预约演示

更新于：2025-05-28

Lutetium (177 Lu) Vipivotide Tetraxetan

镥[177Lu] 特昔维匹肽

更新于：2025-05-28

概要

基本信息

药物类型

多肽偶联核素、治疗用放射药物

别名

177-Lutetium-PSMA-617(RadioMedix, Inc.)、[Lu-177] vipivotide tetraxetan、Lu-177-PSMA-617 Lutetium-177-PSMA-617

+ [13]

靶点

PSMA

作用方式

抑制剂

作用机制

PSMA抑制剂(前列腺癌特异性膜抗原抑制剂)

治疗领域

肿瘤泌尿生殖系统疾病消化系统疾病

在研适应症

转移性去势抵抗性前列腺癌PSMA阳性去势抵抗性前列腺癌转移性前列腺癌+ [12]

非在研适应症-

原研机构

RadioMedix, Inc.

在研机构

Novartis Pharmaceuticals Corp.

Novartis Pharmaceuticals Canada, Inc.Novartis Pharma AG

+ [12]

非在研机构-

权益机构

Endocyte, Inc.

ABX advanced biochemical compounds GmbH

Novartis AG

最高研发阶段批准上市

首次获批日期

美国 (2022-03-23),

PSMA阳性去势抵抗性前列腺癌

最高研发阶段(中国)申请上市

特殊审评优先审评 (中国)、孤儿药 (韩国)、突破性疗法 (美国)

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结构/序列

分子式C49H68LuN9O16

InChIKeyRSTDSVVLNYFDHY-NLQOEHMXSA-K

CAS号1703749-62-5

使用我们的ADC技术数据为新药研发加速。

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查看完整样例数据

关联

项与镥[177Lu] 特昔维匹肽相关的临床试验

NCT06964958

/ Not yet recruiting临床2期IIT

LASER - a Phase 2 Trial of 177Lu-PSMA-617 as Systemic Therapy for Renal Cell Carcinoma

This study aims to evaluate the efficacy and safety of 177Lu-PSMA-617 as a systemic therapy in patients with PSMA-positive advanced clear cell renal cell carcinoma (ccRCC).
The name of the study drug involved in this research study is:
-177Lu-PSMA-617 (a type of radioligand therapy)

开始日期2025-11-01

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+1]

NCT06783348

/ Not yet recruiting临床2期IIT

Phase II Trial Evaluating the Efficacy of 177Lutetium-PSMA-617 Treatment in Patients With Metastatic Clear Cell Renal Carcinoma Cell With Progressive Disease on First-line or Second-line Systemic Treatment

Background This study is for adults with advanced kidney cancer that has spread to other parts of the body and has continued to progress despite treatment with immunotherapy and targeted therapy. Unfortunately, treatment options at this stage of the disease are limited. The existing treatments' ability to work against cancer has not been fully looked into.
Rationale The goal of this study is to examine if a new drug treatment called 177Lutetium-PSMA-617, hereafter referred as 177Lu-PSMA-617, which holds the active ingredient 177Lutetium-PSMA and has been used as a standard treatment for advanced prostate cancer since December 2022, can also help treat advanced kidney cancer.
The drug 177Lu-PSMA-617 is being tested as an experimental treatment that targets a specific protein on cancer cells. This protein, known as prostate-specific membrane antigen (PSMA), is present on the surface of kidney cancer cells. Therefore, before the treatment begins, participants will undergo a PET (positron-emission tomography) scan to check if their kidney cancer cells express high levels of PSMA. This scan uses a small amount of radioactive material (in the form of 177Lutetium) to visualize the presence of PSMA on the cancer cells. Only participants who test positive for PSMA can take part in the study. In this approach, PSMA serves two purposes. First, it helps assess whether the cancer expresses this protein and allows 177Lu-PSMA-617 to specifically target and attach to the cancer cells. Second, 177Lu-PSMA-617 delivers a small amount of radiation directly to the tumour, which helps kill cancer cells while minimizing damage to normal cells. This type of treatment is known as a radiopharmaceutical.
Objective The primary aims are to find out if 177Lu-PSMA-617 is useful against kidney cancer and to assess its safety. Throughout the study, participants will undergo several imaging assessments to check their disease and response to treatment.
The study also includes the collection of tissue samples. Together with the information collected from the imaging assessments, this will allow further research into markers that may lead to earlier detection of tumour spread or help identify individuals who may benefit more from treatment with 177Lu-PSMA-617.
Treatment All participants will receive 177Lu-PSMA-617 through an intravenous injection at a standard dose of 7,400 MBq (megabecquerel: a measure of radioactivity). Treatments will be administered approximately every six weeks, for a maximum of six times.
Blood tests are done before and during treatment to check the participant's health and to detect any early side effects from the treatment. Different types of scans are performed before, during, and after 177Lu-PSMA-617 administration to check how well the treatment is working. After treatment ends, follow-up visits will be scheduled every six weeks during the first year. In the second year, your doctor will decide how often you need to come in for visits. These appointments are important for monitoring how the body continues to respond to the treatment. The entire study period will last approximately two years from the time of study entry.
Participants
The study will include approximately 56 participants who will be tested for PSMA expression, to obtain a minimum of 48 participants expressing PSMA entering the study. To qualify, participants must:
* Be diagnosed with advanced kidney cancer previously treated with immunotherapy and targeted therapy.
* Test positive for PSMA on a PET scan.
* Be generally healthy and able to perform daily activities.
* Be at least 18 years of age.
Benefit-risk analysis The drug 177Lu-PSMA-617 has proven to work well in treating advanced prostate cancer and could be a promising new treatment possibility for kidney cancer, although this has not yet been shown. By joining this study, participants will contribute to valuable research to better understand kidney cancer and improve treatment options for future patients. Participating in this study offers a chance to try a new treatment, which might help people with advanced kidney cancer live longer and prevent the disease from getting worse, especially for those who have limited treatment options left after immunotherapy and targeted therapy.
With all new treatments, there are possible risks and side effects associated with them. Side effects of the drug 177Lu-PSMA-617 may include feeling tired, nausea, dry mouth, loss of appetite, and changes in blood cells. While not all side effects are known yet, the study team will carefully follow participants for any side effects during and after treatment. It is important to understand that while the study is being done to provide new information, there are still some questions on the treatment's safety and how well it will work.

开始日期2025-10-30

申办/合作机构-

NCT06894511

/ Not yet recruiting临床2期

A Phase II, Open-label, Multi-Center, Randomized Study Comparing the Combination of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) and Androgen Receptor Pathway Inhibitor (ARPI) vs. Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in First-line Treatment of Patients With Prostate-Specific Membrane Antigen (PSMA)-Positive Progressive Metastatic Castration Resistant Prostate Cancer (mCRPC)

The purpose of this study is to assess whether the combination of AAA617 (administered for 6 cycles at a dose of 7.4 GBq (200 mCi) +/- 10%) and ARPI improves radiographic progression-free survival (rPFS) or time to death compared to AAA617 alone in PSMA-positive mCRPC patients who were previously treated and progressed on ARPI in the biochemical recurrence (BCR)-non metastatic hormone sensitive prostate cancer (mHSPC), mHSPC, or non-metastatic Castration Resistant Prostate Cancer (nmCRPC) setting and have not previously received a taxane-containing regimen in the castrate resistant prostate cancer (CRPC) setting.

开始日期2025-08-29

申办/合作机构

Novartis Pharmaceuticals Canada, Inc.

100 项与镥[177Lu] 特昔维匹肽相关的临床结果

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100 项与镥[177Lu] 特昔维匹肽相关的转化医学

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100 项与镥[177Lu] 特昔维匹肽相关的专利（医药）

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573

项与镥[177Lu] 特昔维匹肽相关的文献（医药）

2025-07-01·NUCLEAR MEDICINE AND BIOLOGY

Enhancing the therapeutic index of [211At]YF2 with iodo pseudo carrier: A simple strategy for reducing accumulation in kidneys, salivary and lacrimal glands

Article

作者: Feng, Yutian ; Vaidyanathan, Ganesan ; Banks, Rebecca L ; Huynh, Truc T ; Zalutsky, Michael R

INTRODUCTION:

Low-molecular-weight (LMW) PSMA-targeted agents have enjoyed success; however, their off-target toxicity in normal tissues such as kidneys, salivary gland and lacrimal gland can be dose limiting. Herein, we have evaluated the effect of co-administration of the non-radioactive iodo pseudo carrier, iodo YF2, on the normal tissue uptake of [²¹¹At]YF2 in xenografted mice. The potential implications for clinical translation of these studies were investigated by evaluating the binding of LMW PSMA-targeted agents to murine and human PSMA.

