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Published on 10 December 2013

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Novartis investigational Phase III multiple myeloma study

 

 

Novartis has 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 haematologic 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 randomised, double blind, placebo controlled, multicentre 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.
About LBH589
LBH589 is a potent oral pan-inhibitor of class I, II, and IV histone (and non-histone) deacetylase enzymes (HDACs/DACs). It works by blocking a set of key enzymes which ultimately leads to cellular stress and death of these cells.[2]
Because LBH589 is an investigational compound, the safety and efficacy profile has not yet been established. Access to this investigational compound is available only through carefully controlled and monitored clinical trials. These trials are designed to understand better the potential benefits and risks of the compound. Because of the uncertainty of clinical trials, there is no guarantee that LBH589 will ever be commercially available anywhere in the world.
About multiple myeloma
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. When the plasma cells become cancerous and multiply, they are known as myeloma cells. The buildup of myeloma cells causes an abnormal plasma cell level in the blood, overwhelming the production of healthy cells.[4]
Multiple myeloma typically occurs in individuals 50 years of age and older, with few cases in individuals younger than 40. Common symptoms include a high level of calcium in the blood, decreased red blood cells, kidney failure, bone damage and pain and fatigue, but may vary from person to person. There are currently no curative therapies available for multiple myeloma.[4] Therefore, there is a high unmet medical need for therapies addressing new relevant molecular targets.
References
  1. Pulte D, et al.Recent improvement in survival of patients with multiple myeloma: variation by ethnicity, Leukemia and Lymphoma. 2013. Available at : http://informahealthcare.com/doi/abs/10.3109/10428194.2013.827188.Accessed November 18, 2013.
  2. Novartis Data on File.
  3. Richardson PG, et al. PANORAMA 2: panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory myeloma. Blood. 2013; 122: 2331-2337.
  4. The Leukemia and Lymphoma Society. Myeloma. Revised 2013; 1:48.


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