Results of GRAIL's Galleri Multi-Cancer Early Detection Blood Test in Prostate Cancer Published in JCO Precision Oncology
Results of GRAIL's Galleri Multi-Cancer Early Detection Blood Test in Prostate Cancer Published in JCO Precision Oncology
Data Support Clinical Performance of Galleri to Detect More Aggressive Prostate Cancers
数据支持 Galleri 检测更具侵略性的前列腺癌的临床表现
MENLO PARK, Calif., Aug. 29, 2024 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL) a healthcare company whose mission is to detect cancer early when it can be cured, today announced that detailed findings of the performance of its Galleri multi-cancer early detection (MCED) test in prostate cancer were published in JCO Precision Oncology. The data support the clinical performance of the Galleri test to preferentially screen for aggressive, clinically significant prostate cancer as compared to slow-growing (indolent) cases in the Circulating Cell-free Genome Atlas (CCGA) and PATHFINDER studies.
加利福尼亚州门洛公园,2024年8月29日 /PRNewswire/ — GRAIL, Inc.(纳斯达克股票代码:GRAL)是一家医疗保健公司,其使命是在癌症可以治愈时及早发现癌症。该公司今天宣布,其前列腺癌Galleri多癌症早期检测(MCED)测试表现的详细研究结果已发表在JCO Precision Oncology上。与循环无细胞基因组图集(CCGA)和PATHFINDER研究中的生长缓慢(惰性)病例相比,Galleri测试优先筛查侵袭性、具有临床意义的前列腺癌的临床表现。
"All screening tests run the risk of overdiagnosis. In the case of prostate cancer, this is largely due to the high prevalence of low-grade, indolent cancers," said Brandon Mahal, M.D., a radiation oncologist at Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine, and lead author of the study. "The results of this study demonstrate that the use of MCED tests in a population-based screening program is unlikely to contribute to overdiagnosis of slow-growing prostate cancers that may not need treatment. That being said, clinically validated MCED tests like Galleri reveal that when a prostate cancer signal is detected, it usually indicates aggressive disease and additional diagnostic evaluation is necessary."
“所有筛查测试都有过度诊断的风险。就前列腺癌而言,这主要是由于低度惰性癌症的高患病率。” 迈阿密大学米勒医学院下属西尔维斯特综合癌症中心的放射肿瘤学家、该研究的主要作者布兰登·马哈尔万德说。“这项研究的结果表明,在基于人群的筛查计划中使用MCED测试不太可能导致对可能不需要治疗的生长缓慢的前列腺癌的过度诊断。话虽如此,像Galleri这样的经过临床验证的MCED测试表明,当检测到前列腺癌信号时,通常表明存在侵袭性疾病,因此需要进行额外的诊断评估。”
The published data is from an analysis of 420 prostate cancer patients identified in the independent clinical validation portion (substudy 3) of the multi-center, case-control observational study Circulating Cell-free Genome Atlas (CCGA) study and 18 cases from the prospective intended-use PATHFINDER study. The data were previously presented at the American Association for Cancer Research (AACR) Annual Meeting in March 2024.
公布的数据来自对在多中心病例对照观察性研究的独立临床验证部分(子研究3)中确定的420名前列腺癌患者的分析 循环无细胞基因组图谱 (CCGA) 研究和预期用途的18个案例 开拓者 学习。这些数据此前曾在2024年3月的美国癌症研究协会(AACR)年会上公布。
Results from this analysis showed that of the prostate cancers that were detected by the MCED test, most were clinically significant (93% were intermediate or high grade and 67% were stage III or IV). For detected prostate cancers, the cancer signal of origin (CSO) prediction accuracy was > 90%. Detectability for stage I and II cancers were 4.2% across both studies combined, which is expected with low shedding prostate cancer tumor fraction and is consistent with cfDNA literature in prostate cancer. Test sensitivity of prostate cancer for all stages was 11.2% in substudy CCGA-3. Notably, the MCED test detected no low-grade cancers, 1.9% of intermediate-grade cancers, and only 4.2% of stage I and II cancers across both studies combined. Of the detected cases, 93% were Gleason grade groups 3-5. This analysis demonstrates the MCED test preferentially detects high-grade, clinically significant prostate cancer. This is important because an MCED test, when used in addition to standard-of-care screening, should not exacerbate overdiagnosis of indolent cancers. These findings also suggest that individuals with a cancer signal detected and a prostate CSO prediction should undergo a prompt diagnostic evaluation to determine the presence of aggressive disease for which treatment is generally indicated1.
