The goal of this Phase III randomized controlled, open-label clinical trial is to evaluate the efficacy and safety of adding peptide receptor radionuclide therapy (PRRT) with Lutetium-177 DOTATATE to standard-of-care chemotherapy (CAPTEM), compared with CAPTEM alone, in adults with unresectable or metastatic, WHO Grade 3 well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with a Ki-67 index of >20% to <55% and positive somatostatin receptor imaging.
The main questions it aims to answer are:
* Whether the addition of PRRT to CAPTEM improves 1-year progression-free survival (PFS) compared with CAPTEM alone.
* Whether the addition of PRRT to CAPTEM results in differences in **disease control rate, overall survival, treatment-related toxicity, and quality of life** compared with CAPTEM alone.
Researchers will compare Arm A (CAPTEM alone) with Arm B (PRRT plus CAPTEM) to evaluate differences in progression-free survival, disease control, overall survival, toxicity, and quality of life between the two treatment groups. Participants will be randomly assigned in a 1:1 ratio to either treatment arm.
Participants will:
* Undergo screening and baseline assessments, including physical examination, blood investigations, cardiac assessment, and imaging with Ga-68 DOTA PET/CT and FDG PET/CT.
* Receive CAPTEM (capecitabine and temozolomide) as oral chemotherapy according to the study protocol.
* If assigned to Arm B, receive four sessions of Lutetium-177 DOTATATE PRRT, at intervals of approximately 6-8 weeks, in addition to CAPTEM.
* Undergo regular clinical assessments, laboratory investigations, imaging assessments, and monitoring for adverse events and treatment-related toxicity.
* Complete EORTC QLQ-C30 and QLQ-GINET21 questionnaires to assess quality of life.
* Continue follow-up after treatment, including clinical and imaging assessments, until disease progression or death.

开始日期2026-10-11

申办/合作机构

Tata Memorial Centre

[+1]

ChiCTR2600132243

/ SuspendedN/AIIT

A Prospective Clinical Trial of Preliminary Efficacy and Safety of the Combination of 177Lu-FAP-2286 and 177Lu-DOTATATE (Cocktail Therapy) for Advanced Grade 3 Gastroenteropancreatic Neuroendocrine Tumors (FAP-TATE Trial)

开始日期2026-09-15

申办/合作机构

西南医科大学附属医院

NCT04529044

/ Recruiting临床2期IIT

A Phase II Pilot Study of (Lutetium (177Lu)-DOTATATE in Patients With Metastatic Breast Cancer

This phase II trial investigates how well 177Lu-DOTATATE works in treating patients with breast cancer that is stage IV or has come back (recurrent). 177Lu-DOTATATE may shrink or destroy the tumor or circulating breast cancer stem cells if they show evidence of the SSTR2. 177Lu-DOTATATE is a targeted therapy that uses DOTATATE, linked to a radioactive agent called 177Lu. DOTATATE attaches to tumor cells with SSTR2 and delivers 177Lu to kill them. Giving 177Lu-DOTATATE may help decrease the number and size of tumors and the number of circulating cancer stem cells in patient's blood for the treatment of patients with breast cancer positive for SSTR2.

开始日期2026-06-30

申办/合作机构

OHSU Knight Cancer Institute

[+3]

100 项与 (177镥)镥氧奥曲肽相关的临床结果

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100 项与 (177镥)镥氧奥曲肽相关的转化医学

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100 项与 (177镥)镥氧奥曲肽相关的专利（医药）

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1,258

项与 (177镥)镥氧奥曲肽相关的文献（医药）

2027-01-01·BIOORGANIC & MEDICINAL CHEMISTRY

Linear and SS cyclized radiopeptides for estrogen receptor targeting

Article

作者: Gupta, Sonal ; Guha, Ananda Majumdar ; Repaka, Krishna Mohan ; Satpati, Drishty ; Subramanian, Mahesh ; Kumar, Manoj ; Kengar, Ajit A

Breast cancer is the most prevalent cancer globally, accounting for 18% of all cancers in women. Majority of breast cancers (75%) are associated with over-expression of estrogen receptors (ER). In this report, two ER-targeting peptides were synthesized manually on solid phase. The ER-affine pentapeptide motif LHRLL was conjugated with cell penetrating cationic amino acid sequence, RRRRK to obtain the peptide construct ERK (RRRRKILHRLLQDS-NH₂) and a cyclic variant cERK (RRRRKCLHRCLQDS). The two peptides were conjugated with DOTA chelator and radiolabeled with Lu-177. [¹⁷⁷Lu]Lu-DOTA-ERK and [¹⁷⁷Lu]Lu-DOTA-cERK showed high binding affinity (~30 nM) towards human breast carcinoma MCF-7 cells. High cellular internalization was observed for the two radiopeptides. The cyclic variant, [¹⁷⁷Lu]Lu-DOTA-cERK exhibited higher human serum stability and metabolic stability in mouse urine sample. Higher tumor uptake and tumor-to-organ ratios were presented by [¹⁷⁷Lu]Lu-DOTA-cERK. This first attempt of evaluation of LXXLL motif radiopeptide will broaden the scope of synthesis of diverse ligands with improved biological profile.

