On October 26, 2018 PharmaMar (MSE:PHM) has reported that the Phase III ATLANTIS trial has received from the Independent Data Monitoring Committee (IDMC) its recommendation that the trial, currently under way with Zepsyre (lurbinectedin, PM1183) in combination with doxorubicin in relapsed small-cell lung cancer patients should continue without any changes. This is the fourth IDMC safety data review that has been passed.

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The IDMC’s recommendation came after having reached the targeted number of 600 patients recruited.

The ATLANTIS trial compares 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 the expected number of events, the results are expected around the end of 2019. The trial is 90% powered to deliver a hazard ratio of 0.75.

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