Dr Michael Wang discusses the primary results from the double‐blind, placebo‐controlled, phase III SHINE study of ibrutinib in combination with bendamustine‐ rituximab and R maintenance as a first‐line treatment for older patients with mantle cell lymphoma.
Initially Dr Wang talks about the background and the methodology of the study. This randomised Phase III SHINE clinical trial was conducted at 183 sites in 28 countries since 2013. The double-blinded study evaluated treatment with bendamustine-rituximab and rituximab maintenance plus either ibrutinib or placebo. The primary endpoint was progression-free survival (PFS) assessed by the investigators.
He then explains the results of this trial. The median PFS was 80.6 months with the ibrutinib combination versus 52.9 months in the control arm. The complete response rate was 65.5% in the ibrutinib arm and 57.6% in the placebo arm. Median overall survival had not been reached in either treatment arm at the time of data cutoff.
Dr Wang says “These results provide evidence that an ibrutinib-based combination front-line treatment regimen provides a significant progression-free survival benefit and may be a new treatment opportunity for this patient population who previously had few options.”
The patients in this study continue to be followed to evaluate differences in overall survival between treatment arms. Future research may investigate chemotherapy-free or time-limited ibrutinib combinations.
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