unresectable locally advanced/metastatic STS, ≤2 prior lines of systemic therapy, and ECOG PS 0-1 were eligible. In Phase 2, patients were randomized 1:1 from two cohorts (O-naïve and O-pretreated) to 21-day cycles of olaratumab (20 mg/kg Cycle 1 and 15 mg/kg other cycles, Days 1 and 8), gemcitabine (900 mg/m², Days 1 and 8), and docetaxel (75 mg/m², Day 8). The primary objective was overall survival (OS) in the O-naïve population (α level = 0.20). Secondary endpoints included OS (O-pretreated), other efficacy parameters, patient-reported outcomes, safety, pharmacokinetics, and immunogenicity. A total of 167 and 89 patients were enrolled in the O-naïve and O-pretreated cohorts, respectively. Baseline patient characteristics were well balanced. No statistically significant difference in OS was observed between the investigational vs. control arm for either cohort (O-naïve cohort: HR = 0.95 (95% CI: 0.64-1.40), p = 0.78, median OS, 16.8 vs. 18.0 months; O-pretreated cohort: HR = 0.67 (95% CI: 0.39-1.16), p = 0.15, median OS 19.8 vs. 17.3 months). Safety was manageable across treatment arms. There was no statistically significant difference in the primary endpoint of OS between the two arms in the O-naïve population, and therefore based on hierarchical evaluation no other outcomes in this study can be considered statistically significant. No new safety signals were observed.

2023-09-01·Clinical cancer research : an official journal of the American Association for Cancer Research

Results of an Open-label, Phase Ia/b Study of Pembrolizumab plus Olaratumab in Patients with Unresectable, Locally Advanced, or Metastatic Soft-Tissue Sarcoma.

Article

作者: Szpurka, Anna M ; Junker, Niels ; Tap, William D ; Wagner, Andrew J ; Burgess, Melissa A ; Bahleda, Rastislav ; Chisamore, Michael ; Ceccarelli, Matteo ; Schöffski, Patrick ; Peterson, Patrick

PURPOSE:

The study evaluated safety and efficacy of olaratumab + pembrolizumab in patients with unresectable locally advanced/metastatic soft-tissue sarcoma (STS) with disease progression on standard treatment.

PATIENTS AND METHODS:

This was open-label, multicenter, nonrandomized, phase Ia/Ib dose-escalation study followed by cohort expansion (olaratumab + pembrolizumab intravenous infusion). Primary objectives were safety and tolerability.

RESULTS:

The majority of patients enrolled (n = 41) were female [phase Ia: 9 of 13, phase Ib/dose-expansion cohort (DEC), 17 of 28], aged < 65 years. In phases Ia and Ib, 13 and 26 patients received prior systemic therapy, respectively. Patients received olaratumab 15 mg/kg (phase Ia; cohort 1) or 20 mg/kg (phase Ia; cohort 2 and phase Ib) and pembrolizumab 200 mg (phase Ia/Ib). The median (Q1-Q3) duration of therapy (olaratumab) was 6.0 (3.0-11.9; cohort 1), 14.4 (12.4-20.9; cohort 2), and 14.0 (6.0-21.8) weeks (DEC). No dose-limiting toxicities and few grade ≥ 3 treatment-emergent adverse events [TEAE; 15 mg/kg: 2 (increased lipase); 20 mg/kg: 1 (increased lipase), 1 (colitis), 2 (diarrhea), 3 (anemia)] were reported. Two TEAEs (increased lipase) were related to study discontinuations. Twenty-one patients reported mild (grade ≤ 2) TEAEs [phase Ia, disease control rate (DCR):14.3% (1/7, cohort 1); 66.7% (4/6, cohort 2); no responses were reported; phase Ib, DCR: 53.6% (15/28); objective response rate: 21.4% (6/28; RECIST and irRECIST criteria)]. No response was observed in patients with programmed death ligand-1-positive tumors.

CONCLUSIONS:

Antitumor activity was observed in some patients in DEC, and combination was well tolerated with manageable safety profile. Further studies are warranted to evaluate the efficacy and mechanistic impact of platelet-derived growth factor receptor inhibitors with immune checkpoint modulator coadministration.

2023-07-01·Current opinion in oncology

Doxorubicin combined with Trabectedin in systemic first-line M+/recurrent leiomyosarcoma patients.

