Swiss pharma giant Novartis AG (NVS) Friday said data published today in The Lancet Oncology demonstrated a statistically significant and clinically relevant 4-month improvement in median progression-free survival or PFS 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 1 to 5 in every 100,000 people worldwide
each year.
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 most common Grade 3/4 adverse events in the LBH589 combination arm were thrombocytopenia, lymphopenia, neutropenia, diarrhea and neuropathy. Adverse events were generally manageable through supportive care and dose reductions.
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