METHODS:

[²¹¹At]YF2 was synthesized following established protocols. Groups of 5 mice bearing subcutaneous PSMA+ PC3 PIP xenografts received [²¹¹At]YF2 co-injected with varying i.v. doses of iodo YF2 (0-2 nmol), and the biodistribution was evaluated at 1 h post injection (p.i.). In another study, the biodistribution of [²¹¹At]YF2 alone and [²¹¹At]YF2 co-administered with 1.5 nmol iodo YF2 was evaluated at 1 and 8 h p.i. Bead-based radioligand binding assays were conducted for [¹³¹I]YF2 and several other LMW agents to compare their binding to human and murine PSMA.

RESULTS:

At 1 h, no significant difference was seen in kidney uptake of [²¹¹At]YF2 at iodo YF2 concentrations of 0, 0.05 and 0.1 nmol (p > 0.05), but renal accumulations significantly reduced by co-administering 2.0 nmol iodo YF2 (p < 0.0001). Decreases in salivary and lacrimal gland uptake also were observed at 1 h for [²¹¹At]YF2 co-injected with 0.1 nmol iodo YF2 (p < 0.05). A follow-up study revealed a kidney uptake of 1.8 ± 0.4 % ID/g for [²¹¹At]YF2 with 1.5 nmol iodo YF2, compared to 46.5 ± 7.7 % ID/g for [²¹¹At]YF2 alone at 8 h. Tumor uptake showed no significant difference (p > 0.05) between [²¹¹At]YF2 alone (17.1 ± 8.8 % ID/g at 1 h; 13.6 ± 5.3 % ID/g at 8 h) and [²¹¹At]YF2 plus 1.5 nmol iodo YF2 (12.8 ± 2.7 % ID/g at 1 h; 14.1 ± 3.2 % ID/g at 8 h). Bead-based radioligand binding assays showed that [¹³¹I]YF2 has the highest binding fractions to both human PSMA (94.1 ± 0.1 %) and murine PSMA (92.5 ± 0.2 %) with minimal differences between the two, while [¹⁷⁷Lu]PSMA-617 had the greatest species-dependent disparity with a binding fraction of 90.5 ± 0.3 % to human PSMA and 60.9 ± 1.4 % to murine PSMA.

CONCLUSIONS:

Co-administration of iodo YF2 reduced kidney uptake of [²¹¹At]YF2 and decreased accumulation in normal tissues with no significant change in tumor uptake. In some cases, there was a significant difference in binding to human and murine PSMA among LMW PSMA-targeted agents suggesting that particularly for some agents, applying mouse data to predict human dosimetry must be done with caution.

2025-06-01·PROSTATE

Outcome of Subsequent Therapies After ¹⁷⁷Lu‐Vipivotide Tetraxetan for Metastatic Castrate‐Resistant Prostate Cancer: A Tertiary Cancer Center Experience

Article

作者: Liu, Mofei ; Borges, Nuno ; Choudhury, Atish D. ; Kavanaugh, Michael ; Jacene, Heather ; Robertson, Matthew ; Losee, Meryam ; Morgans, Alicia ; Wolanski, Andrew ; Hyun, Hyewon ; Pomerantz, Mark ; Wei, Xiao X. ; Taplin, Mary‐Ellen ; Sakellis, Christopher ; Stoltenberg, Hailey ; Ravi, Praful ; Kilbridge, Kerry L. ; Ng, Thomas ; Haberman, Veronica ; Ritzer, Jolivette ; Bhimaniya, Sudhir ; Shah, Hina

ABSTRACT:

Background:

177Lu‐vipivotide tetraxetan (177Lu‐PSMA‐617, LuPSMA) improves overall survival in patients with metastatic castration‐resistant prostate cancer (mCRPC) after at least one taxane chemotherapy and androgen receptor pathway inhibitor. There are limited data on the clinical course and outcomes of patients with mCRPC after receipt of LuPSMA.

Methods:

We queried an IRB‐approved prospectively maintained registry of all patients with mCRPC who received standard‐of‐care LuPSMA at our institution between June 2022 and January 2024. Clinical data about LuPSMA and subsequent therapies were extracted from the electronic medical record, including the type and number of subsequent systemic therapies, reason for treatment cessation, hematologic toxicity and supportive treatment, and PSA50 response to subsequent therapy (defined as a ≥ 50% decrease in PSA).

Results:

A total of 146 patients were evaluated; mean age 72 (range 52–87), observed median follow‐up 5.9 months (range 0.51–18.7). Forty‐four received systemic treatment after LuPSMA. The most common subsequent treatment after LuPSMA was chemotherapy (n = 27), primarily cabazitaxel ± carboplatin/cisplatin (n = 23), and the median number of cycles received was 4 (range 1–7). In 35/44 men with available hematologic toxicity data, 13 developed grade ≥ 3 anemia, 7 had ≥ grade 3 thrombocytopenia, and 16 received hematologic support. PSA50 to post‐LuPSMA treatment occurred in 10/36 (28%) evaluable patients. Median overall survival from subsequent systemic therapy was 7.6 months (95% CI 5.81–NR).

Conclusions:

30% of patients receiving standard‐of‐care LuPSMA received subsequent therapy, mostly cabazitaxel‐containing regimens. Post‐LuPSMA treatment appeared tolerable and was associated with a PSA50 response rate of 28%. These outcomes may be biased by limited standard‐of‐care life‐prolonging treatment options at the time of LuPSMA FDA approval, but it also highlights the continued need to develop novel therapeutic strategies for mCRPC post‐LuPSMA.

2025-06-01·CLINICAL NUCLEAR MEDICINE

Intense Prostate-specific Membrane Antigen Avid Hepatic Metastatic Lesions Shortly After Finishing 6 Cycle Pluvicto Treatment

Article

作者: Hogan, Thomas ; Heubach, Kody ; Wang, Xiaofei

A 71-year-old man was diagnosed with prostate cancer in 2012. After treatment with hormone, chemo, and combinations subsequently, the baseline prostate-specific membrane antigen PET scan revealed 130+ nodal and osseous metastatic lesions. After 4 doses of pluvicto, a partial response was appreciated. However, new intense prostate-specific membrane antigen avid hepatic lesions occupied around 30% of the liver with poorly differentiated metastatic prostate cancer 55 days after the last dose of pluvicto and markedly elevated prostate-specific antigen. This case highlights the need for vigilant monitoring and alternative treatment strategies.