2026-12-01·Clinical Genitourinary Cancer

Dual-Tracer 68Ga-PSMA and 68Ga-DOTATATE PET/CT in Advanced Prostate Cancer: Persistent PSMA Expression Despite Clinically Suspected Treatment-Emergent Neuroendocrine Differentiation

Article

作者: Okazaki, Chieko ; Enei, Yuki ; Lenzo, Nat ; Kimura, Takahiro ; Sai, Hiroki ; Kuruma, Hidetoshi ; Okada, Atsuya ; Akamatsu, Shusuke ; Yanagisawa, Takafumi ; Miki, Kenta

BACKGROUND:

Neuroendocrine differentiation in advanced prostate cancer is associated with aggressive behavior, resistance to androgen receptor pathway inhibition, and altered tracer expression. Although reduced prostate-specific membrane antigen (PSMA) expression and increased somatostatin receptor expression are often assumed in treatment-emergent neuroendocrine prostate cancer (t-NEPC), direct intrapatient comparisons using dual-tracer imaging remain limited.

MATERIALS AND METHODS:

We retrospectively analyzed eight patients with advanced prostate cancer who underwent both ⁶⁸Ga-PSMA PET/CT and ⁶⁸Ga-DOTATATE PET/CT on consecutive days because of clinically suspected treatment-emergent neuroendocrine differentiation. Histopathological evidence was available in one patient; the remaining seven were included based on clinical suspicion. Patient characteristics were extracted from a clinical dataset, and imaging findings were abstracted from original nuclear medicine reports. Lesions were categorized as concordant, PSMA-dominant, PSMA-positive/DOTATATE-negative, or DOTATATE-positive/PSMA-negative.

RESULTS:

All eight patients had metastatic castration-resistant prostate cancer (mCRPC) at dual-tracer imaging. Based on original clinical reports, PSMA uptake was equal to or greater than DOTATATE uptake in all eight patients. No DOTATATE-positive/PSMA-negative sites were documented, whereas PSMA-positive/DOTATATE-negative sites were described in several patients, particularly in lung and liver metastases and selected nodal and skeletal lesions.

CONCLUSIONS:

In advanced prostate cancer with clinically suspected treatment-emergent neuroendocrine differentiation, PSMA uptake frequently persisted and generally predominated over DOTATATE uptake. No DOTATATE-positive/PSMA-negative sites were documented, whereas PSMA-positive/DOTATATE-negative sites were observed in several patients, consistent with substantial spatial and intrapatient heterogeneity. These findings support assessment of the actual PSMA imaging phenotype before excluding PSMA-targeted approaches solely on the basis of suspected neuroendocrine differentiation.

2026-11-01·European Journal of Nuclear Medicine and Molecular Imaging

Beyond DOTATATE: [68Ga]NODAGA-LM3 PET/CT unmasks the culprit tumor in tumor-induced osteomalacia

