In a recent paper published in Annals of Translational Medicine the EORTC highlights the need to develop new clinical research methodologies to evaluate immune-oncology anti cancer agents. While immune strategies are taking a central role in the spectrum of therapeutic options, current methodologies to define optimal dose and classical activity end-points may not be adapted to the mode of operation of these innovative therapies.
“The lack of fundamental information such as dose and end-points may be an impediment in appropriately and safely integrating new immune therapies in combination with other agents and therapeutic modalities,” alerts first author Dr Jessica Menis, Clinical Research Physician at the EORTC.
“The absence of a solid predictive biomarker and generally accepted standard assay makes it impossible to define an optimal candidate patient population. Duplication of diagnostic solutions will impact the functioning of pathology departments,” emphasizes Dr Saskia Litière, Biostatistician at the EORTC.
Although the safety profile of immune therapies seems to be relatively safe, “there is no mechanism to ensure long-term follow-up monitoring of side effects at a time when real life effectiveness is a crucial aspect of drug development, ” according to Dr Konstantinos Tryfonidis, Clinical Research Physician at EORTC.
“The next hurdle is the economic challenge of immuno-oncology. We urgently need studies addressing schedule and dose optimization, as well as refining patient populations who truly benefit from treatment,” concludes Dr Vassilis Golfinopoulos, Medical Director at EORTC.