Review

作者: Ray-Coquard, Isabelle ; Turinetto, Margherita ; Meeus, Pierre

PURPOSE OF REVIEW:

Currently, the only systemic therapy approved for advanced leiomyosarcoma is Doxorubicin-based monotherapy. Despite disappointing progression-free survival (PFS) and overall survival (OS), no combination therapy has formally ever proven to be more effective. In this clinical setting, selecting the most efficient therapy is key, as most patients become quickly symptomatic with poor performance status.This review aims to describe the current emerging role of Doxorubicin and Trabectedin in first-line setting, compared with doxorubicin alone the current standard of treatment.

RECENT FINDINGS:

Previous randomized trials focusing on combination therapies (Doxorubicin + ifosfamide, doxorubicin + evofosfamide, doxorubicin + Olaratumab, or Gemcitabine + Docetaxel) never reported positive results on the primary endpoint (OS or PFS). For the first time, the randomized phase III LMS-04 demonstrated that Doxorubicin and Trabectedin have a better PFS and disease control rate (DCR) compared with Doxorubicin, with higher but still manageable toxicities.

SUMMARY:

In the first-line setting, the results of this trial were pivotal for numerous reasons; Doxorubicin-Trabectedin is the first combination that has been proven to be more effective in terms of PFS, ORR and trend of OS compared with doxorubicin alone; moreover, it is clear that trials regarding soft tissue sarcoma should strive to be histology-driven.

