Stage III Colon Cancer

Labcorp Plasma Detect is the first clinically validated, whole-genome sequencing MRD solution for early-stage colon cancer BURLINGTON, N.C., April 5, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the launch of Labcorp® Plasma Detect™, the first clinically validated, tumor-informed, whole-genome sequencing circulating tumor DNA (ctDNA) molecular residual disease (MRD) solution in early stage colon cancer to identify patients at increased risk of recurrence after surgery or adjuvant chemotherapy (ACT). This solution, which is designed for research use but also suitable for clinical applications, can be applied across solid tumors with a scalable and standardized approach to facilitate faster turnaround times while maintaining high analytical performance. The launch of the Labcorp Plasma Detect MRD solution further enhances Labcorp's leadership in precision oncology across the solid tumor oncology care continuum. Labcorp Plasma Detect builds on the successful deployment of two existing liquid biopsy platforms – Labcorp® Plasma Focus™, a targeted approach, and Labcorp® Plasma Complete™, a comprehensive profiling solution, both with utility for clinical research and clinical applications. All three solutions were developed by Personal Genome Diagnostics, Inc. (PGDx®), a Labcorp company, and are performed in the PGDx Baltimore CAP-accredited and CLIA-certified laboratory. "Labcorp Plasma Detect is a significant achievement, enhancing Labcorp's liquid biopsy portfolio and strengthening our position at the forefront of driving better patient outcomes in oncology," said Shakti Ramkissoon, M.D., Ph.D., vice president, medical lead for oncology at Labcorp. "Labcorp Plasma Detect delivers a high-impact solution for clinical research and biopharmaceutical drug development to support retrospective and prospective clinical trials with the goal of improving patient outcomes in early stage disease." The Labcorp Plasma Detect integrated whole-genome sequencing sample-to-report workflow was developed under PGDx's quality management system and design control process, undergoing rigorous analytical and clinical validation to demonstrate high sensitivity and specificity for ctDNA detection. It is backed by Labcorp's global network and expertise and does not require the manufacturing of patient-specific, bespoke panels, making it feasible to implement for research programs and clinical trials globally. Labcorp Plasma Detect is currently clinically validated for early-stage colon cancer, with ongoing efforts to expand into other indications, including lung cancer and bladder cancer. In collaboration with the Netherlands Cancer Institute (NKI), Labcorp Plasma Detect validation data will be presented during a podium presentation – Clinical validity of post-surgery circulating tumor DNA testing in stage III colon cancer patients treated with adjuvant chemotherapy: the PROVENC3 study – at the annual meeting of the American Association for Cancer Research® (AACR®). Labcorp Plasma Detect will also be used to support the MEDOCC-CrEATE trial, an interventional, randomized study that will provide insight into the willingness of stage II colon cancer patients to be treated with ACT and whether ACT can prevent recurrences in a high-risk population.1 "There is an unmet clinical need to better determine who benefits from adjuvant treatment after surgical resection. The tumor-informed whole genome sequencing-based approach of Labcorp Plasma Detect