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Watch the full symposium recording and be inspired by the voices leading the way.
We were disappointed to learn that the Galleri multi-cancer early detection (MCED) test, developed by GRAIL, did not meet the primary endpoint in its large randomized trial conducted in partnership with the National Health Service (NHS).¹
The study was designed to determine whether use of the Galleri test could shift cancer diagnoses from late stage (stage III/IV) to earlier stage (stage I/II) disease in a screened population.² While the trial did not meet this primary endpoint, investigators reported a shift from stage IV to stage III cancers in the Galleri arm.³
Only limited high-level results have been released publicly. Without more detailed data—including performance by tumor type, sensitivity by stage, interval cancer rates, and downstream clinical outcomes—it is not yet possible to determine whether the findings reflect limitations of the study design, the test itself, implementation factors, or broader challenges inherent to MCED approaches. There is currently no public information on outcomes by individual cancer type, so we cannot assess whether certain cancers may have benefited more than others.
WHAT THIS MEANS FOR CANCER SCREENING
These results underscore the difficulty of developing and validating cancer screening tests. Early validation studies suggested that circulating tumor DNA–based approaches could detect multiple cancers, but demonstrating meaningful stage shift in a real-world population requires very large, long-duration trials. In this case, approximately 142,000 participants were followed over three years.²
Large-scale prospective studies are essential to determine whether earlier detection meaningfully changes stage at diagnosis and, ultimately, patient outcomes.
The findings also draw attention to the current regulatory landscape in the United States, where some assays are offered as laboratory-developed tests (LDTs) and may be marketed prior to completion of large, randomized trials demonstrating clinical utility.⁴ Prospective validation remains critical for evaluating any screening intervention.
BIOLOGICAL CHALLENGES OF BLOOD-BASED MCED TESTS
Blood-based MCED tests rely on detecting very small amounts of tumor-derived material shed into circulation. For very small or early lesions, particularly in biologically aggressive cancers, circulating tumor DNA levels may be extremely low. This has long been recognized as a potential limitation of tumor DNA–based detection—especially for cancers such as pancreatic cancer, where tumors can progress rapidly even when small.
Lustgarten’s early detection strategy is intentionally broader. In addition to tumor-derived signals, we support research focused on detecting amplified host responses to early tumors or precancerous changes. These include immune and inflammatory signatures, systemic metabolic alterations, and structural or microenvironmental changes within the organ itself. Such signals may be more robust and detectable earlier than tumor DNA alone.
LOOKING AHEAD
No single approach is likely to solve early detection across all cancer types. Progress will require continued biological insight, technological innovation, and rigorous prospective validation. We remain committed to advancing foundational research on disease initiation and progression alongside novel detection strategies that have the potential to identify pancreatic cancer at its earliest, most treatable stages.
These results should not be generalized to other multi-cancer early detection tests currently in development, as technologies, targets, and validation strategies differ. Each platform must ultimately be evaluated based on its own prospective clinical evidence.
Footnotes
- GRAIL announcement regarding NHS-Galleri trial results (2025).
- NHS-Galleri trial: randomized study of approximately 142,000 participants evaluating stage shift in a screening population, conducted in partnership with the National Health Service.
- Public summary statements reporting a shift from stage IV to stage III diagnoses in the intervention arm, though not meeting the predefined primary endpoint of increased stage I/II detection.
- U.S. Food and Drug Administration regulatory framework regarding laboratory-developed tests (LDTs).
While cancer mortality rates in the United States have steadily declined over recent decades, a group of recalcitrant cancers remains stubbornly lethal. For diseases like pancreatic, ovarian, and upper GI cancers, the primary barrier to survival is not just the biology of the tumor, but the timing of the diagnosis.
To combat this pressing issue, the Lustgarten Foundation, in partnership with The Mark Foundation for Cancer Research, the American Association for Cancer Research (AACR), Break Through Cancer, and The Honorable Tina Brozman Foundation (Tina’s Wish), has launched a new coalition committed to solving one of the most urgent challenges in cancer care: detecting deadly cancers earlier, before symptoms appear and treatment options narrow. The coalition will invest in highly collaborative research teams developing new approaches to the early detection and diagnosis of pancreatic, ovarian, and esophageal cancers, as well as cancer predisposition syndromes.
