A Phase 1 Study to Investigate Safety of Escalating Cycle 1 Dose of Lu-177-PSMA-617 Radioligand Therapy (RLT) in Metastatic Castration Resistant Prostate Cancer (mCRPC): The ESCENDO Trial

This phase I trial studies the safety, side effects, and treatment cycle 1 best dose of Lu-177-PSMA-617 in patients with prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castration-resistant) and has spread from where it first started (primary site) to other places in the body (metastatic). Lu-177-PSMA-617 is a radioactive drug. It binds to a protein called prostate-specific membrane antigen (PSMA), which is found on prostate cancer tumor cells. Lu-177-PSMA-617 gives off radiation that may kill these tumor cells. It is a type of radioconjugate. Lu-177-PSMA-617 is currently used in a series of 6 intravenous infusions of the standard dosage, each separated by 6 weeks from the previous infusion. Investigators have observed that the first therapy administration (cycle 1) delivers better radiation treatment to the cancer than each of the following 5 infusions. Giving an increased dosage of Lu-177-PSMA-617 in treatment cycle 1 may have a better effect on metastatic castration-resistant prostate cancer than the standard dosage. The study does not change the total cumulative activity from what is used in the standard dosage treatment but gives an increased dosage in cycle 1 and reduces the total number of cycles.

开始日期2026-12-01

申办/合作机构

Rogel Cancer Center: University of Michigan

[+1]

NCT07698535

/ Recruiting临床2期IIT

Dynamic Assessments of Molecular Response to Guide Early 177Lu-PSMA-617 Treatment Discontinuation: The DYNAMO Study

This clinical trial studies whether measuring circulating tumor deoxyribonucleic acid (ctDNA) tumor fraction (TF) can be used to help guide the early stopping (discontinuation) of lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617) in patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Many types of tumors tend to lose cells or release different types of cellular products including their deoxyribonucleic acid, which is referred to as ctDNA, into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for the disease to grow, spread, or get worse or come back after a period of improvement. ctDNA TF is a type of ctDNA measurement. Research has shown ctDNA TF may be a promising way to predict which patients will respond to 177Lu-PSMA-617 treatment. Measuring ctDNA TF may help doctors identify which patients may benefit from changing treatments sooner, which may be an effective way to guide early 177Lu-PSMA-617 treatment discontinuation in patients with metastatic castration-resistant prostate cancer.

开始日期2026-11-15

申办/合作机构

University of Washington

[+1]

CTIS2026-525520-20-00

/ Not yet recruiting临床2期IIT

Phase 2, open-label, randomized study to investigate safety and efficacy of Pluvicto® therapy in patients with metastatic hormone-sensitive prostate cancer in addition to standard of care treatment with Nubeqa® and ADT (ARALU)

开始日期2026-11-02

申办/合作机构-

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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764

项与镥[177Lu] 特昔维匹肽相关的文献（医药）

2026-12-01·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Discovery of 177Lu-PSMA-MN4 as an improved PSMA-targeted radioligand with enhanced antitumor efficacy

Article

作者: Qu, Chunmiao ; Wang, Xue ; Zhang, Mingjie ; Kong, Xiangsheng ; Lv, Kai ; Li, Peishang ; Zhou, Sheng ; Li, Yuechen ; Wang, Zhiqian ; Cai, Chenchen ; Song, Manchao

Prostate-specific membrane antigen (PSMA)-targeted radioligand therapy with ¹⁷⁷Lu-PSMA-617 improves outcomes in metastatic castration-resistant prostate cancer (mCRPC), yet a substantial subset of patients experiences disease progression, underscoring the need for next-generation agents with improved pharmacological profiles. Guided by the PSMA-617/PSMA co-crystal structure (PDB: 8BOW) and molecular dynamics (MD) simulations, the present study rationally designs seven novel PSMA-617 derivatives (PSMA-MN1-7) to enhance target engagement and pharmacokinetic behavior. Among these, ¹⁷⁷Lu-PSMA-MN4 demonstrates potent PSMA enzymatic inhibition (IC₅₀ = 1.72 nM), enhanced cellular internalization (110.67 ± 2.60% relative to PSMA-617), and a favorable biodistribution profile marked by sustained tumor retention and rapid renal clearance in LNCaP tumor-bearing mice. In both hormone-sensitive LNCaP and castration-resistant 22RV1 xenograft models, ¹⁷⁷Lu-PSMA-MN4 achieves superior tumor growth inhibition and survival prolongation compared with ¹⁷⁷Lu-PSMA-617. Single-dose administration at doses up to 0.6 mCi/animal is well tolerated, with no clinically significant hematological changes, renal biochemical abnormalities, or histopathological findings within the observation period of this study. These findings should be interpreted in light of several limitations: absorbed-dose estimates were derived from mouse biodistribution data and require allometric scaling before comparison with clinical organ constraints; therapeutic efficacy was evaluated under a single-dose regimen rather than a fractionated or multi-cycle schedule; and long-term toxicity, including delayed renal and hematopoietic effects, was not assessed. These findings position ¹⁷⁷Lu-PSMA-MN4 as a promising candidate for next-generation PSMA-targeted radioligand therapy. Collectively, this work establishes a structure-guided linker-optimization paradigm for PSMA radioligands and identifies ¹⁷⁷Lu-PSMA-MN4 as a promising preclinical candidate that warrants further translational evaluation.

2026-11-01·RADIOTHERAPY AND ONCOLOGY

Clinical outcomes among patients treated with Lu-PSMA-617 and metastasis-directed EBRT for metastatic prostate cancer

Article

作者: Killoran, Joseph H ; Huynh, Mai Anh ; Stoltenberg, Hailey ; Jacene, Heather ; Chen, Yu-Hui ; Menon, Kirti ; Adib, Elio ; Lee, Emerson ; Ravi, Praful

Metastasis-directed external beam radiation therapy (EBRT) delivered for limited-volume disease, integrated with systemic radioligand therapy, may improve long-term disease control across the spectrum of metastatic prostate cancer. We examined 88 patients with metastatic prostate cancer who received both lutetium-177 PSMA-617 (LuPSMA) radiopharmaceutical therapy and metastasis-directed external beam radiation therapy (EBRT) between June 2022 and August 2025. EBRT was delivered to a median of three metastatic sites, most commonly bone (69.3 %) and lymph nodes (64.8 %). The PSA50 response rate to LuPSMA was 55.7 %, with a median time to response of 1.6 months. With a median follow-up of 22.1 months, the median overall survival was 20.1 months. Hematologic toxicity was manageable, with grade ≥ 2 anemia in 30.7 % (including one patient with grade 3) and grade ≥ 2 leukopenia in 9.1 % of patients. These findings support the clinical feasibility and tolerability of integrating lesion-directed EBRT with systemic radioligand therapy and suggest that prior focal radiation does not meaningfully compromise tolerability or efficacy of subsequent radiopharmaceutical therapy. Prospective studies are warranted to define optimal patient selection, treatment sequencing, and timing of integration.

2026-11-01·CANCER BIOTHERAPY AND RADIOPHARMACEUTICALS

Characterization of Adverse Drug Effects for Three Radiopharmaceuticals: A Descriptive Analysis from WHO-VigiAccess

Article

作者: Jin, Yiheng ; Chen, Kaixin ; Qu, Shugen ; Wang, Xiaowu ; Wan, Xinlong ; Gui, Kunlun

Background::

Radiopharmaceuticals are being used more frequently to treat neuroendocrine tumors and advanced prostate cancer; however, their clinical application is associated with adverse drug reactions (ADRs) that may affect patient safety. Real-world data from spontaneous reporting systems such as the World Health Organization’s (WHO’s)-VigiAccess can aid in assessing safety after the drugs have been marketed.

