publication date: Oct. 1, 2014

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Phase III Trial: Panobinostat Increases PFS by Four Months

Panobinostat demonstrated a four-month improvement in median progression-free survival in relapsed and/or refractory multiple myeloma, in combination with bortezomib and dexamethasone, in a phase III trial.

In the trial, named PANORAMA-1, the addition of panobinostat (LBH589) also led to clinically meaningful increases in complete and near complete response rates and duration of response, compared to bortezomib and dexamethasone plus placebo. The effect was observed across all patient subgroups.

According to Novartis, the drug’s sponsor, this is the first phase III study to demonstrate PFS superiority (HR=0.63 [95% CI: 0.52 to 0.76]; p<0.0001) of a three-drug over a two-drug combination in this patient population. Data was published in The Lancet Oncology. Overall survival data, the key secondary endpoint of the trial, are not yet mature.

PANORAMA-1 is a randomized, double-blind, placebo-controlled, multicenter global registration trial of patients with relapsed or relapsed and refractory multiple myeloma who failed on at least one prior treatment. The study of 768 patients took place in 215 clinical trial sites worldwide.

If approved, panobinostat, a pan-deacetylase inhibitor, will be first in its class of anticancer agents available to this population. As an epigenetic regulator, panobinostat may help restore cell programming in multiple myeloma.

Side effects were consistent with those previously seen in LBH589 studies. The most common Grade 3/4 adverse events in the panobinostat combination arm were thrombocytopenia, lymphopenia, neutropenia, diarrhea and neuropathy. Adverse events were generally manageable through supportive care and dose reductions.

Based on the PANORAMA-1 data, panobinostat was granted priority review by FDA in May, and a regulatory application was submitted to the European … Continue reading CCL Sept – Multiple Myeloma

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