LUND, SWEDEN – Immunovia today announced results from the PanFAM-1 study. The PanFAM-1 study is a prospective, multi-center, investigational study, designed to assess the performance of the IMMray™ PanCan-d test in early detection of pancreatic ductal adenocarcinoma (PDAC) in high-risk populations. The IMMray PanCan-d test met its primary endpoint of test specificity comparable to imaging in the study. Sensitivity, however, could not be evaluated due to the low number of PDACs among study participants.
“We aimed for more tangible results of the PanFAM-1 study, which are partly inconclusive due to a variety of factors related to the execution of the clinical trial compared with original study design. The PanFAM-1 clinical study was also impacted by the COVID pandemic, when many hospitals were closed for the routine surveillance or screening of patients, as many others in the industry have experienced”, said Philipp Mathieu, CEO and President of Immunovia AB.
Analysis of the sensitivity of IMMray PanCan-d in the PanFAM-1 study was confounded by the unexpectedly low 0.2% prevalence of PDAC in the PanFAM-1 cohort, which was lower than the c.1% prevalence in this risk group observed in other studies1, 2 and was lower than the prevalence assumed in the study design. In addition, the execution of the study was compromised by the following factors:• The COVID pandemic significantly impacted the recruitment and monitoring of patients• Insufficient number of serial blood draws and/or imaging for each patient• Failure to provide a quality/accuracy assessment of imaging results
Philipp Mathieu, CEO and President of Immunovia AB, continues: “We are very grateful to the patients, clinicians and hospitals who participated in this study. In close collaboration with key opinion leaders and participating study sites we are currently analyzing the important learnings from PanFAM-1 which together with our ongoing discussions with payers will inform the way forward in establishing further clinical validation in this risk group.”
Analysts, investors and media are invited to a webcast and teleconference, today Monday, June 27, at 13:00 pm CET for a presentation of the outcome and learnings from the PanFAM-1 study. For details, see the end of the press release.PanFAM-1, background and details
PanFAM-1 was the first prospective, multi-center trial initiated by Immunovia in 2016, with the goal of evaluating the performance (sensitivity and specificity) of the IMMray PanCan-d test in individuals at high risk for developing familial or hereditary pancreatic ductal adenocarcinoma (PDAC) in comparison to conventional imaging.
Individuals enrolled in PDAC surveillance programs were planned to receive imaging and clinical evaluation at least once per year consistent with the study center’s protocol (MRI, EUS or CT) and had a blood draw every 6 months. As an observational study, blood samples were frozen and stored until the IMMray PanCan-d test was clinically validated.
Samples were collected at 23 sites in the US (14) and Europe (9), with 3,457 blood samples collected from 1,255 participants between January 2016 and November 2021. Sites in the U.S. contributed over 2,300 blood samples from two third of the study participants, with a median observation period of 1-2 years. The IMMray PanCan-d results for US participants were in line with those reported for the US PanFAM-1 subjects in the blind validation (88.8% negative, 9.5% borderline, and 1.7% positive) [Clinical and Translational Gastroenterology, 2022; doi.10.14309/ctg.0000000000000468].
Statistical comparison of specific imaging findings and IMMray PanCan-d results is ongoing to examine trends in IMMray PanCan-d results relative to specific germline mutations, family histories, and imaging findings at the direction of the Principal Investigators in this study. Independent analysis of the PanFAM-1 results was conducted by Biostatisticians at the Biostatistical and Epidemiological Data Analysis Center (BEDAC) at Boston University School of Public Health.
1. Overbeek KA, Levink IJ, Koopmann BDM et al. Long-term yield of pancreatic cancer surveillance in high-risk individuals. Gut. 2022;71:1152-1160.2. Overbeek KA, Goggins MG, Dbouk M et al. Timeline of development of pancreatic cancer and implications for successful early detection in high-risk individuals. Gastroenterol. 2022;162:772-785.