Background: Selinexor is a first-in-class, oral selective-inhibitor-of-nuclear-export, granted accelerated approval by FDA (2019) for relapsed and refractory (RRMM).
Objectives: We sought to quantitatively summarize the selinexor efficacy and safety in RRMM.
Methods: We searched PubMed, EMBASE, CENTRAL, clinicaltrial.gov and google scholar, from inception until June 2022, to identify literature assessing the selinexor use in RRMM. The outcome measures of interest were efficacy outcomes, with safety outcomes being of secondary interest. Statistical analyses using a random-effects model were performed, at statistical significance of P< 0.05, using the RevMan software.
Results: Meta-analyses of ten included clinical trials yielded significant 52.32% overall clinical benefit, 44.4% overall response, 4.89% complete response, 23.90% very good partial response, 22.33% partial response, and 29.82% stable disease rates. Due to safey reasons, selinexor caused significant increase in discontinuation rate, 16.80%. Subgroup analyses demonstrated higher efficacy with selinexor plus dexamethasone and proteasome inhibitors combinations compared to selinexor alone. The multiple myeloma type and the high cytogenetic risk did not affect performance. Risk of selection, performance, and detection biases were unclear in the included trials.
Conclusions: Selinexor led to significantly better responses with an acceptable safety profile in RRMM patients, despite higher rates of safety-related discontinuations. Selinexor-based combinations further enhanced response.