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.
Highlights
38 Iwama K, Chihara D, Tsuda K et al Normalization of free light chain kappa/ lambda ratio is a robust prognostic indicator of favorable outcome in patients with multiple myeloma
We propose that surrogate end points be incorporated into study designs as interim analyses which would allow for an earlier read on the data; longer-term end points like overall survival (OS) and progression-free survival (PFS) should remain primary end points
In order to confirm early outcomes with surrogate end points, adequate long-term follow-up continues to be of utmost importance in immuno-oncology clinical trials, in order to capture the overall benefits of these new therapies
Summary
Pembrolizumab A study of pembrolizumab (MK-3475) in (anti-PD1 combination with standard of care treatments antibody) in participants with multiple myeloma (MK-3475-023/KEYNOTE-023) (NCT02036502);. A trial of pembrolizumab (MK-3475) in participants with blood cancers (MK-3475-013). Nivolumab (anti- Safety study of nivolumab by Itself or in PD1 antibody) combination in patients with lymphoma or alone or in multiple myeloma (NCT01592370)
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