Materials and Methods::

A retrospective descriptive analysis was conducted using ADR reports from the WHO-VigiAccess database up to November 2024. Reports related to lutetium ( 177 Lu) dotatate (Lutathera ® ), lutetium ( 177 Lu) vipivotide tetraxetan (Pluvicto ® ), and radium ( 223 Ra) dichloride (Xofigo ® ) were extracted and analyzed with respect to patient demographics, geographic distribution, and ADRs classified by MedDRA System Organ Class and Preferred Terms. Descriptive statistics were used to compare safety profiles.

Results::

A total of 17,743 ADR reports were analyzed. Lutathera was predominantly associated with gastrointestinal disorders and skin or subcutaneous tissue reactions. In contrast, Pluvicto demonstrated a higher frequency of general systemic disorders and a disproportionately higher number of fatal outcomes, a finding consistent with its indication for the treatment of advanced prostate cancer. Xofigo was primarily linked to hematological and musculoskeletal toxicities. In addition to 169 ADRs that were common to all three agents, distinct drug-specific reaction patterns were also observed.

Conclusions::

WHO-VigiAccess data reveal clearly differentiated ADR profiles among Lutathera, Pluvicto, and Xofigo. These results highlight the necessity for individualized risk assessment, careful monitoring, and further prospective investigations to optimize the safe clinical application of radiopharmaceuticals.

2,243

项与镥[177Lu] 特昔维匹肽相关的新闻（医药）

13 小时之前

·PRNewswire

Actinium Pharmaceuticals Unveils ATNM‑400 Data at EANM 2026 with a First‑In‑Human HER3‑Targeted Radiotherapy Approach Beyond PSMA in Prostate Cancer

HER3‑targeted PET imaging demonstrated tumor uptake and retention, supporting ATNM‑400's potential to deliver sustained alpha radiation to tumors over a timeframe consistent with Actinium‑225's 10-day half‑life Initial three‑patient cohort completed the first dose level of 1.0 µCi/kg with no dose‑limiting toxicities, xerostomia or Grade 3/4 hematologic adverse events observed ATNM‑400 advanced to the second dose level of 1.5 µCi/kg, marking continued clinical progress for a first‑in‑class Actinium‑225 antibody radiotherapy with potential across the broad mCRPC population NEW YORK, Oct. 20, 2026 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a pioneer in differentiated targeted radiotherapies with the potential to transform cancer treatment, today announced encouraging initial clinical results from the first‑in‑human Phase 1 study of ATNM‑400 in metastatic castration‑resistant prostate cancer (mCRPC). The findings, presented in an oral presentation on October 19 at the 39th Annual Congress of the European Association of Nuclear Medicine (EANM) in Vienna, Austria, showed a favorable initial safety profile at the first dose level and tumor uptake and retention with the HER3‑targeted imaging agent. Dose escalation has advanced to 1.5 µCi/kg and is ongoing. ATNM‑400 is a first‑in‑class, HER3‑targeted alpha radiotherapy that conjugates the monoclonal antibody barecetamab with Actinium‑225 (²²⁵Ac). HER3 is implicated in tumor progression and resistance to androgen receptor pathway inhibitors (ARPIs), providing a biology‑driven rationale for treatment beyond PSMA. ATNM‑400 combines the antigen specificity of a monoclonal antibody with the potent, high‑energy alpha‑particle radiation of ²²⁵Ac. The study employs a theranostic approach, using Zirconium‑89 (⁸⁹Zr)‑labeled barecetamab PET imaging to visualize tumor uptake and retention and characterize biodistribution and dosimetry to inform ATNM‑400 development. Sandesh Seth, Actinium's Chairman and CEO, said, "These first‑in‑human results mark an important milestone for a differentiated radiotherapy with the potential to expand treatment across the broad mCRPC population. HER3's role in tumor survival and treatment resistance provides a compelling opportunity to address disease that remains underserved by existing approaches. Despite the progress of PSMA‑directed therapies, patients with PSMA‑low or PSMA‑negative disease and those who do not respond to or progress following these treatments need additional options. ATNM‑400 is designed to meet that need through a distinct target and potent alpha‑radiation payload. The initial tumor uptake and tolerability findings support continued clinical development in prostate cancer and our broader vision for ATNM‑400 as a pan‑cancer radiotherapy." Highlights from the EANM 2026 Oral Presentation Preclinical findings support broad potential beyond PSMA. ATNM‑400 demonstrated antitumor activity across PSMA‑high, PSMA‑low and PSMA‑negative prostate cancer models, including a model with low HER3 expression, supporting its potential to address patients underserved by PSMA‑directed therapies. HER3‑directed imaging demonstrated tumor uptake and retention. Serial imaging demonstrated lesion uptake retained through Day 7, supporting the use of ATNM‑400 to deliver high‑energy alpha‑particle radiation to tumors, with sustained retention aligned with the 10-day half‑life of ²²⁵Ac. First dose level cleared in three patients with previously treated mCRPC. Patients received ATNM‑400 at 1.0 µCi/kg. All had received prior ARPI therapy, two had received chemotherapy, and one had also received ¹⁷⁷Lu‑PSMA therapy. At the time of the presentation, all three had received at least two cycles of ATNM‑400, including two patients who had received three cycles. Encouraging initial safety findings supported continued dose escalation. No dose‑limiting toxicities, xerostomia (dry mouth), or Grade 3/4 hematologic adverse events were observed during the dose‑limiting toxicity window or subsequent follow‑up reported in the presentation. No elevations in liver enzymes (ALT/AST) or creatinine, injection‑site reactions, or infusion‑related reactions were observed. Study advanced to the second dose level. Following clearance of the 1.0 µCi/kg cohort, dose escalation proceeded to 1.5 µCi/kg. The study is designed to assess safety and tolerability and establish a recommended Phase 2 dose. Professor Joe Cardaci of GenesisCare Murdoch, a study investigator and presenting author, commented, "Patients whose prostate cancer progresses after established therapies need additional treatment options. In this initial cohort, we observed HER3‑positive tumor uptake with the imaging agent and encouraging tolerability with repeated ATNM‑400 dosing, including in a patient previously treated with ¹⁷⁷Lu‑PSMA. The absence of dose‑limiting toxicities, xerostomia and Grade 3/4 hematologic adverse events is encouraging at this early stage. These findings support continued dose escalation and evaluation in additional patients." Steffen Heeger, MD, MSc, Actinium's Chief Medical Officer, said, "HER3 is involved in tumor survival signaling and treatment resistance across multiple solid tumors, making it