780

项与镥[177Lu] 特昔维匹肽相关的新闻（医药）

2025-05-27

·生物制药进展杂评

核药龙头，先通医药提交港股IPO，能否掀起RDC出海热潮？

老规矩，先写看看新闻，后面杂评君再聊句个人看法。5月26日，北京先通医药提交港股上市申请，中金公司和中信证券担任联席保荐人。首先恭喜我们的服务客户先通医药~，真的很棒；在国内说他们最好，担心大家说商业互捧，但是说第一梯队应该没什么太大争议。先通产品布局包含诊断和治疗产品先通医药核心管线如下：国内核药热，我得理解应该是诺华带起来的，后面远大引入了几个产品，恒瑞医药后来也悄悄滴布局了进来，最快的也该到了II期了吧（他们真是啥都少不了，什么新鲜玩意，都能看到他们悄咪咪的进来）先通医药作为国内的领军企业，布局还是很早，也是扎扎实实自己在做。本次申报港股IPO ，希望也能给国内核药领域带来新一波的热潮。关于核药市场：目前核药市场相对于双抗、ADC、小核酸，还是稍微小众一点目前，全球已有超过十种放射性配体药物获得上市批准。其中，诺华的前列腺癌治疗药物Pluvicto®在2024年创造约14亿美元收入，而同属放射性配体药物的GEP-NET治疗药物Lutathera®同期收入达约7.24亿美元。Lantheus的前列腺癌示踪剂Pylarify®在2024年销售额亦突破10亿美元。这应该是目前表现最好的治疗性药物。诊断产品更多一些，大约有50种上市的产品。国内核药在研格局及特点国内目前在临床阶段的核药产品相对较少，比ADC少了很多，ADC和双抗目前国内进入临床的产品数量大于在250个左右。进入临床阶段的产品放在了文末知识星球里，有兴趣可以进入自己看，或者联系小编都OK。参与企业数量也比较少：现在临床阶段产品较多的就是先通医药和烟台蓝纳成、纽瑞特等不多的公司靶点多样性少：PSMA、FAP、SSTR2这些靶点，国内基本还在处于一个follow的状态，创新的靶点很少，并没有像ADC和双抗一样，组合出各种新的分子。MNC 参与的并购或者交易相对现在比较火的几个领域也少了很多，简单查了2024年主要有下面几个，数量不多，但是价格并不便宜：1、诺华收购 Mariana Oncology：2024 年 5 月，诺华以 10 亿美元预付款 + 7.5 亿美元里程碑收购 Mariana Oncology，以扩大其放射性药物管道并增强研发能力，协议包括临床前 RLT 候选人，重点是小细胞肺癌治疗 MC - 229。2、阿斯利康收购 Fusion Pharmaceuticals：2024 年 3 月 19 日，阿斯利康宣布以 20 亿美元收购 Fusion Pharmaceuticals。Fusion 公司最领先的研发项目是前列腺特异性膜抗原（PSMA）靶向的放射性疗法 FPI - 2265，当时正在进行 2 期临床试验。3、百时美施贵宝收购 RayzeBio：2023 年 12 月 16 日，百时美施贵宝（BMS）宣布以 41 亿美元收购核药生物技术公司 RayzeBio，获得其基于 α 核素的差异化放射性药物平台及多款在研创新产品药物开发项目，如 RYZ101、RYZ801 等。4、诺华与 PeptiDream 达成合作：2024 年 4 月 30 日，诺华与 PeptiDream 达成合作协议，共同开发多款大环肽靶向偶联核药，PeptiDream 将获得 1.8 亿美元预付款，里程碑付款金额高达 27.1 亿美元。5、·赛诺菲达成合作：2024 年 9 月 1 日，赛诺菲宣布与 RadioMedix 以及 Orano Med 就放射性配体疗法 AlphaMedix（Pb212 - DOTAMTATE）达成合作，预付款为 1 亿欧元，里程碑付款为 2.2 亿美元。杂评君：ADC后之后的双抗持续火热，国内现在二级市场上对BD交易出海期望值很高，很多创新药企的市值不断攀升更多就是基于关键品种未来的海外BD预期。RDC本身上市企业数量少，产品开发数量少，从资源池来说，可供MNC选择不多。加上国内RDC的开发相对有些门槛。杂评君也简单看了下国内进入临床阶段的RDC产品，坦率说，可供MNC选择的凤毛麟角~公开的有说服力数据的更是少见~未来出海大潮，只能等待，更多参与者，或者更多创新产品进入，并展示出良好的临床数据来说服MNC~最后，写公众号，一直没有养成校对的习惯，基本是码字一遍完成，有错别字不影响阅读的就凑合看吧，毕竟码字也挺费颈椎的~~~~~~~联系人：药渡咨询事业部合伙人郭雷电话：15810633207（微信号）公众号有个实名群，有兴趣可以加一下，不定时也会分享点报告

