Immunotherapies Often Fail to Show Durable Survival in ASCO Value Framework
Results of a recent analysis showed that only three drug indications of six immuno-oncology agents met the durable survival threshold in the American Society of Clinical Oncology (ASCO) value framework, according to recent research published in JAMA Oncology (online December 28, 2017; doi:10.1001/jamaoncol.2017.4445).
There is a general concern regarding the effectiveness of modern immuno-oncology agents and the cost of cancer care. Multiple frameworks have been developed to assess value, with the ASCO framework awarding bonus points for regimens that demonstrate durable survival – defined as a minimum of 20% survival rate compared with standard care regimens.
To assess whether modern immuno-oncology agents reached the defined durable survival threshold in the ASCO value framework, a group of Israeli researchers led by Omer Ben-Aharon, MBA, MHA, Bar Ilan University, reviewed all US Food and Drug Administration (FDA) approvals for immuno-oncology agents between March 2011 and August 2017. A total of six immuno-oncology agents indicated for 23 metastatic indications were included in the analysis: ipilimumab, pembrolizumab, nivolumab, atezolizumab, avelumab, and durvalumab.
Researchers noted that 10 (43%) of these approvals were based on survival end points, while 13 (57%) were based on response rates.
Results of the analysis showed that only three drug indications met the threshold defined for the survival rate of patients receiving standard care: ipilimumab for second-line treatment of melanoma, nivolumab for first-line treatment of melanoma, and nivolumab for second-line treatment of squamous non-small cell lung cancer.
Dr Ben-Aharon and colleagues acknowledged that long-term follow-up data on immuno-oncology agents is needed to better understand the clinical benefit they provide. Additionally, they reported a potential limitation of the study – the reliance on therapeutic outcomes reported from clinical studies and FDA approvals.
“The selective population participating in these trials might lead to survival results that differ from outcomes in the general population,” they wrote. “However, we are dealing with very new treatments, and the relatively short follow-up period limits the available data.”—Zachary Bessette