These cancers are among the hardest to detect early—and the most lethal as a result.
WHY EARLY DETECTION MATTERS
Pancreatic, ovarian, and esophageal cancers often grow silently in their earliest stages. By the time symptoms appear, disease has frequently spread, limiting treatment options and contributing to persistently low survival rates.
For pancreatic cancer in particular, the stakes could not be higher. The five-year survival rate remains just 13%, largely because most patients are diagnosed too late.
Existing screening tools have not been sufficient. Meaningful progress will require new biological insights, advanced technologies, and unprecedented collaboration across disciplines—exactly what this coalition was built to deliver.
A NEW MODEL FOR PROGRESS
This initiative represents a shift in how early detection research is funded and advanced. Rather than working in silos, the coalition aligns strategy, funding, and expertise to accelerate solutions no single organization could achieve alone.
The effort builds on a scientific workshop convened in early 2025 by AACR, the Lustgarten Foundation, and The Mark Foundation, which brought together researchers from around the world to identify the most pressing gaps—and the most promising opportunities—in early detection science.
Together, the coalition is creating a global early detection ecosystem designed to move discoveries faster from the lab toward patients.
“Pancreatic cancer alone has a five-year survival rate of just 13%, largely due to late detection,” said Linda Tantawi, CEO of the Lustgarten Foundation. “Early detection research is a promising frontier that could give doctors and patients the time and options they need to drastically improve outcomes for some of the deadliest cancers.”
FUNDED RESEARCH PROJECTS
The coalition has awarded up to $2 million each to six collaborative research teams tackling critical barriers to early cancer detection, including two projects with a strong focus on KRAS-driven cancers, a hallmark of pancreatic cancer:
Programmable Recognition of KRAS Neoantigens for Early Cancer Diagnostics Across Patients
Nikolaos G. Sgourakis, PhD, Children’s Hospital of Philadelphia and University of Pennsylvania; Mark A. Sellmyer, MD, PhD, University of Pennsylvania; Possu Huang, PhD, Stanford University
Detection and Interception of KRAS-mutant Pancreatic Cancer Using Small Molecule RAS(ON) Inhibitors
Brian M. Wolpin, MD, MPH, and Andrew J. Aguirre, MD, PhD, Dana-Farber Cancer Institute; Julie L. Sutcliffe, PhD, University of California, Davis; Laura D. Wood, MD, PhD, Johns Hopkins University
Towards a Unified Platform for Li-Fraumeni Syndrome Cancer Risk Prediction and Cell-free DNA Surveillance
Trevor J. Pugh, PhD, Princess Margaret Cancer Centre, UHN, Ontario Institute for Cancer Research; Brian D. Crompton, MD, Dana-Farber Cancer Institute; Paul A. Northcott, PhD, St. Jude Children’s Hospital; Kara N. Maxwell, MD, PhD, University of Pennsylvania
Digital Pathology Diagnostics for Robust Stratification of Esophageal Cancer Risk
Christina Curtis, PhD, and Greg Charville, MD, PhD, Stanford University; William M. Grady, MD, University of Washington; Rebecca Fitzgerald, MD, University of Cambridge
Molecular Profiling of Ovarian Cancer Precursors to Transform Early Detection and Precancer Stratification
Peter K. Sorger, PhD, David R. Walt, PhD, and Sandro Santagata, MD, PhD, Harvard University; Ronny I. Drapkin, MD, PhD, University of Pennsylvania
Harnessing Extrachromosomal DNA (ecDNA) and Aneuploidy Signals in Plasma Whole Genome for Early Detection of Ovarian Cancer
Dan Landau, MD, PhD, Weill Cornell Medicine; Ronny I. Drapkin, MD, PhD, University of Pennsylvania; Paul S. Mischel, MD, FAACR, Stanford University; Adam Widman, MD, Memorial Sloan Kettering Cancer Center
Additional funded projects address ovarian cancer, esophageal cancer, and inherited cancer risk syndromes using approaches such as digital pathology, whole-genome plasma analysis, and molecular profiling of cancer precursors.
