Www.OncologyEducation.com ESMO 2011 Lung Cancer Vantage 014 Study Authors: Dr. Sunil Verma Date posted: September 28 th, 2011.

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ESMO 2011 Lung Cancer Vantage 014 Study Authors: Dr. Sunil Verma Date posted: September 28 th, 2011

Vantage 014 Study Vorinostat in Mesothelioma Presented by Dr. Lee Krug from Memorial Sloan-Kettering Hospital at ESMO 2011 Background: Mesothelioma is a rare cancer subtype but still inflicts between Canadians annually. The incidence has been steadily rising and linked to asbestos exposure seen with mining and milling work history. Recent evidence has suggested that treatment with platinums and pemetrexed in the first line setting is associated with improved overall survival. There is no standard second line therapy and overall median survival is less than one year. Vorinostat is a Hystone deacetylase (HDAC) inhibitor and previous Phase I study showed some activity in patients with Mesothelioma. The Vantage 014 is the largest study conducted in Mesothelioma to date.

R Treatment A: Voriniostat 300mg orally Twice per day 3 of 7 days in a 3-week cycle Treatment B: Placebo Patient Population Patients with advanced pleural mesothelioma who have had up to two lines of previous systemic chemotherapy (one of the lines must have contained platinums and pemetrexed) Vantage 014 Study

RESULTS Treatment A Treatment B p-value OS (median, weeks) The Primary Endpoint of this study was Overall Survival Conclusion: There is no improvement in Overall Survival with single agent Voriniostat in patients with mesothelioma

BOTTOM LINE FOR MEDICAL ONCOLOGISTS This is the largest study conducted in patients with mesothelioma There was no improvement in survival with the use of Vorinostat in the second/third line setting Be careful planning a large Phase III study based on results from Phase I study with a few patients (there was no Phase II trial of Vorinostat in mesothelioma)