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Publish Date : 22-Sep-2014

Data published today 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 the investigational compound 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.

Multiple myeloma is a cancer of white blood cells that predominantly affects the bone marrow, impacting approximately 1 to 5 in every 100,000 people worldwide each year, and is increasing in prevelance. Most people with multiple myeloma ultimately relapse and become resistant to treatment, so new therapies with novel mechanisms of action are critical for continuing to manage the disease and improve outcomes. If approved, LBH589, a pan-deacetylase (pan-DAC) inhibitor, will be first in its class of anticancer agents available to this population.

"The PANORAMA-1 study is the first Phase III trial to show the superiority of LBH589 plus bortezomib and dexamethasone over one of the standard two-drug regimens for patients with relapsing and/or refractory multiple myeloma," said lead study investigator Jesus San-Miguel, MD, Director of Clinical and Translational Medicine, Clínica Universidad de Navarra, Pamplona, Spain. "These results show that by adding a new mechanism of action, pan-DAC inhibition, there is a significant benefit for this patient population."

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.

"The majority of people living with multiple myeloma eventually will stop responding to treatment or relapse, which underscores the need for new treatment options," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "The PANORAMA-1 results provide strong evidence of the potential impact LBH589 could have for the multiple myeloma community. We are committed to working with regulatory authorities to make this treatment available to patients as soon as possible."

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