IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--Agendia®, Inc., announced today it will share new data from the ongoing prospective, observational FLEX Trial (NCT03053193) in two poster presentations at the 41st Annual Miami Breast Cancer Conference (MBCC), taking place March 7 – 10th, 2024.

加利福尼亚州欧文市和阿姆斯特丹——（商业新闻短讯）——Agendia®公司今天宣布，将在2024年3月7日至10日举行的第41届迈阿密乳腺癌年会（MBCC）上，在两张海报上分享正在进行的前瞻性观察性FLEX试验（NCT03053193）的新数据。

The first poster, titled MammaPrint® and BluePrint® predict anthracycline chemosensitivity in patients with HR+HER2-early-stage breast cancer enrolled in FLEX, (Audeh, W., et al.), investigates the associations between MammaPrint and BluePrint classifications, therapy regimen, and the likelihood of achieving a pathologic Complete Response (pCR).

第一张海报名为MammaPrint®和BluePrint®预测参加FLEX的HR+HER2早期乳腺癌患者的蒽环类药物敏感性（Audeh，W。等人），研究了MammaPrint与BluePrint分类，治疗方案之间的关联，以及实现病理完全缓解（pCR）的可能性。

Researchers looked at patients who had hormone receptor-positive (HR+), Human Epidermal Growth Factor Receptor (HER) 2-negative early-stage breast cancer – categorized as MammaPrint High Risk – who had been treated with either a combination of two (taxane and cyclophosphamide, TC) or three (TC with anthracycline, AC-T) types of neoadjuvant chemotherapy.

研究人员观察了激素受体阳性（HR+）、人类表皮生长因子受体（HER）2阴性的早期乳腺癌患者，这些患者被归类为乳腺癌高危人群，他们接受了两种（紫杉烷和环磷酰胺，TC）或三种（TC和蒽环类，AC-T）新辅助化疗的联合治疗。

Patients were then further stratified into MP High 1 and High 2 categories, and further stratified by BluePrint subtype of Luminal and Basal. Results showed that patients with MP High 2 tumors, including Luminal B and Basal subtypes, are more likely to achieve a pCR in response to AC-T, while the addition of anthracycline to the therapy regimen does not appear to improve pCR rates for patients with MP High 1, Luminal B-type tumors..

然后将患者进一步分为MP高1和高2类，并根据鲁米那和基底的蓝图亚型进一步分层。结果显示，MP高2肿瘤（包括鲁米那B和基底亚型）患者更有可能对AC-T产生pCR反应，而在治疗方案中添加蒽环类药物似乎并不能提高MP高1，鲁米那B型肿瘤患者的pCR率。。

The second poster, titled Prediction of chemotherapy benefit by MammaPrint® in patients with HR+HER2-early-stage breast cancer from real-world evidence studies (Audeh, W., et al.), used data from patients with HR+ HER2-negative early-stage breast cancer enrolled in the FLEX and NBRST trials to generate a prediction of the magnitude of chemotherapy benefit based upon a patient’s genomic risk, looking at the MammaPrint index more closely as a continuous variable.

第二张海报名为MammaPrint®在现实世界证据研究（Audeh，W。等人）中预测HR+HER2早期乳腺癌患者的化疗益处，它使用了参加FLEX和NBRST试验的HR+HER2阴性早期乳腺癌患者的数据，根据患者的基因组风险预测化疗益处的大小，将MammaPrint指数作为一个连续变量进行更深入的研究。

Researchers examined the association of the MammaPrint index with benefit from chemotherapy by evaluating two clinical endpoints, the likelihood of pCR in response to neoadjuvant chemotherapy, and the five-year outcome among patients who received chemotherapy and endocrine therapy or endocrine therapy alone..

