Informatics Accelerates the PRINCE Pancreatic Cancer Clinical Trial

Challenge

Whether or not data is clean and accessible can make or break a clinical trial. So when PICI decided to take on the nation’s third deadliest cancer with the PRINCE trial, our in-house informatics team played a crucial role. From start-up to completion, they created new systems to handle data, not only speeding up the trial but also harnessing the data to shed light on how the immune system works.

Enter PICI

Systems built in record speed. Our charge at the beginning of the trial: begin dosing patients as quickly as possible. To fulfill this need, we broke down siloes to integrate multiple systems in 3 short months. The systems ensured consistency and coordination across the study sites. At any given moment, PICI knew how every patient was responding to therapy, and when and why a patient stopped treatment.

Faster decision-making. Rather than waiting months for clean data, our close communication between our in-house biostatisticians and trial operators allowed us to act immediately as data flowed in. We remedied inconsistencies and analyzed safety and response rates quickly and throughout the trial. Our clear view of the trial’s progression helped us make smarter decisions in real time. And, it allowed us to share conclusions with investigators one week after we collected the last data point required for analysis.

Illuminating the immune system. Using our unique analytic capabilities on patient tissues and blood samples, we uncovered insights that could predict which patients might benefit from this treatment in the future. We also built a system called the Cancer Data and Evidence Library (CANDEL). It ensures molecular measurements and clinical information can be captured consistently across PICI studies and beyond. It currently stores measurements from over 100 terabytes of raw data from PICI studies and publicly available information. We’re chipping away at the ultimate question: why and when will a patient respond to immunotherapy?

Impact

Our first patient was dosed just 6 months after we filed the investigational new drug application with the FDA, a process that could have taken twice the amount of time or more. And we’re already seeing positive results. Less than one year after the first patient was dosed, our Phase 1 data revealed that the novel combination of immunotherapy and chemotherapy shrank tumors for a majority of patients and that the dosing was safe. We presented the data, as well as highlighted translational findings, at the 2019 American Association for Cancer Research meeting. The trial has moved on to Phase 2, where we are evaluating the combination’s effect and exploring biomarkers that can predict a response in patients.