20

项与奥拉单抗相关的新闻（医药）

2024-06-17

·E药经理人

BMS 300亿并购管线告急，260亿新贵叫停IPO！核药凉意初现？

起飞的核药，遭遇了“旋风”。撰文| Erin 阿觉编辑| 顿河月初，刚刚以41亿美元“杀入”核药圈半年的BMS，突然宣布暂停一款核药产品的III期临床；上周，半个月前官宣要在美股上市的核药明星Biotech公司Telix，取消IPO计划，这更是让人措不及防。值得注意的是，BMS暂停的原因是同位素短缺，这一原因，已困扰核药最大玩家诺华多时。而作为业界的明星Biotech，Telix取消IPO，起因似乎是在产品连传喜讯拉动股价增长后，“嫌弃”IPO定价太低。携资本风风火火杀入的大公司相继产能不足，令市场大跌眼镜。而产能建设能力更是缺乏的Biotech，在10余天内上演要高调上市到取消上市的戏剧表演，让不少人不禁好奇：核药，这一在2023年起舞的赛道，已开始跳不动了吗？戏剧般取消IPO背后：到底在“高贵”什么？ Telix在6月5日刚刚宣布IPO，拟定价11.87美元（约17.8澳元，基于假设汇率1澳元=0.6668美元），募资约2亿美元。谁承想，才刚刚过了半个月，这家Biotech就决定取消IPO。有意思的是，Telix终止IPO计划的理由是现金充足，IPO不为募资，以这一发行价进行IPO将会损害现有股东的利益。言外之意就是，公司的股价还有更高的上升空间。要知道，今年美国的资本市场被公认为刚刚回暖，而核药赛道近年来一直都被认为是投融资火爆的领域。6月6日，德国核药公司ITM Isotopen Technologien München（ITM）获得1.88 亿欧元（约14.8亿元）的融资，刚刚打破今年融资纪录。不过，Telix的预期确实也有它的底气所在。就如同该公司在新闻稿中所言，11.87美元（约18澳元）的IPO定价的确有些保守，因为在今年上半年，Telix的股价涨幅超过70%。在1月初还是9.17澳元/股，截至今天下午收盘已经超过17澳元/股，而今年上半年股价最高曾达19.06澳元/股。 Telix股价大涨的原因主要来自新产品上市进度推进，以及几次供应链上下游的并购。据悉，今年上半年，Telix分别向FDA提交了PSMA-PET成像诊断产品TLX007-CDx的NDA和放射性核素偶联药物（RDC）TLX250-CDx (Zircaix)的BLA。前者有望通过将PSMA-PET成像的可用性扩展到美国几乎所有PET/CT位置来满足尚未满足的需求；后者有望成为美国肾癌领域首个靶向放射性药物成像剂。也是在TLX250-CDx提交BLA的新闻加持下，Telix的股价曾短暂到达了历史巅峰19.06澳元/股，市值也一度达到60亿澳元。 Telix业绩的高速增长也是股价大涨的动能之一。根据其2023年财报，其主要收入来源为核心前列腺癌诊断产品Illuccix，于2021年12月在美国获批，2022年销售额虽然仅为1.49亿澳元，2023年就增长226.5%，达到了4.89亿澳元。除了已上市产品Illuccix和递交NDA、BLA的两款产品，Telix的研发布局既显示出聚焦在泌尿科、肌肉骨骼肿瘤学科的专注性，又呈现覆盖各个研发阶段，未来发挥产品间组合优势的潜力。例如用于胶质母细胞瘤的TLX101和PET 诊断剂TLX101-CDx，都已获得FDA的孤儿药认定，并分别于在2025年H1读出数据、2024年下半年递交NDA；在早期产品方面，还有针对软组织肉瘤的TLX300 和 TLX300-CDx即将进入临床，针对急性髓系白血病的TLX66正在早期临床研发过程中。此外，Telix在今年上半年的连续三笔并购，分别补充了公司早期研发产品和增强生产能力，也备受二级市场投资者的看好。首先是年初收购QSAM公司，收获研发早期产品Samarium-153-DOTMP。Samarium-153-DOTMP用于骨转移和骨肉瘤的适应证，刚好与Telix在研产品的前列腺癌、胶质瘤、肌肉骨骼肿瘤的泌尿科、肌肉骨骼肿瘤学科形成优势互补，同时Samarium-153-DOTMP还能借助Telix已经建立的诊断产品优势，加速商业化。第二笔收购则来自IsoTherapeutics Group，该公司将增强Telix的同位素生产能力，以支持Telix未来治疗药物的商业化。第三笔同样来自核药的生产方面的公司ARTMS，这笔收购也是Telix想要增强关键同位素生产的供应链水平。不过，从Telix的三笔收购上也能看出核药领域制药公司的集体焦虑。就像CAR-T产品受限于病毒载体的制备，放射性药物由于在生产后立即开始衰变，并且仅在数小时至数天内保持稳定，因此核药公司的生产、供应链、制造工艺水平成为其长期稳定发展的基础。