研究人员通过评估两个临床终点，对新辅助化疗反应的pCR可能性，以及接受化疗和内分泌治疗或单独内分泌治疗的患者的五年结局，研究了MammaPrint指数与化疗获益的关系。。

Consistent with results found in the landmark MINDACT trial, this study showed that the MammaPrint index demonstrates strong efficacy in predicting low chemosensitivity in Low Risk and Ultra Low Risk tumors, reinforcing that these groups do not derive significant chemotherapy benefit. However, it was also observed that chemotherapy effectiveness increased as MammaPrint risk increased in High 1 and High 2 tumors, as evidenced by both pCR rates and 5-year outcomes, demonstrating that the overall benefit of chemotherapy increases as MammaPrint risk increases.

与具有里程碑意义的MINDACT试验中发现的结果一致，这项研究表明，MammaPrint指数在预测低风险和超低风险肿瘤的低化疗敏感性方面显示出强大的功效，这强化了这些组没有获得显着的化疗益处。然而，还观察到化疗有效性随着高1和高2肿瘤中乳腺癌风险的增加而增加，正如pCR率和5年结果所证明的那样，这表明化疗的总体益处随着乳腺癌风险的增加而增加。

Taken together, these findings indicate the utility of MammaPrint to predict neoadjuvant and adjuvant chemotherapy benefit in this patient population..

综上所述，这些发现表明MammaPrint可用于预测该患者人群的新辅助化疗和辅助化疗益处。。

“In this unique real world evidence FLEX study, we were able to look at chemosensitivity for patients who had received neoadjuvant treatment and the chemo benefit for patients who are treated with systemic therapy after surgery, showing that MammaPrint is predictive of chemotherapy benefit in both cases.

“在这项独特的现实世界证据FLEX研究中，我们能够观察接受新辅助治疗的患者的化疗敏感性以及手术后接受全身治疗的患者的化疗益处，表明MammaPrint可以预测两种情况下的化疗益处。

The FLEX Trial, with over 16,000 women enrolled, is now allowing us to look at clinical outcomes as well as analyzing whole transcriptome data,” said William Audeh, MD, MS, Chief Medical Officer of Agendia. “The data we’re sharing at the Miami Breast Cancer Conference confirms that gene expression profiling with these assays identify who may benefit from chemotherapy, and may prove helpful in regimen selection as well.

FLEX试验招募了16000多名女性，现在使我们能够查看临床结果以及分析整个转录组数据，”Agendia首席医学官William Audeh，MD，MS说。“我们在迈阿密乳腺癌会议上分享的数据证实，通过这些检测方法进行的基因表达谱分析可以确定谁可能从化疗中受益，并且可能对方案选择也有帮助。

We look forward to further exploring the capabilities of MammaPrint and BluePrint for women across the entire spectrum of breast cancer risk and subtype.”.

我们期待着进一步探索MammaPrint和BluePrint在乳腺癌风险和亚型的整个范围内为女性提供的能力。”。

The goal of Agendia’s research is to increase the likelihood of managing each individual’s cancer diagnosis by delivering a customized treatment plan to the patients most likely to benefit based on the unique features of their tumor.

Agendia研究的目标是通过根据肿瘤的独特特征为最有可能受益的患者提供定制的治疗计划，提高管理每个人癌症诊断的可能性。

About Agendia

关于Agendia

Agendia is a leading provider of innovative solutions in the field of precision oncology. With a focus on early-stage breast cancer, Agendia offers reliable biological insights that inform personalized treatment decisions for patients and their care teams. Their advanced genomic assays, MammaPrint® + BluePrint®, enable clinicians to quickly identify the most effective treatment plan, minimizing the risk of both under- and over-treatment..