Article

作者: Shi, Yaai ; Huo, Li ; Zheng, Lu ; Zhang, Xinchao ; Bian, Yanzhu ; Hu, Yujing

1,517

项与 (177镥)镥氧奥曲肽相关的新闻（医药）

22 小时之前

·腾讯网

2026 ESMO｜聚焦神经内分泌肿瘤领域最新进展

引言2026年10月23–27日，欧洲肿瘤内科学会（ESMO）年会在西班牙马德里召开。在神经内分泌肿瘤（NEN）领域，本届大会热点覆盖疾病生物学特征、分子分型与液体活检、以生长抑素类似物（SSA）为核心的治疗策略优化，以及肽受体放射性核素治疗（PRRT）与新型靶向治疗（TT）药物的布局。这些探索不仅深化了临床对NEN分子异质性与生物学机制的理解，也为风险评估与治疗决策提供新的循证依据。值此良机，医脉通特邀上海交通大学医学院附属瑞金医院胰腺外科姜毓教授从NEN诊疗新热点、SSA与兰瑞肽相关药物治疗进展、PRRT及治疗策略优化三个维度，对本届大会公布的重磅研究进行系统解读，以期为临床提供学术参考。NEN病理早筛与分子分型热点传统以Ki-67指数与核分裂象计数为核心的分级体系，已难以满足精准分层的需要。本届大会分别从液体活检、跨器官基因组图谱与多组学整合三个层面，推动NEN的分子分型走向临床。2414P：基于cfDNA甲基化的泛癌种早筛（MCED）液体活检在神经内分泌癌（NEC）中表现优异1本研究开发了针对中国16种高负担恶性肿瘤的MCED模型，采用靶向甲基化检测技术分析MCED研究（NCT06217900）的内部与外部验证队列血样，共纳入2,110例新诊断癌症病例与1,682例非癌症对照，包括102例NEC。结果显示，MCED模型在所有组织学类型中的特异性为99.1%，总体敏感性为72.2%，检测阳性者的组织溯源（TOO）准确性为85.5%，而且模型针对NEC的检测敏感性和TOO准确率均保持在较高水平。图表1 不同类别肿瘤的检出灵敏度与TOO预测准确率1MCED检测方法不仅展现出优异的灵敏度，还可对NEC实现高准确度的组织来源定位，是一种极具前景的检测手段，可作为传统筛查的补充，有助于缩小医疗水平差距。研究者表示，后续将在另一更大样本量的独立盲法验证队列中开展进一步分析。2399P：基于日本C-CAT数据库的神经内分泌癌（NEC）与混合性神经内分泌-非神经内分泌肿瘤（MiNEN）跨器官基因组图谱分析2本研究利用日本C-CAT数据库，对接受全面基因组谱分析的病例（NEC 2,352例、MiNEN 277例）开展全国性基因组与临床结局分析，旨在阐明NEC与MiNEN的分子图谱及临床意义。结果显示，MiNEN中常见变异基因包括TP53、RB1、APC、KRAS、PIK3CA、PTEN、CCNE1、ERBB2、CDKN2A、ARID1A及TMB-High；NEC中常见变异基因包括TP53、RB1、KRAS、MYC、PTEN、APC、PIK3CA、CDKN2A、STK11、CCNE1及TMB-High；TP53、APC、KRAS、CDKN2A变异则是两者共同的不良预后因素。此外，疗效与预后分析显示，KRAS突变仍是胰腺NEC的独立不良预后因素，而TMB-High仅在NEC中是显著的良好预后标志物，并且TMB有望成为NEC一线铂类化疗疗效的前瞻性分层指标。2400P：胃肠胰神经内分泌肿瘤（GEP-NET）的分子与代谢图谱：来自多组学整合的见解3本研究对GEP-NET样本进行多层次组学检测，旨在识别GEP-NET潜在的发病机制与生物标志物，为改进治疗策略与患者分层提供依据。结果显示，回肠与胰腺NET共享多个复发性基因变异（TTN、NAA15、PLEC、MUC17、MUC4、OBSCN、RYR1、SYNE1、TSC2、MKI67），但代谢表型存在明确的部位特异性：胰腺NET表现为能量代谢增强与脂肪酸氧化增强；回肠NET则表现为5-羟色胺通路过度激活，伴碳水化合物与氨基酸代谢重编程。脂质组学进一步显示，脂质代谢由储存转向即时利用以供能，并伴胆固醇代谢改变。这一整合性多组学研究不仅揭示了mTOR通路激活、代谢重编程与免疫系统调控在GEP-NET发生发展中的重要意义，并且胰腺来源与回肠来源肿瘤存在特征性代谢谱差异，进一步凸显了其原发灶特异性的生物学差异。NEN药物治疗对于生长缓慢、Ki-67<10%、生长抑素受体阳性的晚期GEP-NET患者（亦包括肺、胸腺等部位的分化良好 NET），SSA为一线标准治疗。近年来，SSA应用拓展至更多治疗线数及联合治疗，扩大了其对NET治疗人群的覆盖广度与宽度。本届大会也同步公布了多项重磅研究。2424P：兰瑞肽治疗G2级GEP-NET：按Ki-67指数分层的真实世界疗效4兰瑞肽已被证明在Ki-67<10%的G1–2级GEP-NET一线治疗中具有显著获益，但在Ki-67≥10%的G2级患者中的疗效始终缺乏直接证据。因此，本项回顾性队列研究纳入2015年1月至2025年12月接受一线兰瑞肽治疗的88例晚期G2级GEP-NET患者，按Ki-67指数（<10% vs ≥10%）分层进一步评估其疗效。结果显示，总人群中位随访70.5个月，中位真实世界无进展生存期（rwPFS）为20.5个月，中位OS为59.5个月。按Ki67分层后的各亚组疗效见下表：图表2 根据Ki67指数分层的一线兰瑞肽疗效4全部接受治疗的G2级GEP-NET探索性分析（N=99 ）显示，共11例患者接受其他一线治疗（10例化疗，1例肽受体放射性核素治疗PRRT）。在Ki-67≥10%患者（n=35）中：兰瑞肽组对比其他治疗组，中位真实世界无进展生存期分别为13.1个月 vs 15.0个月（P=0.553）；中位总生存期分别为33.8个月 vs 尚未达到（P=0.097）；客观缓解率6.7% vs 60.0%（P=0.014）。多变量Cox回归更进一步确认，Ki-67≥10%是OS的独立不良预后因素（HR=2.20，95%CI：1.14–4.27，P=0.019）。