MONROE TOWNSHIP, N.J. & OXFORD, England--(BUSINESS WIRE)--Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative positron emission tomography (PET) radiopharmaceuticals, today announced results from a sub-analysis of data from the Phase 3 SPOTLIGHT trial (NCT04186845) which investigated the use of POSLUMA® (flotufolastat F 18) PET in suspected biochemical recurrence of prostate cancer.

新泽西州门罗镇和英国牛津市——（商业新闻短讯）——Blue Earth Diagnostics，一家Bracco公司，是创新正电子发射断层扫描（PET）放射性药物开发和商业化领域公认的领导者，今天宣布了对第三阶段SPOTLIGHT试验（NCT04186845）数据的子分析结果，该试验调查了POSLUMA®（flotufolastat F 18）PET在疑似前列腺癌生化复发中的应用。

The sub-analysis assessed the impact of POSLUMA on treatment plans for patients with recurrent prostate cancer after curative-intent primary therapy. POSLUMA® (flotufolastat F 18) injection (formerly referred to as 18F-rhPSMA-7.3) is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level..

该子分析评估了POSLUMA对治愈性意向初级治疗后复发性前列腺癌患者治疗计划的影响。POSLUMA®（flotufolastat F 18）注射（以前称为18F-rhPSMA-7.3）适用于疑似转移的前列腺癌患者的前列腺特异性膜抗原（PSMA）阳性病变的正电子发射断层扫描（PET），这些患者是初始确定性治疗的候选者或基于血清前列腺特异性抗原（PSA）水平升高而疑似复发的患者。。

Results highlights:

结果亮点：

Flotufolastat F 18 PET imaging was positive for recurrent prostate cancer in 84% (81/97) of patients in the sub-analysis.

在亚分析中，84%（81/97）的患者中，Flotufolastat F 18 PET显像对复发性前列腺癌呈阳性。

In 89% (86/97) of patients, management plans were changed following review of the flotufolastat F 18 PET scan results.

在89%（86/97）的患者中，在审查了flotufolastat F 18 PET扫描结果后，管理计划发生了变化。

91% (78/86) of changes were considered major, defined as a change in the treatment modality.

91%（78/86）的变化被认为是重大的，定义为治疗方式的变化。

75% (6/8) of patients whose plans were changed in favor of watchful waiting had a negative flotufolastat F 18 scan.

75%（6/8）的计划改变为有利于观察等待的患者的flotufolastat F 18扫描呈阴性。

All patients with management plans that were revised from salvage therapy to non-curative systemic therapy had distant/extrapelvic flotufolastat F 18-avid lesions.

所有管理计划从挽救性治疗修改为非治愈性全身治疗的患者都有远处/骨盆外的氟虫嗪F 18狂热病变。

“Recurrent prostate cancer presents challenges, and the ability to determine the extent and location of recurrent disease to inform appropriate clinical management is key for physicians and their patients, as up to 40% of patients who undergo radical prostatectomy, and up to 50% of patients who undergo radiation therapy will develop local or distant recurrences within 10 years,” said Przemyslaw Twardowski, MD, Saint John’s Cancer Institute at Providence Saint John’s Health Center, Santa Monica, Calif., on behalf of the SPOTLIGHT Study Group.

“复发性前列腺癌面临挑战，确定复发疾病的程度和位置以告知适当的临床管理对于医生和患者至关重要，因为多达40%的接受根治性前列腺切除术的患者和多达50%的接受放射治疗的患者将在10年内发生局部或远处复发，”他说加利福尼亚州圣莫尼卡市普罗维登斯圣约翰健康中心圣约翰癌症研究所医学博士Przemyslaw Twardowski代表聚光灯研究小组。

“The SPOTLIGHT study investigated the diagnostic performance of POSLUMA PET imaging as a potential decision-making aid in assessing suspected biochemical recurrence of the disease. This sub-analysis further examined the impact of POSLUMA PET imaging on patients’ management plans. Results showed that POSLUMA identified recurrence sites in the majority of patients, frequently resulting in major changes to previously planned management plans.

“SPOTLIGHT研究调查了POSLUMA PET成像的诊断性能，作为评估疑似生化复发疾病的潜在决策辅助手段。该子分析进一步检查了POSLUMA PET成像对患者管理计划的影响。结果显示，POSLUMA在大多数患者中发现了复发部位，经常导致严重对先前计划的管理计划的变更。

Patient treatment based on visualization of POSLUMA-avid lesions has the potential to facilitate optimal targeting of recurrence sites and help patients avoid futile salvage therapy.”.