分析结果显示,在MCED测试检测到的前列腺癌中,大多数具有临床意义(93%为中度或高等级,67%为III期或IV期)。对于检测到的前列腺癌,癌症起源信号(CSO)的预测准确度大于90%。在两项研究中,I期和II期癌症的可检测性为4.2%,预计前列腺癌肿瘤脱落率较低,并且与前列腺癌的cfDNA文献一致。在子研究 CCGA-3 中,所有阶段的前列腺癌的测试灵敏度为11.2%。值得注意的是,在这两项研究中,MCED测试没有发现低度癌症,1.9%的中级癌症,只有4.2%的I期和II期癌症加在一起。在发现的病例中,93%是格里森级别的3-5组。该分析表明,MCED测试优先检测具有临床意义的高等级前列腺癌。这很重要,因为除了标准护理筛查外,MCED 测试不应加剧对惰性癌症的过度诊断。这些发现还表明,检测到癌症信号并有前列腺CSO预测的人应立即接受诊断评估,以确定是否存在通常需要治疗的侵袭性疾病1。
"This prostate cancer analysis underscores the power of Galleri in a general population of men at-risk for prostate cancer as it is able to detect biologically significant cancers that need treatment without potentially contributing to the burden of overdiagnosis," said Dr. Eric Klein, Distinguished Scientist at GRAIL and an author on the study. "The very high accuracy of the cancer signal origin prediction for prostate cancer indicates the need for a prompt diagnostic work-up in those with a cancer signal detected."
GRAIL杰出科学家、该研究的作者埃里克·克莱因博士说:“这项前列腺癌分析突显了Galleri在普通有前列腺癌风险的男性群体中的力量,因为它能够在不增加过度诊断负担的情况下检测出需要治疗的具有生物学意义的癌症。”“前列腺癌的癌症信号起源预测的准确性非常高,这表明需要对检测到癌症信号的人进行及时的诊断检查。”
About GRAIL
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art machine learning, software, and automation to detect and identify multiple deadly cancer types in earlier stages. GRAIL's targeted methylation-based platform can support the continuum of care for screening and precision oncology, including multi-cancer early detection in symptomatic patients, risk stratification, minimal residual disease detection, biomarker subtyping, treatment and recurrence monitoring. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission.
关于 GRAIL
GRAIL是一家医疗保健公司,其使命是在癌症可以治愈的时候及早发现癌症。GRAIL致力于通过利用下一代测序、人群规模临床研究以及最先进的机器学习、软件和自动化来在早期阶段检测和识别多种致命癌症类型,从而减轻全球癌症负担。GRAIL基于甲基化的靶向平台可以支持筛查和精准肿瘤学的连续护理,包括有症状患者的多癌症早期发现、风险分层、最小残留疾病检测、生物标志物亚型、治疗和复发监测。GRAIL总部位于加利福尼亚州门洛帕克,在华盛顿特区、北卡罗来纳州和英国设有分支机构。GRAIL, LLC是Illumina, Inc.(纳斯达克股票代码:ILMN)的子公司,根据欧盟委员会临时措施令的条款,目前与Illumina Inc.分开持有。
For more information, visit grail.com.
欲了解更多信息,请访问 grail.com。
About Galleri
The Galleri multi-cancer early detection test is a proactive tool to screen for cancer. With a simple blood draw, the Galleri test can identify DNA shed by cancer cells, which can act as a unique "fingerprint" of cancer, to help screen for some of the deadliest cancers that don't have recommended screening today, such as pancreatic, esophageal, ovarian, liver, and others.* The Galleri test can be used to screen for cancer before a person becomes symptomatic, when cancer may be more easily treated and potentially curable. The Galleri test can indicate the origin of the cancer, giving healthcare providers a roadmap of where to explore further. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. The Galleri test is recommended for adults with an elevated risk for cancer, such as those aged 50 or older.