a compelling target for antibody‑directed alpha radiotherapy. In prostate cancer, its association with ARPI resistance provides a strong rationale for ATNM‑400, both as a monotherapy and in combination with established treatments. Preclinical activity across PSMA‑high, PSMA‑low and PSMA‑negative prostate cancer models, including a model with low HER3 expression, underscores the opportunity to reach patients underserved by PSMA‑directed therapies. Together with sustained tumor control after enzalutamide failure and durable activity in combination with enzalutamide, these findings support a broad mCRPC development strategy spanning monotherapy and ARPI combinations. We believe the combination of HER3 biology, sustained antibody localization and potent alpha radiation also supports investigation of ATNM‑400's pan‑cancer potential, building on our preclinical findings in lung and breast cancer." About the ATNM‑400 Phase 1 Study The ongoing first‑in‑human study uses a 3+3 dose‑escalation design followed by dose expansion in patients with progressive mCRPC who have received at least one ARPI and at least one taxane regimen, unless chemotherapy is unsuitable or declined. Prior ¹⁷⁷Lu‑PSMA treatment is permitted. Patients undergo HER3‑targeted PET imaging with [⁸⁹Zr]Zr‑barecetamab‑DFO before treatment with ATNM‑400, administered intravenously every six weeks for up to four cycles. Planned dose levels are 1.0, 1.5, 2.25 and 3.0 µCi/kg. The study evaluates safety, dosimetry and pharmacokinetics, with dose expansion intended to establish the recommended Phase 2 dose and further assess tolerability and antitumor activity, including PSA responses, objective response rate, radiographic progression‑free survival and overall survival. EANM 2026 Presentation Details Abstract Title: First‑In‑Human Phase 1 Study of ATNM‑400, Actinium‑225 Antibody Radioconjugate, in Metastatic Castration‑Resistant Prostate Cancer (mCRPC) Abstract Number: OP‑525 Presentation Type: Oral presentation Session: 1111 — Theranostics Track: Prostate Cancer Therapy II Session Date and Time: Monday, October 19, 2026, 4:45–6:15 p.m. CEST Location: Hall G1, Vienna, Austria About ATNM‑400 and HER3 ATNM‑400 is an investigational antibody radioconjugate that pairs the HER3‑targeting monoclonal antibody barecetamab with the alpha‑emitting isotope Actinium‑225. Its antibody‑based design combines antigen‑specific targeting with the potential for sustained tumor localization, supporting prolonged delivery of high‑energy alpha radiation. Tumor uptake and retention observed through Day 7 with the ⁸⁹Zr‑labeled imaging counterpart support this development rationale alongside the approximately 10‑day half‑life of ²²⁵Ac. The theranostic approach enables noninvasive visualization of antibody distribution to inform therapeutic development. ATNM‑400 is differentiated from PSMA‑targeted radiotherapies by its focus on HER3, an antigen implicated in tumor survival and treatment resistance. PSMA‑directed approaches include Novartis' Pluvicto and a broad pipeline of investigational therapies, including Telix Pharmaceuticals' TLX591‑Tx, Clarity Pharmaceuticals' ⁶⁷Cu‑SAR‑bisPSMA, Convergent Therapeutics' CONV01‑α, AstraZeneca's AZD2265 (formerly FPI‑2265), Curium's lutetium‑177 zadavotide guraxetan (¹⁷⁷Lu‑PSMA‑I&T), ARTBIO's AB001 and AdvanCell's ADVC001. These programs span small‑molecule and antibody‑based therapies using beta‑ or alpha‑emitting isotopes. ATNM‑400 combines HER3 targeting with an Actinium‑225 antibody radioconjugate, offering a distinct biological approach with the potential to expand radiotherapy across the broad mCRPC population, including patients with PSMA‑low or PSMA‑negative disease and those who do not respond to or progress following PSMA‑directed treatment. Its HER3‑directed mechanism also supports investigation beyond prostate cancer in other HER3‑expressing solid tumors. HER3, also known as ERBB3, is a member of the epidermal growth factor receptor family involved in signaling pathways that support tumor growth, survival and resistance to treatment. HER3‑directed antibody‑drug conjugates in clinical development include BioNTech and MediLink's BNT326/YL202, Bristol Myers Squibb and SystImmune's EGFR × HER3 bispecific ADC izalontamab brengitecan (iza‑bren), and Daiichi Sankyo and Merck's patritumab deruxtecan (HER3‑DXd). These programs underscore the clinical development interest in HER3 as an oncology target. ATNM‑400 applies a distinct payload strategy, using alpha radiation in place of a conventional cytotoxic drug. Its preclinical activity in prostate, non‑small cell lung and breast cancer models supports investigation as a potential pan‑cancer radiotherapy, as a monotherapy and in rational combinations. About Actinium Pharmaceuticals, Inc. Actinium is a pioneer in targeted radiotherapies designed to improve outcomes for patients with cancer. The company employs a biology‑driven approach to develop differentiated radiopharmaceuticals for solid tumors and hematologic malignancies. Its mission is to transform cancer treatment through innovative radioconjugates that maximize therapeutic efficacy while minimizing toxicity to healthy tissue by combining expertise in tumor biology, translational medicine, and radiochemistry. Since inception, Actinium has focused on developing innovative radiotherapies. Its pipeline reflects this strategy across three areas: (1) solid tumor therapeutics including ATNM‑400 and Actimab‑A with pan‑tumor potential; (2) Actimab‑A as a therapeutic backbone for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in collaboration with the National Cancer Institute (NCI); and (3) targeted conditioning agents including Iomab‑B for bone marrow transplant and Iomab‑ACT for cell and gene therapy conditioning. ATNM‑400 targets HER3, an antigen distinct from PSMA, and is in a first‑in‑human Phase 1 study in mCRPC, with preclinical activity across metastatic castration‑resistant prostate cancer (mCRPC), non‑small cell lung cancer (NSCLC), and breast cancer. Actimab‑A has shown improved survival in relapsed/refractory AML with CLAG‑M and is advancing toward a Phase 2/3 trial, with additional development ongoing through a CRADA with the NCI. Actinium is also advancing preclinical solid tumor programs and holds ~250 patents and patent applications, including intellectual property related to cyclotron‑based production of Ac‑225. For more information, please visit . Forward‑Looking Statements This press release may contain projections or other "forward‑looking statements" within the meaning of the "safe‑harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10‑K, subsequent quarterly reports on Forms 10‑Q and Forms 8‑K, each as amended and supplemented from time to time. Investors: [email protected] SOURCE Actinium Pharmaceuticals, Inc. 21% more press release views with Request a Demo