tracks thousands of tumor-specific mutations in cell-free DNA, thereby offering a highly sensitive and specific ctDNA MRD test," said Remond Fijneman, associate group leader and principal investigator at NKI. "Combined with the relatively short turnaround time, which meets the timelines for clinical decision-making, ctDNA-guided treatment de-escalation is now within reach." To learn about Labcorp Plasma Detect, visit About Labcorp Labcorp (NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's more than 67,000 employees serve clients in approximately 100 countries, provided support for 84% of the new drugs and therapeutic products approved in 2023 by the FDA, and performed more than 600 million tests for patients around the world. Learn more about us at . __________________________________ 1 Circulating tumor DNA guided adjuvant chemotherapy in stage II colon cancer (MEDOCC-CrEATE): study protocol for a trial within a cohort study SOURCE Labcorp

Researchers to present on topics ranging from molecular residual disease and immunotherapy to whole-genome sequencing BURLINGTON, N.C., April 2, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, will present abstracts in the areas of immunology, cellular biology, genomics and liquid biopsy at the Annual Meeting of the American Association for Cancer Research® (AACR®) in San Diego (April 5-10, 2024). The depth and breadth of Labcorp's oncology research solidifies the company's commitment to delivering guideline-based, biomarker-driven testing solutions, strengthening existing evidence of clinical utility and supporting the pharmaceutical industry from discovery to companion diagnostics development through commercialization to facilitate patient access to novel targeted therapies. "Labcorp is advancing cancer care through our pioneering research in precision oncology and our global collaborations with pharmaceutical, biotechnology and clinical research partners. Our robust presence at this year's AACR Annual Meeting is a testament to our dedication to leading with science, showcasing our commitment to innovation, and highlighting our role in shaping the future of personalized medicine," said Shakti Ramkissoon, M.D., Ph.D., vice president, medical lead for oncology at Labcorp. "Our research initiatives are focused on transforming the diagnostic landscape, enhancing patient care, and fueling a new era of targeted, effective treatments that will improve health and improve lives." Of the 21 abstracts to be presented at the AACR Meeting, 13 were internal studies by Labcorp researchers and eight were conducted in collaboration with research partners from premiere academic institutions and medical centers. Spotlight Theater Title: Biomarker solutions for all: Innovative solid tumor MRD detection and immune profiling solutions for advanced drug development Date: Tuesday, April 9 Time: 10:00 a.m. PT Location: Spotlight Theater A Oral Presentation s Abstract #6559: Clinical validity of post-surgery circulating tumor DNA testing in stage III colon cancer patients treated with adjuvant chemotherapy: The PROVENC3 study Date: Tuesday, April 9 Time: 3:10 p.m. - 3:25 p.m. PT Location: Ballroom 6 CF - Upper Level - Convention Center Poster Presentations Track: Immunology Session: Biomarkers, Immune Monitoring and Immune Assays Abstract #83: NK cell ADCC assays: Leveraging flow cytometry and reporter cell lines for enhanced biological relevance and throughput Date: Sunday, April 7 Time: 1:30 p.m. - 5:00 p.m. PT