Comparison of Changes in Tumor Burden (Toral Tumor Volume [TMTV] and Total Lesion Activity [TLA]) in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in the Monitoring of Metastatic Castration-resistant Prostate Cancer Treated With 177Lutetium-PSMA-617

To demonstrate the prognostic value of using post-therapy 177Lu-PSMA SPECT/CT versus 68Ga-PSMA-11 PET/CT in mCPRC patients progressing despite chemotherapy and treated with 177Lu-PSMA.

开始日期2024-09-01

申办/合作机构

Centre Hospitalier Regional de Nancy

NCT06145633 / Not yet recruiting临床2期IIT

Vorinostat to Augment Response to Lutetium-PSMA-617 in the Treatment of Patients With PSMA-Low Metastatic Castration-Resistant Prostate Cancer

This phase II trial tests how well vorinostat works in treating patients with prostate-specific membrane antigen (PSMA)-low castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) (mCRPC). Prostate cancer that has not spread to other parts of the body (localized) is typically treated through surgery or radiotherapy, which for many men is curable. Despite definitive local therapy, cancer that has come back after a period of improvement (recurrent) disease develops in 27-53% of men. Often this is detected by measurement of prostate-specific antigen (PSA) without visible evidence of metastatic disease. Lutetium Lu 177 vipivotide tetraxetan (177Lu-prostate specific membrane antigen [PSMA]-617) is a new small molecule PSMA-targeted radioactive therapy that has been approved by the Food and Drug Administration for the treatment of adult patients with PSMA-positive mCRPC who have been treated with androgen receptor inhibitors and taxane-based chemotherapy. Vorinostat is used to treat various types of cancer that does not get better, gets worse, or comes back during or after treatment with other drugs. Vorinostat is a drug which inhibits the enzyme histone deacetylase and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat and 177Lu-PSMA-617 may kill more tumor cells in in patients with PSMA-low mCRPC.

开始日期2024-08-01

申办/合作机构

University of Washington

[+2]

NCT06216249 / Not yet recruiting临床2期

A Phase 2 Randomized Trial in Patients With Metastatic Castration Resistant Prostate Cancer to Determine the Efficacy of a Flexible Dosing Schedule of Lu-PSMA Treatment up to 12 Cycles Including Potential Treatment Holiday Periods in Comparison to the Standard Fixed Dosing Schedule of Six Cycles Every Six Weeks (FLEX-MRT)

The randomized phase 2 FLEX MRT compares a group of patients treated with LuPSMA on a flexible and extended dosing schedule including "treatment holiday" periods (investigational arm, up to 12 cycles) to a control group treated with a fixed dosing schedule of 6 treatments cycles maximum administered every 6 weeks.
The flexible dosing schedule in the investigational arm, will be based on SPECT/CT response assessments obtained 24h after injection of LuPSMA therapy cycle. The response assessment during treatment holiday period will be based on PET/CT every 12 weeks.

开始日期2024-07-01

申办/合作机构

Jonsson Comprehensive Cancer Center

100 项与 Lutetium (177 Lu) Vipivotide Tetraxetan 相关的临床结果

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100 项与 Lutetium (177 Lu) Vipivotide Tetraxetan 相关的转化医学

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100 项与 Lutetium (177 Lu) Vipivotide Tetraxetan 相关的专利（医药）

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346

项与 Lutetium (177 Lu) Vipivotide Tetraxetan 相关的文献（医药）

2024-04-01·International journal of radiation oncology, biology, physics

SENTRI: Single-Particle Energy Transducer for Radionuclide Injections for Personalized Targeted Radionuclide Cancer Therapy

Article

作者: Maharbiz, Michel M ; Seo, Youngho ; Lall, Rahul ; Lee, Kyoungtae ; Evans, Michael J ; Chopra, Shalini ; Anwar, Mekhail

PURPOSE:

Targeted radionuclide therapy (TRT), whereby a tumor-targeted molecule is linked to a therapeutic beta- or alpha-emitting radioactive nuclide, is a promising treatment modality for patients with metastatic cancer, delivering radiation systemically. However, patients still progress due to suboptimal dosing, driven by the large patient-to-patient variability. Therefore, the ability to continuously monitor the real-time dose deposition in tumors and organs at risk provides an additional dimension of information during clinical trials that can enable insights into better strategies to personalize TRT.

METHODS AND MATERIALS:

Here, we present a single beta-particle sensitive dosimeter consisting of a 0.27-mm³ monolithic silicon chiplet directly implanted into the tumor. To maximize the sensitivity and have enough detection area, minimum-size diodes (1 μm²) are arrayed in 64 × 64. Signal amplifiers, buffers, and on-chip memories are all integrated in the chip. For verification, PC3-PIP (prostate-specific membrane antigen [PSMA]+) and PC3-flu (PSMA-) cell lines are injected into the left and right flanks of the mice, respectively. The devices are inserted into each tumor and measure activities at 5 different time points (0-2 hours, 7-9 hours, 12-14 hours, 24-26 hours, and 48-50 hours) after ¹⁷⁷Lu-PSMA-617 injections. Single-photon emission computed tomography/computed tomography scans are used to verify measured data.

RESULTS:

With a wide detection range from 0.013 to 8.95 MBq/mL, the system is capable of detecting high tumor uptake as well as low doses delivered to organs at risk in real time. The measurement data are highly proportional (R² > 0.99) to the ¹⁷⁷Lu-PSMA-617 activity. The in vivo measurement data agree well with the single-photon emission computed tomography/computed tomography results within acceptable errors (±1.5%ID/mL).

CONCLUSIONS:

Given the recent advances in clinical use of TRT in prostate cancer, the proposed system is verified in a prostate cancer mouse model using ¹⁷⁷Lu-PSMA-617.