抗体药物偶联物IPO放射疗法并购临床2期

2025-05-27

·小核说核药

基于创新放药的SPECT肿瘤显像的临床价值分析与市场预测

01. 引言2025年2月24日，佛山瑞迪奥医药（下文简称瑞迪奥）的锝[99mTc]肼基烟酰胺聚乙二醇双环RGD肽注射液（下文简称99mTc-3PRGD2）收到NMPA的通知件，如下图1所示。业内人士反馈，该通知件系瑞迪奥主动撤回新药注册申请，原因不详。图1、国家药监局99mTc-3PRGD2通知件送达信息公示（图片来源：药筛公众号）据相关媒体报道，99mTc-3PRGD2是我国首个自主研发的放射性核素偶联药物（RDC），靶向整合素整合素αvβ3受体，属于核医学放射诊断I类新药，同时也是全球首个用于SPECT显像的广谱肿瘤显像新药。该品种由北京大学王凡教授团队研发，后在佛山进行产业转化，于2022年1月在北京大学发布三期临床试验结果，临床试验首席专家在介绍试验结果时强调：“99mTc-3PRGD2具有良好的安全性，在肺部病灶的良恶性鉴别方面，99mTc-3PRGD2 SPECT/CT与18F-FDG PET/CT没有显著性差异，但在肺部肿瘤淋巴结转移判断方面，99mTc-3PRGD2 SPECT/CT在特异性和准确性方面优于18F-FDG PET/CT，临床试验到达主要终点和次要终点”。2023年，百洋医药官方发布与瑞迪奥签署商业化合作战略协议，瑞迪奥研发的包括核医学肿瘤显像诊断I类创新药99mTc-3PRGD2在内的系列放射性药品及SPECT等影像设备产品等，上市后都交由百洋医药在中国大陆地区做独家商业化运营。2024年8月，99mTc-3PRGD2曾被NMPA纳入突破性治疗药物，直至2025年2月撤回注册。99mTc-3PRGD2的上市波折固然令人遗憾，但也不禁促使我们思考：基于创新放药的SPECT肿瘤显像，临床应用场景有哪些？临床价值是什么？市场有多大？02. 行业背景从全球范围来看，肿瘤与心肌显像是核医学影像的两个最主要的临床应用。肿瘤领域主要显像应用包括两种：用于评估多种肿瘤的骨转移的SPECT骨扫描 (基于99mTc-MDP及类似药物), 用于进行广谱肿瘤良恶性鉴别及TNM分期的18F-FDG PET显像。此外，临床实践中还有针对131I的SPECT显像用于甲状腺癌精准分期及诊疗一体化，以及在18F-FDG PET普及推广之前应用99mTc-MIBI及枸橼酸镓［67Ga］等药物进行SPECT显像，从而针对特定肿瘤进行定位与良恶性鉴别等。SPECT骨扫描及FDG PET在全球主要地区的应用情况见下表。表1、核医学主要肿瘤相关项目在全球开展情况，数据源自参考文献[1-3] 中国美国欧盟SPECT 骨显像 ~160万次/年 ~320万次/年 ~280万次/年FDG PET 肿瘤显像 ~130万次/年 ~200万次/年 ~120万次/年由于PET/CT设备在成像性能上优于常规的双探头SPECT设备，并且18F-FDG PET/CT显像在欧美发达国家被广泛纳入医保，因此，长期以来，欧美发达国家在正电子显像药物研发方面的兴趣和投入远远高于单光子药物，如下图所示。图2、近年来PET与SPECT药物研发表文章统计[4]03. RGD类多肽放射药物的进展21世纪初开始，研究99mTc标记的广谱肿瘤SPECT显像药物的主力实际上是中国学者。其主要动机和逻辑是：18F需要加速器制备且PET诊断费用昂贵，一定程度限制了其广泛应用。而SPECT（单光子发射计算机断层术）显像仪器远多于PET且诊断费用低廉，因此，非常有必要研制一种价格低廉且便于推广的SPECT肿瘤显像剂以满足临床的迫切需求。前文提到的以αvβ3受体为靶点的基于RGD配体分子的诊断放射性药物，最早开展相关研究的主要是三名华人学者：美国普渡大学的刘爽教授（已退休）[5]、新加坡国立大学的陈小元教授以及北京大学的王凡教授[6]。与RGD类药物研究基本同步的，是北京师范大学化学学院张俊波教授团队研发的99mTc标记糖类衍生物药物。其团队研发的第一代肿瘤SPECT显像药物（99mTc-CNDG5，批件号：2021LP02074）的和第二代肿瘤SPECT显像剂（99mTc-CNDG7，批件号：2023LP01981），均已获得临床批件，并得到教育部专项资金8000万支持开展产业化。表2、已进入临床研究的整合素RGD受体显像剂及其特征相比糖类衍生物, 99mTc-3PRGD2开展的临床科研项目更多，并且已经通过了三期注册临床验证，技术成熟度更高。相关专家在《协和医学杂志》上发表了《整合素RGD受体显像临床应用专家共识（2022版）》[7]，专家分析对比了已进入临床研究的多种整合素受体显像剂，如上表所示。在共识中，专家针对选择 SPECT 显像还是 PET 显像等11个问题给出推荐意见，其中仅有针对肺癌淋巴结转移的αvβ3受体显像的临床价值（推荐意见4）得到专家组一致同意和强力推荐，其余10条意见仅获得基本同意和中等推荐，表明仍需要进一步的临床研究提供证据支持。基于以上专家共识，99mTc-3PRGD2 SPECT如能获批，上市后一定时间内最主要的临床应用是进行肺癌18F-FDG PET显像的补充和替代，因此其上市前期（5年内）市场范围应参考18F-FDG PET扫描的肿瘤患者群体。就此问题笔者团队访谈了上海、广东、河北、陕西、吉林的相关核医学临床专家，专家整体上对于99mTc-3PRGD2 SPECT替代18F-FDG PET的临床应用并不看好。主要原因有三个：一方面，99mTc-3PRGD2 在横膈膜以下多个器官有较高摄取，限制了其在肿瘤远端转移评估方面（M分期）的应用场景，而这正是18F-FDG所擅长并且受到临床广泛认可的；另一方面，现有SPECT设备影像质量和扫描效率均较PET/CT设备有较大差距，99mTc-3PRGD2的病灶摄取水平相对于18F-FDG没有明显优势，同时也存在炎症假阳性等问题；此外，近年来国家推动PET/CT扫描降价，北京、上海、广东等地区全身扫描价格均从1万元左右降到7000元左右，浙江、河北等地区PET/CT检查进入医保，某些地区全身扫描价格已经降到3000-4000元，99mTc-3PRGD2 SPECT扫描的价格优势进一步被削弱。基于上述分析，笔者团队估算99mTc-3PRGD2 SPECT扫描对PET肿瘤患者市场渗透率在理想情况下的上限约为15%（考虑肺癌约占18F-FDG PET显像50%，对肺癌市场渗透率约为30%，包括补充和替代），即约20万例显像左右。从药品定价来说，目前各地18F-FDG药品价格均在下降，上海已经明确1500元每支封顶，部分地区已降至1000元以下。因此99mTc-3PRGD2每支药物价格上限约为800元每支，考虑到99mTc核素价格约为300元左右，因此最乐观估计，在没有其它品种竞争的前提下，3PRGD2冷药盒在上市5年内，国内年销售额上限约为1亿元。那么，99mTc-3PRGD2是否有进一步的技术潜力待挖掘？或者可能拓展新的应用场景，比如肺癌以外的其它癌症检查、早期诊断、治疗评估等？其产品生命周期会有多长？就此问题，最新的学界研究，已经给出了较为明确的判断。北京协和医院核医学科霍力教授团队在中华核医学与分子影像学杂志发表的文章《靶向整合素的放射性药物在肿瘤诊疗中的研究进展》[8],在总结和展望部分论述如下：“在过去的20年，关于整合素的放射性药物多为靶向整合素αvβ3的cRGD肽类药物，目前仍有大量研究在探索这类药物的临床价值与应用场景。近几年，研究重点也逐步转向整合素αvβ6、αvβ8、α2β1等其他亚型，靶向分子也不再局限于多肽，小分子、胱氨酸结蛋白等种类逐渐多样化，同时探针在临床肿瘤患者中的应用也更加精准。其中，靶向整合素αvβ6最受关注...(3)仍需进一步寻找靶向整合素放射性药物的临床价值所在。比如针对不同整合素亚型在不同肿瘤中的表达特点，开发相应的放射性药物，以实现对特定肿瘤类型的精准诊断和治疗...”北大药学院崔一民教授团队2023年在药学研究(Pharmacological Research)上发表的《基于αvβ3癌症治疗的机遇与挑战：从研究到临床》[9]一文中的结论部分提到：“已经为靶向整合素αvβ3做出了相当大的努力，但是结果是不令人满意的。许多因素使情况复杂化，针对整合素αvβ3的癌症治疗药物的开发。特别是许多基于RGD的αvβ3拮抗剂，包括环肽，肽类似物和化学化合物在后期临床试验中失败，由于毒性和疗效有限的问题而进行的试验。这些很差的结果部分是由诱导形成高亲和力整合素构象引起的。最近的研究表明基于RGD整合素靶向并不是终点。”从以上两篇综述性文章来看，在整合素靶点研究层面，学者基本达成共识：αvβ3不是单一最理想的靶点，并且RGD类药物也有很多局限，因此可以推断，99mTc-3PRGD2的临床价值和技术潜力有限，而且在上市后很可能面临类似品种的严峻竞争与挑战。那么，是否有其它的靶点和配体分子，更适用于核医学肿瘤显像与治疗呢？04. 肿瘤分子影像的新选择目前行业普遍认为，核医学肿瘤显像与治疗药物及临床应用具有较为广阔的市场前景。发表于科技核心期刊《中国药事》的2025年开年首刊（第39卷第1期）的《我国放射性药品监管法规体系研究一：我国放射性药品发展现状及分析》[10]一文中指出，“2017年我国显像诊断和治疗放射性药物的市场规模为22亿元人民币，2017-2021年复合增长率为9.0%，经过2021-2025年将近32.4%的高速增长期，预计2025-2030年复合增长率将稳定在22.7%左右，2030年市场规模将达到260亿元人民币（见下图）”图3、中国放射性药物市场规模发展趋势[10]该文同时指出，“PSMA、SSTR、FAP是当前最热门靶点，目前围绕这三个靶点的药品共有50个左右。