图表3 所有接受治疗的2级胃肠胰神经内分泌肿瘤患者总生存期（OS）的预后因素（N=99）4本真实世界队列研究表明，兰瑞肽可在不同Ki67亚组的G2级GEP-NET中实现持续的疾病控制，且毒性可控。但Ki-67≥10%是总生存期缩短的独立危险因素，建议临床针对此类患者应在治疗前完成充分评估（包括肿瘤负荷、骨转移状态、年龄与功能状态），对于肿瘤负荷高、症状明显或需要快速缩瘤的患者制定综合策略。不过，本研究结论尚需进一步在前瞻性研究中验证，以明确Ki-67≥10%的G2级GEP-NET的最优一线治疗方案。2395RO：胃肠胰神经内分泌肿瘤二线治疗期间联合使用生长抑素类似物：回顾性retroSAUNA研究的生存结果5疾病进展后，二线阶段延用SSA的生存获益一直临床较为关注的热点话题。对于伴有激素相关症状的功能性NET，SSA通常终身使用；但针对无功能性GEP-NET患者在一线SSA出现进展后、启动二线PRRT或TT时是否应继续SSA，当前领域缺乏共识。本项回顾性国际多中心队列研究——retroSAUNA研究正是针对这一空白，纳入22家NET专家中心，评估了二线治疗继续SSA的生存获益。结果显示，无论二线采用PRRT或是TT，继续联用SSA均与PFS延长存在显著关联。PRRT亚组中，单因素与校正后多因素分析均提示联合SSA可显著改善PFS（HR=0.63，aHR=0.63，均P=0.001），但两组OS无统计学差异（HR=0.84，P=0.328；aHR=0.87，P=0.442）。TT亚组同样观察到PFS获益（HR=0.67，P=0.023；aHR=0.63，P=0.010），且经多因素校正后，TT联用SSA呈现显著的OS获益（HR=0.67，P=0.057；aHR=0.61，P=0.028）。这可能提示，二线治疗继续SSA的具体OS获益或和其联合方案的机制协同相关，但回顾性研究无法确立因果关系，因此TT亚组的OS阳性信号尚待验证。图表4 PRRT亚组的PFS与TT组的PFS、OS分析5本回顾性研究证实，无论二线治疗采用PRRT或是TT，持续SSA治疗和PFS延长存在显著相关性。基于本研究结果，两项前瞻性随机试验SAUNA、STOPNET正在开展，以进一步确证该临床问题，期待为临床提供高级别证据。2413P：卡博替尼联合兰瑞肽治疗既往靶向治疗或化疗失败的晚期GEP-NET（SCALET：TCOG 2221）6I/II期研究SCALE试验（TCOG 2221）纳入42例既往分子靶向治疗或化疗失败的晚期G1/2或G3级GEP-NET患者，以评估卡博替尼联合兰瑞肽的安全性与疗效，旨在探索SSA联合靶向治疗晚期GEP-NET是否能产生协同效应。研究I期阶段采用3+3剂量探索（卡博替尼40/60mg qd+兰瑞肽120mg q4w，n=10），未观察到剂量限制性毒性，因此II期推荐剂量采用I期确定的最大耐受剂量卡博替尼60mg qd+兰瑞肽120mg q4w（n=32）。结果显示，在31例符合方案人群中，卡博替尼联合兰瑞肽取得25.2个月的中位PFS与35.5%的PR率。值得注意的是不同部位的疗效差异：胰腺NET（pNET）亚组中位PFS达27.5个月、PR率50.0%，而胰腺外NET（epNET）仅为12.0个月、PR率15.4%（P=0.014）。不过，epNET的SD率高达84.6%。这可能提示该方案在pNET中具有显著的PFS改善，而在epNET主要以疾病稳定为获益模式。安全性方面，整体毒性谱与既往单药临床试验结果具有可比性，未出现全新的安全性风险。图表5 31例患者及各亚组的缓解率与生存数据（左侧）、肿瘤最大径变化（右侧）6综合来看，本研究证实对于既往靶向治疗或化疗失败的晚期GEP-NET，卡博替尼联合兰瑞肽具备可观的抗肿瘤活性，尤其对胰腺来源NET获益更突出。但该研究为单臂I/II期、样本量有限，其联合方案的价值仍有待随机对照研究进一步验证。PRRT序贯前移与DLL3靶向联合的治疗策略优化新药研发与联合治疗的最佳序贯顺序一直是NEN临床治疗策略优化的重要内容，对此，本届大会更新了PRRT与新型靶向药物的探索研究。2425P：排兵布阵：PRRT-CAPTEM序贯治疗晚期G1–3 GEP-NET的真实世界疗效与安全性7本项回顾性队列研究共纳入37例同时接受过PRRT与CAPTEM的高分化G1–3级SSTR阳性晚期GEP-NET患者，分为二线早期PRRT后续序贯CAPTEM组（PRRT→CAPTEM，n=20）、二线早期CAPTEM后续序贯PRRT组（CAPTEM→PRRT，n=17），组间允许穿插靶向药物。结果显示，自二线治疗起始计算，PRRT优先组中位PFS显著更长（42.0个月 vs 9.2个月，P=0.04），但两组OS无统计学差异。以PRRT给药启动为时间节点分析，早期使用PRRT的队列无论PFS（42.0个月 vs 13.9个月，P=0.03）和OS（71.0个月 vs 31.3个月，P=0.02）均获得显著获益。这表明，SSA进展后更早启用¹⁷⁷Lu-DOTATATE或许可以改善生存，且安全性数据显示，PRRT＞4周期并未带来具有统计学差异的短期毒性升高。这不仅是对传统将PRRT放在后线的观念提出挑战，而且提示经过严格筛选患者，个体化、维持治疗模式具备可行性。但本研究样本量局限、基线特征不均衡，还需进一步开展前瞻性、随机大样本量研究加以验证。2432TiP：DAREON-NEC-1：一线obrixtamig联合卡铂+依托泊苷对比标准治疗用于DLL3阳性肺外神经内分泌癌的III期试验8本次大会披露了DAREONNEC1研究的研究设计。DAREON-NEC-1研究是首项针对不可切除局部晚期或转移性DLL3 阳性阳性肺外神经内分泌癌（epNEC），评价Obrixtamig联合标准治疗（卡铂+依托泊苷）对比单纯标准治疗作为一线方案疗效的全球多中心、随机、开放标签III期临床试验。