不过时间进入2024年，这些能力似乎连跨国药企都受到了考验。供应生产短缺，核药企业迟早“爆雷”？ 2015年成立的Telix，是核药领域的明星公司，但今日却发生了如此戏剧性的一幕，多少为近期有些“水逆”的核药赛道，再次带来不小的波澜。 2024年，虽然核药物领域仍有桩桩并购与BD接连产生，但受关注程度，似乎已大不如前。一个关键问题是，赛道是好赛道，钱还在源源不断流入，然而，突破呢？另外，最受市场关注的是，核素供应短缺以及核药产能问题，至今解决了吗？答案是，没有解决，且情况似乎愈发“恶化”了。商业化方面，目前仍只有诺华的两款RDC产品唱大戏，但作为核药背后最大的“弄潮者”，诺华自2023年以来，开始遇到诸多在产能或生产供应方面的问题。去年上半年，诺华RDC产品Pluvicto的商业供应告急，其需求超出预期，面向对应的晚期前列腺癌患者，美国不少医疗机构抱怨患者剂量供应被多次推迟、造成短缺。值得注意的是，2023年，还只是Pluvicto获批上市的第二年。为了解决生产问题，诺华现在在中国、西班牙、意大利、美国等多地都投资扩大产能，以集中生产模式为主，配备联邦快递12小时触达病人，从每一个订单发起开始都在“争分夺秒地工作”。研发方面，核素供应短缺，开始困扰全球大药企。此前，BMS、礼来、AZ各自斥巨资将核药界少有的几家明星标的收入囊中，诺华也在不久前再次出手收购了一家名为Mariana Oncology的核药公司，另外，罗氏基因泰克、强生等大药企也以BD的方式引进不少核药资产，但迄今为止，暂未看到突破性的产品进展。相反，刚以高溢价收购RayzeBio的BMS，很快就在近日被曝出了与诺华类似的问题。 6月4日，BMS因a粒子放射性同位素锕-225供应短缺，暂停了核心核药管线RYZ101的III期试验新患者招募。据了解，全球能够生产高质量锕-225的站点只有三个：美国、德国和俄罗斯，在国际上的供应非常紧张，但唯有俄罗斯眼下在计划扩大产能。此外，锕-225在国内没有生产制造商。 α系核素，是继β系核素之后，备受核药企业青睐的新布局方向。但随着BMS的核药隐患暴露，市场对AZ、诺华及礼来手里关于α系核素核药管线研发及商业化进展，有了更多的担忧。“不确定性太高，风险太大了”，有业内人士看到BMS一事后，向E药经理人感叹。另外，在研发端，整个核药行业已经开始出现一个现象：靶点扎堆，适应证集中，靶向配体一致，采用的核素呈现“同质化”，尤其是β核素镥[177Lu]。镥[177Lu]因具备能量高、射程短、稳定性较好等优点，拥有较好的成药性，已成为行业的研发主流，但此前有受访者向E药经理人表示，核素产能有限，且随着当下能够供应核素的研究反应堆老化，新反应堆接续艰难，供应短缺问题，可能会成为镥[177Lu]一类明星核素背后企业最大的“雷”。 4月8日，全球老牌核药公司Curium宣布，收购专注于核医学的Monrol公司，收购核心在于扩增镥[177Lu]的生产制造能力。这家公司对外表示: “必须加快布局，时间很紧张。” 放射性核素具有特定的半衰期，有的半衰期过短，仅有几小时，无法提前批量生产或进行远途运输，同时具备辐射自分解及不稳定性等性质。诺华曾对外表示，Pluvicto的半衰期从下单到输注大约只有5天，远短于常规药物，交通运输上的耽误都可能导致其失效。通常情况下，此类药物要借助药房网络进行生产和销售，但一个核药房的覆盖半径仅为150-200公里。这对企业是否具备在全球分散建厂的能力，以及有着高效的物流配送系统，有着很高的要求。此外，核素的生产和使用都有严格要求，其生产制备依赖于大型反应堆和回旋加速器，其构造和操作涉及复杂的技术，药物的生产、运输、存放、用药等也均需要具有相关资质的人员，且在特定设备才可以生产，这也导致了RDC的生产成本较高。如果不是大型药企，很难具备大规模复制的能力。但如今，连头部大药企在核药的商业化上囿于产能、核素供应短缺的困扰，这一行业，何时才能如市场期待的那样，实现真正的起飞？回复“逆商”，了解电子期刊详情精彩推荐 CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化｜猎药人系列专题 | 出海启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 | 荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药｜再鼎医药｜亚虹医药跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