LOOKING AHEAD
At the Lustgarten Foundation, we believe time is everything—and early detection has the power to give patients more of it.
By joining forces with visionary partners and supporting bold, high-risk science, this coalition aims to change what’s possible for patients facing cancers that have gone undetected for far too long.
Learn more about the coalition and funded projects here.
The American Cancer Society has released its Cancer Facts & Figures 2026—and for pancreatic cancer, the story is not one of progress. It is an alarm we can no longer ignore.
The five-year relative survival rate remains stuck at just 13%. Incidence continues to rise. And for tens of thousands of families, the outcome remains heartbreakingly predictable.
In 2026 alone, an estimated 67,530 Americans will be diagnosed with pancreatic cancer. Approximately 52,740 will die. Pancreatic cancer is now the third leading cause of cancer-related death among both U.S. men and women—behind only lung and colorectal cancers—despite accounting for just 3% of all cancer diagnoses.
This crisis has been building for decades.
- Incidence has increased by about 1% per year since the 1990s
- The five-year survival rate has shown no meaningful improvement year over year
- Only 17% of patients are diagnosed at a localized stage, where five-year survival is 44%—a figure that has also remained largely unchanged
While overall cancer death rates in the United States continue to decline, pancreatic cancer has been left behind. Late diagnosis, limited effective therapies, and chronic underinvestment in research mean most patients are diagnosed with too little time—and far too few options.
This is unacceptable.
These statistics demand more than attention. They demand urgency: more innovation, more resources, more treatment options, and more time for patients. Pancreatic cancer patients cannot wait for incremental progress. With survival flatlined year after year, the need to accelerate bold, transformative research has never been clearer.
That is why the Lustgarten Foundation remains steadfast in its mission to change the trajectory of this disease. We are advancing the most promising science across early detection and interception, therapeutic development, and personalized medicine—areas where progress can fundamentally alter outcomes and quality of life.
At the forefront of this effort is ourLABS (Lustgarten Advancing Breakthrough Science) Program, which provides sustained, long-term funding to fuel high-risk, high-reward ideas, accelerate discovery, and bring interdisciplinary teams together to tackle the hardest problems in pancreatic cancer. Across our broader research portfolio—including the Innovation and Collaboration Program,Lustgarten Equity, Accessibility, and Diversity (LEAD) Project, Clinical Accelerator Initiative (CAI), and Therapeutics-Focused Research Program—we are moving with focus, rigor, and speed to deliver impact where patients need it most.
“This year’s ACS Facts & Figures report underscores our responsibility to do better for pancreatic cancer patients and their families,” said Linda Tantawi, CEO of the Lustgarten Foundation. “An estimated 185 people will be diagnosed today—and every day this year. They deserve more options, more time, and real hope. Together, we have the power to accelerate progress and deliver life-saving breakthroughs.”
But philanthropy alone is not enough. To deliver the breakthroughs patients urgently need, pancreatic cancer research must receive greater and sustained federal funding that reflects the disease’s disproportionate mortality. Policymakers must act, so scientists have the resources to accelerate discovery, expand clinical trials, and save lives.
The data are clear. The stakes could not be higher.
Patients deserve MORE—and they deserve it now.
Join us. Advocate. Give. Help transform pancreatic cancer into a curable disease.
How our Bold Research Strategy, Visionary Scientific Leadership, and Powerful Community Advanced Progress in 2025
With your support, 2025 was a pivotal year for Lustgarten —accelerating pancreatic cancer research and laying groundwork to transform patient outcomes. WATCH the latest LustgartenLIVE! webinar for insights on key breakthroughs and what’s ahead.