2024-03-01·Biosensors & bioelectronics

Low cost, high temporal resolution optical fiber-based γ-photon sensor for real-time pre-clinical evaluation of cancer-targeting radiopharmaceuticals

Article

作者: Seo, Youngho ; Anwar, Mekhail ; Lee, Kyoungtae ; Evans, Michael ; Lall, Rahul ; Chopra, Shalini ; Niknejad, Ali ; Kandala, Averal

Cancer radiopharmaceutical therapies (RPTs) have demonstrated great promise in the treatment of neuroendocrine and prostate cancer, giving hope to late-stage metastatic cancer patients with currently very few treatment options. These therapies have sparked a large amount of interest in pre-clinical research due to their ability to target metastatic disease, with many research efforts focused towards developing and evaluating targeted RPTs for different cancer types in in vivo models. Here we describe a method for monitoring real-time in vivo binding kinetics for the pre-clinical evaluation of cancer RPTs. Recognizing the significant heterogeneity in biodistribution of RPTs among even genetically identical animal models, this approach offers long-term monitoring of the same in vivo organism without euthanasia in contrast to ex vivo tissue dosimetry, while providing high temporal resolution with a low-cost, easily assembled platform, that is not present in small-animal SPECT/CTs. The method utilizes the developed optical fiber-based γ-photon biosensor, characterized to have a wide linear dynamic range with Lutetium-177 (¹⁷⁷Lu) activity (0.5-500 μCi/mL), a common radioisotope used in cancer RPT. The probe's ability to track in vivo uptake relative to SPECT/CT and ex vivo dosimetry techniques was verified by administering ¹⁷⁷Lu-PSMA-617 to mouse models bearing human prostate cancer tumors (PC3-PIP, PC3-flu). With this method for monitoring RPT uptake, it is possible to evaluate changes in tissue uptake at temporal resolutions <1 min to determine RPT biodistribution in pre-clinical models and better understand dose relationships with tumor ablation, toxicity, and recurrence when attempting to move therapies towards clinical trial validation.

2024-02-01·Clinical nuclear medicine

Promising Therapeutic Activity of 177Lu-PSMA-617 in Synchronous High-Volume Metastatic Hormone-Sensitive Prostate Cancer

Article

作者: Ballal, Sanjana ; Satapathy, Swayamjeet ; Yadav, Madhav Prasad ; Bal, Chandrasekhar ; Sahoo, Ranjit Kumar

Purpose:

177Lu-PSMA-617 has been shown to improve survival outcomes in patients with end-stage metastatic castration-resistant prostate cancer. However, data in earlier lines remain limited. In this study, we intended to evaluate the efficacy and safety of 177Lu-PSMA-617 in patients with synchronous high-volume metastatic hormone-sensitive prostate cancer (mHSPC).

Patients and Methods:

Hormone-sensitive prostate cancer patients with synchronous high-volume metastases (defined as ≥4 skeletal metastases with ≥1 extra-axial site or any visceral metastasis) showing high PSMA expression on 68Ga-PSMA-11 PET/CT and ineligible/unwilling for conventional chemohormonal treatment options were selected. Approximately, ~5.55–7.4 GBq of 177Lu-PSMA-617 was administered intravenously at 8–12 weeks intervals, up to 6 cycles. All patients underwent concomitant androgen deprivation therapy/orchiectomy. The outcome measures included the proportion of patients achieving an undetectable serum prostate-specific antigen (PSA) (ie, ≤0.2 ng/mL) at any time point after therapy, best PSA response rate, objective radiographic response rate, radiographic progression-free survival, overall survival, and adverse events.

Results:

Ten patients with high-volume mHSPC received a median cumulative activity of 32.4 GBq (range, 7.4–44.4) of 177Lu-PSMA-617 over 1–6 cycles. Five patients (50%) achieved an undetectable PSA with 9 patients (90%) showing a ≥50% decline in PSA from baseline. Nine patients underwent radiological follow-up, of which 7 (77.8%) had an objective response. The median radiographic progression-free survival was 24 months (95% confidence interval, 18–30), whereas the median overall survival was not reached. None of the patients had any grade 3/4 adverse event.

Conclusions:

177Lu-PSMA-617 seems to be a promising efficacious and safe treatment option for patients with synchronous high-volume mHSPC.

