Earlier Detection – Led By Lustgarten
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Lustgarten Foundation-funded science has been a driving force in every major advancement in pancreatic research. We can confidently claim this because the Foundation played a pivotal role in funding the basic science of pancreatic cancer and laid the groundwork for research to follow, including studies on earlier detection.
One such Lustgarten-funded study was a 2007 multi-million-dollar grant to Bert Vogelstein, PhD, Director of the Ludwig Center, and a Howard Hughes Medical Institute investigator at The Johns Hopkins Medical School and Kimmel Cancer Center, who was working to sequence the genome of pancreatic cancers. The findings, published the following year, were hailed by the prestigious journal Science as one of the top three “Breakthroughs of the Year.” Dr. Vogelstein and his colleagues then used sequencing data of early lesions in the pancreas to develop a blood test capable of detecting early cancer markers. In 2009, the Foundation funded the development of CancerSEEK, a multi-cancer blood test using circulating tumor DNA and proteins released by tumors to detect disease even before a tumor has developed.
The team at Hopkins first tested CancerSEEK on blood from patients known to have early-stage cancers. In 2018, the Lustgarten Foundation Dedicated Pancreatic Cancer Research Laboratory at Johns Hopkins, led by Dr. Vogelstein, published the findings from this retrospective study. The results showed a greater than 99% specificity, meaning the test will return a false-positive result on less than one out of 100 samples. High sensitivity is essential for screening tests to avoid subjecting patients to unnecessary, invasive follow-up. The median overall sensitivity, or the ability to find cancer, was 70% for all cancers combined and 72% for pancreatic cancer. These results, plus the lack of an effective detection test for pancreatic and ovarian cancers, led the FDA to give Breakthrough Device Designation for these diseases, potentially accelerating its availability for patients.
“An Ounce of Prevention is Worth a Pound of Cure.”
Dr. Vogelstein applies Ben Franklin’s “ounce of prevention” adage to cancer to demonstrate the importance of cancer before it develops.
For example, the death rate from heart disease has plummeted over the past 60 years, thanks in part to research focused on warning signs recognition and prevention. Today, there are significantly fewer cardiac events due to preventative efforts. The death rates from cancer are decreasing, but much less significantly, and cancer research historically has focused on treating advanced diseases.
According to the National Cancer Institute, pancreatic cancer’s high mortality rate is due primarily to it being detected at an advanced stage, when surgical intervention is not an option due to metastasis, and chemotherapy and radiation are only somewhat effective. Despite being relatively rare in the United States, the incidence of pancreatic cancer is increasing, and the disease is the third-leading cause of cancer-related deaths. By the end of the decade, pancreatic cancer is projected to become increase to the second-leading cause of cancer death behind lung cancer.
Detecting Cancer in Healthy Individuals?
A prospective interventional study was completed to determine CancerSEEK’s ability to detect cancer in healthy individuals and the findings were published in the journal Science in April 2020. When the blood test was administered in a real-world setting, it more than doubled the number of cancers first identified through screening methods. This study showed it is possible for a blood test to detect cancers, including early cancers, in individuals with no history of cancer.
In January 2021, CancerSEEK was acquired by Exact Sciences, a leader in cancer diagnostics, to bring the test to market. Exact Sciences brings its unique experience in launching Cologuard®, the first and only FDA-approved multi-target stool DNA test for detecting colorectal cancer and precancer covered by Medicare. To secure FDA approval, Exact Sciences will launch a registration trial for CancerSEEK designed to obtain sufficient data and results to support regulatory approval.
The Ultimate Goal
According to Dr. Vogelstein, “Currently, far fewer than 20% of cancers are detected in the U.S. by screening. More than 80% are detected by signs and symptoms when it’s often too late for effective treatment. It is reasonable CancerSEEK will help move that 20% to 75% of cancers detected through screening—50% by liquid biopsies and 25% by conventional methods.” He notes, “The earlier the cancer is detected, even if it’s not early enough to be cured by surgery, the more likely conventional therapies can have positive outcomes for a patient.”
Other Early Detection Tests
A growing number of companies are refining blood tests to detect many kinds of cancers. The two tests available in the U.S. are GRAIL’s multi-cancer early detection test, Galleri™, and Immunovia, Inc.’s, IMMray® PanCan-d test for people at higher risk of pancreatic cancer.
In June 2021, GRAIL announced the results of their study, which analyzed 6,629 individuals aged 50 years or older with no suspicion of active cancer. This test looks at DNA methylation patterns in patient blood samples to detect cancer and predict cancer origin. In the interim analysis, an earlier version of Galleri™ accurately detected 29 cancers across 13 types. Participants will continue to be followed for 12 months, with final results expected in the first half of 2022.
The NHS-Galleri Study is open for enrollment by invitation from the National Health Service (NHS) in England. NHS is inviting 140,000 volunteer participants aged 50-77 who have not been diagnosed or treated for cancer in the last three years and live in one of the areas where the trial is active. Results from the trial will help determine if Galleri™ becomes part of routine cancer screening in England.
GRAIL’s multi-cancer early detection test, Galleri™, was made available in the U.S. in June 2021 when ordered by a healthcare provider. The Galleri™ test has not been cleared or approved by the FDA. Instead, its performance characteristics were determined by GRAIL. The Galleri test is not currently covered by insurance and costs $949.
Immunovia, Inc. announced in August 2021 that it had received final approval to begin patient testing for the IMMray® PanCan-d test, the first blood test on the market dedicated solely to the early detection of pancreatic cancer. This approval was received from the Massachusetts Department of Public Health. The IMMray® PanCan-d test is the first product developed from Immunovia’s proprietary immunoproteomics-based technology platform, IMMray®, that measures the immune system’s response to diseases in the blood.
In a validation study presented in March, early stage (stages I and II) pancreatic ductal adenocarcinomas were detected with 99% specificity and 89% sensitivity in familial/hereditary risk group cohorts. To date, there has not been a prospective test on healthy individuals. The test is currently available in all states, except for NY, RI, MD, PA and CA and is intended only for individuals at high risk for developing familial or hereditary pancreatic cancer. The IMMray® PanCan-d test is not FDA approved, is not yet covered by insurance and costs $995. Consult with your healthcare provider before determining which early detection method may be most appropriate for you or your loved one.
Much of this blog is based on Dr. Vogelstein’s presentation in LustgartenLIVE! Early Detection: The Path Forward held on April 21 and available on YouTube.