Merck has recently announced that its clinical trial of Vorinostat as second-line therapy for pleural mesothelioma patients who’ve failed the standard chemotherapy regimen for mesothelioma treatment has moved to Phase III status. Merck is now enrolling patients from cancer centers in the United States and the United Kingdom, as well as in Belgium, Germany, the Netherlands, New Zealand, Spain and Sweden.

Vorinostat, which is marketed as Zolinza, is an anticancer agent that has already won approval by the FDA for the treatment of cutaneous T-cell lymphoma, a type of Non-Hodgkin lymphoma that mainly affects the skin. Vorionstat’s use for the second-line treatment of mesothelioma is being studied in this randomized, double-blind trial, where its safety, tolerability and anti-tumor activity will be compared to a control group given only placebo, along with best supportive care. The primary endpoints of the trial include Vorionstat’s effects on overall survival, as well as an investigation regarding its safety and toxicity. The trial’s secondary endpoints will examine its overall response rate and any demonstration of progression-free survival, as well its effects on dyspnea and forced vital capacity.

The trial is mainly being conducted as an investigation of Vorionstat’s applicability as second-line therapy on patients who have failed the standard therapies of pemetrexed and cisplatin or carboplatin, but its use for patients who are not eligible for a pemetrexed-based protocol will also be investigated.

Labels: mesothelioma