基于POSLUMA-avid病变可视化的患者治疗有可能促进复发部位的最佳靶向，并帮助患者避免徒劳的挽救治疗。”。

“We are very pleased to present these results to the oncology community at ASCO GU,” said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. “POSLUMA represents a new class of high-affinity PSMA-targeted radiopharmaceuticals based on novel radiohybrid technology, and provides physicians with clinically useful information based on its performance at low PSA levels, PSMA binding and low urinary bladder activity.

Blue Earth Diagnostics首席执行官David E.Gauden，D.Phil说：“我们很高兴将这些结果提交给ASCO GU的肿瘤学界。”。“POSLUMA代表了一类基于新型放射性杂交技术的高亲和力PSMA靶向放射性药物，并根据其在低PSA水平，PSMA结合和低膀胱活性方面的表现为医生提供了临床有用的信息。

Our product has been added to nationally recognized clinical oncology guidelines for prostate cancer, alongside and for all the same categories as the other currently FDA-approved PSMA PET radiopharmaceuticals. POSLUMA is labeled with the radioisotope fluorine-18 (18F) to leverage high image quality and to enable broad, readily available geographic access for patients via the manufacturing and distribution network of our commercial U.S.

我们的产品已被添加到国家认可的前列腺癌临床肿瘤学指南中，与其他目前FDA批准的PSMA PET放射性药物类别相同。POSLUMA用放射性同位素氟-18（18F）标记，以利用高图像质量，并通过我们的美国商业制造和分销网络为患者提供广泛，随时可用的地理访问。

manufacturer and distributor, PETNET Solutions Inc, A Siemens Healthineers Company.”.

制造商和分销商，PETNET Solutions Inc，一家西门子Healthineers公司。

The findings were discussed in a moderated poster presentation at the ASCO GU 2024 Genitourinary Cancers Symposium (ASCO GU) on January 25, 2024. “Impact of 18F-flotufolastat PET on management of patients with recurrent prostate cancer: Data from the SPOTLIGHT study,” was presented by Przemyslaw Twardowski, MD, Saint John’s Cancer Institute at Providence Saint John’s Health Center, Santa Monica, Calif., on behalf of the SPOTLIGHT Study Group.

2024年1月25日，在ASCO GU 2024泌尿生殖系统癌症研讨会（ASCO GU）上，这些发现在一张有主持人的海报上进行了讨论。加利福尼亚州圣莫尼卡市普罗维登斯圣约翰健康中心圣约翰癌症研究所医学博士Przemyslaw Twardowski代表SPOTLIGHT研究小组介绍了“18F-flotufolastat PET对复发性前列腺癌患者管理的影响：来自SPOTLIGHT研究的数据”。

Full session details are available in the ASCO GU online program here..

ASCO GU在线计划中提供了完整的课程详细信息。。

About the study

关于这项研究

The sub-analysis of SPOTLIGHT data from the 389 patient study assessed the impact of flotufolastat F 18 on planned treatment after curative-intent primary therapy. The present analysis focused on patients who had a flotufolastat F 18 scan and sufficient data for management plan evaluation. Onsite investigators recorded patients’ management plans before and after flotufolastat F 18 PET.

来自389名患者研究的聚光灯数据的子分析评估了flotufolastat F 18对治愈意图初级治疗后计划治疗的影响。目前的分析集中在接受flotufolastat F 18扫描并有足够数据用于管理计划评估的患者。现场调查人员记录了flotufolastat F 18 PET前后患者的管理计划。

Plans were then categorized as “no change,” “major change,”” other change,” “additional information required” or “intended plan not valid.” A “major change” was defined as a change in treatment modality (e.g., salvage radiation to systemic therapy), while “other change” represented a change within a modality (e.g., modified radiation therapy field).

然后将计划分类为“无变化”，“重大变化”，“其他变化”，“需要额外信息”或“预期计划无效”。“重大变化”被定义为治疗方式的变化（例如，全身治疗的挽救性辐射），“其他变化”表示一种方式（例如，改进的放射治疗领域）内的变化。

All imaging data were then submitted for blinded image evaluation by 3 central readers..

