Early gastric cancer

AUSTIN, Texas & MENLO PARK, Calif.--( BUSINESS WIRE )-- Curative Insurance Company , a pioneering healthcare services company, and GRAIL , LLC, a healthcare company whose mission is to detect cancer early when it can be cured, today announced the availability of Galleri®, a multi-cancer early detection (MCED) screening test to eligible insurance plan members. The Galleri test will be available to all members, across all plan types, who are over the age of 50 and to all other members with risk factors for developing cancer. 1 The Galleri test is part of the expansive list of benefit offerings available for $0 copay and $0 deductible* on Curative's health insurance plan. A simple blood draw used in addition to current single-cancer screenings, Galleri can identify DNA shed by cancer cells to help screen for some of the deadliest cancers that don’t have recommended screening today, such as pancreatic, esophageal, ovarian, liver and others. Studies have shown a 75% sensitivity for screening cancers responsible for two-thirds of cancer deaths, rising as high as 80% for the most serious cancers. Galleri can indicate the origin of the cancer with 88% accuracy, giving doctors a roadmap for where to explore further. 2, 3, 4 “We are excited to be working with GRAIL and proud to offer Curative health plan members the groundbreaking Galleri test that is truly key in helping detect cancer early on for our members,” said Fred Turner, CEO and Co-founder of Curative. “Preventive care is at the core of our health insurance plan, and the Galleri test may allow qualified members to screen for potential cancer early, before any symptoms appear when it may be more easily treated and potentially curable. This is not just about early detection; it's also about empowering our members with the tools to be proactive with their health. Curative's partnership with GRAIL is a testament to our commitment to preventive care and the well-being of our members.” “Single-cancer screenings play an important role in detecting five specific cancers today. However, nearly 70% of deaths are caused by cancers that don’t have recommended screenings,” said Bob Ragusa, CEO at GRAIL. “By providing the Galleri test to eligible health insurance members, Curative is helping to screen for the deadliest cancers that often come with no warning today, demonstrating their commitment to preventative and proactive care.” Curative members eligible for Galleri may request the test through an independent telemedicine provider at Galleri.com/curative . Curative’s health insurance plan includes an annual preventive care visit called the Baseline Visit, where members get the opportunity to speak with a Curative clinician about their overall health. In addition, plan members are assigned a personal Healthcare Navigator, who walks members through health plan benefits and onboard members, setting up a roadmap for whole health and showing the member their 24/7 telemedicine plan feature. Curative’s unique $0 copay, $0 deductible plan* offers comprehensive coverage, encompassing wellness, preventive care, behavioral health services, primary and specialty care, office and hospital visits, prescription drugs, and all accessible through a high-quality PPO network at competitive monthly premiums. The Curative plan is currently available to employers headquartered in Texas and Florida with 50 or more eligible employees nationwide, with broad national network coverage and access to almost 1 million providers nationwide. To learn more about Curative's revolutionary health insurance plan and how it can benefit employers and employees alike, visit https://curative.com/ . ​​* Every Curative member qualifies for the $0 deductible, $0 copay for in-network care and preferred prescriptions by completing a Baseline Visit within 120 days of the plan effective date. See https://curative.com to learn more. Curative Insurance Company PPO. GA240129-1. About Curative Curative is a leading healthcare services company that has created and launched a first-of-its-kind employer-based health insurance plan with an AM-Best rating of A-. Co-founded by CEO Fred Turner and CTO Isaac Turner (no relation) in 2020, Curative is reengineering health insurance by providing unmatched simplicity and cost transparency with a competitive monthly premium and zero additional costs*. Curative is remaking our healthcare system into one that works for and supports members’ whole health and well-being through every step of their personal health journey. Previously, Curative and its managed medical entities were national leaders bringing COVID-19 testing and vaccine-administration resources to bear in response to the pandemic. For more information on Curative, visit https://curative.com/ or follow us on Facebook , Instagram , Twitter , or LinkedIn . 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 developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. 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. For more information, please visit grail.com . About Galleri® The Galleri multi-cancer early detection test is a proactive tool in finding cancer early. With a simple blood draw, the Galleri test can identify DNA shed by cancer cells (unique “fingerprints”) 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. It is recommended for people over the age of 50, or those with an elevated risk for cancer due to genetics, family history, environmental exposure, or other risk factors. For more information about Galleri, visit galleri.com . **Editor’s note: Sensitivity in study participants with - Liver/bile duct cancer: 93.5% overall (100% stage I, 70.0% stage II, 100% stage III, 100% stage IV). Esophagus cancer 85.0% overall (12.5% stage I, 64.7% stage II, 94.7% stage III, 100% stage IV). Pancreas cancer: 83.7% overall (61.9% stage I, 60.0% stage II, 85.7% stage III, 95.9% stage IV). Ovary cancer: 83.1% overall (50.0% stage I, 80.0% stage II, 87.1% stage III, 94.7% stage IV). 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. Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “Cancer Signal Not 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. 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. 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. References https://www.galleri.com/what-is-galleri/multi-cancer-early-detection Klein EA, Richards D, Cohn A, et al. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann Oncol. 2021;32(9):1167-1177. Doi: 10.1016/j.annonc.2021.05.806. American Cancer Society. Cancer Facts & Figures. 2021. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2021/cancer-facts-and-figures-2021.pdf . Schrag D, Beer TM, McDonnell CH, et al. Blood-based tests for multi-cancer early detection (PATHFINDER): a prospective cohort study. Lancet. 2023;402:1251-1260. doi: 10.1016/S0140-6736(23)01700-2.