Section: 3 Track: Molecular/Cellular Biology and Genetics Session: Cellular Stress Responses 1 Abstract #379: Landscape of HIF-1α expression across 24,186 solid tumors using comprehensive immune profiling Date: Sunday, April 7 Time: 1:30 p.m. - 5:00 p.m. PT Section: 16 Track: Clinical Research Session: Circulating Nucleic Acids 1 Abstract #970: Liquid biopsy-informed precision oncology clinical trial to evaluate the utility of ctDNA comprehensive genomic profiling Date: Sunday, April 7 Time: 1:30 p.m. - 5:00 p.m. PT Section: 40 Track: Clinical Research Session: Predictive Biomarkers 1 Abstract #2496: Molecular characterization of stage III colon cancer patients with recurrence after adjuvant chemotherapy Date: Monday, April 8 Time: 9:00 a.m. - 12:30 p.m. PT Section: 43 Track: Clinical Research Session: Biomarkers in Clinical Trials Abstract #3629: Prevalence of claudin18.2 expression in gastric/gastroesophageal junction adenocarcinoma among patients in TranStar101 and TranStar102 clinical trials Date: Monday, April 8 Time: 1:30 p.m. - 5:00 p.m. PT Section: 40 Track: Clinical Research Session: Biomarkers in Clinical Trials Abstract #3652: Spatial transcriptomic study of the tumor microenvironment in HNSCC Date: Monday, April 8 Time: 1:30 p.m. - 5:00 p.m. PT Section: 40 Track: Experimental and Molecular Therapeutics Session: Molecular Classification of Tumors for Diagnostics, Prognostics, and Therapeutic Outcomes Abstract #4628: Validation of an Automated, Scalable Comprehensive Genomic Profiling Assay for Hematologic Malignancies Date: Tuesday, April 9 Time: 9:00 a.m. - 12:30 p.m. PT Section: 26 Track: Clinical Research Session: Circulating Nucleic Acids 4 Abstract #5020: Pre-analytical characterization of cell-free DNA to enable liquid biopsy for solid tumors Date: Tuesday, April 9 Time: 9:00 a.m. - 12:30 p.m. PT Section: 40 Track: Clinical Research Session: Circulating Nucleic Acids 4 Abstract #5022: MEDOCC-CrEATE trial: Feasibility of measuring circulating tumor DNA after surgery to guide adjuvant chemotherapy in stage II colon cancer patients Date: Tuesday, April 9 Time: 9:00 a.m. - 12:30 p.m. PT Section: 40 Track: Clinical Research Session: Circulating Nucleic Acids 4 Abstract #5017: Analytical performance of contrived samples for validation of liquid biopsy assays Date: Tuesday, April 9 Time: 9:00 a.m. - 12:30 p.m. PT Section: 40 Track: Tumor Biology Session: Models to Study Immune Cells in the Tumor Microenvironment Abstract #4204: Subcutaneous vs. orthotopic tumor models: a comparative assessment Date: Tuesday, April 9 Time: 9:00 a.m. - 12:30 p.m. PT Section: 10 Track: Tumor Biology Session: Tumor Evolution Models and Technologies Abstract #4305: Analysis of tumor heterogeneity in syngeneic models; CT26.WT colon carcinoma and 4T1-Luc2-1A4 breast carcinoma in female BALV/cAnNHsd mice Date: Tuesday, April 9 Time: 9:00 a.m. - 12:30 p.m. PT Section: 13 Track: Immunology Session: Adoptive Cell Therapies 3: CAR-T Cells Abstract #4002: Investigating CAR-T cell efficacy and activation in the disseminated NALM6-luc human B-cell acute lymphoblastic leukemia model Date: Tuesday, April 9 Time: 9:00 a.m. – 12:30 p.m. PT Section: 2 Track: Clinical Research Session: Predictive Biomarkers 6 Abstract #6443: Enhanced detection of ctDNA molecular response for immunotherapy treated non-small cell lung cancer through analyses of cell-free and matched white blood cell DNA Date: Tuesday, April 9 Time: 1:30 p.m. - 5:00 p.m. PT Section: 44 Track: Clinical