除此之外，人表皮生长因子受体（HER1/HER2/HER3）、细胞表面受体（FGFR、GRPR、CXCR-4、αvβ3/αvβ5、GRPR）、膜糖蛋白（Mesothelin、CD38、CD147）以及血液肿瘤相关受体CD38和CD45等等也是临床研究的重点对象.”2025年1月，中国工程院院士王锐教授与中国医学科学院药物研究所胡宽教授为共同通讯于《Signal Transduction and Targeted Therapy》( IF 40.8 )期刊发表题为“Radiopharmaceuticals and their applications in medicine”的综述[11]，本综述全面总结了放射性药物的演变，涵盖FDA批准及临床在研的药物，文中指出肿瘤方向放射性药物靶点包括：“ 1. 成纤维细胞活化蛋白 -α（FAP）：在肿瘤微环境中，FAP呈现高表达状态。其靶向放射性药物在肿瘤诊断和治疗方面具有巨大的潜力。目前，研究人员通过开发循环肽类FAPIs、结合白蛋白结合剂等多种策略，积极克服肿瘤内滞留时间不足等问题...2. 前列腺特异性膜抗原（PSMA）：PSMA 在前列腺癌中高度表达，针对其开发的放射性药物在前列腺癌的诊断和治疗中取得了显著的成果。例如，[177Lu]Lu-PSMA-617 已获批用于治疗转移性去势抵抗性前列腺癌，显著延长了患者的生存期。目前，研究方向主要集中在开发兼具诊断和治疗功能的配体，以及探索更多放射性核素在其中的应用...3. 生长抑素受体（SSTR）：SSTR 在神经内分泌肿瘤（NETs）的诊断和治疗中发挥着至关重要的作用。其靶向放射性药物包括多种激动剂和拮抗剂，近年来 SSTR 拮抗剂的研究取得了重要进展...4. 整合素家族：整合素家族中的αvβ3和αvβ6等成员在肿瘤进展和转移过程中起着关键作用。其靶向放射性药物在肿瘤成像方面具有一定的应用价值，如[18F]FPPRGD2 能够检测到一些[18F]FDG难以发现的小转移灶。此外，在心血管疾病评估方面，整合素靶向放射性药物也展现出潜在的应用潜力，如通过检测血管壁上整合素的表达来评估血管炎症和动脉粥样硬化的程度。但目前存在如最优配体稀缺等问题，限制了其进一步的临床应用...5. 其他靶点：除上述靶点外，还有 C-X-C 趋化因子受体 4（CXCR4）、胃泌素释放肽受体（GRPR）、人表皮生长因子受体 2（HER2）、碳酸酐酶同工酶 IX（CAIX）、尿激酶型纤溶酶原激活物受体（uPAR）、代谢型谷氨酸受体 1（mGluR1）、神经降压素受体 1（NTSR-1）、Claudin-18同工酶2（Claudin18.2）、分化群38（CD38）、磷脂酰肌醇蛋白聚糖 - 3（GPC3）、Nectin 细胞粘附分子4（Nectin - 4）、血管内皮生长因子受体（VEGFR）等靶点。针对这些靶点的放射性药物研究在不同肿瘤的诊断和治疗方面均取得了一定的进展...”上述两篇综述文章反映出，学界和产业界在有潜力的放射性药物肿瘤靶点方面基本达成共识，FAPI、PSMA与SSTR是目前学界和产业界公认的最有价值和潜力的靶点，相较于整合素家族（包括αvβ3），在临床价值和潜力方面有明显优势，产业化热度也显著领先。针对上述三个靶点的99mTc标记药物也已问世，目前已经开展了多项临床研究及临床转化。在2024年5月发布的一篇综述性文章中[12]，对近年来以FAP为靶点的SPECT/CT肿瘤临床研究的不完全总结见下表：表3、近年来以FAP为靶点99mTc标记药物SPECT显像的临床研究[12]AuthorYear/countryCompoundClinical settingPatient cohortCommentJia et al. (2023)2023/中国FAPI-04消化系统肿瘤40[99mTc]Tc-HFAPi SPECT/CT 在骨和肝转移方面的诊断效能优于增强CTRuan et al. (2022, 2023a, 2023b)2023/中国DP-FAPI胃肠道肿瘤7 (其中4 个健康志愿者)[99mTc]Tc-DP-FAPI 在受试者体内无不良反应并在诊断胃肠道肿瘤方面表现出高效能Coria-Domínguez et al. (2022)2022/墨西哥iFAP健康志愿者、颈部、肺部及乳腺肿瘤9 (其中6个健康志愿者)[99mTc]Tc-iFAP 摄取水平是(颈部 > 乳房 > 肺)，正好与 [18F]FDG 相反Vallejo-Armenta et al. (2022)2022/墨西哥iFAP5个脑胶质瘤和 27个其它类型肿瘤32[99mTc]Tc-iFAP SPECT/CT 比 [18F]FDG PET/CT检测的转移病灶少, 但在高低级别脑胶质瘤鉴别方面表现出了较高的效能上表中所列第一项研究，是西安交大一附院高蕊教授团队发表在欧洲核医学与分子影像学杂志的《99mTc-HFAPi SPECT/CT 在消化道癌症的价值：首次临床研究》[13] 是全球范围内病例数较多的基于99mTc-HFAPi的SPECT/CT显像临床研究，该研究揭示了99mTc-HFAPi的SPECT/CT在消化道肿瘤，特别是结肠癌肝转移方面的诊断效能优于现有的临床金标准增强CT。该研究所使用的99mTc-HFAPi产品，目前在国内已进入由复旦大学附属中山医院的牵头的多中心注册临床试验II期。在PSMA靶点方面，一篇发表在美国核医学（JNM）杂志上的《99mTc-MIP-1404 SPECT/CT 伴随诊断用于转移性去势抵抗性前列腺癌的 177Lu-PSMA 治疗》文章指出[14]，99mTc-MIP-1404成像适用于评估晚期转移性去势抵抗性前列腺癌患者是否符合RPT资格。特别是，治疗前摄取强度可预测对177Lu-PSMA RPT的反应。福建医科大学附属省立医院的陈文新教授团队发表在科学报告(Scientific Reports)杂志上的99mTc-PSMA SPECT/CT与99mTc-MDP SPECT/CT头对头研究表明[15]，对于前例腺癌骨转移患者，99mTc-PSMA SPECT/CT诊断效能领先于99mTc-MDP SPECT/CT，特别是对于小病灶以及低PSA水平的情况，并且99mTc-PSMA SPECT/CT还能够指出骨外转移的病灶，因此可以改变相关患者的诊疗方案。另一篇由河南省人民医院高永举教授团队发表在中华核医学与分子影像医学杂志的文章[16]，研究结论指出，99mTc-PSMA SPECT/CT显像在前列腺癌生化复发病灶探测、诊疗决策和随访观察中具有早期诊断、特异性高和全身显像的优势。在SSTR靶点方面，由复旦大学上海癌症中心团队发表在核医学年历(Ann Nucl Med)的文章[17]和河南省人民医院高永举教授团队发表在中华核医学与分子影像杂志的研究文章[18]均表明，99mTc-HYNIC-TOC显像在诊断GEP-NETs、探测肝转移及早期骨转移病灶、协助优化临床治疗策略中具有临床价值。05. 基于创新药SPECT肿瘤显像的临床应用场景及市场价值分析基于以上研究结果可以看出，基于99mTc标记的以FAP、PSMA和SSTR为靶点的SPECT新药临床研究，中国学者和其他发展中国家学者（如墨西哥）是主力。在欧美国家，当前SPECT肿瘤显像的主要研究热点在于针对177Lu等治疗核素标记新药进行疗效评价、预后以及剂量学研究。相关研究文章较多，不一一列举。近期发表在美国核医学杂志（JNM）上的一篇综述性文章《SPECT值得尊重：SPECT/CT在最优化诊疗一体化治疗结果中的潜力》指出[19]：“177Lu-PSMA SPECT/CT 改变了高达49%的患者的治疗策略，因其可以比序列PSA检测更准确的揭示治疗反应...在有些疾病进展和PSA升高的患者中，177Lu-PSMA SPECT/CT有助于进一步揭示进展模式。SPECT/CT提示的寡转移性部位可能受益于进一步外照射放疗。持续PSMA阳性疾病进展的患者可能可以通过转向alpha核素治疗中获益，而那些PSMA低或没有PSMA表达的患者则应该切换到其它治疗方式...虽然SPECT/CT在治疗指导中的价值证据主要来源于177Lu-PSMA治疗前列腺癌，以及部分的67Cu和212Pb治疗，但是在其它受体靶向治疗中也大概率将表现出类似的价值。”综合相关研究，SPECT/CT用于177Lu、90Y等Beta核素标记药物在肿瘤治疗过程中的显像评估应该是确定性非常强的首选应用场景，基于24年市场数据，177Lu-PSMA与177Lu-Dotatate全球的年治疗患者数约在1.5万例左右，以每个患者平均4个疗程，每个疗程2次SPECT/CT显像估计，SPECT/CT年显像量约在12万次左右，考虑到上述两个品种25年、26年即将在中国获批，预计在28年左右国内SPECT/CT在上述两个治疗品种的临床应用数量可以达到5-6万次/年。后续随着临床渗透率提高，适应症范围扩大，以及新治疗靶点和药物的临床转化，保守估计，到2035年，SPECT/CT在核素药物治疗评估的临床场景中，全球应用有望达到150-200万次/年，其中在中国市场应用有望达到20-30万次/年。SPECT/CT在肿瘤显像的第二个确定性较高的应用场景应该是基于创新药的显像对现有SPECT骨扫描替代。虽然SPECT骨扫描目前是核医学肿瘤第一大应用，但是受限于技术局限性，临床上已经表现出逐渐被PET/CT扫描取代的趋势，相比之下，其唯一的优势可能在于经济性。而采用针对FAP、PSMA和SSTR三个靶点的99mTc标记药物进行SPECT/CT显像，已有临床研究指出了其在骨转移方面完全可以替代SPECT常规骨扫描，虽然这一结论有待进一步大规模临床数据的验证，但综合其在原发病灶及骨外转移方面的效能，以及其与后续靶向核素治疗之间的密切联系（包括治疗前跟踪以及治疗后随访评估），在相关适用症中对SPECT骨扫描的替代应该是大概率事件。这一替代主要的技术难点在于：首先，受限于软组织本底摄取，针对这一类新药的SPECT平面显像无法满足诊断要求，需要行断层显像，而现有双探头SPECT设备断层显像的效率与图像质量距离临床要求有一定差距；其次，以PSMA和SSTR为靶点的99mTc标记药物，市场空间相对于较小，产品转化动力可能不足，未来可能主要以院内试剂的方式在有四类证的核医学科应用，其商业模式和临床使用方式需要进一步探讨。相对而言，FAP是更为广谱的靶点，相关99mTc标记药物的市场前景更为看好。