Pharmacovigilance Unit (UFPV)

Head of unit  

Salim Laghouati
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Pharmacovigilance Unit (UFPV)

The PREMIS Study

In oncology, immunostimulatory agents, in particular immune checkpoint inhibitors targeting PD-1/PD-L1 and CTLA4, have revolutionised the treatment of a number of cancers. The number of patients treated with these compounds has increased considerably with the approval of numerous new drugs and the setting up of various clinical trials, notably involving associations, in different indications.
These new therapies generate new types of adverse events, including inflammatory or immune-related adverse events (irAEs), which can affect all of the organs and which can be severe and sometimes fatal if not detected early and managed appropriately. The risk of occurrence of irAEs is greater when patients are treated with associations of immunotherapies rather than single-drug therapy.
There is currently no way to predict the occurrence of irAEs in patients treated with immunotherapy. Induction of immunity depends on the immune status of the host and differs from one patient to another. The mechanisms that lead to the occurrence of irAEs have not yet been fully elucidated. It is necessary to better understand these mechanisms in order to identify patients at risk and to implement appropriate management of the toxicities.
The PREMIS study, sponsored by Gustave Roussy, is an interventional study with only minimal risks and constraints, designed to investigate predictive markers for immune-related adverse events (irAEs) in patients treated with immunostimulatory agents. The primary objective is to identify non-invasive predictive biomarkers of irAEs in patients who receive immunotherapy.
The study is planned to include 1000 patients treated for cancer with monoclonal antibodies targeting the immune checkpoints (mainly anti-PD1, anti-PD-L1, anti-CTLA4 and associations of immunotherapies), regardless of the indication and line of treatment.
The study was set up by Gustave Roussy in late September 2018.
Clinical data and laboratory samples are collected from all patients just before the start of treatment with immunotherapy and 6 weeks after the start of treatment, as well as in patients who experience irAEs, at the time of onset of the irAE.
Based on data from the samples, it should be possible to identify biological and immunity markers that are present prior to or appear soon after starting treatment and that predispose patients to developing irAEs.
The results will enable us to develop strategies for prevention and appropriate management of irAEs, to make the use of immunotherapy safer and to improve the prognosis of treated patients.
They will also contribute to the development of personalised medicine in the area of immunotherapy.
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