493

项与 Lutetium (177 Lu) Vipivotide Tetraxetan 相关的新闻（医药）

2024-07-01

·E药经理人

辉瑞“挖”诺华战将掌舵肿瘤商业化，决战肿瘤“五霸”，还差点啥？

销售额占比接近1/2的产品专利将到期、增速已疲软，430亿美元世纪并购后核心产品陷增长困境，三天前官宣的辉瑞肿瘤商业化新负责人如何收拾这笔“烂摊子”？撰文| 润屿 Erin 编辑| 顿河润屿 2023年，116亿美元抗肿瘤业务收入，一款专利将到期、增速已疲软的产品就占到一半。增长压力下，辉瑞豪掷430亿美元将ADC先驱Seagen收入麾下，力图换来多款重磅炸弹“希望之星”。这笔收购的完成在2023年短暂拯救了辉瑞持续下滑的股价。然而此后，辉瑞的股价至今仍在27～29美元之间徘徊，Seagen带来的市值高点似乎也在1700亿美元止步不前。于是，辉瑞在2024年重振旗鼓，成立肿瘤事业部，提出2030年拥有至少8种重磅抗肿瘤药物，新产品占肿瘤业务总收2/3的目标。有Seagen的加持，数量不在话下。但在质量上，前有罗氏、BMS、默沙东等公认的肿瘤“五霸”封路，后有诺华、第一三共等源源不断的新品上市，狼环伺虎下，辉瑞又将如何突出重围？这或许也是三天前辉瑞从诺华挖来商业化负责人Tina Deignan的原因，这位曾经的“O”药灵魂人物，率领诺华两大核药在美商业化的“老将”，如何重领辉瑞“硬刚”肿瘤五霸，直面新品冲击？ O药战将如何“盘活”辉瑞肿瘤销售？ 2023年12月，伴随Seagen的加入，辉瑞进行了一次组织架构调整，成立“the Pfizer Oncology Division”（辉瑞肿瘤事业部），并任命辉瑞肿瘤业务研发主管Chris Boshoff担任该事业部的负责人、执行副总裁。同时，辉瑞肿瘤事业部的调整还“以人才为中心”进行了相应的调整，根据肿瘤药物的早期研发、临床开发、商业化等环节分别任命了相应的主管。本次Tina Deignan的加入就是接替原来商业化负责人Suneet Varma的职位。Suneet Varma即将在2025年初从该职位退休。值得一提的是，辉瑞肿瘤事业部于今年1月1日启用后，Chris Boshoff还在今年2月的投资者活动上宣布了辉瑞的野心，“公司的目标是到2030年拥有至少八种重磅抗肿瘤药物，重点发力乳腺癌、泌尿生殖系统肿瘤、血液肿瘤和胸腔癌症，并且来自新产品/新适应证的收入将占到肿瘤药物总收入的三分之二。” 其实从产品数量上来看，在提出这一目标时，辉瑞已经手握Ibrance（哌柏西利），Inlyta（阿昔替尼）和Xtandi（恩扎卢胺）三款重磅药物，再加上Seagen的ADC产品Padcev、Adcetris、Tivdak，以及目前辉瑞/Seagen正在高速增长的诸多抗肿瘤药物，2030年8款重磅药物的目标对于辉瑞来说简直轻而易举。不过，尽管对于数量目标十拿九稳，辉瑞最大的挑战其实是新产品/新适应证占据抗肿瘤总收入的三分之二——这是一个质量上的目标。要知道，如今在哌柏西利之后，辉瑞的重磅炸弹产品其实已经出现了断层。2023年抗肿瘤业务总收入才116亿美元，哌柏西利收入就几乎占据了一半。如何在六年时间内使创新产品销售快速放量，并成为业绩发展的新动能，辉瑞缺的不仅是爆款产品，更是为实现产品商业价值更精密的布局。其中，人才无疑是关键要素之一。从Tina Deignan的履历上来看，其实是业内少有曾经兼具肿瘤免疫疗法、放射疗法商业化经验的商业化负责人。 Tina Deignan拥有柏林圣三一学院免疫学博士学位和柏林商学院商业研究硕士学位。 2007年，Tina Deignan加入BMS，在此后的15年间，一路从产品经理做到美国免疫学负责人。自2014年O药首次在FDA获批后，Tina Deignan也是O药美国商业化团队的主要负责人之一，几乎伴随O药最重要的市场准入阶段。而在2022年，Tina Deignan加入诺华后，也是诺华核药疗法的美国商业化团队的“灵魂人物”之一，两大核心重磅产品Lutathera和Pluvicto在美国的商业化都少不了Tina Deignan的身影。据悉，Pluvicto已经是全球销售额最高的核药产品，在2023年已经实现了9.8亿美元销售额，增速高达260%，美国市场贡献了主要收入。而辉瑞与安斯泰来合作的产品雄激素受体信号转导抑制剂恩扎卢胺（Xtandi），已经于2023年11月获批新适应证早期前列腺癌，是诺华Pluvicto的直接竞争对手。此外，辉瑞在2023年10月推出的Braftovi-Mektovi组合疗法，用于治疗携带BRAF V600E突变的转移性非小细胞肺癌（NSCLC）患者，也直击阻击诺华Tafinlar-Mekinist组合疗法的市场。 “新东家”和“老东家”的“正面刚”是一方面，对于Tina Deignan的挑战还有如何盘活辉瑞的成熟产品。