Scientists have decoded critical genetic factors in intestinal metaplasia patients, shedding light on early signs and prevention strategies for stomach cancer -- often a 'ticking time bomb' as patients experience no or only mild symptoms in the early stages. In a breakthrough study published in the journal Cancer Cell, researchers have decoded critical genetic factors in intestinal metaplasia patients, shedding light on early signs and prevention strategies for stomach cancer -- often a "ticking time bomb" as patients experience no or only mild symptoms in the early stages. Intestinal metaplasia, which is a change in the cells of the mucous membrane lining the stomach that often stems from chronic gastritis and manifests with symptoms akin to acid reflux, is also a sinister link to stomach cancer. Individuals afflicted with intestinal metaplasia cells face a sixfold increased risk of succumbing to this lethal cancer. In Singapore alone, stomach cancer ranks as the fourth leading cause of cancer deaths in men and the fifth among women, claiming 300 to 500 lives annually, largely due to late detection. Two thirds of stomach cancer patients are only diagnosed at an advanced stage. Unveiling early indicators through collaborative breakthrough research The longitudinal study, which represents the world's largest genomic survey of patients with intestinal metaplasia, examines more than 1,100 tissue samples using powerful technologies such as single-cell RNA sequencing and spatial transcriptomics*. Based on this extensive survey, researchers identified 26 'driver genes' that play a pivotal role in the transition to stomach cancer. This landmark finding provides a glimpse into the mechanisms governing the transformation and offers a critical window for early detection and targeted prevention. "Advances in DNA sequencing have made it possible for us to uncover diverse cell populations within these stomach changes, hinting at their potential transformation into cancerous cells influenced by various factors. It's akin to understanding the ticking mechanism of a time bomb," explained Dr Huang Kie Kyon, co-first author and Senior Research Fellow with the Cancer & Stem Cell Biology Programme at Duke-NUS Medical School (Duke-NUS). Professor Patrick Tan, Senior Vice-Dean for Research at Duke-NUS and a professor with the School's Cancer & Stem Cell Biology Programme said: "The comprehensive dataset we've assembled provides unprecedented insights into the progression of cell changes in the stomach to cancer. By using both clinical information and genetic data from advanced molecular technologies, we can better predict which stomach conditions might turn into stomach cancer compared to using only clinical information. This can help in the development of new and more precise ways to prevent and stop stomach cancer." Prof Tan is also a member of the Genome Institute of Singapore, Cancer Science Institute of Singapore, and Precision Health Research Singapore (PRECISE). The multi-institutional effort by researchers from Duke-NUS, National University Hospital (NUH), National University of Singapore's Yong Loo Lin School of Medicine (NUS Medicine) and Seoul National University Hospital reflects the strengths of Singapore's multi-institutional cancer research ecosystem and its strong links with global partners. This study was supported by the Singapore Gastric Cancer Consortium (SGCC), a national translational research group comprising clinicians and scientists working in stomach cancer research from academic medical centres, universities, hospitals and research institutes across Singapore. The published work is derived from the prospective Gastric Cancer Epidemiology Programme cohort. The study offers clues into whether intestinal metaplasia cells directly transform into stomach cancer. It was revealed that a subpopulation of intestinal stem-like cells in patients with intestinal metaplasia closely resembles early stomach cancer cells, pointing to a possible early origin and potential of its malignant future. This discovery highlights the importance of screening for intestinal metaplasia in managing stomach cancer risk. Co-senior author Professor Jimmy So, Head & Senior Consultant, Division of General Surgery (Upper Gastrointestinal Surgery), NUH commented on the clinical implications: "This molecular roadmap of disease progression from intestinal metaplasia offers many translational opportunities. We can now explore more targeted surveillance for patients at highest risk, as well as anti-inflammatorial or antibiotic agents to intercept premalignant clones before they evolve into cancer, potentially leading to improved patient outcomes through early detection." He is also a professor at the Department of Surgery, NUS Medicine. More efficient and targeted preventive measures for populations At the population level, the findings hold promise for refining screening strategies and allocating resources more effectively to intercept the development of gastric cancer in high-risk individuals, ultimately contributing to more efficient and targeted preventive measures. This is especially relevant in countries such as Singapore, where the incidence of stomach cancer is moderate compared to Japan and South Korea where stomach cancer incidence is high enough to warrant mass screening. "Encouragingly, our results revealed that combining genomic data with clinical check-ups can make predictions about stomach cancer more accurate. This means we might use genetic tests, including simple and inexpensive blood tests, to