PharmaMar Presents Positive Results From a Phase II Study of lurbinectedin in Ewing's Sarcoma at the CTOS International Congress
MADRID, November 13, 2017 /PRNewswire/ --
PharmaMar (MCE: PHM) has presented positive results from a Phase II study of lurbinectedin in Ewing's sarcoma at the Connective Tissue Oncology Society's (CTOS) International Congress that took place in Hawaii from the 8th to the 11th of November.
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In abstract #2768194 entitled "Efficacy and safety of lurbinectedin (PM1183) in Ewing Sarcoma: results from a Phase 2 study" the efficacy and safety results from the Phase II basket trial were presented, in which a group of patients with this type of advanced sarcoma, that hadn't received more than 2 prior chemotherapeutic treatment in metastatic disease, were included. The study is ongoing, although the cohort of patients with Ewing's sarcoma has now closed.
At the moment of this abstract, 25 patients with Ewing's sarcoma were enrolled. The observed disease control rate (overall response, partial response and stabilization of the disease) was 60%, including partial responses in 12% of cases, and a stabilization of the disease in the 48% of cases. The observed median duration of response was 2.9 months and 3 months of median progression free survival was reached.
The study showed that adverse effects were generally related to myelosuppression, which were reported to be manageable with dose adjustments. No treatment withdrawals due to toxicity or toxic deaths occurred. The patients with Ewing's sarcoma have a poor outcome. The authors of the abstract would like to highlight that new therapeutic agents with different mechanism of action are needed, as in the case of lurbinectedin, which has exhibited a favorable safety and tolerability profile as a single agent in pre-treated patients with advanced Ewing's sarcoma.
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