另一个棘手的问题是，辉瑞CEO曾将公司在抗肿瘤业务的发展定为公司的头等大事，接下来，在这位抗肿瘤药物商业化拥有20年丰富经验的“老将”的加盟下后，辉瑞又将如何与BMS、罗氏等老牌选手“硬刚”？推荐阅读 * 辉瑞困于辉瑞 * 辉瑞“硬刚”肿瘤五霸，BMS大裁员，罗氏再砍管线，Q1营收TOP10药企仍在阵痛中… 对战肿瘤“五霸”，辉瑞到底差什么？很明显，无论是制定花钱花在刀刃上的调整计划，还是肿瘤业务的组织架构迅速配合到位，辉瑞明显已经正式出击了。但是，他能在2030年实现8款重磅级肿瘤药的目标吗？他能单挑肿瘤五大“霸主”——默沙东、BMS、罗氏、强生和阿斯利康吗？悬念非常大。肿瘤“五霸”内部混战本身就很激烈：争百亿元级重磅畅销药排位，比拼肿瘤业务总收入，争肿瘤领域新型技术产品布局，最关键的，是在争夺下一个大药大爆的机会。但从新冠一梦中苏醒过来的辉瑞，既缺早期研发能力，又缺成熟或潜在的重磅炸弹产品。过去很长一段时间，辉瑞肿瘤管线十分丰富，已获批抗肿瘤药不低于20款，但最大的问题是，始终缺乏爆款。收购Seagen之前，辉瑞抗肿瘤药主要是上述三款小分子药——哌柏西利，阿昔替尼和恩扎卢胺。成为肿瘤业务支柱的，只有哌柏西利。但可惜的是，这款产品的“花期”太短，由于后继竞争者强势进攻，以及临床试验数次失利，辉瑞没能坚守哌柏西利50亿美元重磅药物的地位。作为内分泌治疗进入靶向时代后全球首款上市的CDK4/6抑制剂，哌柏西利的出现，具有划时代意义。2020年，哌柏西利突破50亿美元大关。2019至2021年，哌柏西利均在辉瑞销售额TOP3产品之列。但自竞品礼来阿贝西利上市后，由于阿贝西利打入各市场的策略和节奏把控得较好，很快就造成了较强劲的威胁。近几年，哌柏西利销售额在全球市场增速放缓，2022年同比下降6%，2023年，延续下降趋势，降幅同样为6%。2023年，该产品营收额已跌出50亿美元开外。2027年，哌柏西利专利届满，留给辉瑞的时间，其实不多了。在失守50亿美元大药的同时，辉瑞肿瘤业务存在一个最大的问题是，目前没有一个产品立马接续。 2023年，辉瑞的肿瘤业务部门表现不佳。在初级保健、专业护理和肿瘤三大业务板块中，肿瘤业务营收占比最低，为116.27亿美元，较上一年下滑了4%，比起其余两大业务表现相对较为弱势。同时，这一收入情况，与肿瘤“五霸”比起来，还存在较大的差距。如果仅按照主要产品收入来看，2023年，拥有K药、O药的默沙东与BMS肿瘤业务收入均在260亿美元以上水平，罗氏逾200亿美元，强生、AZ也在170亿美元之上。关键是，尽管都遇到了专利悬崖等危机，但“五霸”中多数企业能够再坚守几年市场地位，抑或是产品销售额已无限趋近百亿美元水平，又或是已经找到了潜在重磅炸弹。但于辉瑞而言，除了哌柏西利，目前能够支撑肿瘤业务收入的产品，似乎力量是受限的。 2023年，辉瑞销售额排名前20的产品中，肿瘤药仅贡献了3款，除了哌柏西利，剩下两款小分子药，销售额均限于10亿美元上下水平。其中，恩扎卢胺（Xtandi，前列腺癌领域）销售额在2023年出现小幅下降，至11.91亿元，该药同样也将在2027年失去专利保护。辉瑞有意识地将肿瘤业务KPI，放在了发展大分子药物上，他将Seagen的几款产品，视作扭转肿瘤业务的拐点。不能忽略的是，今年Q1，辉瑞抗肿瘤领域的收入同比增长了19%，表现算很亮眼，辉瑞强调由收购Seagen而获得的4种产品，带来了重磅增长潜力。但从长期来看，Seagen这几款产品竞争力如何？ Seagen四款产品分别是Adcetris、Padcev、Tivdak、Polivy，其中三款为“first-in-class”的ADC药物，一款为合作ADC药物。在2023年被辉瑞收购之前，四款药物能为Seagen带来了17亿美元的收入。不过，Evaluate Pharma数据显示，2023年，辉瑞/Seagen的ADC销售额为19.52亿美元。这样来看，Seagen的ADC收入增速并不快。值得注意的是，Evaluate Pharma预测，2028年，第一三共的ADC收入将由2023年的24.59亿美元增长至99.98亿美元，说明有DS-8201等明星产品加持，市场给到的预期非常高。但与此同时，Evaluate Pharma预计2028年辉瑞/Seagen的ADC收入达52.77亿美元，据此推算，按现有辉瑞的商业化产品实力，实现2030年的销售既定目标，是有一些难度的。那么如何实现预期，一边要看焕新的肿瘤业务团队能不能打赢这场仗，另一边要看辉瑞能不能不能在剩下的6年时间里，诞生一款增速相当快的肿瘤产品。今年Q1，辉瑞启动了三项关键的III期研究，包括选择性CDK4抑制剂atirmociclib的首次III期试验，以及Elrexfio用于治疗多发性骨髓瘤的第四次III期临床试验。但系列后期产品何时上市，潜力如何，能否抵御同疾病领域市场竞争？这仍是悬在辉瑞头上的一个大问题。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

