Clinical benefit of immune checkpoint inhibitors approved by US Food and Drug Administration
Knowledge of the potential benefits and risks associated with the use of anticancer therapies is fundamental for making treatment-related recommendations and decisions. Two important oncology societies have recently taken a step forward to quantize the clinical benefit. The American Society of Clinical Oncology (ASCO) Value Framework (ASCO-VF), which was updated in 2016, and the European Society for Medical Oncology developed its Magnitude of Clinical Benefit Scale (ESMO-MCBS) for drugs indicated in the treatment of solid cancer, which also updated in 2017. They have been used to grade US Food and Drug Administration (FDA)-approved new drugs for treating advanced solid cancers. In the study by Vivot and colleagues, they found that Many recently FDA-approved new cancer drugs did not have high clinical benefit as measured by ASCO-VF and ESMO-MCBS.
The growing wave of progress using cancer immunotherapy, which has extended and improved the lives of patients, many of whom had few other effective treatment options has yielded high expectations from all stakeholders. However, there are also concerns about the value of check point inhibitors. Many immune checkpoint inhibitors were approved based on single-arm studies, only recently more RCTs were finished and reported.
Patient-reported outcomes (PROs), such as symptoms, quality of life (QOL), and patient-perceived health status supplement clinical data and are now more important dur