关于画廊
Galleri多癌症早期检测测试是筛查癌症的主动工具。通过简单的抽血,Galleri测试可以识别癌细胞脱落的DNA,癌细胞可以充当癌症的独特 “指纹”,从而帮助筛查一些目前不建议进行筛查的最致命的癌症,例如胰腺、食道、卵巢、肝脏等。* Galleri测试可用于在患者出现症状之前筛查癌症,此时癌症可能更容易治疗,有可能治愈。Galleri测试可以指明癌症的起源,为医疗保健提供者提供进一步探索的路线图。Galleri测试需要持牌医疗保健提供者的处方,并且应在推荐的癌症筛查(例如乳房X光检查、结肠镜检查、前列腺特异性抗原(PSA)测试或宫颈癌筛查之外使用。建议癌症风险较高的成年人进行Galleri测试,例如50岁或以上的成年人。
For more information, visit galleri.com.
欲了解更多信息,请访问 galleri.com。
Sensitivity in study participants with –
Pancreas cancer: 83.7% overall (61.9% stage I, 60.0% stage II, 85.7% stage III, 95.9% stage IV). Esophagus cancer 85.0% overall (12.5% stage I, 64.7% stage II, 94.7% stage III, 100% stage IV). Ovary cancer: 83.1% overall (50.0% stage I, 80.0% stage II, 87.1% stage III, 94.7% stage IV). Liver/bile duct cancer: 93.5% overall (100% stage I, 70.0% stage II, 100% stage III, 100% stage IV).
灵敏度在 学习 有 — 的参与者
胰腺癌:总体比例为83.7%(一期61.9%,二期60.0%,三期85.7%,第四阶段95.9%)。食道癌总体比例为85.0%(第一阶段12.5%,第二阶段64.7%,第三阶段94.7%,第四阶段100%)。卵巢癌:总体比例为83.1%(一期50.0%,二期80.0%,三期87.1%,第四阶段94.7%)。肝脏/胆管癌:总体比例为93.5%(100%为第一阶段,70.0%为第二阶段,100%为第三阶段,100%为第四阶段)。
Important Galleri Safety Information
The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.
重要画廊安全信息
建议将Galleri测试用于癌症风险较高的成年人,例如50岁或以上的成年人。Galleri测试不能检测出所有癌症,应与医疗保健提供者推荐的常规癌症筛查测试一起使用。Galleri旨在检测癌症信号并预测癌症信号在体内的位置。不建议孕妇、21岁或以下或正在接受积极癌症治疗的人使用Galleri。
Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of No Cancer Signal Detected does not rule out cancer. A test result of Cancer Signal Detected requires confirmatory diagnostic evaluation by medically established procedures (e.g. imaging) to confirm cancer.
医疗保健提供者应根据病史、临床体征和症状来解释结果。未检测到癌症信号的测试结果并不排除癌症。检测到的癌症信号的测试结果需要通过医学上确立的程序(例如成像)进行确认性诊断评估,以确认癌症。
If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only.
如果未通过进一步的检测确认癌症,则可能意味着癌症不存在或检测不足以发现癌症,包括由于癌症位于人体的不同部位。确实会出现假阳性(不存在癌症时检测到的癌症信号)和假阴性(存在癌症时未检测到癌症信号)的检测结果。仅限 Rx。
Laboratory/Test Information
GRAIL's clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the U.S. Food and Drug Administration. GRAIL's clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.