identify people who are at a very high risk of getting stomach cancer. With this approach, we can divide people into groups based on their risk using either regular check-ups or these affordable blood tests. This helps to save resources by making sure those at the highest risk get the right tests and care they need," added Professor Khay Guan Yeoh, Lead Principal Investigator of the Singapore Gastric Cancer Consortium and Senior Consultant in the Division of Gastroenterology & Hepatology, National University Hospital. Prof Yeoh is also the Kishore Mahbubani Professor in Medicine and Health Policy, Department of Medicine, NUS Medicine. Senior author Associate Professor Chung Hyunsoo from Seoul National University Hospital stressed the clinical ramifications: "This breakthrough may refine screening protocols, enabling early interventions for high-risk patients, while sparing others unnecessary procedures." The research was funded by the Open Fund-Large Collaborative Grant that is supported by the National Research Foundation, Singapore and administered by the Singapore Ministry of Health's National Medical Research Council. The team also received support from Singapore's Ministry of Education, Cancer Science Institute of Singapore under the National University of Singapore and the Francis Crick Institute. In addition, the project could not have been made possible without the contributions of researchers from Tan Tock Seng Hospital, Singapore General Hospital, Changi General Hospital, Nihon University School of Medicine, Yonsei University Wonju College of Medicine and The Chinese University of Hong Kong. * Single-cell RNA sequencing (scRNA-seq) is a powerful technology that allows scientists to study individual cells' genetic material (RNA) one cell at a time. Spatial transcriptomics is another technique used to study gene expression in tissues but with an added dimension of spatial information. It allows scientists to see where specific genes are being expressed within tissues or organs, providing insight into the organisation and communication between cells in their actual location within the tissue.

Domvanalimab is the only FC-silent anti-TIGIT antibody in phase 3 trials for upper gastrointestinal adenocarcinomas. In another sign that anti-TIGIT antibodies may yet live up to some of the hype, Gilead Sciences has unveiled preliminary data showing that its Arcus Biosciences-partnered candidate domvanalimab is effective against gastric cancers in combo with Arcus’ anti-PD-1 drug. The early readout comes from the first arm of the EDGE-Gastric study, which is investigating various combinations of domvanalimab with the anti-PD-1 antibody zimberelimab as well as chemotherapy in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma. As of Sept. 4, there was an overall response rate of 80% among the 15 patients enrolled so far with PD-L1-high tumors who received a domvanalimab-containing regimen, Gilead reported. This dropped to 46% among the 24 patients with PD-L1-low tumors. There were two confirmed complete responses in the trial at that point. The progression-free survival (PFS) rate was 93% among patients in the PD-L1-high group and 68% among the low cohort, Gilead added. Median PFS was not reached, and the Big Pharma is expecting to report mature data on that metric in the second half of next year. Domvanalimab is the only FC-silent anti-TIGIT antibody in phase 3 trials for upper gastrointestinal adenocarcinomas, pointed out Gilead, which harbors hopes of the drug being the first TIGIT to market for these cancers. FC receptors are found on the cell surface and contribute to the protective functions of the immune system by binding to antibodies that are attached to infected cells or invading pathogens. TIGITs are broadly split into those that have an FC receptor function—such as Roche’s tiragolumab —and those that have mutated out the receptor function, like domvanalimab. “These data add to the growing body of evidence that domvanalimab, an FC-silent anti-TIGIT antibody, has a differentiated safety and tolerability profile relative to published data from studies with FC-enabled anti-TIGIT antibodies,” Gilead said in the postmarket release yesterday. “These early data are encouraging and indicate the potential for the anti-TIGIT, domvanalimab-based therapy to improve upon anti-PD-1 and chemotherapy in this setting, with a similar safety profile to anti-PD-1 and chemotherapy,” said Memorial Sloan Kettering Cancer Center’s Yelena Janjigian, M.D., a principal investigator for study, in the release. The preliminary data support an ongoing phase 3 study of the combo in unresectable or metastatic upper gastrointestinal cancers, the Big Pharma said. Various domvanalimab-containing regimens are also undergoing three separate lung cancer studies where they are going head-to-head with the likes of Merck & Co’s blockbuster Keytruda. While still early days, Gilead and Arcus’ readout marks another promising clinical development for a once-hyped class of potential medicines that was knocked off track by a pair of phase 3 failures for Roche’s TIGIT tiragolumab in lung cancer last year. Since then, tiragolumab has shown some promise in liver cancer, while Gilead and Arcus’ domvanalimab-zimberelimab combo was found to induce a 33% reduction in the risk of disease progression compared to zimberelimab alone. Still, other Big Pharmas have withdrawn from the space. Bristol Myers Squibb recently terminated an anti-TIGIT from its phase 2 pipeline, while Novartis handed back ociperlimab to BeiGene in the summer.