On August 2, 2016, PharmaMar announced the start of a pivotal phase III ATLANTIS study evaluating the efficacy and safety of lurbinectedin (PM1183), a novel synthetic tetrahydroisoquinoline that targets active transcription. The study is evaluating lurbinectedin combined with doxorubicin vs topotecan or the combination VCR (cyclophosphamide, doxorubicin, and vincristine) in patients with small cell lung cancer after the failure of one prior platinum-containing therapy. Topotecan is the only drug approved in both the United States and Europe for this indication.
ATLANTIS is a multicenter, open-label, randomized, and controlled phase III clinical trial that is to include 600 patients at clinical sites across 21 countries. The primary endpoint of this study is to improve the progression free-survival of those patients who will be evaluated by an Independent Review Committee following Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Secondary objectives include overall survival and duration of the response, along with quality-of-life indicators, response rate according to the RECIST 1.1 criteria, and the correlation between pharmacokinetics and pharmacodynamics.
“We are pleased to start this pivotal phase III clinical trial after lurbinectedin demonstrated encouraging results in a phase IB study, where 67% of the patients responded to the treatment of lurbinectedin in combination with doxorubicin,” said Arturo Soto, MD, Director of Clinical Development of PharmaMar´s Oncology Business Unit.
More information can be found at clinicaltrials.gov, with trial identifier NCT02566993. ■