然后将所有成像数据提交给3位中央读者进行盲法图像评估。。

In total, 97 patients (median [range] PSA: 0.08 [0.09-134.6]] ng/mL) had an evaluable flotufolastat F 18 PET scan and sufficient data to evaluate management plan changes. Most patients, 86/97 (89%) had a change to their management plan post-scan. A “major change” was noted for 78 (80%) patients, while 8 (8.2%) had an “other change.” Onsite imaging reads showed that both positive and negative flotufolastat F 18 scans influenced management planning.

总共有97名患者（中位[范围]PSA:0.08[0.09-134.6]]ng/mL）进行了可评估的flotufolastat F 18 PET扫描，并有足够的数据来评估管理计划的变化。大多数患者中，86/97（89%）在扫描后改变了管理计划。78名（80%）患者出现了“重大变化”，而8名（8.2%）患者出现了“其他变化”。现场成像读数显示，阳性和阴性flotufolastat F 18扫描均影响了管理计划。

While 88% of revisions occurred after a positive scan, 75% of those whose management plans were revised to watchful waiting had negative scans. All patients with management plans revised from salvage therapy to non-curative systemic therapy had distant/extrapelvic flotufolastat F 18-avid lesions..

虽然88%的修订发生在阳性扫描后，但75%的管理计划被修订为观察等待的人进行了阴性扫描。所有管理计划从挽救性治疗修改为非治愈性全身治疗的患者都有18个狂热病变的远处/盆腔外氟虫嗪。。

No serious adverse reactions were attributed to flotufolastat F 18 in the SPOTLIGHT study. Overall, 16/389 (4.1%) patients had at least one treatment-emergent adverse event that was considered possibly related/related to flotufolastat F 18. The most frequently reported events were: hypertension: 1.8% (n=7); diarrhea: 1.0% (n=4); injection site reaction: 0.5% (n=2), and headache: 0.5% (n=2)..

在SPOTLIGHT研究中，flotufolastat F 18没有严重的不良反应。总体而言，16/389（4.1%）患者至少有一次治疗紧急不良事件被认为可能与氟妥福司他F 18有关/相关。最常报告的事件是：高血压：1.8%（n=7）；腹泻：1.0%（n=4）；注射部位反应：0.5%（n=2），头痛：0.5%（n=2）。。

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

关于放射性杂交前列腺特异性膜抗原（rhPSMA）

Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) compounds consist of a radiohybrid (“rh”) Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells, and they may be radiolabeled with imaging isotopes for PET imaging, or with therapeutic isotopes for therapeutic use – providing the potential for creating a true theranostic technology.

放射性杂化前列腺特异性膜抗原（rhPSMA）化合物由放射性杂化（“rh”）前列腺特异性膜抗原靶向受体配体组成，该配体附着于前列腺癌细胞并被其内化，它们可以用成像同位素进行PET成像，或者使用治疗性同位素进行治疗-为创造真正的治疗诊断技术提供了潜力。

Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and sublicensed the therapeutic application to its sister company Blue Earth Therapeutics.

Radiohybrid技术和rhPSMA起源于德国慕尼黑工业大学。Blue Earth Diagnostics于2018年从Scintomics GmbH获得了rhPSMA诊断成像技术的全球独家权利，并于2020年获得了治疗权利，并将治疗应用分许可给了其姐妹公司Blue Earth Therapeutics。

Blue Earth Diagnostics received U.S. Food and Drug Administration approval for its radiohybrid PET diagnostic imaging product for use in prostate cancer in 2023. rhPSMA compounds for potential therapeutic use are investigational and have not received regulatory approval..

Blue Earth Diagnostics于2023年获得美国食品和药物管理局（FDA）批准其用于前列腺癌的放射性杂交PET诊断成像产品。用于潜在治疗用途的rhPSMA化合物正在研究中，尚未获得监管部门的批准。。

Indication and Important Safety Information About POSLUMA

关于POSLUMA的指示和重要安全信息

INDICATION

指示

POSLUMA® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer

POSLUMA®（flotufolastat F 18）注射适用于前列腺癌男性前列腺特异性膜抗原（PSMA）阳性病变的正电子发射断层扫描（PET）

with suspected metastasis who are candidates for initial definitive therapy

疑似转移的患者是最初确定治疗的候选人

with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level

由于血清前列腺特异性抗原（PSA）水平升高而怀疑复发

IMPORTANT SAFETY INFORMATION

重要安全信息

Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping.

