PharmaMar Announces That the ATLANTIS Study Has Reached the Goal of Patient Recruitment

MADRID, July 31, 2018 /PRNewswire/ --

• ATLANTIS study, in small-cell lung cancer with lurbinectedin, recruited 600 patients in a total of 160 hospital centers in 20 countries  
• Top line data is expected to readout around the end of 2019   

PharmaMar (MCE: PHM) has today announced that the pivotal phase III trial ATLANTIS in relapsed small-cell lung cancer has reached the targeted number of 600 patients recruited. This number will increase once those patients currently in screening evaluation are included into the study.

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The ATLANTIS trial compared Lurbinectedin plus doxorubicin to physician's choice of either Topotecan or CAV (cyclophosphamide, adriamycin, vincristine) in a 1 to 1 randomization. The primary endpoint is overall survival, and based on expected number of events, top line data analysis will be available once 510 events occurs, around the end of 2019. The trial is 90% powered to deliver a hazard ratio of 0.75. ATLANTIS recruited these 600 patients in 160 hospital centers in 20 countries being the largest recruiting countries Spain, Germany and the United States.  

Anna Farago M.D., Ph.D., co-Principal Investigator of the ATLANTIS trial from Massachusetts General Hospital in Boston said, "The completion of enrollment to ATLANTIS marks an important moment for clinical trials in small cell lung cancer. New approaches for treating this aggressive cancer are sorely needed. We look forward to seeing the overall survival data from ATLANTIS soon, and we are hopeful that the combination lurbinectedin and doxorubicin will demonstrate a benefit compared to current standard of care therapy, and therefore provide a new option for patients with this terrible disease."

Luis Paz-Ares, M.D., Professor of Medicine, co-Principal Investigator of the ATLANTIS trial from Hospital Universitario 12 de Octubre, Madrid added, "The completion of the recruitment of the ATLANTIS clinical trial represents an important milestone. In a disease as relapsed small cell lung cancer, we are in need of new therapeutic opportunities for these patients and the results of this trial with lurbinectedin could help to change the therapeutic landscape in a setting in which, unfortunately, there have been no large advances in recent years. We are eagerly waiting for the trial data to mature and have the results available."