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Novartis Investigational Compound LBH589 Met Primary Endpoint in Phase III Study

Novartis (NYSE: NVS) today announced that results of a Phase III trial of the investigational compound 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.

Full results from the PANORAMA-1 (PANobinostat ORAl in Multiple MyelomA) trial, continue to be evaluated and will be presented at an upcoming medical congress and discussed with regulatory authorities worldwide.

Multiple myeloma 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%[1].

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[2].

"Results from this study show improved outcomes for these multiple myeloma patients who otherwise have few options to treat this incurable disease," said Alessandro Riva, Global Head, Oncology Development and Medical Affairs, Novartis Oncology. "Given its mechanism of action, LBH589 has the potential to be an important treatment option for multiple myeloma."

Prior data demonstrated that oral LBH589, when combined with bortezomib and dexamethasone, recaptures responses in heavily pretreated and bortezomib-refractory multiple myeloma patients, thereby providing these patients with a potential new option after failing prior standard treatments[3]. The compound's possible benefits and risks are also being explored in additional hematologic malignancies through ongoing clinical trials.

Study Design The PANobinostat ORAl in Multiple MyelomA (PANORAMA) clinical trial program is evaluating LBH589 in patients with relapsed or relapsed and refractory multiple myeloma.

The PANORAMA-1 clinical trial is a Phase III randomized, double blind, placebo controlled, multicenter global registration trial to evaluate LBH589 in combination with bortezomib and dexamethasone against bortezomib and dexamethasone alone in patients with relapsed or relapsed and refractory multiple myeloma. The primary endpoint of the trial was progression-free survival (PFS) and the key secondary endpoint is overall survival (OS). Other secondary endpoints include overall response rate, duration of response and safety.

Posted-In: News FDA Global


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