Clinical Trials

LBH589 (panobinostat) is a potent oral pan-inhibitor of class I, II, and IV histone (and non-histone) deacetylase enzymes (HDACs/DACs). It works by blocking a set of key enzymes which ultimately leads to cellular stress and death of these cells.

* On September 19, 2014, Novartis announced that data published in The Lancet Oncology demonstrated a statistically significant and clinically relevant 4-month improvement in median progression-free survival (PFS) (hazard ratio=0.63 [95% confidence interval (CI): 0.52 to 0.76]; p<0.0001) for patients with relapsed or relapsed and refractory multiple myeloma when using LBH589 (panobinostat) in combination with bortezomib* and dexamethasone compared to placebo plus the same combination. In the Phase III PANORAMA-1 (PANobinostat ORAl in Multiple MyelomA) trial, the addition of LBH589 also led to clinically meaningful increases in complete and near complete response rates and duration of response. The effect of LBH589 was observed across all patient subgroups. Side effects were consistent with those previously seen in LBH589 studies. The most common Grade 3/4 adverse events in the LBH589 combination arm were thrombocytopenia (67% versus 31% with placebo), lymphopenia (53% versus 40% with placebo), neutropenia (35% versus 11% with placebo), diarrhea (26% versus 8% with placebo) and neuropathy (18% versus 15% with placebo). Adverse events were generally manageable through supportive care and dose reductions. Based on the PANORAMA-1 data, in May, LBH589 was granted priority review by the FDA and a regulatory application was submitted to the European Medicines Agency (EMA). Additional global regulatory submissions are underway. (San-Miguel J, et al. "Randomized Phase 3 Trial of Panobinostat Plus Bortezomib and Dexamethasone Versus Placebo Plus Bortezomib and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma". The Lancet Oncology. 2014. Volume 15, Issue 11, Pages 1195 - 1206)

* On December 6, 2013, Novartis has announced that results of a Phase III trial of  LBH589 (panobinostat) in combination with bortezomib and dexamethasone, met the primary endpoint of significantly extending progression-free survival (PFS) in patients with relapsed or relapsed and refractory multiple myeloma when compared to bortezomib plus dexamethasone alone. LBH589 showed significant clinical benefit bringing it a step closer to becoming the first in its class of anticancer agents to be available to patients with multiple myeloma. As a pan-deacetylase (pan-DAC) inhibitor, LBH589 works by blocking a key cancer cell enzyme which ultimately leads to cellular stress and death of these cells.