Research Session: Adoptive Cellular Therapy 2 Abstract #6334: Metabolic reprogramming enhances expansion and potency of CAR T cells Date: Tuesday, April 9 Time: 1:30 p.m. - 5:00 p.m. PT Section: 40 Track: Tumor Biology Session: Spatial Resolution of the Tumor Microenvironment Abstract #5493: Digital spatial profiling of MC38 colon carcinoma following checkpoint inhibition Date: Tuesday, April 9 Time: 1:30 p.m. - 5:00 p.m. PT Section: 10 Track: Experimental and Molecular Therapeutics Session: Novel Therapeutics and Preclinical Models Abstract #6005: Generation of new oncology cell models through long-term acclimation under hypoxic and hyperbaric culture conditions Date: Tuesday, April 9 Time: 1:30 p.m. - 5:00 p.m. PT Section: 28 Track: Clinical Research Session: Predictive Biomarkers 5 Abstract #6393: The predictive role of TNF-related genes in patients receiving immune checkpoint inhibitors Date: Tuesday, April 9 Time: 1:30 p.m. - 5:00 p.m. PT Section: 43 Track: Prevention/Early Detection/Interception, Population Sciences Session: Biomarker-Based Screening Abstract #6079: Comparison of FIT and ctDNA tests for detection of individuals with colorectal cancer in population-based screening Date: Tuesday, April 9 Time: 1:30 p.m. - 5:00 p.m. PT Section: 31 Track: Clinical Research; Molecular/Cellular Biology and Genetics Session: Immune Checkpoint Inhibitor Therapy Abstract #7526: Landscape of TIGIT and PD-L1 co-expression in solid tumors Date: Wednesday, April 10 Time: 9:00 a.m. - 12:30 p.m. PT Section: 42 About Labcorp Labcorp (NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's more than 67,000 employees serve clients in approximately 100 countries, provided support for 84% of the new drugs and therapeutic products approved in 2023 by the FDA, and performed more than 600 million tests for patients around the world. Learn more about us at . SOURCE Labcorp

▎药明康德内容团队编辑3月29日，中国国家药监局药品审评中心（CDE）官网公示，信达生物IBI310（一款抗CTLA-4单抗）及信迪利单抗（IBI308，抗PD-1单抗）两款产品拟纳入突破性治疗品种，针对适应症为：IBI310联合信迪利单抗用于可切除的高微卫星不稳定性（MSI-H）或错配修复基因缺陷型（dMMR）结肠癌的新辅助治疗。根据信达生物近日发布的新闻稿，IBI310联合信迪利单抗新辅助治疗可切除的MSI-H/dMMR结肠癌（cT4或cN+期）患者的随机、对照、多中心3期临床研究（Neoshot），已经于今年3月完成中国首例受试者给药。截图来源：CDE官网IBI310是信达生物自主研发的重组全人源抗CTLA-4单克隆抗体注射液。该产品能特异性结合CTLA-4，从而阻断CTLA-4介导的T细胞抑制，促进T细胞的激活和增殖，提高肿瘤免疫反应，达到抗肿瘤的效果。信迪利单抗是信达生物和礼来（Eli Lilly and Company）公司共同合作研发的抗PD-1单抗，已经在中国获批七项适应症，涵盖经典型霍奇金淋巴瘤、非小细胞肺癌、肝细胞癌、食管鳞癌、胃癌等。T4和N2是MSI-H/dMMR结肠癌重要的预后指标。研究显示，T4和/或N2的MSI-H/dMMR III期结肠癌3年无病生存率约为60%~65%。因此，对于II-III期MSI-H/dMMR结肠癌患者的围手术期治疗手段急需提高。NICHE研究结果已经证实，局部晚期结肠癌接受“抗CTLA-4单抗+抗PD-1单抗”新辅助治疗，术后病理完全缓解能良好地转化为生存获益。今年3月27日，信达生物宣布Neoshot研究完成首例受试者给药，这是一项探索新辅助免疫组合疗法针对可根治性手术切除MSI-H/dMMR结肠癌的3期临床研究。该研究将对照IBI310联合信迪利单抗新辅助治疗结肠癌，相较根治性手术后辅助化疗的有效性和安全性。研究的主要终点为病理完全缓解率（pCR）和无事件生存期（EFS）。此前，一项在可切除MSI-H/dMMR结肠癌受试者新辅助治疗的随机、对照、多中心1b期研究中，IBI310联合信迪利单抗组pCR率显著高于信迪利单抗单药组；联合治疗组无受试者因不良反应导致无法手术，未增加额外的安全性风险。信达生物新闻稿表示，该1b期研究数据计划在未来学术大会或期刊上公布。据Neoshot研究的主要研究者、中山大学肿瘤防治中心徐瑞华教授此前在新闻稿中的介绍，目前T4和/或N+期结肠癌根治性手术难度大，创伤范围广，部分患者难以达到R0切除，预后较差。FOxTROT研究结果提示，新辅助化疗在MSI-H/dMMR结肠癌中的疗效欠佳，化疗新辅助术后pCR率约5%。因此亟需有效的新辅助治疗手段降低术前分期，减轻肿瘤负荷，缩小根治性手术切除范围，提高R0切除率，从而改善长期预后。IBI310联合信迪利单抗有望成为新的针对可根治性手术切除MSI-H/dMMR结肠癌的新辅助免疫疗法，在1b期研究中已展现出令人鼓舞的疗效和良好的耐受性。参考资料：[1]中国国家药监局药品审评中心（CDE）官网. Retrieved Mar 29 , 2024, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d[2]信达生物IBI310（抗CTLA-4单抗）结肠癌新辅助III期临床研究（Neoshot）完成首例受试者给药. Retrieved Mar 27 , 2024, from https://mp.weixin.qq.com/s/Qw8__dEBAf_haMEd5JvKyg本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转发授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。