PharmaMar Initiates a Pivotal Phase III ATLANTIS Study with PM1183 in Combination with Doxorubicin in Patients with Small Cell Lung Cancer
MADRID, August 2, 2016 /PRNewswire/ --
PharmaMar (MSE:PHM) today announced the start of a pivotal Phase III ATLANTIS study evaluating efficacy and safety of PM1183 (lurbinectedin) in combination with doxorubicin versus topotecan or the combination VCR (cyclophosphamide, adriamicine (doxorubicin) and vincristine) in patients with small cell lung cancer (SCLC) after the failure of one prior platinum-containing line. Topotecan is the only drug approved both in USA and Europe for this indication.
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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 (PFS) of those patients that will be evaluated by an Independent Review Committee following Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Secondary objectives include overall survival (OS); duration of the response (DR); along with quality of life indicators; response rate (RR) according to the RECIST 1.1 criteria; and also the correlation between pharmacokinetics and pharmacodynamics.
"We are pleased to start this pivotal Phase III clinical trial after PM1183 demonstrated encouraging results of the Phase IB study, where 67% of the patients responded to the treatment of lurbinectedin in combination with doxorubicin. In the Phase IB study we have seen a complete response, with total remission of the symptoms of the illness in 10% of the patients", explains Dr Arturo Soto, director of Clinical Development of PharmaMarīs Oncology Business Unit, who also adds "that the novel mechanism of action of PM1183, along with the synergy observed in the combination with doxorubicin, could provide a new treatment option for patients with small cell lung cancer, an indication that has such a poor prognosis" .
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