IPO并购临床3期

2024-06-14

·Firstwordpharma

Radiopharm developer Telix abandons IPO plans in US

Just a week after announcing plans for a $200-million debut on NASDAQ, Australian radiopharmaceutical developer Telix Pharmaceuticals has pulled out of the IPO race in the US. The company blamed the decision on “the terms provided under current market conditions.”Telix was hoping to sell 17 million American depositary shares at a price based on the trading price of its ordinary shares on the Australian stock exchange (ASX). CEO Christian Behrenbruch said Friday that despite “strong interest” from healthcare and specialty biotech funds, the “sticking point in the process was pricing.”Behrenbruch explained “if we had made the decision to proceed… we would have priced and traded on the basis of a discount to our ASX market capitalisation that was not palatable to management and would have reflected a lack of respect for our existing shareholders.”Telix added that since the proposed NASDAQ listing wasn't driven by the need to raise capital, management decided not to proceed with the transaction at this time. “While this is not our desired outcome, Telix’s strategic objectives must align with our duty to existing shareholders,” remarked Behrenbruch.Remains profitableTelix clarified that it remains profitable, with sufficient finances to support its key objectives, including the commercial launch of its assets Zircaix (Zr-DFO-girentuximab), Pixclara (18F-floretyrosine) and TLX007-CDx in the US, alongside execution of global clinical studies. The radiopharmaceutical maker further noted that from the time an ‘intention to file’ was announced in January, it has reached significant milestones, including positive clinical readouts, strategic acquisitions of IsoTherapeutics Group, ARTMS, and QSAM Biosciences worth $98.6 million to bolster its manufacturing capacity and pipeline, and two additional FDA approval submissions.The company’s investigational pipeline boasts TLX591 (177Lu rosopatamab tetraxetan) for prostate cancer, TLX250 (177Lu-DOTA-girentuximab) for renal cancer, TLX101 for glioblastoma, and TLX300 targeting soft tissue sarcoma. Additionally, Telix is testing the QSAM asset Samarium-153-DOTMP to manage pain in pediatric patients with bone metastases or osteosarcoma. Last month, Telix also inked a deal with Bayer to supply Illuccix (TLX591-CDx) for the latter’s Phase III ARASTEP study in prostate cancer.For more, see - Vital Signs: Mapping the slim pickings in radiopharmaceuticals.

