End points and statistical considerations in immuno-oncology trials: impact on multiple myeloma.

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End points and statistical considerations in immuno-oncology trials: impact on multiple myeloma.

Future Oncol. 2017 Apr 11;:

Authors: Hoering A, Durie B, Wang H, Crowley J

Abstract
Unlike conventional cancer treatment, immuno-oncology therapies are commonly associated with delayed clinical benefit and durable responses, as seen with immuno-oncology therapies for multiple myeloma (MM). Therefore, a longer-term approach to immuno-oncology data assessment is required. Appropriate study designs, end points and statistical methods are essential for evaluating immuno-oncology therapies to assess treatment outcomes, and may better accommodate immuno-oncology clinical trial data. In addition to conventional end points including median progression-free survival (PFS) and overall survival (OS), end points such as hazard ratios for PFS and OS over time, PFS and OS landmark analyses beyond the median, and immune-response end points might provide better indications of the efficacy of immuno-oncology therapies. Long-term data with these agents will allow better prediction of outcomes in MM.

PMID: 28395525 [PubMed - as supplied by publisher]

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