以当前市场骨扫描基数测算（见前文表），根据不同新药转化节奏和推广力度，预估最晚在2035年，基于99mTc标记肿瘤新药的SPECT/CT显像可以在中国市场实现80-100万次每年的临床应用，全球可以达到300-500万次的年应用。SPECT/CT在肿瘤显像的第三个场景是基于99mTc标记药物显像对基于同靶点或同病谱正电子标记药物PET肿瘤显像的补充和替代，比如99mTc-PSMA SPECT对68Ga/18F-PSMA PET的补充替代，99mTc-HYNIC-TOC SPECT对68Ga/18F-Dotatate PET的补充替代，以及99mTc-FAPI SPECT对68Ga/18F-FAPI以及18F-FDG PET的补充和替代。这一场景的基本逻辑是明确的，SPECT显像具有更低的成本，PET显像具有更好的性能，因此市场的格局取决于新一代SPECT技术（如全环SPECT或AI图像增强技术）与优化后的99mTc标记药物联合，在临床实践中准确率是否可以达到同类药物PET显像相当和相近的水平，以及两种显像收费定价的未来走向。笔者团队可以预见，未来围绕这一场景会有大量的争议和博弈，目前难以准确预测。但以史为鉴，基于符合线路成像设备的18F-FDG显像退出历史舞台以及18F-NaF在美国FDA获批近20年未能撼动99mTc-MDP SPECT的地位的事实来看，以临床价值为导向的技术性能提升与综合成本下降，是产品能够真正被市场接受的唯一路径。05. 结语SPECT是否是落后的技术？是否会被PET替代？临床前景如何？多年以来一直有很多的争论。这让笔者团队想起了电动车和燃油车的竞争史：1834年，苏格兰商人罗伯特·安德森（Robert Anderson）研发了一辆电动三轮车，虽然仅能行驶一公里且无法充电，但它标志着电动汽车的起点。1881年，法国工程师古斯塔夫·特鲁夫（Gustave Trouve）在巴黎国际电力博览会上展示了全球首辆可充电的三轮电动车，使用铅酸电池驱动，最高时速可达12公里。1885年，德国工程师卡尔·本茨发明了第一辆使用内燃机驱动的汽车，这标志着现代燃油汽车的原型的诞生。1899年，比利时人卡米尔·耶纳茨（Camille Jenatzy）驾驶电动车“永不满足号”（Jamais Contente）创下110公里/小时的世界纪录，比燃油车早十多年。1900年，美国汽车销量中电动汽车占比38%，燃油车仅占22%，蒸汽机车占40%。1905年，丹麦生产的电动车被引入中国，拍卖记录显示，这台车换上现代电池后仍能行驶，最高时速达48公里。之后，燃油车垄断20世纪，电动车在21世纪卷土重来，各位看官想必耳熟能详了。仅以彼得.德鲁克的一句名言结束本文：预测未来的最好方法就是创造它。参考文献1.中华医学会核医学分会.2024年全国核医学现状普查结果简报[J] .中华核医学与分子影像杂志, 2024, 44(10) : 617-618.2.Delbeke D, Segall GM. Status of and trends in nuclear medicine in the United States. J Nucl Med. 2011 Dec;52 Suppl 2:24S-8S.3.Status of Nuclear Medicine in Europe-2010,EANM4.Crișan G, Moldovean-Cioroianu NS, Timaru DG, Andrieș G, Căinap C, Chiș V. Radiopharmaceuticals for PET and SPECT Imaging: A Literature Review over the Last Decade. Int J Mol Sci. 2022 Apr 30;23(9):5023.5. Liu S. Radiolabeled cyclic RGD peptides as integrin alpha(v)beta(3)-targeted radiotracers: maximizing binding affinity via bivalency. Bioconjug Chem. 2009 Dec;20(12):2199-213.6.Liu Z, Shi J, Jia B, Yu Z, Liu Y, Zhao H, Li F, Tian J, Chen X, Liu S, Wang F. Two ⁹⁰Y-labeled multimeric RGD peptides RGD4 and 3PRGD2 for integrin targeted radionuclide therapy. Mol Pharm. 2011 Apr 4;8(2):591-97. 中华医学会核医学分会,中国生物物理学会分子影像学分会,朱朝晖,等.整合素RGD受体显像临床应用专家共识(2022版)[J].协和医学杂志, 2022(002):0138. 杨广杰,霍力.靶向整合素的放射性药物在肿瘤诊疗中的研究进展[J] . 中华核医学与分子影像杂志, 2025, 45(2) : 114-119.9. Gu Y, Dong B, He X, Qiu Z, Zhang J, Zhang M, Liu H, Pang X, Cui Y. The challenges and opportunities of αvβ3-based therapeutics in cancer: From bench to clinical trials. Pharmacol Res. 2023 Mar;189:1066910. 傅洁,刘爽,王玉坤,等. 我国放射性药品监管法规体系研究一:我国放射性药品发展现状及分析[J]. 中国药事,2025,39(1):1-12. DOI:10.16153/j.1002-7777.2024-11-0026.11. Zhang, S., Wang, X., Gao, X. et al. Radiopharmaceuticals and their applications in medicine. Sig Transduct Target Ther 10, 1 (2025)12. Boschi, A., Urso, L., Uccelli, L. et al. 99mTc-labeled FAPI compounds for cancer and inflammation: from radiochemistry to the first clinical applications. EJNMMI radiopharm. chem. 9, 36 (2024)13. Jia, X., Li, X., Jia, B. et al. The role of [99mTc]Tc-HFAPi SPECT/CT in patients with malignancies of digestive system: first clinical experience. Eur J Nucl Med Mol Imaging 50, 1228–1239 (2023)14. Derlin T, Widjaja L, Harke NN, Czerner C, Weiberg D, Ross TL, Bengel FM. 99mTc-MIP-1404 SPECT/CT Companion Diagnostic for 177Lu-PSMA Therapy in Metastatic Castration-Resistant Prostate Cancer. J Nucl Med. 2025 Mar 3;66(3):366-372.15. Zhang Y, Lin Z, Li T, Wei Y, Yu M, Ye L, Cai Y, Yang S, Zhang Y, Shi Y, Chen W. Head-to-head comparison of 99mTc-PSMA and 99mTc-MDP SPECT/CT in diagnosing prostate cancer bone metastasis: a prospective, comparative imaging trial. Sci Rep. 2022 Sep 26[16] “99mTc -HYNIC-PSMA SPECT/CT 在前列腺癌生化复发中的临床价值,中华核医学与分子影像杂志2024年4月第44卷第4期ChinJNucl Med Mol Imaging,Apr.2024,Vol.44,No.4”[17] Clinical application of 99mTc-HYNIC-TOC SPECT/CT in diagnosing and monitoring of pancreatic neuroendocrine neoplasms. Ann Nucl Med. 2018 Aug;32(7):446-452.[18] 柳舒心，武新宇，李博,等. 99Tcm-HYNIC-TOC SPECT/CT在胃肠胰神经内分泌肿瘤诊疗中的增益价值[J] . 中华核医学与分子影像杂志, 2025, 45(1) : 13-18.[19] Emmett L. SPECT Deserves RESPECT: The Potential of SPECT/CT to Optimize Patient Outcomes with Theranostics Therapy. J Nucl Med. 2025 Mar 3;66(3):349-350●FAP靶向治疗核药TLX400甲状腺癌临床研究结果●PSMA靶向治疗核药177Lu-rhPSMA-10.1 I期临床研究结果揭晓●2025 AACR核药笔记——下篇●2025 AACR核药笔记——上篇声明：本文观点仅代表小核本人，视角局限，欢迎批评指正；如需转载，请务必注明文章作者和来源。如有其它问题，请在本平台留言或联系xiaoheshuoheyao777@163.com，小核将在第一时间处理。内容编辑 | 守拙排版设计 | 小核媒体合作 | 科研宣传 | 转载开白xiaoheshuoheyao777（小核微信）