放射疗法临床结果临床1期

2026-10-19

·BiG生物创新社

一款25万美元的药，仿制竞争只带来5%的折扣

随着放射性配体治疗（Radioligand Therapy，RLT）在肿瘤治疗领域加速发展，围绕新靶点、放射性核素和药物生产供应体系的竞争日益激烈。诺华凭借Lutathera和Pluvicto两款产品，率先建立了放射性配体治疗的商业化优势。如今，随着早期上市产品的专利保护逐渐受到挑战，这一新兴治疗领域也开始迎来仿制药竞争。然而，刚刚出现的市场竞争却呈现出一个令人意外的现象：一款原研药替代产品的价格，竟然只比原研药低5%。 2026年9月， FDA先后批准了Curium的Bexlutry和Lantheus的Bravnetsa，两款产品均直接挑战诺华2018年上市的Lutathera。其中，Bexlutry通过505(b)(2)新药申请途径获批，属于放射性配体等效药；Bravnetsa则通过简化新药申请（ANDA）途径获批，成为美国首款获得FDA生物等效性及治疗等效性认定的放射性配体治疗仿制药。 Curium为Bexlutry制定的公开标价为每次输注63524美元，而诺华Lutathera的价格约为67000美元，折扣仅为5.2%。按照标准的4次输注方案计算，Bexlutry整个疗程的药品标价约为25.41万美元，仅比原研药低约1.39万美元。对于一款单疗程价格超过25万美元的治疗药物，如此有限的价格差距尤其引人关注。在传统化学仿制药市场，仿制竞争通常意味着显著的降价压力。但在放射性配体治疗领域，即使产品已经可以通过简化监管路径获批，企业仍然需要面对放射性核素供应、复杂生产工艺、短半衰期和特殊物流配送带来的成本与商业化限制。Bexlutry的5%折扣由此提出了一个重要的产业问题：放射性配体治疗药物的仿制竞争，是否会形成一套不同于传统化学仿制药的价格体系？ 01 首款放射性配体治疗仿制药获批 Lutathera是放射性配体治疗商业化的重要代表，其活性成分为镥-177标记的DOTA-TATE环肽，通过结合肿瘤细胞表面的生长抑素受体，尤其是生长抑素受体2（SSTR2），将放射性核素定向递送至肿瘤组织，利用镥-177释放的β射线杀伤肿瘤细胞。 2018年1月，FDA批准Lutathera用于成年生长抑素受体阳性的胃肠胰神经内分泌肿瘤（GEP-NET）。2024年4月，其适应症进一步扩大至12岁及以上儿童患者。作为最早实现规模化商业应用的放射性配体治疗产品之一，Lutathera在2025年实现8.16亿美元销售额，同比增长13%。同期，诺华另一款放射性配体治疗药物Pluvicto的销售额达到19.94亿美元。两款产品合计年销售额已超过28亿美元，显示出这一治疗领域的商业潜力。随着Lutathera上市时间延长，竞争者也开始进入这一市场。2026年9月14日，Curium的Bexlutry获得FDA批准，成为首款针对Lutathera开发并获批的放射性配体等效药。该产品通过505(b)(2)新药申请途径获批，利用已有研究证据及补充桥接数据，证明其与原研药具有相似的化学和生物学特征。一周后的9月21日，Lantheus的Bravnetsa获得FDA正式批准。与Bexlutry不同，Bravnetsa通过505(j)简化新药申请（ANDA）途径获批，获得FDA生物等效性及治疗等效性认定，成为美国首款严格意义上的放射性配体治疗仿制药。这项批准为后续同类产品提供了可参考的监管先例，也表明放射性配体治疗药物能够在符合相应要求的情况下，通过传统仿制药监管路径进入市场。表1. Lutathera及其非原研竞争产品的FDA批准情况与监管路径比较 02 5%折扣背后的产业壁垒传统化学仿制药通常通过简化临床开发、成熟工艺和规模化生产降低成本，随着多个仿制产品上市，价格竞争往往日趋激烈。放射性配体治疗药物虽然同样能够减少重复临床开发，但其生产与供应体系受到放射性核素特性的制约，成本结构和市场进入条件与普通化学药物存在明显差异。首先，放射性药物无法依靠长期库存平衡生产与市场需求。以Lutathera为例，其生产需要将DOTA-TATE多肽前体与放射性镥-177进行标记，并完成放射化学纯度、活度及其他质量检测。镥-177的物理半衰期约为6.65天，经过48小时，放射性活度便下降约19%。因此，核素供应、药物生产、质量放行及临床给药必须紧密衔接，运输延误或患者临时取消治疗都可能造成额外损失。与此同时，镥-177依赖专门的核反应堆生产及分离纯化设施，稳定的核素供应本身也构成了较高的行业进入门槛。其次，放射性配体治疗药物需要专业化的制造与配送网络。生产设施必须满足GMP和辐射安全要求，涉及专用设备、屏蔽防护、放射性质量控制及废物处理。Curium在美国印第安纳州和密苏里州设有生产设施，通过公路、航空及核药房网络向全国配送Bexlutry，声称能够在两天内将产品送达当地市场。诺华则依靠成熟的供应体系，实现了报道所称的99.5%运输准时率。对于需要提前安排核医学设施、专业人员和患者治疗时间的医院而言，稳定交付直接关系到治疗能否按计划进行，因而也是选择供应商的重要因素。最后，市场规模和竞争者数量也会影响降价幅度。放射性配体治疗主要面向特定肿瘤患者群体，市场规模相对有限，而核素供应、GMP设施及专业配送网络需要持续投入。新进入者很难仅依靠低价迅速扩大销量并摊薄固定成本。具备成熟供应体系的企业，则可能更倾向于通过适度降价和可靠交付争取医院采购份额。 Bexlutry仅5%的标价折扣，正是这一特殊竞争环境下的定价选择。随着严格意义上的仿制药Bravnetsa获批，放射性配体治疗市场的竞争将进一步展开，但价格变化仍将受到核素供应、制造能力、配送网络及市场集中度的共同影响。 03 80亿美元并购与行业竞争新格局放射性配体治疗市场的竞争格局正在发生新的变化。2026年8月3日，Curium宣布计划以最高约80亿美元收购Lantheus，交易预计于2027年上半年完成。值得关注的是，两家公司随后分别获得了Bexlutry和Bravnetsa的FDA批准。如果并购顺利完成，Lutathera的两款非原研竞争产品将归于同一集团，形成诺华与Curium在这一细分市场竞争的局面。这项并购也反映了放射性药物产业整合的发展方向。Curium拥有成熟的核医学药物生产与配送网络，Lantheus则凭借前列腺特异性膜抗原（PSMA）显像剂PYLARIFY等产品，在美国核医学诊断市场占据重要地位。双方整合有望进一步强化诊断、治疗及药品供应之间的协同，并提高现有生产和配送设施的利用效率。随着放射性配体治疗市场扩大，产业竞争可能呈现三个发展趋势。首先，放射性核素供应与药物制造将加速整合。镥-177、锕-225等治疗性核素的稳定供应，是放射性药物研发和商业化的重要条件。随着更多产品进入临床后期及商业化阶段，掌握核素生产能力、长期供应协议及专业化制造设施的企业，将在成本控制和供应保障方面获得竞争优势。其次，放射性配体治疗的仿制竞争可能维持较高的市场集中度。Bravnetsa通过简化新药申请（ANDA）途径获批，为后续同类仿制药提供了监管先例，但核素供应、专用生产设施和配送网络仍然构成较高的市场进入门槛。尤其对于患者群体相对有限的肿瘤适应症，新增企业需要足够的销售规模才能分摊固定投入。因此，未来市场可能长期由少数具备完整供应体系的企业主导，价格竞争也可能比传统化学仿制药更加温和。第三，诊断与治疗的一体化将进一步推动产业整合。放射性配体治疗通常需要借助分子影像技术筛选患者，诊断性与治疗性放射性药物之间具有密切联系。兼具诊断产品、治疗药物及商业化配送能力的企业，有望在临床合作、市场覆盖和基础设施利用方面形成协同优势。Curium与Lantheus的并购正体现了这一发展趋势。对于中国放射性药物企业而言，Lutathera的仿制竞争提供了重要参考。随着国内放射性药物研发持续推进，企业除了布局新靶点和新型核素，还需要加强放射性核素供应、多肽前体及标记工艺、GMP制造和跨区域配送能力建设。Bravnetsa的获批也为未来中国企业进入国际放射性药物仿制市场提供了可参考的监管路径。 Bexlutry仅5%的价格折扣，为观察放射性配体治疗市场的未来竞争提供了一个独特视角。随着首款严格意义上的仿制药获批，这一领域正逐步进入原研药与非原研产品共同竞争的新阶段。放射性药物特殊的生产与供应条件，使专利保护之外的产业能力持续影响市场格局，也赋予了成熟制造和配送体系更高的商业价值。未来，随着仿制竞争扩大与产业整合深入，放射性配体治疗领域的竞争优势将越来越取决于企业对核素资源、生产能力和商业化网络的系统性掌控，而这一变化也将深刻影响整个行业的发展方向与价值分配。 Ref. Curium prices generic radioligand at 5% discount to Novartis' Lutathera. Endpoints News. 2026. Curium announces FDA approval of BEXLUTRY lutetium Lu 177 dotatate injection for adults with SSTR-positive GEP-NETs. Curium. 16. 09. 2026. Lantheus Receives Final FDA Approval for BRAVNETSA. Lantheus. 22. 09. 2026. Curium Announces Definitive Agreement to Merge with Lantheus. Curium. 03. 08. 2026. Novartis Delivered High Single-Digit Sales Growth, Achieved 40% Core Margin and Further Advanced the Pipeline in 2025. Novartis. 04. 02. 2026. 共建Biomedical创新生态圈！加入BiG会员

