We are consequently witnessing the ringing in of a new era characterized by considering tumours as genetic diseases as opposed to tissue‐dependent processes.
#TRIALS EVOLUTION VS TRIALS FUSION DRIVER#
These discoveries have led to the development of drugs targeting driver gene alterations irrespective of their primary tumour location. Scientific and technological advances have unmasked numerous genetic deregulations that are common across multiple cancer types. Over recent years, much progress has been made in rendering cancer treatments more precise.
#TRIALS EVOLUTION VS TRIALS FUSION TRIAL#
In this review article, we describe the main challenges and opportunities that these new trial designs may provide for a more efficient drug development process, which may ultimately help ensure that PCM becomes a reality for patients. Alongside the growing complexity of these clinical trials, new frameworks for stronger and faster collaboration between all stakeholders in drug development, including academic institutions and frameworks, clinicians, pharma companies and regulatory agencies, have been established. Currently, we have seen rapid phase 1 dose‐escalation trials followed by remarkably large expansion cohorts, and are witnessing the emergence of new trials, such as adaptive studies with basket and umbrella designs aimed at optimizing the biomarker–drug co‐development process. These factors, added to strong collaboration with regulatory agencies, which have approved novel agents based on data obtained from phase 1/2 trials, have led to unprecedented evolution in the design of early‐stage clinical trials. At the same time, the therapeutic armamentarium is rapidly increasing and the number of new drugs (including immune‐oncology agents) entering drug development continues to rise. Precision Cancer Medicine (PCM) was born out of accumulated evidence matching targeted agents with these tumour molecular deregulations. Recent scientific advances have shown that there are numerous genetic deregulations that are common in multiple cancer types, raising the possibility of developing drugs targeting those deregulations irrespective of the tumour type. Cancer treatment has made significant strides towards the promise of personalized medicine.