临床3期临床1期放射疗法临床2期突破性疗法

2025-05-27

·GlobeNewswire-Health Care

BioNTech to Present Progress Across Diversified Oncology Pipeline at the 2025 ASCO Annual Meeting

MAINZ, Germany, May 27, 2025 -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present clinical trial data from select pipeline candidates across the Company’s diversified oncology portfolio at the American Society of Clinical Oncology (“ASCO”) Annual Meeting, to be held in Chicago, IL, from May 30 to June 3, 2025. The data highlight continued progress of the Company’s clinical programs consisting of complementary therapeutic modalities, including mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies, including antibody-drug conjugates (“ADCs”). “We believe that the next era of cancer medicine will be defined by the interplay of complementary mechanisms and innovative molecules, unlocking their full potential through synergy. Our data presentations at this year's ASCO Annual Meeting show how we aim to help shape this era,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “We will present clinical progress with two of our therapeutic modalities: our next generation immunomodulators, most notably our investigational anti-PD-L1xVEGF-A antibody BNT327, and for one of our ADC programs, which are an important pillar of our combination strategy. These data underline the potential of our assets to improve outcomes for patients.” Highlights of BioNTech’s oncology programs to be presented at ASCO 2025: Three presentations on BNT3271, an investigational anti-PD-L1xVEGF-A antibody, will detail data from ongoing later-stage and potentially registrational clinical trials: An oral presentation will feature the first data from a Phase 2 clinical trial (NCT05918107) of BNT327 in combination with chemotherapy as first-line treatment for patients with unresectable malignant mesothelioma. Malignant mesothelioma is a type of cancer that develops in the tissue that covers the lung or the abdomen. The preliminary data indicated anti-tumor activity and a manageable safety profile. Two posters will detail the ongoing global Phase 3 and Phase 2/3 clinical trials, ROSETTA Lung-01 (NCT06712355) in extensive-stage small cell lung cancer (“ES-SCLC”) and ROSETTA Lung-02 (NCT06712316) in non-small cell lung cancer (“NSCLC”). BNT327 combines the two complementary anti-tumor mechanisms of PD-L1 checkpoint and VEGF-A signaling blockade in the tumor microenvironment, thereby aiming to enhance anti-tumor activity. Data on BNT324/DB-1311, a B7H3-targeted ADC candidate, from an ongoing Phase 1/2 clinical trial (NCT05914116) in patients with heavily pre-treated castration-resistant prostate cancer (“CRPC”) will be presented during an oral session. The data indicated early clinical activity and a manageable safety profile. BNT324/DB-1311 received Fast Track Designation by the U.S. Food & Drug Administration (“FDA”) for this patient population in 2024 and is being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”). Preliminary data on BNT316/ONC-392 (gotistobart), an investigational anti-CTLA-4 antibody, from two ongoing Phase 1/2 clinical trials evaluating the antibody candidate in combination with current standard of care treatments will be presented. Data from the PRESERVE-001 clinical trial (NCT04140526) in patients with advanced melanoma indicated a manageable safety profile and early signs of anti-tumor activity. The data included an analysis of overall survival (“OS”) and an ad-hoc analysis of next-treatment free survival (“NTFS”), a measure for potential long-lasting benefit after initial treatment. Data from the PRESERVE-006 clinical trial (NCT05682443) in patients with metastatic CRPC indicated a manageable safety profile and preliminary efficacy. BNT316/ONC-392 is being developed in collaboration with OncoC4, Inc. (“OncoC4”).Data on BNT142 from an exploratory Phase 1/2 dose finding trial (NCT05262530) in patients with CLDN6-positive advanced solid tumors will be featured in an oral presentation. BNT142 is an investigational lipid nanoparticle-formulated mRNA immunotherapy that encodes a CD3xCDLN6 T cell engager antibody. Preliminary data indicated a manageable safety profile and early signs of clinical activity, supporting scientific proof-of-concept and underscoring the potential of mRNA-encoded bispecific antibodies. BioNTech has established a diversified oncology portfolio to develop novel treatment approaches for patients living with cancer. The Company is advancing its oncology pipeline across multiple solid tumor indications, including more than 20 active Phase 2 and 3 clinical trials with a strategic focus on two pan-tumor priority programs: investigational mRNA cancer immunotherapies and the next-generation immunomodulator candidate BNT327. BioNTech expects multiple data readouts in 2025 and 2026 aimed at supporting its strategy and advancing the Company towards becoming a diversified multi-product oncology company. The full abstracts are available on the ASCO Annual Meeting website. Click here for further information on BioNTech’s pipeline assets. Full presentation details: Oral presentations Asset: BNT327Session Title: Clinical Science Symposium | Two Targets, One Goal: The Potential for Bispecific Antibodies in Thoracic MalignanciesAbstract Title: First report of efficacy and safety results from a phase 2 trial evaluating BNT327/PM8002 plus chemotherapy (chemo) as first-line (1L) treatment in unresectable malignant mesothelioma Location: E451Abstract Number: 8511Date: June 3, 2025Time: 9:45 AM – 11:15 AM CDT Asset: BNT324/DB-1311Session Title: Rapid Oral Abstract Session | Genitourinary Cancer—Prostate, Testicular, and PenileAbstract Title: DB-1311/BNT324 (a novel B7H3 ADC) in patients with castrate-resistant prostate cancer (CRPC)Location: Hall D2Abstract Number: 5015Date: June 1, 2025Time: 4:30 PM – 6:00 PM CDT Asset: BNT142Session Title: Oral Abstract Session | Developmental Therapeutics—ImmunotherapyAbstract Title: First-in-human phase I/II trial evaluating BNT142, a first-in-class mRNA encoded, bispecific antibody targeting Claudin 6 (CLDN6) and CD3, in patients (pts) with CLDN6-positive advanced solid tumors.Location: Hall D2Abstract Number: 2501Date: May 31, 2025Time: 3:00 PM - 6:00 PM CDT Poster Presentations Asset: BNT327Session Title: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic CancersAbstract Title: A global Phase 3 double-blind, randomized trial of BNT327/PM8002 plus chemotherapy (chemo) compared to atezolizumab plus chemo in patients (pts) with first-line (1L) extensive-stage small cell lung cancer (ES-SCLC)Poster Board: #242aAbstract Number: TPS8129Date: May 31, 2025Time: 1:30 PM – 4:30 PM CDT Asset: BNT327Session Title: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic CancersAbstract Title: Phase 2/3, global, multisite, randomized, open-label trial of BNT327/PM8002 in combination with chemotherapy (chemo) in first-line (1L) non-small cell lung cancer (NSCLC)Poster Board: #138bAbstract Number: TPS8670Date: May 31, 2025Time: 1:30 PM – 4:30 PM CDT Asset: BNT316/ONC-392 (gotistobart)Session Title: Melanoma/Skin CancersAbstract Title: Gotistobart in combination with pembrolizumab in patients with advanced melanoma who have progressed on PD-1 inhibitors with or without CTLA-4 inhibitorsPoster Board: #34Abstract Number: 9551Date: June 1, 2025Time: 9:00 AM – 12:00 PM CDT Asset: BNT316/ONC-392 (gotistobart)Session Title: Genitourinary Cancer—Prostate, Testicular, and PenileAbstract Title: Phase 1 study of gotistobart (BNT316/ONC-392) in combination with lutetium Lu 177 vipivotide tetraxetan (Lu 177) in patients with metastatic castration-resistant prostate cancer (mCRPC)Poster Board: #266Abstract Number: 5067Date: June 2, 2025Time: 9:00 AM – 12:00 PM CDT About BioNTechBiopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel investigative therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic modalities with the intent of rapid development of novel biopharmaceuticals. Its diversified portfolio of oncology product candidates aiming to address the full continuum of cancer includes mRNA cancer immunotherapies, next-generation immunomodulators and targeted therapies such as antibody-drug conjugates (ADCs) and innovative chimeric antigen receptor (CAR) T cell therapies. Based on its deep expertise in mRNA development and in-house manufacturing capabilities, BioNTech and its collaborators are researching and developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron. For more information, please visit www.BioNTech.com. BioNTech Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the initiation, timing, progress and results of BioNTech’s research and development programs in oncology, including the targeted timing and number of additional potentially registrational trials; BioNTech’s and its collaborators’ current and future preclinical studies and clinical trials in oncology, including the investigational bispecific antibody BNT327 in various indications, the B7H3-targeted ADC candidate BNT324/DB-1311 in advanced solid tumors, the anti-CTLA-4 antibody candidate BNT316/ONC-392 in advanced melanoma, and the mRNA-based RiboMab candidate BNT142 in CLDN6-positive advanced solid tumors; the nature and characterization of and timing for release of clinical data across BioNTech’s platforms, which is subject to peer review, regulatory review and market interpretation; the planned next steps in BioNTech’s pipeline programs, including, but not limited to, statements regarding timing or plans for initiation or enrollment of clinical trials, or submission for and receipt of product approvals and potential commercialization with respect to BioNTech’s product candidates; the ability of BioNTech’s mRNA technology to demonstrate clinical efficacy outside of BioNTech’s infectious disease platform; and the potential safety and efficacy of BioNTech’s product candidates. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the ability to produce comparable clinical results in future clinical trials; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; discussions with regulatory agencies regarding timing and requirements for additional clinical trials; BioNTech’s and its counterparties’ ability to manage and source necessary energy resources; the impact of tariffs and escalations in trade policy; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech’s development candidates and investigational medicines; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market, if approved, its product candidates; BioNTech’s ability to manage its development and expansion; regulatory developments in the United States and other countries and regions; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time. You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended March 31, 2025 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at www.sec.gov. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. CONTACTS Media Relations Jasmina Alatovic Media@biontech.de Investor Relations Michael Horowicz Investors@biontech.de 1 BNT327, formerly also known as PM8002, was initially jointly developed by BioNTech and Biotheus Inc (“Biotheus”). Since February 2025, Biotheus is a member of the BioNTech Group.