Ib期DAREON-7已初步证实该联合方案安全性可控，本次研究拟入组约390例该类初治患者。按1:1随机分组，试验组诱导期接受Obrixtamig联合卡铂+依托泊苷标准方案化疗，完成5周期诱导后以Obrixtamig维持治疗；对照组仅接受卡铂+依托泊苷化疗，诱导结束后仅观察随访，不允许对照组交叉至试验组。研究主要终点为OS。本研究目前处于招募阶段，共覆盖全球29个国家、167个中心（欧洲、南北美洲、亚洲、大洋洲）。专家点评姜毓教授上海交通大学医学院附属瑞金医院本届ESMO年会发布的系列NEN相关数据，从预后分层、全程系统治疗策略以及新药探索层面丰富了领域诊疗的循证依据。在预后分层方面，真实世界研究证实G2级GEP-NET属于异质性群体，Ki67增殖指数、年龄及骨转移状态是影响总生存的独立危险因素，即便接受SSA一线治疗，Ki67指数较高亚组的生存结局显著劣于低增殖亚组，提示临床需结合增殖指标与临床特征共同完成风险评估，不能仅依靠分级单一指标制定治疗决策；在系统治疗全程管理领域，现有证据提示，一线SSA进展后，二线实施PRRT或TT时继续保留生长抑素类似物，可观察到PFS的改善，但OS获益信号在不同治疗手段中并不一致，相关结论仍有待前瞻性随机研究进一步验证；关于治疗时序，研究观察到PRRT时机前移可带来生存获益，延长疗程并未显著增加临床相关毒性，但受回顾性研究固有局限，尚不能直接作为标准治疗推荐，与此同时，针对epNEC的新型双特异性抗体联合化疗的全球III期研究正在推进，有望为该类预后较差的肿瘤提供新的治疗思路。专家简介- 姜毓教授 -上海交通大学医学院附属瑞金医院胰腺外科主治医师上海交通大学医学院附属瑞金医院胰腺神经内分泌肿瘤多学科协作组成员上海市抗癌协会神经内分泌肿瘤专委会秘书上海市普通外科临床质量控制中心秘书上海市医学会普外科专科分会青年学组委员中国医药教育协会医学国际交流促进工作委员会委员擅长内容：胰腺神经内分泌肿瘤及胰腺癌的外科治疗；胰腺良恶性疾病的微创治疗注：截止2026年11月，卡博替尼、¹⁷⁷Lu-DOTATATE（镥 [177Lu] 氧奥曲肽）及 obrixtamig 目前均未在中国大陆获批上市审批号DRSC-CN-001420，有效期到2027年11月9日参考文献：H. Liu, et al. A Cell-Free DNA Methylation-Based Liquid Biopsy for Multi-Cancer Early Detection (MCED) Demonstrates Excellent Performance in Neuroendocrine Carcinomas (NECs). 2026 ESMO. Poster 2414P.Yuya Matsui, et al. Cross-organ Genomic Profiling of Neuroendocrine Carcinoma (NEC) and Mixed Neuroendocrine-non-neuroendocrine Neoplasms (MiNEN) using the Japanese C-CAT database. 2026 ESMO. Poster 2399P.A. BONGIOVANNI, et al. Molecular and Metabolic Landscapes of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET): Insights from Multi-Omics Integration. 2026 ESMO. Poster 2400P.S. Putraveephong, et al. Lanreotide in Grade 2 GEP-NETs: Real-World Efficacy According to Ki-67 Index. 2026 ESMO. Poster 2424P.Siddharth Chhajlani, et al. Concomitant Somatostatin Analogue Use In Second-Line Therapy Of Gastroenteropancreatic Neuroendocrine Tumors: Survival Results From The Retrospective RetroSAUNA Study. 2026 ESMO. Oral 2395RO.Hui-Jen Tsai, et al. Updated result of a phase I/II study using cabozantinib and lanreotide as treatment for advanced GEP-NET failed molecular targeted therapies or chemotherapy (SCALET): TCOG 2221 study. 2026 ESMO. Poster 2413P.Alda Aleksi, et al. Sequencing Matters: Real-World Effectiveness and Safety of PRRT–CAPTEM Sequencing in Advanced G1–3 GEP-NETs. 2026 ESMO. Poster 2425P.Timon Vandamme, et al. DAREON-NEC-1: Phase III trial of first-line obrixtamig plus carboplatin and etoposide (SoC) vs SoC in patients with DLL3-positive extrapulmonary neuroendocrine carcinoma (epNEC). 2026 ESMO. Poster 2432TiP.撰写：Astra审核：Astra排版：Marina