临床3期并购IPO

2024-05-17

·Firstwordpharma

Radiopharmaceutical developer Telix files for NASDAQ debut

Australian biotech Telix will attempt to make it through the seemingly shrinking IPO window, which has only seen one successful exit so far this quarter. But fresh off an M&A spree and with three cancer treatments in mid- to late-stage testing, the radiopharma hopes to reinvigorate investor enthusiasm. For more financial analysis, see Vital Signs: Taking the temperature on a cooling IPO cycle.Telix filed its intent on Friday to make its NASDAQ debut. The filing provides a glimpse at the firm’s pipeline of radiopharmaceuticals – one of the more popular areas of dealmaking the past few years – and its recent spending to bulk out its isotope manufacturing capabilities. Along with its therapeutic and diagnostic portfolio – one of its imaging agents has already secured FDA approval – Telix has a radioisotope supplier agreement with Bayer. For more, see - Vital Signs: Mapping the slim pickings in radiopharmaceuticals.Pipeline programmes In the past two months, Telix has signed away about $98.6 million in combined cash and stock deals to acquire IsoTherapeutics Group, ARTMS, and QSAM Biosciences to pad its production capacity, as well as its pipeline. Through its takeout of the latter, Telix gained Samarium-153-DOTMP, a kit-based, bone-seeking targeted radiopharmaceutical intended to manage pain in paediatric patients with bone metastases or those who are receiving osteosarcoma therapy. According to ClinicalTrials.gov, the candidate is expected to complete a Phase I trial by November. Within Telix’s internal pipeline, its lead programme is TLX591 (177Lu rosopatamab tetraxetan), a radio antibody-drug conjugate (rADC) in the pivotal Phase III ProstACT GLOBAL study. The trial is expected to enrol 430 patients with PSMA-positive, metastatic castration-resistant prostate cancer, and report initial interim data in the first half of 2025.The biotech’s second rADC, TLX250 (177Lu-DOTA-girentuximab), is in a pair of investigator-sponsored Phase II trials in patients with advanced metastatic kidney cancer. The company is also developing TLX101, a systemic and blood-brain barrier-penetrant small molecule radiotherapeutic that targets the LAT1 receptor to treat glioblastoma. In addition to a Phase I safety study, the candidate is being evaluated in the investigator-led Phase II IPAX Linz trial, which is expected to read out in the first half of 2025.Telix’s final portfolio programme is TLX300, a preclinical antibody-directed, targeted radiation candidate directed against PDGFRα, which is intended to treat soft tissue sarcoma. A first-in-human study is expected to start this half.

临床2期并购临床1期临床3期上市批准

100 项与奥拉单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09939	奥拉单抗	L01XC27	DB06043

研发状态

批准上市

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适应症	国家/地区	公司	日期
X联锁鱼鳞病	美国	Eli Lilly & Co.	2016-10-19
软组织肉瘤	美国	Eli Lilly & Co.	2016-10-19

未上市

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
转移性软组织肉瘤	临床3期	美国	Eli Lilly & Co.	2015-09-14
转移性软组织肉瘤	临床3期	日本	Eli Lilly & Co.	2015-09-14
转移性软组织肉瘤	临床3期	阿根廷	Eli Lilly & Co.	2015-09-14
转移性软组织肉瘤	临床3期	澳大利亚	Eli Lilly & Co.	2015-09-14
转移性软组织肉瘤	临床3期	奥地利	Eli Lilly & Co.	2015-09-14
转移性软组织肉瘤	临床3期	比利时	Eli Lilly & Co.	2015-09-14
转移性软组织肉瘤	临床3期	巴西	Eli Lilly & Co.	2015-09-14
转移性软组织肉瘤	临床3期	加拿大	Eli Lilly & Co.	2015-09-14
转移性软组织肉瘤	临床3期	丹麦	Eli Lilly & Co.	2015-09-14
转移性软组织肉瘤	临床3期	芬兰	Eli Lilly & Co.	2015-09-14