抗体药物偶联物并购专利到期高管变更

2024-06-25

·同写意

“没花冤枉钱”的重磅交易TOP10

同写意20周年大会：中国医药创新未来之路！“意”同创新，穿越周期，赢取未来。7月中旬，苏州金鸡湖畔，让我们与“新药写意人”一起为中国医药创新“同写意”！在过去的几年中，大型制药公司纷纷投入巨资，在ADC、核药和减肥药物等热门领域进行巨额押注。 Fierce Pharma此前已整理罗列了2023年全球金额最大的并购交易TOP 10，近日，Fierce Biotech又一次回顾了近年最吸引眼球的、最明智的交易。顾名思义，该篇汇总从“回报”情况评估这些大额交易——哪些重磅交易钱花的不亏？当然，这里的“回报”，包括陆续发布的临床数据、可能的历史性批准，以及组合疗法的规模化应用等等，并综合考虑了交易方在全球市场的长期布局。 1 BMS 140亿美元收购Karuna 2023年的最后一个月，向来“低调”的CNS领域接连发生了两起重磅交易，其中之一就是BMS斥资140亿美元收购Karuna Therapeutics。 Karuna最终被以每股330美元现金收购，较2023年12月21日收盘时的股价溢价53%。收购总价为140亿美元，或扣除预计获得的现金后的127亿美元。这场交易标志着BMS重返神经精神病学领域。可以看到，BMS对于该交易的热情，在目前的会议巡回之旅中有所表现。今年4月展示数据显示，KarXT在精神分裂症中可以持续改善症状，且患者体重不会增加。 BMS有理由说这是一笔明智的交易——早在2023年1月，业内就预测Karuna是制药公司必收购的股票之一。据悉，交易后公布的监管文件中显示，另一家公司曾在最后一刻对Karuna公司发起竞购，难怪BMS会急于完成这笔交易。 KarXT是今年最受期待的药物之一，分析师估计，它可以在2028年带来28亿美元的销售额。FDA预计将在今年第三季度做出审批决定。值得关注的是，该药物的中国市场权益由再鼎医药持有。虽然BMS趁热打铁是明智之举，但真正值得称赞的是开发KarXT的Karuna团队，目前该药物也正在阿尔茨海默病精神病领域进行测试。 2 罗氏巧妙截胡 31亿美元收购Carmot 诺和诺德和礼来都从各自的GLP-1资产中赚取了数十亿美元，其他大药厂也正跃跃欲试。但罗氏的入局方式比较巧妙，在Carmot准备IPO时，罗氏与Carmot进行了秘密收购谈判。最后，Carmot甚至还没来得及登陆纳斯达克，罗氏就抢先一步，以31亿美元（27亿美元预付款）收购了这家Biotech，获得了其皮下和口服肠促胰岛素的临床产品线，包括目前正在进行临床III期试验的每周一次和每天一次注射用GLP-1/GIP双受体激动剂。临床试验正在如期推进。5月份进行的一项为期24周的Ib期研究显示，每周一次的CT-388试验组，经安慰剂调整后的平均体重减轻了18.8%。对比15mg的替尔泊肽的数据——52周体重较基线时减轻了17.5%，该药物未来数据十分可期。同时，Carmot的CT-388如果与罗氏的抗肌肉生长抑制素抗体联合，31亿美元的高昂交易价格就十分合理了。罗氏正在研究RO7204239增强脊髓性肌肉萎缩症患者肌肉的潜力，他们提前布局了减肥药的下半场——减重不减肌。罗氏似乎非常偏爱这笔交易，希望以此为跳板进一步扩大研发规模。在今年2月份与分析师召开的全年收益电话会议上，罗氏制药首席执行官Teresa Graham暗示，“收购Carmot还将带来更多收益”，并称罗氏将把该笔收购所得资产，视为未来在心脏代谢领域以及其他潜在疾病领域开展业务的支柱。 3 诺和诺德收购Inversago 减肥药后继有人诺和诺德在肥胖症领域一直处于领先地位，但这家公司已经在考虑下一步的战略布局。近几个月来，诺和诺德开展了一系列动作，包括2023年8月的两次连续收购。先是以1500万欧元（约合1600万美元）收购了是总部位于丹麦的Embark Therapeutics，这是诺和诺德的一家长期合作企业。另一项收购的对象是加拿大公司Inversago Pharma，总金额高达10.7亿美元，包括未披露的开发和商业里程碑金额，这一收购获得的主要资产是该公司管线CB1反向激动剂INV-202。如果接下来的试验取得成功，这场豪赌将带来丰厚的回报。 Inversago正在研发阻断大麻素CB1受体的药物（INV-202）——16年前，赛诺菲曾因该领域遭受重创，欧洲监管机构因CB1受体阻断剂减肥药Acomplia存在精神障碍风险，撤销了对该药的批准。 INV-202正在糖尿病肾病患者中进行II期试验。但诺和诺德更关注其在治疗肥胖症上的潜力，据悉，该候选药物在Ib期试验中已证明具有减肥效果。诺和诺德已将这种更名为monlunabant的药物转入肥胖症的II期临床试验。此外，原本Inversago旗下名为INV-347的下一代CB1受体阻断剂，也被推向临床。 4 GSK收购Bellus Health 开战默沙东有时，明智的交易，一个主要作用就是向竞争对手开战，GSK在2023年8月斥资20亿美元收购Bellus Health时就是这么做的。 GSK因此获得了慢性咳嗽药camlipixant，其作用机制与默沙东的gefapixant相同。这两种药物都是P2X3的拮抗剂，P2X3是一种外周神经系统受体，可引发神经元过敏，与咳嗽冲动有关。默沙东的gefapixant在监管方面遇到了麻烦，其首次上市申请于2022年被FDA拒批，但在日本和欧洲却已成功上市。2023年末，FDA第二次拒批这款药物。这使camlipixant迎来绝佳机会。 Bellus已经引起了海外分析师们的关注，他们当时称该公司“凭借更具选择性的产品和差异化的数据集，一举成为P2X3抑制剂领域的佼佼者”。到2023年6月GSK完成收购时，其首席商务官Luke Miels将这次收购描述为，“与GSK在呼吸药物领域的优势高度协同”。此后，GSK一直在推进camlipixanIII期临床试验，预期2026年获得FDA批准，在2031年及以后实现大规模销售。 5 渤健73亿美元收购Reata 孤注一掷 2023年7月，渤健宣布以73亿美元收购Reata Pharmaceuticals引发关注。这家公司过去几年一直在走下坡路，73亿美元对于渤健来说并不是一个小数目，渤健2023全年营收仅98.36亿美元，产品收入仅为72.47亿美元。收购最终以每股172.50美元的价格进行，较交易宣布前一天收盘价高出59%。用近全年产品收入押注罕见病，主要为获得Reata的主要资产Skyclarys——这是第一个批准用于治疗遗传性神经疾病弗里德里克共济失调的药物。该药物于2023年2月获得FDA批准，分析师预测，Skyclarys到2030年的销售额有望达到15亿美元。 