临床1期临床研究生物类似药临床结果

2026-11-09

·pharmalogicgroup.com

PharmaLogic to Acquire Lantheus’ CDMO Business and Springfield, New Jersey Manufacturing Facility

Expands U.S. therapeutic manufacturing capacity and creates the first transatlantic CDMO platform with a proven commercial track record in radioligand therapies Waltham, MA, November 9, 2026 – PharmaLogic Holdings Corp. (“PharmaLogic” or the “Company”), the only independent contract development and manufacturing organization (CDMO) of scale dedicated exclusively to radiopharmaceuticals, today announced a definitive agreement to acquire the CDMO business and Springfield, New Jersey manufacturing facility from Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH). The financial terms of the transaction were not disclosed. The Springfield facility is a state-of-the-art radiopharmaceutical manufacturing site with a proven track record in theranostic manufacturing, research and clinical development. Its highly skilled team will join Agilera, PharmaLogic’s therapeutic CDMO franchise, upon completion of the transaction. The transaction also includes a long-term supply agreement under which Agilera will manufacture lutetium Lu 177 dotatate for Lantheus. The acquisition expands PharmaLogic’s capacity to manufacture radiopharmaceutical therapeutics in the U.S. Agilera brings more than 15 years of experience supporting the development and commercial launch of radioligand therapies (RLTs) and currently supplies an alpha therapy to more than 30 countries. With the Springfield facility, PharmaLogic becomes the first therapeutic CDMO to offer a transatlantic platform, giving partners an end-to-end solution for RLTs, from early clinical development through commercial launch and global supply. “This acquisition strengthens Agilera’s unique capabilities in radioligand therapies and expands our capacity in the U.S.,” said Etienne Montagut, President and Chief Executive Officer of PharmaLogic. “We are proud to welcome the talented Springfield team, who will help us scale our operations to meet growing demand from our partners and the patients they serve.” “We have a long-standing relationship with PharmaLogic, which has been an important manufacturing partner for our PET products,” said Mary Anne Heino, Executive Chairperson and Chief Executive Officer of Lantheus. “With its proven radiopharmaceutical expertise and manufacturing capabilities, PharmaLogic is the right long-term owner for the CDMO business and Springfield facility, with the capabilities to build on this foundation while supporting reliable supply of our newly approved radiotherapeutic for patients and healthcare providers.” The transaction is subject to applicable regulatory review and the satisfaction of other customary closing conditions. The parties will continue to operate independently until the closing. Advisors Leerink Partners LLC served as financial advisor to the Company, and Goodwin Procter LLP served as legal advisor. Solomon Partners Securities LLC served as financial advisor to Lantheus, and Covington & Burling LLP served as legal advisor. About PharmaLogic Holdings Corp. PharmaLogic is the only independent contract development and manufacturing organization (CDMO) of scale dedicated exclusively to radiopharmaceuticals in North America, serving both diagnostics and therapeutics. With decades of industry expertise and a robust network of more than 45 facilities across the U.S., Puerto Rico, Canada, and Norway, PharmaLogic delivers comprehensive solutions spanning development, manufacturing, and distribution of both clinical and commercial-stage radiopharmaceutical products, all in accordance with the highest quality and regulatory standards. Its integrated diagnostic and therapeutic capabilities allow PharmaLogic to support theranostic programs across the full product lifecycle, from first-in-human studies to long-term commercial supply. Our rapidly expanding diagnostics business leverages advanced technologies to enhance patient access to novel diagnostics in oncology, cardiology, and neurology. In the therapeutic segment, PharmaLogic is the world’s only cGMP-compliant CDMO currently manufacturing and distributing a commercial radiopharmaceutical therapeutic to more than 30 countries, with a strong track record of inspections by regulators in the U.S., Europe, China and other markets. PharmaLogic is dedicated to enabling global patient access to radiopharmaceuticals through strategic development partnerships with industry innovators, advancing the future of the field and supporting our partners throughout the product lifecycle. For more information, visit pharmalogicgroup.com and follow us on LinkedIn. About Lantheus Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Switzerland, Sweden and the United Kingdom, Lantheus has been providing radiopharmaceutical solutions for 70 years. For more information, visit www.lantheus.com. Contacts: PharmaLogic Taylor Prejna, Sr. Director, Corporate Communications communications@pharmalogicgroup.com Lantheus Melissa Downs, Executive Director, External Communications media@lantheus.com