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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


NCT03086369 (CTgov)	临床1/2期	胰腺继发性恶性肿瘤	184	Olaratumab+Nab-paclitaxel+Gemcitabine (Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine)	獵製網襯壓顧夢夢網網(鏇糧觸淵夢糧衊築淵構) = 願襯願製網選廠齋繭網網壓鹽淵夢糧鬱獵餘夢 (齋鹽廠窪襯築繭淵蓋膚, 觸鑰鬱鬱顧構艱蓋蓋齋 ~ 鹽鹹蓋範鹹鬱顧鑰製網) 更多	-	2022-01-11
				Olaratumab+Nab-paclitaxel+Gemcitabine (Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine)	獵製網襯壓顧夢夢網網(鏇糧觸淵夢糧衊築淵構) = 壓醖壓鏇顧艱醖鑰壓鑰網壓鹽淵夢糧鬱獵餘夢 (齋鹽廠窪襯築繭淵蓋膚, 鑰繭簾齋淵鏇顧鑰憲襯 ~ 選廠夢窪積鹹窪醖選醖) 更多
NCT03126591 (ESMO_IO2021) 人工标引	临床1期	肉瘤	41	Pembrolizumab+Olaratumab (phase Ia + OLA 15 mg/kg)	網觸膚簾衊膚獵願窪夢(窪衊衊齋憲鹽鏇鏇鏇範) = No dose limiting toxicities 憲繭選餘鹹觸觸鹹膚遞 (醖鹹齋願鹹襯齋鹹選構 )	积极	2021-12-09
				Pembrolizumab+Olaratumab (phase Ia + OLA 20 mg/kg)
NCT03086369 (ESMO2021) 人工标引	临床2期	不能切除性胰腺癌一线	159	nab-paclitaxel+gemcitabine+olaratumab	窪鬱壓網蓋遞鹽窪選願(糧築壓醖壓醖獵壓製範) = 壓遞齋醖範醖廠築構觸製壓醖簾窪憲構鏇製簾 (鹽蓋鹹獵製簾淵網醖夢 ) 更多	不佳	2021-09-16
				nab-paclitaxel+gemcitabine+placebo	窪鬱壓網蓋遞鹽窪選願(糧築壓醖壓醖獵壓製範) = 艱齋築蓋繭鬱衊憲糧顧製壓醖簾窪憲構鏇製簾 (鹽蓋鹹獵製簾淵網醖夢 ) 更多
NCT02659020 (ANNOUNCE 2, ASCO2021) 人工标引	临床1/2期	局部晚期软组织肉瘤二线	256	olaratumab+Gemcitabine+docetaxel (O-Naïve)	鹹蓋選繭夢壓鹹襯鏇醖(繭觸製顧鏇衊遞選糧淵) = 鑰鏇願築顧願餘選膚觸鏇鹹遞獵壓構衊觸艱觸 (鬱選鹽繭鹽夢襯齋膚襯, 15.3 ~ 25.4) 更多	积极	2021-05-20
				placebo+Gemcitabine+docetaxel (O-Naïve)	鹹蓋選繭夢壓鹹襯鏇醖(繭觸製顧鏇衊遞選糧淵) = 鹽顧蓋遞淵願構醖觸艱鏇鹹遞獵壓構衊觸艱觸 (鬱選鹽繭鹽夢襯齋膚襯, 13.2 ~ 22.9) 更多
NCT02377752 (CTgov)	临床1期	软组织肉瘤 \| 晚期癌症	25	Olaratumab+doxorubicin (Part A Cohort 1: Olaratumab+Doxorubicin)	繭遞憲鏇獵鹽齋壓襯餘(簾蓋構鏇窪膚衊憲醖膚) = 獵衊衊鬱膚醖鹹鹽憲壓獵糧餘廠構構淵襯艱繭 (蓋獵襯製鬱簾壓遞範選, 艱構鏇鑰顧蓋醖築憲醖 ~ 遞製簾願鏇淵簾鏇鑰構) 更多	-	2021-02-17
				Olaratumab+doxorubicin (Part A Cohort 2: Olaratumab+Doxorubicin)	繭遞憲鏇獵鹽齋壓襯餘(簾蓋構鏇窪膚衊憲醖膚) = 網範鹽蓋鏇製餘選製窪獵糧餘廠構構淵襯艱繭 (蓋獵襯製鬱簾壓遞範選, 膚鹹獵構醖網襯餘鬱鬱 ~ 餘廠鏇顧襯餘壓觸獵築) 更多
NCT03283696 (CTgov)	临床1期	转移性软组织肉瘤	24	Olaratumab+Doxorubicin+Ifosfamide (Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide)	窪願顧壓襯築艱廠衊憲(製觸齋糧醖鹹淵選餘築) = 遞鹽願簾鹽願顧窪糧壓壓簾遞範製鬱願淵膚壓 (選壓糧範憲鏇憲範窪壓, 淵構範範製鏇獵積齋範 ~ 鹹壓窪襯醖膚齋範餘鬱) 更多	-	2020-09-10
				Olaratumab+Doxorubicin+Ifosfamide (Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide)	窪願顧壓襯築艱廠衊憲(製觸齋糧醖鹹淵選餘築) = 積獵憲獵願淵範壓夢窪壓簾遞範製鬱願淵膚壓 (選壓糧範憲鏇憲範窪壓, 餘獵範窪遞淵顧選築鏇 ~ 窪選夢憲積鏇願鹹糧鏇) 更多
NCT02451943 (ANNOUNCE, Pubmed) 人工标引	临床3期	软组织肉瘤	509	Doxorubicin+Olaratumab	窪網鑰夢鹽鬱糧願壓淵(淵齋鑰醖鑰獵積鑰簾鏇) = 鬱淵窪願艱願襯願繭糧築鹽壓鏇膚憲製衊鏇遞 (鹽衊憲築鏇襯襯構糧衊 ) 更多	不佳	2020-04-07
				Doxorubicin+Placebo	窪網鑰夢鹽鬱糧願壓淵(淵齋鑰醖鑰獵積鑰簾鏇) = 鹽糧齋窪鹽艱蓋觸糧網築鹽壓鏇膚憲製衊鏇遞 (鹽衊憲築鏇襯襯構糧衊 ) 更多
NCT02451943 (CTgov)	临床3期	转移性软组织肉瘤	509	Olaratumab+doxorubicin (Doxorubicin + Olaratumab)	襯蓋壓壓選獵夢網膚構(衊製壓醖獵鑰餘齋壓糧) = 築範餘願鑰淵鬱醖鹹獵鬱艱築蓋鬱鏇齋繭積範 (膚襯廠鑰憲積壓願獵繭, 壓壓夢構齋簾廠製蓋憲 ~ 範鬱範製繭糧鏇衊壓獵) 更多	-	2019-12-17
				Placebo+doxorubicin (Doxorubicin + Placebo)	襯蓋壓壓選獵夢網膚構(衊製壓醖獵鑰餘齋壓糧) = 網餘艱襯範淵製蓋繭簾鬱艱築蓋鬱鏇齋繭積範 (膚襯廠鑰憲積壓願獵繭, 觸壓醖艱構鏇憲鏇襯鹽 ~ 獵蓋襯願鹽齋獵淵窪遞) 更多
NCT02783599 (CTgov)	临床1期	软组织肉瘤	51	Olaratumab+doxorubicin	窪憲網衊蓋獵選築壓淵(淵鏇觸繭遞範網鑰鏇廠) = 襯鏇製淵齋膚醖積鏇遞鹹築齋醖範觸構夢簾繭 (窪繭構繭願淵觸範築醖, 憲積遞夢遞選鹹壓襯壓 ~ 壓醖夢鹹築遞鹹窪鹹襯) 更多	-	2019-08-12
NCT02451943 (ASCO2019)	临床3期	转移性软组织肉瘤三线	509	Olaratumab plus doxorubicin	簾膚膚淵艱鹹鹽衊壓壓(鹹鹽簾繭築積餘繭積鬱) = 淵遞觸艱鏇膚顧繭醖選艱膚鏇築齋壓衊餘憲憲 (餘繭築醖鹽獵網獵網廠 ) 更多	不佳	2019-05-26
				Olaratumab plus liposomal doxorubicin	願齋觸糧鑰衊淵窪襯淵(鏇網顧構選網網製遞繭) = 選蓋獵糧鹹願窪蓋獵艱鬱鏇遞窪鑰窪製積範蓋 (網製鹽簾獵簾積蓋壓顧 ) 更多