Agendia是精准肿瘤学领域创新解决方案的领先供应商。Agendia专注于早期乳腺癌，提供可靠的生物学见解，为患者及其护理团队的个性化治疗决策提供信息。他们的先进基因组检测技术MammaPrint®+BluePrint®，使临床医生能够快速确定最有效的治疗计划，最大程度地降低治疗不足和过度的风险。。

Founded in 2003 in Amsterdam, Agendia is headquartered in Irvine, California with a state-of-the-art laboratory facility. Led by world-renowned scientists and oncologists, Agendia is committed to advancing genomic insights through ongoing research. This includes the notable FLEX Study– the world's largest whole transcriptome Real-World Evidence-based Breast Cancer database which aims to revolutionize precision in breast cancer management.

Agendia于2003年在阿姆斯特丹成立，总部位于加利福尼亚州欧文市，拥有最先进的实验室设施。在世界著名科学家和肿瘤学家的带领下，Agendia致力于通过正在进行的研究来推进基因组学的见解。这包括著名的FLEX研究-世界上最大的全转录组真实世界循证乳腺癌数据库，旨在彻底改变乳腺癌管理的准确性。

With cutting-edge technology, research and innovation, Agendia strives to shape the future of precision oncology and make a significant impact in the fight against breast cancer..

凭借尖端技术、研究和创新，Agendia致力于塑造精准肿瘤学的未来，并在抗击乳腺癌方面产生重大影响。。

About MammaPrint

关于MammaPrint

MammaPrint® is a gene expression profiling test that reveals the distinct underlying biology of an early-stage tumor to determine its risk of spreading. As the only FDA-cleared gene expression profiling test to assess a woman's risk of distant metastasis, MammaPrint® provides critical answers that help inform the future of her treatment plan at the point of diagnosis, including the timing and benefit to chemotherapy and endocrine therapy.

MammaPrint®是一种基因表达谱测试，可揭示早期肿瘤的独特潜在生物学特性，以确定其扩散风险。作为FDA批准的唯一评估女性远处转移风险的基因表达谱测试，MammaPrint®提供了关键的答案，有助于在诊断时告知她的治疗计划的未来，包括化疗和内分泌治疗的时机和益处。

MammaPrint® listens to the signals from 70 key genes in a woman’s tumor to stratify her risk within four distinct categories - ranging from UltraLow, Low, High 1, and High 2– to fuel a right-sized care plan tailored to her biology and her life's plans..

MammaPrint®倾听女性肿瘤中70个关键基因的信号，将其风险分为超低、低、高1和高2四个不同类别，以推动根据其生物学和生活计划量身定制的适当规模的护理计划。。

About BluePrint

关于蓝图

BluePrint® is a gene expression profiling test that reveals the driving forces behind a tumor’s growth at the earliest stage possible in a woman’s breast cancer care journey to help optimize and personalize treatment planning. As the only molecular subtyping test available in the U.S., BluePrint® goes where pathology cannot, offers critical insights that providers may otherwise have not known to act on, and gives women the best chance to return to a life not defined by cancer.

BluePrint®是一种基因表达谱测试，可在女性乳腺癌护理旅程的最早阶段揭示肿瘤生长背后的驱动力，以帮助优化和个性化治疗计划。作为美国唯一可用的分子亚型检测方法，BluePrint®提供了病理学无法提供的关键见解，提供了提供者可能不知道采取行动的关键见解，并为女性提供了重返癌症未定义的生活的最佳机会。

BluePrint® measures the activity of 80 key genes that are involved in a tumor's growth to classify a tumor as Luminal-type, HER2-type, or Basal-type, each of which warrant distinct treatment pathways. By revealing the distinct underlying biology of a woman's tumor, BluePrint® can catch often misclassified, yet highly aggressive, Basal tumors, so women can be prescribed the most appropriate treatment from the start..

BluePrint®测量与肿瘤生长有关的80个关键基因的活性，将肿瘤分为管腔型，HER2型或基础型，每种类型都需要不同的治疗途径。通过揭示女性肿瘤独特的潜在生物学特性，BluePrint®可以捕捉到经常被错误分类但具有高度侵袭性的基底肿瘤，因此女性可以从一开始就接受最合适的治疗。。