免疫疗法ASCO会议临床结果临床2期临床1期

100 项与镥[177Lu] 特昔维匹肽相关的药物交易

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研发状态

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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	加拿大	Advanced Accelerator Applications USA, Inc.	2022-08-25
PSMA阳性去势抵抗性前列腺癌	美国	Novartis Pharmaceuticals Corp.	2022-03-23

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适应症	最高研发状态	国家/地区	公司	日期
转移性前列腺癌	临床3期	法国	Novartis AG	2024-09-12
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	中国	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	阿根廷	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	奥地利	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	比利时	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	巴西	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

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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


AACR2025	N/A	前列腺癌	117	177Lutetium-PSMA-617 (Luminal A-like (LumA))	淵鏇觸願鏇糧糧膚積齋(觸壓繭窪壓簾窪獵夢襯) = 構廠觸淵積觸觸壓範壓構衊鹹糧醖製築衊鏇獵 (簾齋築構築襯鹹簾憲醖 )	积极	2025-04-28
				177Lutetium-PSMA-617 (Luminal B-like (LumB))	淵鏇觸願鏇糧糧膚積齋(觸壓繭窪壓簾窪獵夢襯) = 範鑰蓋簾夢顧網鑰艱鏇構衊鹹糧醖製築衊鏇獵 (簾齋築構築襯鹹簾憲醖 )
ASCO_GU2025 人工标引	N/A	转移性前列腺癌 EPCAM \| DLL3 \| CHGA ... 更多	24	177Lu-PSMA-617	餘範網網壓範膚觸繭襯(餘夢遞餘範廠糧選蓋齋) = 選鑰齋淵夢獵憲衊選淵淵夢鏇顧鬱廠衊鬱繭糧 (夢淵築糧夢鏇憲襯鹽廠 )	积极	2025-02-13
				177Lu-PSMA-617 (AR-V7-positive)	觸獵鏇蓋鏇膚膚鏇鏇顧(餘鑰製繭窪構齋範選窪) = 鑰選夢顧鬱獵觸鹹憲餘餘構觸膚衊餘淵繭範衊 (簾壓艱鹽艱製憲鏇齋顧 )
ASCO_GU2025 人工标引	N/A	转移性去势抵抗性前列腺癌	643	177Lu-PSMA-617	膚淵觸窪淵簾製窪廠齋(蓋鑰蓋夢膚獵壓淵繭淵) = 夢糧製憲構蓋壓蓋蓋觸繭簾網鹹願窪積艱範鹽 (膚糧壓蓋顧構壓廠壓簾, 14.6 ~ 16.3) 更多	不佳	2025-02-13
NCT03511664 (VISION, ASCO_GU2025) 人工标引	临床3期	转移性去势抵抗性前列腺癌	551	177Lu-PSMA-617 + ARPIs	醖憲壓範築醖積壓遞醖(網鬱構蓋構築膚憲艱壓) = 憲壓製獵鹽淵餘糧築願積憲網積願齋獵淵鏇壓 (淵蓋網獵獵範願願廠築 )	积极	2025-02-13
				177Lu-PSMA-617	醖憲壓範築醖積壓遞醖(網鬱構蓋構築膚憲艱壓) = 蓋廠醖鹹觸構蓋襯網遞積憲網積願齋獵淵鏇壓 (淵蓋網獵獵範願願廠築 )
ASCO_GU2025	N/A	转移性去势抵抗性前列腺癌三线 prostate-specific membrane antigen (PSMA)	303	First line of therapy	夢衊觸醖積願醖築鏇築(蓋觸選築糧積遞壓壓淵) = 構衊繭顧壓蓋構淵製獵艱範簾窪膚餘築廠積淵 (蓋簾壓網鏇構蓋製餘鹹, 11 ~ 15) 更多	积极	2025-02-13
				Second line of therapy	夢衊觸醖積願醖築鏇築(蓋觸選築糧積遞壓壓淵) = 廠願網獵獵範網觸壓醖艱範簾窪膚餘築廠積淵 (蓋簾壓網鏇構蓋製餘鹹, 8.9 ~ to ) 更多
ASCO_GU2025	N/A	转移性去势抵抗性前列腺癌 PSMA-positive \| SUVm \| prostate-specific antigen (PSA)	152	Lutetium-177-vipivotide tetraxetan	構範襯窪壓鑰遞鏇網醖(壓選鑰憲顧構艱夢築鏇) = 顧鹹艱衊遞蓋糧鏇築壓齋積鏇襯夢夢遞網餘繭 (糧願選餘壓鏇壓襯鹽網 ) 更多	积极	2025-02-13
PRECISION (ASCO_GU2025)	N/A	转移性去势抵抗性前列腺癌 prostate-specific antigen	152	Abiraterone	夢製淵壓夢蓋獵鑰簾齋(衊鹹鏇夢衊鑰顧鹽蓋鹽) = 憲糧蓋繭窪簾襯鑰餘艱襯鹹淵鹽艱構壓構製淵 (蓋積憲夢鹽鏇齋範顧遞 ) 更多	积极	2025-02-13
				Enzalutamide	夢製淵壓夢蓋獵鑰簾齋(衊鹹鏇夢衊鑰顧鹽蓋鹽) = 襯蓋範膚餘鬱糧積築範襯鹹淵鹽艱構壓構製淵 (蓋積憲夢鹽鏇齋範顧遞 ) 更多
VISION trial (ASCO_GU2025)	N/A	转移性去势抵抗性前列腺癌 PSMA PET+	84	177Lu-PSMA-617 (Caucasian patients)	淵選窪艱獵構廠憲衊積(顧齋獵鏇構衊鬱艱顧積) = 窪廠襯夢鬱選糧積顧衊獵鬱願夢鹽壓網齋壓遞 (遞醖襯淵壓鑰鹹鬱壓憲 ) 更多	积极	2025-02-13
				177Lu-PSMA-617 (Black patients)	淵選窪艱獵構廠憲衊積(顧齋獵鏇構衊鬱艱顧積) = 艱齋艱壓蓋製獵醖繭製獵鬱願夢鹽壓網齋壓遞 (遞醖襯淵壓鑰鹹鬱壓憲 ) 更多
ASCO_GU2025	N/A	转移性去势抵抗性前列腺癌	100	lutetium-177-PSMA-vipivotide tetraxetan (Lu177-PVT) (Bone only)	選鏇顧鑰遞獵齋遞憲獵(願餘餘夢糧獵夢獵構選) = 衊壓獵艱網餘鏇築夢願廠網鹹襯網構顧鏇鬱選 (鹽鹹願齋簾觸窪範衊範, 43 ~ 70) 更多	积极	2025-02-13
				lutetium-177-PSMA-vipivotide tetraxetan (Lu177-PVT) (Lung-involved)	選鏇顧鑰遞獵齋遞憲獵(願餘餘夢糧獵夢獵構選) = 築醖顧醖醖觸齋築鬱製廠網鹹襯網構顧鏇鬱選 (鹽鹹願齋簾觸窪範衊範, 27 ~ 79) 更多
PRECISION (ASCO_GU2025)	N/A	转移性去势抵抗性前列腺癌 prostate-specific antigen	431	177Lu-PSMA-617taxane (Prompt cohort (1 ARPI and 1 taxane))	憲襯淵鬱觸齋構鏇積顧(膚遞夢蓋醖鏇膚廠窪簾) = 觸製製顧網糧齋繭鹹鹹構遞遞糧觸觸簾憲鑰築 (鏇壓鑰顧夢膚壓夢鑰選 ) 更多	积极	2025-02-13
				177Lu-PSMA-617 (Deferred cohort (>1 ARPI and/or >1 taxane))	憲襯淵鬱觸齋構鏇積顧(膚遞夢蓋醖鏇膚廠窪簾) = 積憲醖願衊鑰醖壓鬱齋構遞遞糧觸觸簾憲鑰築 (鏇壓鑰顧夢膚壓夢鑰選 ) 更多