放射疗法上市批准

2026-10-19

·ioncology

ESMO Asia 2026丨瞭望前瞻，近60项中国泌尿肿瘤研究闪耀狮城，不止参与，更是主角

点击蓝字，关注我们编者按：2026年欧洲肿瘤内科学会亚洲年会（ESMO Asia）将于12月4日~6日在新加坡召开。作为肿瘤学界的年度盛典，ESMO Asia汇聚亚太地区前沿进展与临床经验，为亚洲及全球学者提供良好的交流平台。目前，ESMO Asia官网已公布口头报告标题（LBA尚未公布）、壁报、电子壁报标题，其中泌尿系统肿瘤领域共有58项中国研究入选（包括8项口头报告+50项壁报），肿瘤瞭望-泌尿时讯特别整理相关内容，以供参考（如有遗漏或错误，欢迎留言指正）。口头报告摘要号：402O 英文标题：Perioperative enfortumab vedotin plus pembrolizumab (EV + pembro) versus neoadjuvant cisplatin-based chemotherapy in participants (pts) with muscle-invasive bladder cancer (MIBC) in the Asia subset of KEYNOTE-B15 中文标题：在KEYNOTE-B15研究的亚洲亚组中，针对肌层浸润性膀胱癌（MIBC）患者，围手术期使用维恩妥尤单抗联合帕博利珠单抗（EV + pembro）对比新辅助顺铂类化疗的研究讲者：叶定伟教授单位或地区：复旦大学附属肿瘤医院摘要号：404RO 英文标题：NEOBLAST Study Update： A Prospective, Single-Arm, Multi-Center, Pilot Study of Neoadjuvant Adebrelimab plus Etoposide and Cisplatin in Patients with Neuroendocrine Bladder Carcinoma 中文标题：NEOBLAST研究更新：一项针对神经内分泌膀胱癌患者，采用阿得贝利单抗联合依托泊苷及顺铂进行新辅助治疗的前瞻性、单臂、多中心、先导性研究讲者：陈海戈教授单位或地区：上海交通大学医学院附属仁济医院摘要号：405RO 英文标题：Induction chemotherapy followed by toripalimab, disitamab vedotin, and radiotherapy for bladder preservation in HER2-positive muscle-invasive bladder cancer (MIBC)： An open-label, single-arm study 中文标题：针对HER2阳性肌层浸润性膀胱癌（MIBC）的诱导化疗联合特瑞普利单抗、维迪西妥单抗及放疗以实现膀胱保留：一项开放标签、单臂研究讲者：刘博教授单位或地区：华中科技大学同济医学院附属同济医院摘要号：406RO 英文标题：SC-101, a Nectin-4-targeting peptide–drug conjugate, in patients with advanced urothelial carcinoma： Updated results from a phase 1 dose-escalation and dose-expansion study 中文标题：SC-101（一种靶向Nectin-4的多肽偶联药物）在晚期尿路上皮癌患者中的应用：一项1期剂量递增与剂量扩展研究的最新结果讲者：李娟教授单位或地区：北京大学肿瘤医院摘要号：407RO 英文标题：Prognostic Implications of ypTNM Staging After Neoadjuvant Systemic Therapy in Non-metastatic Clear Cell Renal Cell Carcinoma： A Propensity Score–Matched Analysis 中文标题：非转移性透明细胞肾细胞癌新辅助系统治疗后ypTNM分期的预后意义：一项基于倾向评分匹配的分析讲者：宋佳龙教授单位或地区：中国人民解放军总医院摘要号：408RO 英文标题：Circulating metabolomics Analysis in a Prospective Co-clinical Trial Identifies succinate-modifying metabolites as Response Biomarkers for Combination Immunotherapy in Advanced Fumarate hydratase Deficient Renal Cell Carcinoma 中文标题：一项前瞻性联合临床试验中的循环代谢组学分析发现，琥珀酸修饰相关代谢物可作为晚期延胡索酸水合酶缺陷型肾细胞癌联合免疫治疗的疗效生物标志物讲者：徐云泽教授单位或地区：上海交通大学医学院附属仁济医院摘要号：740RO 英文标题：HRS-1738, an 18F‑labeled prostate-specific membrane antigen (PSMA)‑targeted PET tracer, for imaging of prostate cancer (PCa)： a multicenter phase I/II study 中文标题：HRS-1738——一种靶向前列腺特异性膜抗原（PSMA）的18F标记PET示踪剂，用于前列腺癌（PCa）显像：一项多中心I/II期研究讲者：杨志教授单位或地区：北京大学肿瘤医院摘要号：741RO 英文标题：Comparative Biomarker Profiling in the First-in-Human (FIH) Trial of Pasritamig in Visceral and Nonvisceral Metastatic Castration-Resistant Prostate Cancer (mCRPC) 中文标题：Pasritamig首次人体（FIH）试验中针对内脏及非内脏转移性去势抵抗性前列腺癌（mCRPC）的生物标志物特征对比分析讲者：戴君勇教授单位或地区：重庆大学附属肿瘤医院壁报及电子壁报摘要号：413P 英文标题：Predicting Response to Neoadjuvant Enfortumab Vedotin and Pembrolizumab Using Neoadjuvant Chemotherapy Vesical Imaging-Reporting and Data System(nacVI-RADS) in Bladder Cancer： A Retrospective Pilot Study 中文标题：利用膀胱癌新辅助化疗影像报告与数据系统（nacVI-RADS）预测膀胱癌患者对新辅助维恩妥尤单抗联合帕博利珠单抗治疗的反应：一项回顾性初步研究讲者：JIA-JYUN Jhang 单位或地区：中国台湾摘要号：418P 英文标题：Efficacy and safety of disitamab vedotin plus toripalimab versus chemotherapy plus toripalimab in advanced urothelial carcinoma： A retrospective analysis 中文标题：晚期尿路上皮癌中维迪西妥单抗联合特瑞普利单抗与化疗联合特瑞普利单抗的疗效及安全性：一项回顾性分析讲者：申智勇教授单位或地区：贵州医科大学附属肿瘤医院摘要号：419P 英文标题：Real-world outcomes of enfortumab vedotin-based regimens in first-line, neoadjuvant, and organ-preserving urothelial carcinoma： a multicenter Chinese analysis 中文标题：基于维恩妥尤单抗的治疗方案在尿路上皮癌一线治疗、新辅助治疗及器官保留治疗中的真实世界疗效：一项中国多中心分析讲者：李和程教授单位或地区：西安交通大学第二附属医院摘要号：420P 英文标题：Enfortumab Vedotin (EV) in Patients (pts) With Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) in China： Long-term Follow-up of the EV-203 Trial 中文标题：维恩妥尤单抗用于中国既往接受过治疗的局部晚期或转移性尿路上皮癌 (la/mUC) 患者：EV-203试验的长期随访结果讲者：盛锡楠教授单位或地区：北京大学肿瘤医院摘要号：423P 英文标题：Blood- and Urine-Based ctDNA Profiling and Monitoring in Bladder Carcinoma In Situ： A Prospective Liquid Biopsy Study 中文标题：基于血液和尿液的ctDNA分析与监测在膀胱原位癌中的应用：一项前瞻性液体活检研究讲者：张瑞赟教授单位或地区：上海交通大学医学院附属仁济医院摘要号：424P 英文标题：ARID1A-Deficient Urothelial Carcinoma with High CD8⁺ T-Cell Infiltration Exhibits Favorable Clinical Outcomes 中文标题：ARID1A缺失且伴有高水平CD8⁺ T细胞浸润的尿路上皮癌具有良好的临床预后讲者：Zhaopei Liu 单位或地区：复旦大学附属肿瘤医院摘要号：425P 英文标题：Discordance Between Complete Response and Urinary Tumor DNA Dynamics After Low-Dose Nab-Paclitaxel Plus PD-1 Blockade in Extensive Very High-Risk NMIBC： TRUCE02-MoRE 中文标题：针对广泛性极高危非肌层浸润性膀胱癌（NMIBC），采用低剂量白蛋白结合型紫杉醇联合PD-1阻断治疗后，完全缓解与尿液肿瘤DNA动态变化之间的不一致性：TRUCE02-MoRE研究讲者：Liliang Li 单位或地区：天津医科大学第二医院摘要号：427P 英文标题：KAT2A-mediated MeCP2 lactylation enhanced malignancy of SMARCB1-deficient bladder cancer via transcriptional regulation of FGF1 中文标题：KAT2A介导的MeCP2乳酸化通过对FGF1的转录调控，增强了SMARCB1缺失型膀胱癌的恶性程度讲者：Guanghui Xu 单位或地区：南京大学医学院附属鼓楼医院摘要号：428P 英文标题：Absolute monocyte count (AMC) dynamics is associated with overall survival in urothelial carcinoma patients receiving chemotherapy 中文标题：接受化疗的尿路上皮癌患者中，绝对单核细胞计数（AMC）的动态变化与总生存期相关讲者：Hsuan-ying Cheng 单位或地区：中国台湾摘要号：430P 英文标题：Tumor shrinkage and depth of response of fruquintinib plus sintilimab in patients with advanced renal cell carcinoma： a post-hoc analysis from