并购

2026-11-07

·诺华集团

从跨境引入到临床应用诺华香港与广药深化大湾区合作

在第九届中国国际进口博览会（以下简称“进博会”）期间，诺华公司与广州医药股份有限公司（以下简称“广药”）举行“湾区通达，创享可及——诺华公司携手广药推动‘港澳药械通’创新疗法合作启动仪式”，并集中展示双方依托“港澳药械通”政策框架，推动放射配体疗法Lutathera®（通用名：镥[177Lu]奥索度曲肽注射液）跨境引入并在大湾区开展临床应用。该产品由此首次亮相进博会。双方将在现有合作基础上，进一步深化跨境供应与本地落地的协同，探索创新疗法在大湾区的可及路径。诺华公司携手广药推动“港澳药械通”创新疗法合作启动仪式我们诚挚期待以本次合作为契机，进一步深化与诺华等全球优质企业的多领域合作，携手广州医药等本土龙头企业，共建更完善的产业生态，吸引更多全球创新医药成果在穗落地、在大湾区转化。我们也将持续释放政策红利、升级服务效能，与各方一道，共同推动大湾区医疗健康产业高质量发展，让更多创新成果惠及广大群众。韩祯祥副主任现场分享创新的价值，不仅在于带来新的治疗选择，更在于让有需要的患者能够及时获得治疗。‘港澳药械通’为国际医疗创新与大湾区临床需求搭建了重要桥梁。此次深化合作，我们希望充分发挥诺华在放射配体疗法领域的全球布局优势，与广药的本地供应链能力形成合力，推动创新疗法更顺畅地走进临床。未来，诺华将持续携手各方，推动更多全球创新成果在中国落地。诺华公司中国区总裁兼董事总经理李尧先生现场分享三项重要突破展现放射配体疗法可及进展随着粤港澳大湾区医疗卫生合作持续深化，“港澳药械通”机制为符合条件的临床急需药品和医疗器械进入大湾区内地指定医疗机构提供了重要渠道，也为国际前沿创新疗法的临床应用创造了条件。 2026年5月，诺华公司与广药签署经销协议，依托“港澳药械通”，围绕镥[177Lu]奥索度曲肽注射液向大湾区内地九市指定医疗机构的供应与分销建立协作机制。在此合作框架下，双方围绕镥[177Lu]奥索度曲肽注射液的引入与应用，协同推进药监审批、跨境运输、海关协调、医院配送及临床应用等关键环节，取得了三项突破成果：镥[177Lu]奥索度曲肽注射液成为首个通过“港澳药械通”机制在大湾区指定医疗机构使用的放射配体疗法；项目首次通过该机制打通核药从欧洲直航广州并完成本地清关的链路；完成了大湾区首例神经内分泌肿瘤放射配体治疗的临床实践。深化多方协同衔接国际供应与本地交付三项重要突破体现了“港澳药械通”政策在具体临床场景中的应用，使符合条件的患者能够在大湾区指定医疗机构接受相关治疗。将政策支持转化为患者实际可及，需要产品供应方、本地供应链伙伴和医疗机构在国际供应、进口清关、运输配送及医院接收等环节紧密协作。在诺华公司整体战略引领下，诺华香港发挥香港连接国际医疗创新资源与大湾区临床需求的桥梁作用，提供产品供应支持。广药则依托其放射性药品经营资质、本地供应链能力及医院端衔接经验，在获准范围内承担进口清关、经销、运输、仓储、医院配送及接收协调等环节。双方将国际供应与本地执行能力相结合，共同支持镥[177Lu]奥索度曲肽注射液从跨境引入到指定医院交付的关键路径。创新药物从海外获批上市到内地临床可及，供应链挑战重重，放射性药物对流通全流程辐射管控、转运安保的标准尤为严苛。双方合作攻克了跨境远程运输与辐射安全管控的双重难点，打通了关键流通链路，让患者在家门口用上前沿创新疗法。未来，我们将以这一成功试点为起点，持续深化与诺华的合作，打磨专业服务、优化供应链体系，把单点突破转化为可持续、可复制的核药跨境可及模式，为创新治疗方案的引入与应用提供支撑。程震总裁现场分享以镥[177Lu]奥索度曲肽注射液的可及实践为基础，双方将继续加强与政府、医疗机构及相关伙伴的协作，持续完善创新疗法从跨境引入到临床应用的衔接机制，探索更多复杂创新疗法在大湾区引入与应用的可行路径，让更多符合条件的患者从创新疗法的可及中获益。 — 声明 — 1. 本资料目的在于提供诺华参展第九届进博会相关信息，不应被理解为对特定药物或治疗手段的推荐或者建议。 2. 本资料中提及的产品尚未在中国大陆地区获批上市，本资料中的任何信息不构成对相关产品的疗效或安全性的陈述。 3. 本资料中涉及的信息仅供参考，请遵从医生或其他医疗卫生专业人士的意见或指导。 4. 相关方案目前处于概念性探索阶段，后续将结合实际场景、法律法规和监管要求及行业标准，逐步论证与推进。

放射疗法

100 项与 (177镥)镥氧奥曲肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	V10XX04	DB13985

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
胃肠胰神经内分泌肿瘤	美国	Curium Pharma UK Ltd.	2026-09-14
生长抑素受体阳性神经内分泌肿瘤	日本	Novartis Pharma KK	2021-06-23
生长抑素受体阳性神经内分泌肿瘤	日本	FUJIFILM Toyama Chemical Co., Ltd.	2021-06-23
SSTR阳性胃肠胰神经内分泌肿瘤	欧盟	Novartis Europharm Ltd.	2017-09-26
SSTR阳性胃肠胰神经内分泌肿瘤	冰岛	Novartis Europharm Ltd.	2017-09-26
SSTR阳性胃肠胰神经内分泌肿瘤	列支敦士登	Novartis Europharm Ltd.	2017-09-26
SSTR阳性胃肠胰神经内分泌肿瘤	挪威	Novartis Europharm Ltd.	2017-09-26

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
晚期神经内分泌肿瘤	临床3期	中国	北京先通国际医药科技股份有限公司	2024-06-11
神经内分泌癌	临床3期	中国	北京先通国际医药科技股份有限公司	2024-06-11
神经内分泌肿瘤	临床3期	中国	北京先通国际医药科技股份有限公司	2024-06-11
晚期胰腺神经内分泌肿瘤	临床3期	中国	江苏恒瑞医药股份有限公司	2023-07-06
大肠类癌	临床3期	美国	Advanced Accelerator Applications SA	2012-09-06
大肠类癌	临床3期	比利时	Advanced Accelerator Applications SA	2012-09-06
大肠类癌	临床3期	法国	Advanced Accelerator Applications SA	2012-09-06
大肠类癌	临床3期	德国	Advanced Accelerator Applications SA	2012-09-06
大肠类癌	临床3期	意大利	Advanced Accelerator Applications SA	2012-09-06
大肠类癌	临床3期	葡萄牙	Advanced Accelerator Applications SA	2012-09-06