POSLUMA PET可能会出现图像解释错误。负面图像不排除前列腺癌的存在，正面图像不确认前列腺癌的存在。在初始明确治疗之前，POSLUMA对患者转移性盆腔淋巴结成像的表现似乎受到血清PSA水平和风险分组的影响。

The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues.

POSLUMA对具有前列腺癌复发生化证据的患者进行成像的表现似乎受到血清PSA水平的影响。Flotufolastat F 18摄取对前列腺癌不是特异性的，可能发生在其他类型的癌症，非恶性过程和正常组织中。

Clinical correlation, which may include histopathological evaluation, is recommended..

建议临床相关性，可能包括组织病理学评估。。

Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline..

疑似前列腺癌复发患者的图像误解风险：根据成像读取器的不同，POSLUMA PET的解释可能会有所不同，特别是在前列腺/前列腺床区域。由于假阳性解释的相关风险，当临床决策取决于仅在前列腺/前列腺床区域摄取flotufolastat F 18或仅在被解释为临界摄取时，请考虑多学科咨询和组织病理学确认。。

POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers..

POSLUMA的使用有助于患者的整体长期累积辐射暴露。长期累积辐射暴露与癌症风险增加有关。建议患者在给药前后补充水分，并在给药后经常排空。确保安全处理，以尽量减少对患者和医疗保健提供者的辐射暴露。。

The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.

临床研究中≥0.4%的患者报告的不良反应是腹泻，血压升高和注射部位疼痛。

Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established..

药物相互作用：雄激素剥夺疗法（ADT）和其他针对雄激素途径的疗法，如雄激素受体拮抗剂，可能导致前列腺癌中氟妥司他F 18摄取的变化。这些疗法对POSLUMA PET性能的影响尚未确定。。

To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

要报告对POSLUMA的疑似不良反应，请致电1-844-POSLUMA（1-844-767-5862）或通过1-800-FDA-1088或www.FDA.gov/medwatch与FDA联系。

Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf.

有关POSLUMA处方的完整信息，请访问www.POSLUMA.com/prescribing-information.pdf。

About Blue Earth Diagnostics

关于Blue Earth Diagnostics

Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals.

Blue Earth Diagnostics是Bracco Imaging S.p.A.的间接子公司，是一家不断发展的国际分子成像公司，专注于提供创新的，差异化的诊断解决方案，为患者护理提供信息。该公司成立于2014年，其成功得益于其管理专业知识，并得到了正电子发射断层扫描（PET）放射性药物快速发展和商业化的良好记录的支持。

Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: www.blueearthdiagnostics.com..

Blue Earth Diagnostics不断扩大的肿瘤学组合涵盖了多种疾病状态，包括前列腺癌和神经肿瘤学。Blue Earth Diagnostics致力于精确放射性药物的及时开发和商业化，以用于成像和治疗。有关更多信息，请访问：www.blueearthdiagnostics.com。。

About Bracco Imaging

关于Bracco Imaging

Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need.

Bracco Imaging S.p.A.是Bracco集团的一部分，是世界领先的诊断成像提供商。Bracco Imaging总部位于意大利米兰，负责开发、制造和销售诊断成像剂和解决方案。它为所有关键的诊断成像方式提供了产品和解决方案组合：X射线成像（包括计算机断层扫描CT，介入放射学和心脏导管插入术），磁共振成像（MRI），对比增强超声（CEUS），和核医学通过放射性示踪剂和新型PET显像剂，为临床管理提供信息，并在未满足医疗需求的地区指导癌症患者的护理。

Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics.

我们不断发展的产品组合由一系列医疗设备、先进的管理系统和剂量管理软件完成。2019年，Bracco Imaging通过收购Blue Earth Diagnostics，扩大泌尿科和其他专业的肿瘤核成像解决方案范围，丰富了其产品组合。

In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: www.braccoimaging.com..

2021年，Bracco Imaging将Blue Earth Therapeutics确立为一种独立的尖端生物技术工具，用于开发放射性药物疗法。访问：www.braccoimaging.com。。

POSLUMA is a registered trademark of Blue Earth Diagnostics Ltd.

POSLUMA是Blue Earth Diagnostics Ltd.的注册商标。

For U.S audiences only

仅限美国观众