Reata首席执行官Warren Huff在一份新闻稿中表示：“凭借对罕见病患者和现有商业基础设施的清晰了解，我们相信Biogen能够把Skyclarys确立为治疗这种毁灭性遗传病的标准疗法。” Skyclarys自带一份“优先审批券“，用于加快FDA对药品申请或销售的审查流程。Reata还拥有其他几种针对神经系统疾病的药物，但都处于早期开发阶段。此前备受争议的是，就在这次收购之前，渤健刚宣布计划在2024年底前裁员1000人，占员工总数的11%。裁员是对公司进行重组的一部分，过去三年来，该公司的收入一直在下降。 6 礼来收购Versanis Bio 减肥药物联用的回击去年7月，礼来以19.2亿美元的价格收购了Versanis Bio。Versanis Bio的管线主要是激活素受体II型拮抗剂bimagrumab。礼来如今已经凭借Zepbound占据了领先地位，19.2亿美元的收购价对其他人来说是一笔巨款，但对礼来来说甚至算不上九牛一毛。该交易带来了一种名为bimagrumab的II期单克隆抗体，目前正在对超重或肥胖的成年人进行单独测试，并与司美格鲁肽进行肥胖症的联合临床测试。换句话说，最终买下Versanis Bio如果不是礼来，那就可能是他的老对手诺和诺德。 bimagrumab曾经是诺华的临床资产，其在开发包涵体肌炎时因临床失败而被迫中止。礼来之所以看中Versanis的产品组合，是因为它能与肠促胰岛素药物结合起来，有望实现减脂不减肌。虽然Zepbound和Wegovy对肥胖或超重人群的减肥效果不错，但这些药物可能会导致肌肉损失。因此，借助Versanis，礼来或许有望稳住其减重产品组合及Zepbound在市场上占据多年的主导地位。 7 诺华收购Chinook 变废为宝去年6月，诺华花费32亿美元买下Chinook，该公司手握曾被艾伯维放弃的管线Atrasentan，交易仅四个月，这项资产就为诺华带来了回报。虽然诺华已经有自己的IgA肾病候选药物iptacopan，目前正在进行III期临床试验，但它跟Atrasentan的机制并不相同。该药物最初由艾伯维开发，2013年，该公司因该药物临床数据低于预期而停止了慢性肾病的III期试验。幸运的是，2023年10月公布的一项为期36周的中期分析显示，在该药物的III期研究中，蛋白尿的改善程度明显高于安慰剂组。受此消息鼓舞，诺华计划于2024年上半年在美国申请加速审批，随后不久将提交iptacopan的IgA肾病适应症审批。同时，诺华还从Chinook获得了另一项IgA肾病资产，名为zigakibart，目前正在进行III期试验。诺华首席执行官Vasant Narasimhan在4月份的财报电话会议上解释：“我们认为，拥有三种IgA肾病药物将使我们在患者、医生、美国供应链各个环节以及全球范围内占据有利地位。” 8 罗氏71亿美元收购Televant 前雇主卖“后悔了” 我们可以通过“前雇主”是否难以释怀来判断这笔交易是否“划算”。Televant的情况确实如此，交易达成的几个月后，其前身公司Roivant首席执行官Matt Gline坦言，他仍然对出售Televant感到“后悔不已”。 2022年12月，Roivant与辉瑞合作，成立了一家专注于炎症和纤维化疾病的新公司即Televant，用于开发TL1A定向抗体RVT-3101。一个月后，公布的IIb期数据显示，RVT-3101使32%的IBD患者得到缓解，而安慰剂组这一比例仅为12%。当时，各大制药公司对抗TL1A的兴趣十分浓厚，默沙东以108亿美元收购了Prometheus，赛诺菲也与Teva就IBD治疗药物TEV-574展开了合作。到2023年10月，罗氏以71亿美元拿下了同样热门的Televant。 Gline在1月份表示，收购完成后，他一直感到遗憾，是因为RVT-3101的“机会实在太大了”。罗氏对新收购感到十分满意，并宣布计划今年将RVT-3101投入III期试验。2月份举行的财报电话会议上，罗氏制药首席执行官Teresa Graham形容，该资产“有机会真正重新设定患有毁灭性疾病患者的护理标准”。 Graham对外宣称：“我们相信TL1A还有很多其他的适应症，我们期待着为其探索更多的试验计划。请继续关注它的发展方向，前景一片光明。” 9 BMS收购RayzeBio 冲进核药赛道 BMS一举以41亿美元收购了RayzeBio，加入了核药赛道竞逐，瞄准α射线同位素。收购交易以每股62.50美元的价格进行，这一价格是RayzeBio几个月前IPO价格的三倍多。 BMS的出价，足以击败另外两家也提出报价的未具名公司。竞争和中标价格，也能表明核药领域有多火爆，并使BMS能够与诺华同台竞争。与诺华获批的核药疗法Lutathera和Pluvicto（使用名为镥的β发射同位素）不同，RayzeBio的研究基于名为锕-225的α发射同位素。 RayzeBio的主要资产是RYZ101，该药物靶向生长抑素受体2（SSTR2），这是一种在胃肠胰神经内分泌肿瘤（GEP-NET）和广泛期小细胞肺癌（ES-SCLC）中过度表达的蛋白质。该药物的3期试验目前正在进行中，试验对象为之前接受过镥-177生长抑素疗法治疗的SSTR阳性GEP-NET患者，预计2025年将公布研究数据。 BMS还获得了RayzeBio位于印第安纳波利斯的“最先进”制造工厂。礼来也于2023年进入了核药领域，以14亿美元收购Point Biopharma Global，后者是一家专注于放射性配体疗法且拥有内部制造能力的生物技术公司。 10 阿斯利康收购Fusion 押注RDC BMS并非唯一一家刚踏入核药领域的大型制药公司。阿斯利康也大手笔投资入局，今年3月以24亿美元（预付20亿美元）将Fusion纳入其资产配置。该交易确保FPI-2265的II期临床试验如期推进，该药物可提供锕-225，其释放的能量比诺华的Pluvicto等β疗法更高。阿斯利康认为，FPI-2265有可能成为首个获批用于治疗镥后转移性去势抵抗性前列腺癌的PSMA靶向放射治疗方法。但这笔交易的意义远不止将FPI-2265送上FDA审批关口。在宣布收购消息的一个月后，第一季度财报电话会议上，阿斯利康肿瘤研发部执行副总裁Susan Galbraith热情洋溢地谈到，将“放射性结合物与我们研发线中的其他疗法相结合的巨大潜力，包括下一代免疫肿瘤双特异性抗体、细胞疗法、T细胞接合剂和我们的DNA损伤反应剂”。交易也带来了制造方面的好处，放射性同位素的半衰期较短，而且全球生产基地相对较少，这使得制药公司很难进入该领域。幸运的是，Fusion已经在自己的工厂生产临床GMP剂量，并与服务商展开了密切合作。 Galbraith解释说，这意味着此次收购将加速阿斯利康实现商业规模核药生产能力的目标，并强调这一目标将在“三年内”完成，同时还能确保锕的供应。参考资料： 1.Top 10 smartest deals in biopharma；Fierce Biotech 近期直播推荐:

并购临床3期抗体药物偶联物IPO申请上市

2024-06-25

·BioSpace

Radiopharmaceutical Industry Outlook: Growth Trends and Future Prospects

The concept of radiopharmaceuticals has been around for several decades. The field of radiotherapeutics has seen rapid development due to advances in radioisotope-based therapies, multimodality bioimaging technology, nanotherapeutics, and interventional oncology. The success of Novartis' prostate cancer drug Pluvicto further led to the resurgence of interest among prominent players in the field, leading to numerous clinical trials testing novel radiotheranostics. What are radiopharmaceuticals, and what are some statistics about the procedures performed globally? Radiopharmaceutical is a combination of radioactive isotopes and pharmaceutical drugs. They are used to diagnose and treat life-threatening diseases such as cancer, cardiac disorders, and neurological disorders. They are utilized in 3 procedures: SPECT imaging, PET imaging and therapeutics. Radiopharmaceuticals are transforming the treatment of various diseases, especially cancers, with targeted radionuclide therapy. Radioligand therapy targets cancer cells with high doses of radiation, promising advancements in cancer treatment. The widespread use of nuclear medicines is evident from a number of procedures performed globally. According to the World Nuclear Association, the annual number of nuclear medicine procedures performed exceeds 50 million, and the need for radioisotopes is rising. Radioisotopes are employed in the medical field by more than 10,000 hospitals worldwide, with approximately 90% of the procedures being diagnostic. Technetium-99 (Tc-99m) is the most often used radioisotope in nuclear medicine diagnostics; it is utilized in approximately 80% of nuclear medicine procedures and 85% of diagnostic scans performed globally. Additionally, in the US and Europe, 20 million and about 10 million nuclear medicine procedures are performed annually, respectively, with 2 million being therapeutic. SPECT is the current major scanning technology employed to diagnose and monitor a wide range of medical conditions; however, PET is expected to be preferred in future over SPECT as it is a more precise and sophisticated technique in the diagnosis of cancers and is well-used in cardiac and brain imaging. Tc-99m and 18F- FDG are the major radiopharmaceuticals for SPECT and PET imaging, which account for 80% of all nuclear medicine procedures. However, the availability of new radiopharmaceuticals, such as PET imaging agents flutemetamol and florbetapir used in neurological conditions and cancer theranostic, drive molecular imaging in the clinical setting. Read our related market research report’s key insights: Radiopharmaceutical CDMO/CMO Services Market Key Insights 2024 Radiotheranostics Market Key Insights 2024 Radiopharmaceuticals Market Key Insights 2024 Radioligand Therapy Market Key Insights 2024 Radioactive Tracer Market Key Insights 2024 What are the different components of the radiopharmaceuticals market: Radioligand therapy, nuclear pharmacy, radiotheranostics, and radioactive tracers are various components used in radiopharmaceuticals to diagnose and treat diseases. The increasing utilization of these components drives substantial growth in the radiopharmaceutical industry. With rising demand for targeted cancer treatments, advanced diagnostic procedures, and integrated therapeutic solutions, these segments play pivotal roles in expanding the market. As technological innovations continue to enhance precision and efficiency, the radiopharmaceutical industry is poised for sustained growth and global expansion in the coming years. Radioligand Therapy/ Radiopharmaceutical Therapeutics Radioligand therapy (RLT) utilizes targeted medicines, often employing radioactive isotopes like lutetium-177, to bind to tumour targets, offering high rates of long-term tumour remission and stability, particularly for metastasized disease. Nuclear Pharmacy Nuclear pharmacy, a pharmacy subspecialty, focuses on preparing, dispensing, and managing radioactive materials used in nuclear medicine operations. Radiotheranostics Radiotheranostics uses radioactive probes to diagnose and treat specific cells, usually cancer cells. It's a combination of molecular imaging and targeted therapy that uses a ligand-linker-radioisotope design. Radioactive Tracer Radioactive tracers are diagnostic radiopharmaceuticals used to image the body and identify diseases. These are composed of tightly bonded molecules with a radioactive atom. So, what are the market dynamics of the Radiopharmaceutical industry? Key driving factors: Advancements in imaging technology Growth in PET imaging procedures driven by prostate, cardiac, and amyloid imaging due to better imaging, significantly lower false negatives and faster examination time Diagnostic and therapeutic application expansion of radiopharmaceuticals in new applications such as cardiology, neurology apart from oncology The ageing population and rising prevalence of target diseases increase the target population Availability of new products in PET and Theranostics segment Expansion of radioligand therapy into earlier lines of treatment (i.e., from 3L to include 2L, 1L and mHSPC populations) Innovative use of AI to enhance diagnostic accuracy and prognostics Rising demand for targeted cancer treatments Measures to close the gap between supply and demand for Mo-99 Market restraints: Stringent manufacturing and regulatory environment Requirement of robust raw material supply, manufacturing, and product transportation due to the short half-life of products Lack of skilled workforce Preconceived negative perceptions around the use of radioactive substances Trends - Investigation of new/ alternative radioisotopes such as 211 At, 223 Radium, and 212 Lead Supply chain advancements Integration with AI for diagnostic imaging Availability of radionuclide therapy programs in hospitals and cancer centers The radiopharmaceuticals sector is highly specialized, competitive and rapidly growing. Cardinal, GE, Novartis, Curium, and Jubilant are some of the prominent players in the industry. Major industry players are acquiring smaller companies with radiopharmaceuticals pipelines and investing in potential blockbuster products to get a foot in the door, which has resulted in significant investments, M&A, and funding. This can be attributed to the effectiveness of radiopharmaceuticals in cancer treatment and the commercial success of recently approved products such as Lutathera (Novartis) and Pluvicto (Novartis). In March 2024, AstraZeneca PLC completed the Canadian biotech Fusion Pharmaceuticals Inc. acquisition for $2 billion. In May 2024, Novartis AG acquired Mariana Oncology to enhance its research capabilities and clinical supply capacity in radioligand therapies. Similarly, in December 2023, Eli Lilly acquired POINT Biopharma Global Inc. with its lutetium-based portfolio for $ 1.4 billion. That same month, BMS purchased RayzeBio, Inc., including its Phase III actinium-based RYZ101, for $4.1 billion. Additionally, radiopharmaceuticals are being developed by significant drugmakers, a few publicly traded companies, and at least a dozen biotechnology startups. The under-development pipeline includes several PET & SPECT imaging agents, and targeted theranostic radiopharmaceuticals for diagnosing cancer and non-cancer indications. For instance, Clarity Pharmaceuticals, an innovative radiopharmaceutical with its Targeted Copper Theranostic (TCT) platform of products, has SARTATE, SAR-bisPSMA, and SAR-Bombesin, next generation, highly targeted theranostic radiopharmaceutical for cancer. GE Healthcare has two new radiopharmaceuticals in the pipeline, PET and SPECT imaging. Expanding the radiopharmaceutical pipeline presents a substantial opportunity for improved patient care with increased access to cutting-edge imaging, improved treatment options, greater personalized treatment, lower radiation exposure, and potential for future advancements. Radioligand therapy is currently used in a small number of cancers. It appears to be a promising treatment option, and its use is anticipated to increase over time to treat various cancer types. The radiopharmaceutical market growth will be further boosted by the use of radioligand therapy together with other therapies, raising patient and healthcare professional awareness of radioligand therapy, coordinating and collaborating specialities involved in providing cancer care (medical oncologists, nuclear medicine physicians, and others), planning hospital capacity—both human and physical—to deliver radioligand therapy safely and effectively, and developing efficient nuclear waste disposal protocols tailored to the various types of therapy.

并购临床3期放射疗法

100 项与 Lutetium (177 Lu) Vipivotide Tetraxetan 相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
转移性去势抵抗性前列腺癌	韩国	Novartis AG	2024-05-29
PSMA阳性去势抵抗性前列腺癌	欧盟	Novartis Europharm Ltd.	2022-12-09
PSMA阳性去势抵抗性前列腺癌	冰岛	Novartis Europharm Ltd.	2022-12-09
PSMA阳性去势抵抗性前列腺癌	列支敦士登	Novartis Europharm Ltd.	2022-12-09
PSMA阳性去势抵抗性前列腺癌	挪威	Novartis Europharm Ltd.	2022-12-09
去势抵抗性前列腺癌	美国	Novartis Pharmaceuticals Corp.	2022-03-23

未上市

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适应症	最高研发状态	国家/地区	公司	日期
寡转移性前列腺癌	临床3期	美国	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	日本	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	澳大利亚	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	加拿大	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	以色列	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	新加坡	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	瑞士	Novartis Pharmaceuticals Corp.	2024-03-12
PSMA阳性前列腺癌	临床3期	美国	Novartis Pharmaceuticals Corp.	2024-03-12
PSMA阳性前列腺癌	临床3期	日本	Novartis Pharmaceuticals Corp.	2024-03-12
PSMA阳性前列腺癌	临床3期	澳大利亚	Novartis Pharmaceuticals Corp.	2024-03-12

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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


