Phase 3 goal met by Novartis’ multiple myeloma drug

Novartis' investigational compound, LBH589, for multiple myeloma has met its primary endpoint in phase 3 clinical trials.

LBH589 (panobinostat) was being evaluated in combination with bortezomib and dexamethasone and 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.

"Results from this study show improved outcomes for these multiple myeloma patients who otherwise have few options to treat this incurable disease. Given its mechanism of action, LBH589 has the potential to be an important treatment option for multiple myeloma."

Alessandro Riva, Global Head, Oncology Development and Medical Affairs, Novartis Oncology.

Multiple myeloma is a cancer of plasma cells, a type of white blood cell in the bone marrow that produces antibodies and helps fight infection. It affects approximately 1 to 5 in every 100,000 people worldwide each year. The five year survival-rate for patients with the disease is about 44%.

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.

Full results from the trial are still being evaluating and will be presented at an upcoming medical congress and discussed with regulatory authorities worldwide.