FRUSICA-2 中文标题：晚期肾细胞癌患者接受呋喹替尼联合信迪利单抗治疗后的肿瘤缩小情况及应答深度：FRUSICA-2研究的一项事后分析讲者：瞿元元教授单位或地区：复旦大学附属肿瘤医院摘要号：437P 英文标题：Real-World Comparison of First-Line Nivolumab plus Ipilimumab versus Pembrolizumab plus Lenvatinib in Advanced Renal Cell Carcinoma (RCC) in a Chinese Population： A Propensity Score-Weighted Analysis 中文标题：中国人群晚期肾细胞癌（RCC）中纳武利尤单抗联合伊匹木单抗一线治疗对比帕博利珠单抗联合仑伐替尼一线治疗的真实世界结果：一项基于倾向评分加权的分析讲者：Kelvin C. Yan 单位或地区：中国香港摘要号：438P 英文标题：Identification and validation of a urine DNA methylation biomarker for noninvasive detection of clear cell renal cell carcinoma 中文标题：用于无创检测透明细胞肾细胞癌的尿液DNA甲基化生物标志物的鉴定与验证讲者：宋佳龙教授单位或地区：中国人民解放军总医院摘要号：441P 英文标题：Pretreatment MRI Radiomics-Based Model for Predicting Response to Neoadjuvant Therapy in Nonmetastatic Clear Cell Renal Cell Carcinoma with Venous Tumor Thrombus： A Single-Center Prospective Study 中文标题：基于治疗前MRI影像组学的模型：预测伴有静脉瘤栓的非转移性透明细胞肾细胞癌对新辅助治疗的反应——一项单中心前瞻性研究讲者：宋佳龙教授单位或地区：中国人民解放军总医院摘要号：442P 英文标题：Single-Cell and Spatial Multi-Omics Reveal Mechanistic Insights of FOLH1+ Endothelial Cells in Clear Cell Renal Cell Carcinoma 中文标题：单细胞与空间多组学揭示透明细胞肾细胞癌中FOLH1+内皮细胞的机制分析讲者：Li Cheng 单位或地区：中国芜湖摘要号：447P 英文标题：Platinum chemotherapy for genitourinary cancer in patients receiving maintenance dialysis：use, drug selection, and supportive care 中文标题：接受维持性透析的泌尿生殖系统癌症患者的铂类化疗：应用、药物选择及支持治疗讲者：Iwei Ho 单位或地区：中国台北摘要号：449P 英文标题：Comparative Outcomes of Transperitoneal and Retroperitoneal Robot-Assisted Partial Nephrectomy in Patients with Completely Endophytic Renal Tumors： A Propensity Score-Matched Analysis 中文标题：完全内生型肾肿瘤患者行经腹腔与腹膜后机器人辅助肾部分切除术的预后比较：一项基于倾向性评分匹配的分析讲者：马强教授单位或地区：南京大学医学院附属鼓楼医院摘要号：450TiP 英文标题：Neoadjuvant/adjuvant disitamab vedotin with hexaminolevulinate-guided TURBT and BCG in HER2-overexpressing high/very-high-risk NMIBC： a prospective, multicenter phase II trial 中文标题：在HER2过表达的高危/极高危非肌层浸润性膀胱癌（NMIBC）患者中，使用维迪西妥单抗新辅助/辅助治疗联合氨基乙酰丙酸引导的经尿道膀胱肿瘤切除术（TURBT）和卡介苗（BCG）治疗：一项前瞻性、多中心II期临床试验讲者：蓝天杭教授单位或地区：中山大学孙逸仙纪念医院摘要号：451TiP 英文标题：A Multi-Center Single-Arm Phase II Trial in Progress： Becotatug Vedotin Combined with Pucotenlimab as First-Line Therapy for EGFR-Positive Locally Advanced/Metastatic Penile Squamous Cell Carcinoma (MH-Penile-001) 中文标题：一项正在进行的多中心、单臂II期临床试验：Becotatug Vedotin联合Pucotenlimab作为EGFR阳性局部晚期/转移性阴茎鳞状细胞癌的一线治疗（MH-Penile-001）讲者：Hong-Shuai Li 单位或地区：四川大学华西医院摘要号：452TiP 英文标题：Neoadjuvant becotatug vedotin plus pucotenlimab for penile preservation or regional lymph-node metastases in penile squamous cell carcinoma： a prospective, single-arm phase II study 中文标题：在新辅助治疗阶段使用becotatug vedotin联合pucotenlimab治疗阴茎鳞状细胞癌，旨在实现阴茎保留或针对区域淋巴结转移进行治疗：一项前瞻性、单臂II期研究讲者：邵彦翔教授单位或地区：四川大学华西医院摘要号：459eP 英文标题：SERPINA1 drives bladder cancer metastasis by promoting a metastasis-initiating cell state 中文标题：SERPINA1通过促进一种转移起始细胞状态来驱动膀胱癌转移讲者：Jing Zhang 单位或地区：中国南京摘要号：460eP 英文标题：Mediating Effects of Social Appearance Anxiety and Self-Concealment on the Relationship Between Body Image and Social Alienation in Bladder Cancer Patients with Urostomy 中文标题：社交外貌焦虑与自我隐瞒在膀胱癌尿路造口患者身体意象与社会疏离感之间的中介效应讲者：Yin Zhang 单位或地区：中国南京摘要号：461eP 英文标题：A CT-Based Radiomics Ensemble Model (CRIPEM) for Preoperative Prediction of Pathological Upstaging in Clear Cell Renal Cell Carcinoma 中文标题：基于CT影像组学的集成模型（CRIPEM）：用于术前预测透明细胞肾细胞癌的病理分期升级讲者：Shaojian Zhang 单位或地区：中国济南摘要号：463eP 英文标题：Tumor SLC7A2-mediated arginine metabolism and CD8+ T-cell exhaustion in renal cell carcinoma 中文标题：肾细胞癌中由SLC7A2介导的肿瘤精氨酸代谢与CD8+ T细胞耗竭分析讲者：Ziyi Chen 单位或地区：中国南京摘要号：742P 英文标题：Long-course versus short-course neoadjuvant rezvilutamide plus androgen deprivation therapy in patients with oligometastatic prostate cancer： an exploratory randomized controlled trial 中文标题：寡转移性前列腺癌患者中，长疗程与短疗程新辅助瑞维鲁胺联合雄激素剥夺疗法的对比：一项探索性随机对照试验讲者：顾腾飞教授单位或地区：丽水市中心医院摘要号：743P 英文标题：which group of patients with GS 3+3 may not be suitable for acitve surveillance ?： evidence from a large retrospective cohort study 中文标题：哪些GS 3+3患者群体可能不适合主动监测？——一项大型回顾性队列研究的证据讲者：Xun Wang 单位或地区：中国南京摘要号：745P 英文标题：Current Application and Pathological Benefit of Pelvic Lymph Node Dissection During Radical Prostatectomy： A Retrospective Single-Center Study of 2,786 Cases 中文标题：前列腺癌根治术中盆腔淋巴结清扫术的当前应用及病理获益：一项包含2786例病例的单中心回顾性研究讲者：Shuai Jiang 单位或地区：中国上海摘要号：746P 英文标题：Prostate Biopsy Strategies in Patients with Anal Atresia or Stenosis： A Multicenter Retrospective Study 中文标题：肛门闭锁或狭窄患者的前列腺活检策略：一项多中心回顾性研究讲者：Rui Su 单位或地区：中国宁波摘要号：747P 英文标题：Plasma Extracellular Vesicle-Derived GDF15 and PSMA Refine Detection of Clinically Significant Prostate Cancer in PSA/MRI Gray-Zone Patients 中文标题：源自血浆细胞外囊泡的GDF15和PSMA可优化PSA/MRI灰区患者临床显著性前列腺癌的检测讲者：Yanxiang Shao 单位或地区：中国成都摘要号：748P 英文标题：An MRI-Based Radiomic-Clinicopathological Nomogram for Preoperative Identification of PTEN-Deficient Prostate Cancer Using Machine Learning 中文标题：基于MRI的影像组学-临床病理列线图：利用机器学习术前识别PTEN缺失型前列腺癌讲者：Xuantong Huang 单位或地区：中国南京摘要号：749P 英文标题：A Parsimonious Machine-Learning Model Based on Preoperative PSA and Routine mpMRI Features for Persistent PSA After Radical Prostatectomy： A Multicenter Retrospective Study 中文标题：基于术前PSA及常规多参数MRI特征、用于预测前列腺癌根治术后PSA持续存在的精简机器学习模型：一项多中心回顾性研究讲者：Zhifa Chen 单位或地区：中国温州摘要号：750P 英文标题：Neoadjuvant/perioperative