NCT04689828 (PSMAfore, ASCO2024) 人工标引	临床3期	转移性去势抵抗性前列腺癌 AR \| TP53 \| PTEN	468	177Lu-PSMA-617 (ctDNA fraction >1%)	構願衊鑰窪遞醖願網醖(襯淵簾選製積膚艱簾廠) = 繭鹽範窪淵壓鹹鹽齋鹽餘衊積憲衊衊獵鹹鬱壓 (淵憲夢膚構鑰願鹽構網, 5.8–11.3) 更多	积极	2024-05-24
				177Lu-PSMA-617 (ctDNA fraction ≤1%)	構願衊鑰窪遞醖願網醖(襯淵簾選製積膚艱簾廠) = 蓋築製鏇齋壓選簾蓋鹽餘衊積憲衊衊獵鹹鬱壓 (淵憲夢膚構鑰願鹽構網, 11.5–NE) 更多
TheraP trial (ASCO2024)	N/A	转移性去势抵抗性前列腺癌 PSMA \| FDG avid disease	32	Lutetium-PSMA-617	繭簾築壓鏇遞鑰窪淵鏇(積膚遞蓋構遞網糧遞憲) = 淵齋範廠齋餘齋鹹餘蓋蓋壓鏇遞襯廠衊鹹蓋艱 (壓餘繭襯夢遞鏇鬱鏇鑰 ) 更多	积极	2024-05-24
PROMISE (ASCO2024)	N/A	PSMA阳性去势抵抗性前列腺癌 PSMA PET+ \| DDR alterations \| tumor suppressor gene alterations (TSGa) (PTEN,p53,RB1) ... 更多	115	PSMA PET+ mCRPC patients treated with 177Lu-PSMA-617	積膚製艱膚鹹淵繭憲膚(願鏇製壓鬱鏇製顧襯築) = 鬱顧繭選構夢窪鹹齋壓憲醖膚顧糧淵簾鬱獵鹽 (鹽憲構艱窪鏇顧夢積鏇 ) 更多	积极	2024-05-24
ASCO2024	N/A	转移性去势抵抗性前列腺癌	-	[177Lu]Lu-PSMA-617	範願蓋齋衊繭衊蓋製觸(廠廠積簾衊衊壓蓋壓蓋) = 襯製窪築衊鹽願窪願齋鬱醖廠窪鏇獵鹽選鑰鏇 (餘憲窪觸夢觸築醖構蓋 ) 更多	-	2024-05-24
177Lu-PSMA-617 (ASCO2024)	N/A	PSMA-bTTV	138	177Lu-PSMA-617 treatment	積壓簾鏇艱膚鹽鏇廠鑰(願蓋網獵鬱窪齋選膚糧) = 8 (5.8%) patients had grade 3 anemia 繭襯獵艱蓋廠窪鹹襯憲 (艱觸膚觸網鏇艱膚膚夢 ) 更多	不佳	2024-05-24
				177lu-PSMA-617
NCT03392428 (TheraP ANZUP 1603, ASCO2024)	临床2期	转移性去势抵抗性前列腺癌 ctDNA	180	[177Lu]Lu-PSMA-617 (LuPSMA)	願選膚觸艱憲製構衊餘(積鹽網獵廠淵鬱鹹糧夢) = 憲衊顧衊製壓鹽構範獵廠繭製網窪糧觸憲築繭 (繭觸簾窪構襯糧網顧願 )	积极	2024-05-24
				Cabazitaxel	願選膚觸艱憲製構衊餘(積鹽網獵廠淵鬱鹹糧夢) = 製顧獵窪壓壓窪壓醖範廠繭製網窪糧觸憲築繭 (繭觸簾窪構襯糧網顧願 )
NCT06216249 (FLEX-MRT, ASCO2024)	临床2期	PSMA positron emission tomography (PET)	90	Flexible dosing schedule of 177Lu-PSMA-617 RLT up to 12 cycles	鏇夢鬱憲鑰築廠築範淵(築餘窪憲膚簾鬱齋築選) = 艱簾衊願築壓積齋選鹽夢觸窪憲構鏇壓襯構艱 (願餘壓憲獵製齋製憲願 )	积极	2024-05-24
				Fixed dosing schedule of 177Lu-PSMA-617 RLT 6 cycles	鏇夢鬱憲鑰築廠築範淵(築餘窪憲膚簾鬱齋築選) = 餘鑰鹹顧繭艱顧鬱襯鏇夢觸窪憲構鏇壓襯構艱 (願餘壓憲獵製齋製憲願 )
ASCO2024	N/A	转移性去势抵抗性前列腺癌	-	177Lu-PSMA-617	齋鑰蓋網憲窪選鏇襯醖(製遞簾獵鏇鑰醖鑰鏇網) = 齋鹽願遞膚鹽簾簾憲廠觸糧窪襯網鹽鬱醖範襯 (構廠願鏇膚獵廠廠選製, 45% ~ 66%) 更多	-	2024-05-24
				177Lu-PSMA-617	齋鑰蓋網憲窪選鏇襯醖(製遞簾獵鏇鑰醖鑰鏇網) = 鑰繭膚衊築構壓觸選簾觸糧窪襯網鹽鬱醖範襯 (構廠願鏇膚獵廠廠選製, 23% ~ 59%) 更多
ASCO2024	N/A	PSMA阳性肿瘤	-	177Lu-PSMA plus protocol permitted standard of care (SOC)	願鏇夢蓋繭糧製選餘鑰(鬱觸餘遞淵艱選襯鬱鑰) = 鬱淵衊襯膚製齋齋網衊製網範遞築廠憲範製窪 (衊獵願蓋願廠範齋鑰衊 )	-	2024-05-24
NCT04689828 (PSMAfore, AUA2024) 人工标引	临床3期	转移性去势抵抗性前列腺癌	-	177Lu-PSMA-617	襯廠廠廠蓋網糧繭願鏇(壓範壓鹹製顧壓鑰鏇餘) = 鏇鑰醖醖製糧鏇膚積築鹽製淵獵蓋範製範積醖 (鹹窪獵製範構鹹範膚膚, 9.30-14.42) 达到更多	积极	2024-05-03
				ARPI change	襯廠廠廠蓋網糧繭願鏇(壓範壓鹹製顧壓鑰鏇餘) = 鹹獵壓窪網鏇艱網蓋鹹鹽製淵獵蓋範製範積醖 (鹹窪獵製範構鹹範膚膚, 4.17-5.95) 达到更多