Early detection of pancreatic cancer (stages I & II) in high-risk groups is our best chance of saving lives. Three such groups with an increased risk of developing pancreatic cancer that would benefit from improved routine investigation and testing are:
Together with Key Opinion Leaders in the US and Europe, Immunovia has summarized and analyzed existing research on these groups to better define their unmet clinical needs.
Sporadic pancreatic adenocarcinoma (PDAC) occurs worldwide at an approximate frequency of 1 in 10,000 people. The risk of developing PDAC increases with the number of affected family members from 2.3 fold with one to 32 fold with three affected family members. An estimated 5-10% of pancreatic cancers diagnosed have a familial background. Disease prevalence in this group is 1 percent. Immunovia estimates that, in the US, there are between 315,000 and 350,000 individuals with a familial/hereditary risk of pancreatic cancer.
The maximum potential market size, in terms of number of tests assuming twice a year surveillance, today ranges from 630,000 to 700,000 tests annually in the US, following current recommendations and guidelines (press release April 21, 2021).
Familial Pancreatic Cancer (FPC) is a rare syndrome defined as those families with two or more first-degree relatives with pancreatic cancer that do not fulfil the criteria of any other inherited tumour syndrome. FPC appears to be inherited in an autosomal dominant manner and around 15–20% of families carry germline mutations in BRCA2, PALB2 and ATM, although for the majority of families the major underlying genetic defect(s) are unknown. Families present with either a high incidence of only pancreatic cancer or in combination with other cancer syndromes such as breast/ovarian, Peutz Jeghers Syndrome (PJS) and Familial Atypical Multiple Mole Melanoma (FAMMM). Furthermore, patients with hereditary pancreatitis and a germline mutation in PRSS1 have an increased risk of developing PDAC.
Screening and routine testing of this high-risk group offer an opportunity for earlier detection of pancreatic cancer in time for effective treatment.
There are several screening programs running today in reference centers worldwide for high-risk individuals even though screening for pancreatic cancer in the familial/hereditary risk group is not yet part of all national guidelines. However, in Sweden, for example, there are recommendations in the national guidelines for diagnosis of pancreatic cancer for such screening programs: https://www.cancercentrum.se/samverkan/cancerdiagnoser/bukspottkortel/vardprogram/gallande-vardprogram/6.-screening-av-familjar-pankreascancer/ (information in Swedish).
You will also find information about pancreatic cancer and high-risk individuals at the Swedish patient organization PALEMA’s website (information in Swedish).
The early symptoms of pancreatic cancer are often vague, and include back pain, stomach pains, digestive problems, fatigue, unexplained weight loss or onset jaundice. This makes the disease difficult to detect.
On average, it takes 6–9 months and 18 visits to the doctor, before a patient with pancreatic cancer presenting with vague symptoms is actually diagnosed. The delay may cause the patient to go from early stage, treatable to later stage, non-treatable pancreatic cancer.
Thus, patients with early, non-specific symptoms, where the clinicians suspect or want to rule out pancreatic cancer is an important risk group.
Testing for pancreatic cancer in risk groups with early, non specific symptoms with the IMMray™ platform could help clinicians to diagnose the cancer while it is still resectable by surgery, thereby dramatically improving survival rates, and at the same time lowering healthcare costs.
Immunovia has a great opportunity to establish the IMMray™ platform, through potential collaboration with so-called (rapid) diagnostic centers, in Scandinavia as well as the United Kingdom for the purpose of promoting an earlier diagnosis of cancer in healthcare.
In order to influence medical practice and national guidelines, Immunovia is working actively on a global basis with Key Opinion Leaders (KOL) (read more about PanSYM-1). The goal is to achieve routine testing of patients with early, non specific symptoms were the clinician suspects – or wants to rule out – pancreatic cancer.
Patients with vague non-specific symptoms are usually examined in primary care and disease prevalence in this group is 2-3%. The number of new high-risk patients with vague symptoms is estimated at 1-2 million patients annually in the United States and Europe.
Researchers have been looking for the link between pancreatic cancer and diabetes for many years, and while we still cannot explain it fully, we can say that diabetes is associated with pancreatic cancer.
Diabetes is found in approximately 50% of patients newly diagnosed with pancreatic cancer. And while innate diabetes type I is not a cause of pancreatic cancer, diabetes type II may indeed be an early symptom of pancreatic cancer.
In fact, a diagnosis of diabetes type II after the age of 50 years is associated with a 6-8 times higher risk of developing pancreatic cancer within 1-3 years. This high-risk group is called New Onset Diabetes type II (NOD). About 1% of these patients go on to develop pancreatic cancer within 3 years. Patients need to be monitored by tests twice a year for 2-3 years. If we can find them in time by screening, healthcare has a chance to offer them treatment that is far more likely to improve their survival chances.
The market for screening of NOD from the age of 50 years is estimated to approximately 3,000,000 patients annually in Europe and the United States.
The National Cancer Institute has estimated that the number of new diabetic patients over 50 years amounts to approximately 1.4 million annually, in the United States alone.