Background
Cancer patients, especially in times of widespread community based virulent viral infections, face clinically important challenges relating to their intrinsic disease, complex treatment regimens, and potentially immune-compromised state. If a treated cancer patient cannot make antibodies to a SARS-CoV-2 (COVID-19) EUA or approved vaccine, their risk for infection and its sequelae are significantly increased.
Overview
- EIMPRIS was an Investigator-Initiated Study with patients enrolled from private practice community-based oncology centers throughout the United States.
- EIMPRIS was designed to leverage MediMergent’s technology in order to capture the Voice of the Patient (VOP) using proprietary data collection instruments and comparing these data to patient proxy sources including patient medical records, pharmacy data, and claims data. The VOP data were designed to integrate with data related to Social Determinants of Health (SDoH), Quality-of-Life and other behavioral and attitudinal data to determine how real-world data (RWD) impacted real-world treatment and outcomes.
- The MediMergent digital clinical trials platform served as the trial management system. The system was designed to directly engage patients, track and monitor all study-related activities, detect adverse events, and yield unprecedented data on patient experiences.
Objectives of the Eimpris Study
- To determine whether a patient treated for cancer who received a dose of an EUA approved monoclonal antibody administered either intramuscularly or intravenously would maintain a stable/protective effect against symptomatic SARS-CoV-2 infection including SARS-CoV-2 related hospitalization and/or SARS-CoV-2 related death.
- To extract new real-world evidence (RWE) that would empower cancer patients and aid in designing better preventive/therapeutic interventions to fight a global infectious pandemic.
Patient Population
- Patients with cancer who had been treated with chemotherapy, immunotherapy, targeted therapy, other therapy or combination therapy with or without radiation therapy within 12 months prior to study enrollment.
- All patients were required to have undergone at least one vaccination of an EUA approved COVID-19 vaccine prior to study enrollment
Immunologic Evalutions
Extensive assessments were performed of immune cells’ functionality and their role in prevention of COVID-19 breakthrough infections in immuno-compromised patients following administration of an EUA approved monoclonal antibody. These included assessments of both B-cell function and antibody titers plus T-cell functionality (CD4+ T cells and CD8+ T cells).
Results
At the present time, extensive data analyses and correlative evaluations are being performed. These include analyses to determine if T-cell activity has an impact on SARS-CoV-2 breakthrough infections, especially in immuno-compromised cancer patients.
Preliminary Conclusions
- EIMPRIS is an ideal proving ground for the value of innovative hybrid patient-centric research using RWD. It has exceptional potential as an analytic model for research with immuno-compromised patients who do not mount a response to traditional vaccines.
- The implementation of our RWD model in this investigator-initiated program demonstrates MediMergent’s ability to efficiently and economically collect, track and analyze high-quality patient data in the real-world.
- Our forward-looking approach to clinical trial management and data aggregation improves patient enrollment, speeds up data input, and allows for earlier evaluation of study results.
- The EIMPRIS Study represents proof that an Investigator-Initiated clinical trial can use a hybrid study design to merge real-world data collection with sophisticated immunologic assessments to better understand and prevent/treat dangerous infections in highly vulnerable patient populations.