This year, the cost of cancer was unmistakably clear. Behind every statistic is a life, and behind every loss is a story that sharpens our resolve to transform pancreatic cancer into a curable disease for patients and their families. We lost individuals whose lives shaped medicine, culture, and public understanding, losses that demand more than remembrance. They demand urgency, action, and measurable progress for those still waiting.
We honor the lives of four remarkable individuals whose passing in 2025 moved our community and reinforced why this work cannot slow.
JUDGE FRANK CAPRIO, CHAMPION OF JUSTICE AND COMPASSION
Judge Frank Caprio, beloved for his decades of service on the Rhode Island bench, passed away from pancreatic cancer on August 20, 2025. He left behind a legacy defined by fairness, empathy, and unwavering commitment to the people he served. Known for his compassionate approach to justice, he inspired not only those who appeared in his courtroom but also communities across the nation who admired his humanity and integrity.
Judge Caprio’s life reminds us that leadership, in any form, can be a force for good, creating systems of care, understanding, and accountability.
DR. MICHAEL J. ZINNER, SURGEON, INNOVATOR, PANCREATIC CANCER ADVOCATE
Dr. Michael J. Zinner was a visionary leader and cherished friend – a pioneering pancreatic and hepatobiliary surgeon whose leadership advanced both clinical care and scientific discovery. As Founding CEO and Executive Medical Director of the Miami Cancer Institute, Dr. Zinner reimagined what cancer treatment could be, combining surgical excellence with compassionate, patient-centered care.
After losing his beloved wife, Ronny, to pancreatic cancer, Dr. Zinner became a passionate advocate for research and better outcomes for patients and families. When pancreatic cancer came into his own life, he faced it with courage, grace, and humility, the same qualities that defined his decades of service and mentorship.
Dr. Zinner’s legacy includes not just breakthroughs in surgical practice, but also the countless clinicians and scientists he mentored, those who carry forward his commitment to excellence and hope.
D’ANGELO (MICHAEL EUGENE ARCHER), MUSIC PIONEER AND SOUL ICON
In October 2025, the world lost D’Angelo, a transformative voice in modern music whose artistry reached millions. Known for groundbreaking albums including Brown Sugar, Voodoo, and Black Messiah, D’Angelo helped define a generation of soul and R&B with depth, musicality, and soul.
His music transcended genre and time, and his influence will live on through the artists he inspired and the fans who found comfort, rhythm, and truth in his songs.
TATIANA SCHLOSSBERG, JOURNALIST, STORYTELLER, MOTHER
On December 30, 2025, Tatiana Schlossberg – American journalist, author and beloved daughter, wife and mother – passed away at the age of 35 after a courageous battle with acute myeloid leukemia. Her family announced her death with the heartfelt words: “Our beautiful Tatiana passed away this morning. She will always be in our hearts.”
Tatiana was an incisive and compassionate voice in journalism, telling stories that illuminated science, environment and the world around us. In November, she published a deeply personal essay in The New Yorker, sharing her leukemia diagnosis and reflecting on the challenges of facing a life-threatening illness while raising young children and advocating for truth in science and public health.
Her honesty, insight, and courage resonated with many, especially those who know the toll that cancer and other serious diseases take on families. We grieve her loss, and we amplify her voice as one that reminded us why science, medical research, and community support are essential.
CARRYING THEIR LEGACY FORWARD
In 2025, an estimated 67,440 Americans were diagnosed and nearly 52,000 were projected to die from pancreatic cancer – a disparity we refuse to accept. For more than 25 years, the Lustgarten Foundation has led bold, collaborative research to detect the disease earlier, develop better treatments, and move the field toward cures. Our work continues in labs, clinics, and communities, driven by the belief that loss should never be inevitable.
We honor the legacies of Judge Frank, Dr. Zinner, D’Angelo, and Tatiana Schlossberg by turning remembrance into action – prioritizing science, standing up for research, and fueling the discoveries that will change what’s possible for patients and families. Together, we will make 2026 a transformative year, turning ideas into insights and hope into life-saving progress.