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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	胃肠胰神经内分泌肿瘤	37	PRRT→CAPTEM	艱鹽衊積獵襯鏇醖壓壓(遞遞繭構願築醖製選鏇) = 糧構鬱觸鹽繭簾餘膚鬱襯築夢憲壓選觸築鹽衊 (膚淵餘積夢鏇夢鏇蓋繭 ) 更多	积极	2026-10-23
ESMO2026	N/A	胃肠胰神经内分泌肿瘤	37	CAPTEM→PRRT	艱鹽衊積獵襯鏇醖壓壓(遞遞繭構願築醖製選鏇) = 選鹹壓蓋鹹築願觸糧願襯築夢憲壓選觸築鹽衊 (膚淵餘積夢鏇夢鏇蓋繭 ) 更多	积极	2026-10-23
ESMO2026	N/A	胃肠胰神经内分泌肿瘤	51	177Lu-DOTATATE	壓鹹願製壓膚範壓糧餘(憲鏇衊網遞膚窪獵窪顧) = 鹹壓蓋鹹鹹構淵廠鬱選餘築鏇顧範衊蓋鑰齋遞 (壓鑰餘糧窪醖夢製積願, 37.4 ~ 52.0) 更多	不佳	2026-10-23
ESMO2026	N/A	胃肠胰神经内分泌肿瘤	51	177Lu-DOTATATE (Non-functioning NETs)	齋夢選齋獵製顧廠齋築(廠鹹糧遞構鹽齋廠衊製) = 製構鹽鹽構餘願網鏇淵壓蓋夢鏇選齋鬱觸襯鏇 (艱餘廠範淵憲築簾觸鹽 ) 更多	不佳	2026-10-23
EANM2026	N/A	神经内分泌肿瘤	24	177Lu-DOTATATE	鏇襯糧蓋夢鏇構鹽遞積(網膚壓鑰鹹鏇觸糧構壓) = 艱餘膚壓遞鬱顧夢鹹窪繭鏇願選鏇願鏇鹹鑰夢 (窪淵鬱夢觸衊衊壓願觸 ) 更多	积极	2026-10-17
EANM2026	N/A	-	38	177Lu-DOTATATE	淵衊積壓簾齋積齋網獵(簾餘鏇膚積壓淵顧鏇糧) = RECIN partial response was achieved in 20 of 34 evaluable patients (58.8%), with the remainder showing stable disease 廠積選鑰鏇鹹願膚範繭 (製淵窪遞鏇衊艱餘窪願 ) 更多	积极	2026-10-17
EANM2026	N/A	神经内分泌肿瘤 somatostatin receptor expression	134	177LuDOTATATE	鹽鹹觸製壓糧襯網構願(憲構選積顧構艱鹽顧蓋) = 遞窪廠襯憲鹹鬱壓艱構艱選構鹹衊鏇鹹獵觸齋 (餘簾繭憲糧艱鑰襯繭壓 ) 更多	积极	2026-10-17
NCT02754297 (P-PRRT, EANM2026)	临床2期	神经内分泌肿瘤	251	Personalized 177Lu-DOTATATE PRRT	淵築淵鑰壓觸鬱鹹襯糧(鹽齋遞願範鹽繭鬱醖顧) = 蓋積蓋願衊蓋製糧繭艱網齋廠膚壓醖鏇淵製鏇 (壓醖淵艱網壓淵築醖醖 ) 更多	积极	2026-10-17
EANM2026	N/A	神经内分泌肿瘤	64	177Lu-DOTATATE	獵鑰艱醖簾鬱範積鹹衊(簾齋憲選淵鏇糧積夢選) = 範襯壓築遞憲餘鹹衊廠憲壓選襯齋鏇糧壓鑰製 (憲構觸顧壓餘艱觸繭範 ) 更多	积极	2026-10-17
EANM2026	N/A	脑膜瘤	21	177Lu-DOTATATE	範構網鑰夢糧窪廠獵艱(鏇鏇遞窪鏇壓鏇壓網夢) = 衊願鹽憲憲網膚鑰顧憲廠顧鹽繭鹹積鹽廠積顧 (網壓鑰糧鬱廠獵選繭衊 ) 更多	积极	2026-10-17
NCT06398444 (EANM2026)	临床2期	晚期神经内分泌肿瘤 SSTR-positive	20	[177Lu]Lu-Oxodotreotide (XTR008)	觸積窪衊鏇衊淵選選糧(糧遞顧衊鬱鑰鹹築顧夢) = 齋窪齋遞鹹鑰糧繭鑰願獵壓繭廠繭顧願齋齋鑰 (簾窪淵鬱廠觸鏇繭窪艱 ) 更多	积极	2026-10-17
EANM2026	N/A	神经内分泌肿瘤	145	Corticosteroids and short-acting subcutaneous octreotide	願膚鑰獵廠襯遞願觸廠(構糧繭夢廠顧淵遞醖糧) = 積廠醖壓觸鹹鏇淵鬱襯選獵積憲淵觸鹽齋簾憲 (願繭壓鹹糧簾構蓋鹽窪 )	积极	2026-10-17