darolutamide plus androgen-deprivation therapy before radical prostatectomy： a real-world 49-patient analysis 中文标题：根治性前列腺切除术前新辅助/围手术期使用达罗他胺联合雄激素剥夺疗法：一项包含49例患者的真实世界分析讲者：Peimin Zhou 单位或地区：中国北京摘要号：751P 英文标题：Efficacy and safety of darolutamide triplet therapy in patients with metastatic hormone-sensitive prostate cancer： A retrospective real-world study 中文标题：达罗他胺三联疗法在转移性激素敏感性前列腺癌患者中的疗效与安全性：一项回顾性真实世界研究讲者：Yu Bai 单位或地区：中国昆明摘要号：753P 英文标题：A Real-World Study of Darolutamide Dual and Triple Therapy in Chinese mHSPC Patients with Multiple Comorbidities 中文标题：达罗他胺双药及三药疗法在中国合并多种共病的转移性激素敏感性前列腺癌（mHSPC）患者中的真实世界研究讲者：Shengke Yang 单位或地区：中国成都摘要号：754P 英文标题：Six-month PSA response depth and subsequent PSA progression in Chinese patients with de novo metastatic hormone-sensitive prostate cancer receiving darolutamide-based therapy： a real-world landmark cohort study 中文标题：接受达罗他胺治疗的中国初诊转移性激素敏感性前列腺癌患者：6个月时PSA应答深度及后续PSA进展情况——一项真实世界里程碑队列研究讲者：Wei Yu 单位或地区：中国北京摘要号：756P 英文标题：Long-term real-world efficacy of darolutamide-based triple therapy with or without cytoreductive surgery in patients with metastatic hormone-sensitive prostate cancer (mHSPC) 中文标题：在转移性激素敏感性前列腺癌（mHSPC）患者中，基于达罗他胺的三联疗法（联合或不联合减瘤手术）的长期真实世界疗效讲者：Pu Zhang 单位或地区：中国杭州摘要号：757P 英文标题：Superior Real-World Efficacy of PARP Inhibitors in Hormone-Sensitive Disease and HRR Co-Mutated Advanced Prostate Cancer： A Single-Center Analysis 中文标题：PARP抑制剂在激素敏感性疾病及HRR共突变晚期前列腺癌中的真实世界疗效更优：一项单中心分析讲者：Yixiao Liu 单位或地区：中国香港摘要号：758P 英文标题：Sequential PARP inhibitor intensification before castration resistance in CDK12-altered metastatic prostate cancer： a Chinese real-world cohort 中文标题：在CDK12发生变异的转移性前列腺癌中，于去势抵抗阶段前序贯应用PARP抑制剂进行强化治疗：一项中国真实世界队列研究讲者：Yixiao Liu 单位或地区：中国香港摘要号：759P 英文标题：Updated results of PROspect： A multi-center, single-arm, prospective study to investigate the efficacy and safety of Olaparib monotherapy in newly diagnosed mCRPC patients who progressed on NHA with HRR gene mutation 中文标题：PROspect研究最新结果：一项多中心、单臂、前瞻性研究，旨在评估奥拉帕利单药治疗新诊断的、经新型激素疗法（NHA）治疗后出现进展且携带同源重组修复（HRR）基因突变mCRPC患者中的疗效与安全性讲者：Hao Liu 单位或地区：中国广州摘要号：761P 英文标题：Integration of 68Ga-PSMA-11 PET/CT PRIMARY Score and mpMRI PI-RADS Score for Risk Stratification of Biochemical Recurrence Following RARP 中文标题：结合68Ga-PSMA-11 PET/CT PRIMARY 评分与 mpMRI PI-RADS评分，对机器人辅助根治性前列腺切除术（RARP）后的生化复发风险进行分层讲者：Xinping Wang 单位或地区：中国南京摘要号：763P 英文标题：Quantitative PSMA PET/CT tumour burden for predicting deep PSA response in metastatic hormone-sensitive prostate cancer： a multicentre retrospective study 中文标题：利用定量PSMA PET/CT肿瘤负荷预测转移性激素敏感性前列腺癌患者的深度PSA缓解：一项多中心回顾性研究讲者：Yikai Chen 单位或地区：中国温州摘要号：767P 英文标题：Therapy-Induced Neural Remodeling Drives Castration Resistance in Prostate Cancer via Sensory Innervation and Glutamate Signaling 中文标题：治疗诱导的神经重塑通过感觉神经支配和谷氨酸信号传导驱动去势抵抗前列腺癌发展讲者：Jingyan Shi 单位或地区：中国南京摘要号：769P 英文标题：KBD991： A Novel Prostatic Acid Phosphatase Ligand for Targeted Prostate Cancer Therapy 中文标题：KBD991：一种用于前列腺癌靶向治疗的前列腺酸性磷酸酶新型配体讲者：Zhilong Jia 单位或地区：中国成都摘要号：770P 英文标题：Cardiovascular outcomes of second-generation androgen receptor inhibitors in Chinese patients with metastatic hormone‑sensitive prostate cancer 中文标题：中国转移性激素敏感性前列腺癌患者使用第二代雄激素受体抑制剂的心血管结局讲者：Wenlong Zhong 单位或地区：中国广州摘要号：771P 英文标题：Discrete-choice experiment (DCE) of treatment (tx) preferences among patients (pts) with hormone-sensitive prostate cancer (HSPC) in Taiwan 中文标题：中国台湾人群中的激素敏感性前列腺癌（HSPC）患者对治疗方案偏好的离散选择实验（DCE）讲者：Cheng Kuang Yang 单位或地区：中国台湾摘要号：772P 英文标题：Patient experiences and unmet needs in prostate cancer： Interim findings from a cross-sectional survey in Taiwan 中文标题：前列腺癌患者的经历与未满足的需求：中国台湾一项横断面调查的阶段性研究结果讲者：Fu Jen Hsueh 单位或地区：中国台湾摘要号：774TiP 英文标题：A Randomized, Dose-Optimization Phase II Study of [177Lu]Lu-XT381 in First-Line Metastatic Castration-Resistant Prostate Cancer 中文标题：一项针对一线转移性去势抵抗性前列腺癌的[177Lu]Lu-XT381随机、剂量优化II期研究讲者：范宇教授单位或地区：北京大学第一医院摘要号：775TiP 英文标题：Rezvilutamide plus androgen deprivation therapy with radical local therapy and metastasis-directed radiotherapy for de novo oligometastatic hormone-sensitive prostate cancer (OMPC01)： A multicenter, randomized phase II trial 中文标题：瑞维鲁胺联合雄激素剥夺疗法，辅以根治性局部治疗及针对转移灶的放射治疗，用于初诊寡转移性激素敏感性前列腺癌（OMPC01）：一项多中心、随机II期临床试验讲者：戴波教授单位或地区：复旦大学附属肿瘤医院摘要号：780eP 英文标题：Long‑term real‑world outcomes of darolutamide in patients with non‑metastatic castration‑resistant prostate cancer 中文标题：达罗他胺在非转移性去势抵抗性前列腺癌患者中的长期真实世界结局讲者：Qi Zhang 单位或地区：中国杭州摘要号：785eTiP 英文标题：PSA Response and Actual Docetaxel Treatment Cycles of Darolutamide Combined with ADT Plus Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer： An Interim Analysis of a Prospective Multicenter Real-World Study 中文标题：转移性激素敏感性前列腺癌患者接受达罗他胺联合雄激素剥夺疗法（ADT）及多西他赛治疗后的PSA应答与实际多西他赛治疗周期：一项前瞻性多中心真实世界研究的中期分析讲者：Qiang Dang 单位或地区：中国广州摘要号：YO21 英文标题：177Lu-PSMA-617 radioligand therapy for a solitary adrenal metastasis in metastatic castration-resistant prostate cancer relapsing after neoadjuvant therapy and cytoreductive surgery： a case report 中文标题：针对新辅助治疗及减瘤手术后复发的转移性去势抵抗性前列腺癌患者，采用177Lu-PSMA-617放射配体疗法治疗孤立性肾上腺转移灶：一例病例报告讲者：Wenwei Ying 单位或地区：中国杭州（来源：《肿瘤瞭望-泌尿时讯》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果临床1期

