Adding panobinostat to bortezomib and dexamethasone did not significantly improve overall survival compared with bortezomib plus dexamethasone alone in patients with relapsed multiple myeloma, a study published in The Lancet Haematology has shown.1
The phase 3 PANORAMA 1 trial (ClinicalTrials.gov Identifier: NCT01023308) previously demonstrated that panobinostat plus bortezomib and dexamethasone significantly prolonged progression-free survival vs bortezomib and dexamethasone alone.
The final overall survival analysis of this trial has shown that median overall survival was 40.3 months (95% CI, 35.0-44.8) with panobinostat compared with 35.8 months (95% CI, 29.0-40.6) with placebo (hazard ratio [HR], 0.94; 95% CI, 0.78-1.14; P =.54), suggesting no significant difference between the 2 treatment arms.
Similarly, researchers found that among patients who had received at least 2 previous regimens including bortezomib and an immunomodulatory drug, median overall survival was 25.5 months (95% CI, 19.6-34.3) and 19.5 months (95% CI, 14.1-32.5) with panobinostat and placebo, respectively (HR, 1.01; 95% CI, 0.68-1.50).
The investigators hypothesize that optimizing this 3-drug regimen could potentially prolong treatment duration, thereby improving patient outcomes; however, further investigation would be needed to confirm this approach.
For the double-blind trial, investigators enrolled 768 patients with relapsed or relapsed and refractory multiple myeloma who had received 1 to 3 previous treatment regimens. Participants were randomly assigned 1:1 to receive panobinostat or placebo, in combination with bortezomib and dexamethasone.
1. San-Miguel JF, Hungria VT, Yoon S, et al. Overall survival of patients with relapsed multiple myeloma treated with panobinostat or placebo plus bortezomib and dexamethasone (the PANORAMA 1 trial): a randomised, placebo-controlled, phase 3 trial. Lancet Haematol. 2016 Oct 14. doi: 10.1016/S2352-3026(16)30147-8. [Epub ahead of print]