实验室/测试信息
GRAIL的临床实验室已获得1988年《临床实验室改进修正案》(CLIA)的认证,并获得了美国病理学家学会的认可。Galleri测试是开发的,其性能特征由GRAIL确定。Galleri测试尚未获得美国食品药品监督管理局的批准或批准。GRAIL的临床实验室受CLIA监管,可以进行高复杂度的测试。Galleri 测试仅用于临床目的。
Forward Looking Statements
This press release contains forward-looking statements. In some cases, you can identify these statements by forward-looking words such as "aim," "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "should," "would," or "will," the negative of these terms, and other comparable terminology. These forward-looking statements, which are subject to risks, uncertainties, and assumptions about us, may include expectations and projections of future tests or products, technology, clinical studies, regulatory compliance, potential market opportunity, anticipated growth strategies, and anticipated trends in our business.
前瞻性陈述
本新闻稿包含前瞻性陈述。在某些情况下,您可以通过前瞻性词语来识别这些陈述,例如 “目标”、“预测”、“相信”、“继续”、“可能”、“估计”、“预期”、“打算”、“可能”、“计划”、“潜力”、“预测”、“应该” 或 “将”,这些术语的否定部分以及其他类似的术语。这些前瞻性陈述受风险、不确定性和对我们的假设的影响,可能包括对未来测试或产品、技术、临床研究、监管合规性、潜在市场机会、预期增长战略和业务预期趋势的预期和预测。
These statements are only predictions based on our current expectations and projections about future events and trends. There are important factors that could cause our actual results, level of activity, performance, or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements, including those factors discussed under the section entitled "Risk Factors" in the Registration Statement on Form 10 filed by GRAIL (the "Form 10"), as may be further amended. Moreover, we operate in a dynamic and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results, level of activity, performance, or achievements to differ materially and adversely from those contained in any forward-looking statements we may make.
这些陈述只是基于我们当前的预期以及对未来事件和趋势的预测所做的预测。有些重要因素可能导致我们的实际业绩、活动水平、业绩或成就与前瞻性陈述所表达或暗示的业绩、活动水平、业绩或成就存在重大不利差异,包括在GRAIL提交的表格10注册声明(“表格10”)中题为 “风险因素” 的部分中讨论的因素,这些因素可能会进一步修订。此外,我们在动态和快速变化的环境中运营。新的风险不时出现。我们的管理层无法预测所有风险,也无法评估所有因素对我们业务的影响,也无法评估任何因素或因素组合在多大程度上可能导致实际业绩、活动水平、业绩或成就与我们可能做出的任何前瞻性陈述中包含的结果存在重大和不利的差异。
Forward-looking statements relate to the future and, accordingly, are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Although we believe the expectations and projections expressed or implied by the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Except to the extent required by law, we undertake no obligation to update any of these forward-looking statements after the date of this press release to conform our prior statements to actual results or revised expectations or to reflect new information or the occurrence of unanticipated events.
前瞻性陈述与未来有关,因此会受到固有的不确定性、风险和环境变化的影响,这些变化难以预测,其中许多是我们无法控制的。尽管我们认为前瞻性陈述所表达或暗示的预期和预测是合理的,但我们无法保证未来的业绩、活动水平、业绩或成就。我们的实际业绩和财务状况可能与前瞻性陈述中显示的业绩和财务状况存在重大差异。除非法律要求,否则我们没有义务在本新闻稿发布之日之后更新任何前瞻性陈述,以使我们先前的陈述符合实际业绩或修订后的预期,也没有义务反映新信息或意外事件的发生。
This press release shall not constitute an offer of any securities for sale, nor shall there be any offer, sale or distribution of securities in any jurisdiction in which such offer, sale or distribution would be unlawful prior to appropriate registration or qualification under the securities laws of such jurisdiction.
本新闻稿不构成任何待售证券的要约,在根据该司法管辖区的证券法进行适当注册或资格审查之前,在任何司法管辖区的证券要约、出售或分销是非法的,也不得有任何证券的要约、出售或分销。
References
参考文献
- "Initial Treatment of Prostate Cancer, by Stage and Risk Group." American Cancer Society, 22 Nov. 2023, .
- “按阶段和风险组分列的前列腺癌的初始治疗。”美国癌症协会,2023 年 11 月 22 日,。
SOURCE GRAIL, Inc.
来源 GRAIL, Inc.