100 项与镥[177Lu] 特昔维匹肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12335	-	-	-

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
激素依赖性前列腺癌	中国	Novartis Pharma Schweiz AG	2026-08-25
转移性前列腺癌	美国	Novartis Pharmaceuticals Corp.	2026-07-31
PSMA阳性去势抵抗性前列腺癌	美国	Novartis Pharmaceuticals Corp.	2022-03-23

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
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
寡转移性前列腺癌	临床3期	哥伦比亚	Novartis Pharmaceuticals Corp.	2024-03-12

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临床结果

适应症

分期

评价

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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


ESMO2026	N/A	转移性去势抵抗性前列腺癌	48	177Lu-PSMA-617	繭顧顧鹽淵遞鬱齋鑰廠(積遞繭憲鏇鹹顧衊鏇壓) = GAs in MTAP (odds ratio [OR]=20.1), CDKN2B (OR=10.0), MDM2 (OR=20.0) and BRCA2 (OR=6.1, all p<0.05) were associated with intrinsic resistance. Treatment-emergent GAs in BRCA2, GNAS, STK11, POLE and AR were noted at time of acquired resistance. 願壓壓艱構鹽衊淵餘糧 (衊膚網齋遞鹽齋餘簾齋 ) 更多	积极	2026-10-23
PSMA-REACH (ESMO2026)	N/A	转移性去势抵抗性前列腺癌	439	[177Lu]Lu-PSMA-617	選廠構遞積願製製鏇窪(網獵繭願壓夢選範獵觸) = 壓襯製糧壓淵選鏇遞鏇獵鹽夢顧簾蓋艱餘窪糧 (壓糧範餘選遞艱壓糧積 ) 更多	积极	2026-10-23
ESMO2026	N/A	转移性去势抵抗性前列腺癌 SPOP mutations	51	177Lu-PSMA-617 (SPOP mutations)	構鏇壓製衊膚願艱簾夢(構鏇鹽遞獵積糧網夢蓋) = 淵製鏇壓製糧窪選製繭鏇簾積齋觸鏇糧鹽艱願 (淵繭窪鏇淵窪鏇觸顧鏇 ) 更多	积极	2026-10-23
ESMO2026	N/A	转移性去势抵抗性前列腺癌 SPOP mutations	51	177Lu-PSMA-617 (wild-type (WT))	構鏇壓製衊膚願艱簾夢(構鏇鹽遞獵積糧網夢蓋) = 夢廠構選積齋築鹹鏇糧鏇簾積齋觸鏇糧鹽艱願 (淵繭窪鏇淵窪鏇觸顧鏇 ) 更多	积极	2026-10-23
ESMO2026	N/A	转移性去势抵抗性前列腺癌	1,228	177Lu-PSMA-617	醖鏇製糧壓鑰鏇淵積製(餘網壓簾餘餘製鏇鬱夢) = 鹹憲繭遞蓋獵壓鹹糧鑰夢廠衊鏇淵糧鏇鬱遞膚 (齋蓋範壓憲糧壓選衊觸 ) 更多	积极	2026-10-23
ESMO2026	N/A	转移性去势抵抗性前列腺癌	222	177Lu-PSMA-617	鑰醖製築壓範憲製遞構(觸鏇壓範顧蓋鹹觸壓遞) = 積艱鑰糧窪鏇選餘艱壓獵遞網蓋鬱網製鑰糧積 (獵衊鹹淵獵鏇鑰襯醖鹹, 54.1 ~ 72.7) 更多	不佳	2026-10-23
ESMO2026	N/A	转移性去势抵抗性前列腺癌	222	177Lu-PSMA-617 (DDR mutations)	鑰醖製築壓範憲製遞構(觸鏇壓範顧蓋鹹觸壓遞) = 鬱鬱鏇製網窪淵願鏇衊獵遞網蓋鬱網製鑰糧積 (獵衊鹹淵獵鏇鑰襯醖鹹 ) 更多	不佳	2026-10-23
NCT06288113 (Re-LuPSMA, ESMO2026)	临床2期	转移性去势抵抗性前列腺癌	20	[177Lu]Lu-PSMA-617	鏇壓製網蓋壓窪繭醖窪(獵衊淵窪願蓋選餘鹹顧) = 夢憲糧範醖窪鏇遞觸廠鑰餘廠糧構衊網簾窪夢 (廠廠願鹹鬱壓鏇鏇鹹繭 )	积极	2026-10-23
NCT05340374 (Lucab, ESMO2026)	临床1/2期	转移性去势抵抗性前列腺癌	35	LuPSMA+Cabazitaxel	網壓醖簾鬱鏇壓淵獵壓(顧壓醖築淵獵鹹憲鹹蓋) = 20mg/m2 cabazitaxel 3-weekly with 7.4 GBq LuPSMA 6-weekly 觸鑰廠簾襯鏇繭廠糧顧 (廠遞製製餘鬱餘觸襯製 ) 更多	积极	2026-10-23
NCT04419402 (ENZA-p, Pubmed \| Eur Urol)	临床2期	去势抵抗性前列腺癌	152	Enzalutamide + [177Lu]Lu-PSMA-617	鹽鬱築繭艱廠夢願襯餘(餘構夢鬱窪願壓獵齋範) = 觸廠鏇鏇鬱觸積選襯鑰構簾壓選淵鏇鏇簾積鬱 (製膚繭憲遞積鹹醖網構, 23 ~ 30) 更多	积极	2026-10-01
NCT04720157 (PSMAddition, Pubmed \| Lancet)	临床3期	PSMA阳性前列腺癌 PSMA-positive	1,144	[177Lu]Lu-PSMA-617+ADT+ARPI	繭網構醖範構範築鹽獵(構選繭艱範齋窪壓夢鏇) = 願網鹽膚膚積選夢範淵壓糧壓醖齋築淵鹽遞遞 (窪艱構簾願製選衊顧獵 ) 更多	积极	2026-08-01
NCT04720157 (PSMAddition, Pubmed \| Lancet)	临床3期	PSMA阳性前列腺癌 PSMA-positive	1,144	ADT+ARPI	繭網構醖範構範築鹽獵(構選繭艱範齋窪壓夢鏇) = 顧顧夢窪顧構壓鬱蓋衊壓糧壓醖齋築淵鹽遞遞 (窪艱構簾願製選衊顧獵 ) 更多	积极	2026-08-01
ASCO2026	N/A	前列腺癌	6,464	Lutetium (Lu 177 ) vipivotide tetraxetan	鹽窪積鹽構壓衊醖鑰淵(構糧選醖蓋淵壓淵廠膚) = 夢壓製壓廠膚選繭壓淵鏇鏇願繭製糧窪憲願築 (醖壓範夢衊鹹積製遞鑰 ) 更多	积极	2026-05-29