Study of ZOLINZA® (vorinostat) for Investigational Use for Advanced Malignant Pleural Mesothelioma Did Not Meet Primary Endpoint
September 23, 2011 7:00 am ET
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that a Phase III study of ZOLINZA® (vorinostat) for an investigational use in patients with advanced malignant pleural mesothelioma who previously have been treated with systemic chemotherapy containing pemetrexed did not meet its primary endpoint of demonstrating an improvement in overall survival. Full results of the trial, called VANTAGE 14 (Vorinostat Clinical Trials in Hematological and Solid Malignancies), will be presented at the 2011 annual joint Congresses of the European Multidisciplinary Cancer Congress (ECCO) and the European Society of Medical Oncology (ESMO), in Stockholm, Sweden, September 23-27, 2011.
Vorinostat (marketed as ZOLINZA®) is an oral histone deacetylase (HDAC) inhibitor manufactured by MSD and is indicated for use in the United States for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies.
Mesothelioma is a type of cancer that begins in the mesothelium, a thin layer of tissue that lines several different organs and spaces inside the body. The most common form is pleural mesothelioma, in which tumors develop in the tissue that lines the chest cavity. The incidence of malignant pleural mesothelioma is increasing worldwide, with approximately 2,000 to 3,000 new cases occurring each year in the United States. Although rare, mesothelioma is a serious, aggressive cancer that often reaches an advanced stage before symptoms appear.
Details on the design of the study are available at www.clinicaltrials.gov, identifier NCT00128102.
ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated in the United States for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies.
Selected Important Safety Information for ZOLINZA
As pulmonary embolism and deep vein thrombosis have been reported as adverse reactions, physicians should monitor patients for the signs and symptoms of these events, particularly patients with a prior history of thromboembolic events. Treatment with ZOLINZA can cause dose-related thrombocytopenia and anemia. If platelet counts and/or hemoglobin are reduced during treatment with ZOLINZA, the dose should be modified or discontinued. Gastrointestinal disturbances, including nausea, vomiting and diarrhea, have been reported and may require the use of antiemetic and antidiarrheal medications. Fluid and electrolytes should be replaced to prevent hydration. Pre-existing gastrointestinal disturbances should be adequately controlled before beginning therapy with ZOLINZA. Patients should be instructed to drink at least 2 L/day of fluids for adequate hydration. Hyperglycemia has been observed in patients receiving ZOLINZA. Serum glucose should be monitored, especially in diabetic or potentially diabetic patients receiving ZOLINZA. Adjustment of diet and/or glucose therapy may be necessary to prevent hyperglycemia. Electrolytes should be monitored at baseline and periodically during treatment. Hypokalemia or hypomagnesemia should be corrected prior to administration with ZOLINZA.
Severe thrombocytopenia and gastrointestinal bleeding have been reported with concomitant use of ZOLINZA and other HDAC inhibitors (e.g., valproic acid). Platelet count should be monitored every 2 weeks for the first 2 months.
Patients who are concurrently administered ZOLINZA and coumarin derivatives should be carefully monitored for prolongation of prothrombin time and international normalized ratio.
The most common adverse events observed in clinical trials with ZOLINZA, regardless of causality, were fatigue (52 percent), diarrhea (52 percent), nausea (41 percent), dysgeusia (28 percent), thrombocytopenia (26 percent), anorexia (24 percent), decreased weight (21 percent), and muscle spasms (20 percent).
The most common serious adverse events, regardless of causality, were pulmonary embolism (4.7 percent), squamous cell carcinoma (3.5 percent), and anemia (2.3 percent). ZOLINZA can cause fetal harm when administered to a pregnant woman.
Please see prescribing information at: www.merck.com/product/usa/pi_circulars/z/zolinza/zolinza_pi.pdf.
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ZOLINZA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA.
Please see Prescribing Information for ZOLINZA® at http://www.merck.com/product/usa/pi_circulars/z/zolinza/zolinza_pi.pdf and Patient Information for ZOLINZA® at http://www.merck.com/product/usa/pi_circulars/z/zolinza/zolinza_ppi.pdf