The results from PANORAMA-1 ( PANobinostat ORAl in Multiple MyelomA ) trial were presented at ASCO meeting, showing a 37% improvement in progression-free survival ( PFS ) when using the investigational compound Panobinostat ( LBH589 ) in combination with Bortezomib ( Velcade ) and Dexamethasone compared to treatment with the same regimen with placebo in patients with relapsed or relapsed and refractory multiple myeloma, meeting the primary endpoint of the study ( hazard ratio, HR=0.63; p less than 0.0001 ).
In the Panobinostat arm, there was a 4-month prolongation of median progression-free survival ( 12 months versus 8 months in the placebo arm ).
The effect of Panobinostat was observed across all patient subgroups ( for example by age or prior exposure to Bortezomib or immunomodulatory therapy ).
The findings also showed that adding Panobinostat, a pan-deacetylase ( pan-DAC ) inhibitor, to Bortezomib and Dexamethasone led to a significant increase in higher quality responses compared to standard-of-care therapy alone, as evidenced by a nearly two-fold increase in complete/near complete response rates ( 28% versus 16%, respectively; p=0.00006 ).
Side effects were consistent with those previously seen in Panobinostat studies. The most common grade 3/4 adverse events in the Panobinostat combination arm were thrombocytopenia ( 67% versus 31% with placebo ), lymphopenia ( 53% versus 40% with placebo ), neutropenia ( 35% versus 11% with placebo ) and diarrhea ( 26% versus 8% with placebo ).
Adverse events were generally manageable through supportive care and dose reductions. ( Xagena )
Source: 50th Annual Meeting of the American Society of Clinical Oncology ( ASCO ), 2014