On September 6, 2018 PharmaMar (MCE: PHM) reported that the International Association for the Study of Lung Cancer (IASLC) has released today the abstracts for presentation during the Conference that will take place from the 23rd to the 26th of September in Toronto (Canada) (Press release, PharmaMar, SEP 6, 2018, View Source [SID1234529320]). The abstract to be presented by PharmaMar shows Overall Survival (OS) data obtained from the Phase I/II Study of lurbinectedin in combination with doxorubicin for the treatment of relapsed small-cell lung cancer.
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In the study, PharmaMar observed Overall Survival (OS) of 10.2 months in patients treated with lurbinectedin in combination with doxorubicin, and OS of 11.5 months in platinum-sensitive patients (patients with a chemotherapy free interval (CTFI) of more than 90 days) in patients treated with lurbinectedin in combination with doxorubicin. We believe that the OS periods observed in this trial is are more favorable than those seen in historical trials of the primary treatments used for second line in small-cell lung cancer, as topotecan or the CAV combination (cyclophosphamide, adriamycin, vincristine).
This multicenter, Phase I/II Clinical Study enrolled patients with relapsed small-cell lung cancer (n=27) in cohort B, using the dose 2mg/m[2] of lurbinectedin + 40mg/m[2] of doxorubicin, the same dose that is being evaluated in the Phase III randomized ATLANTIS study in a similar population. In both cases the refractory patients are excluded, meaning those patients that have relapsed or have suffered a progression of the disease up to 30 days after first line treatment (CTFI <30 days).
Following the receipt of early data from this study in August 2016 PharmaMar initiated the pivotal Phase III ATLANTIS Study, that reached in July 2018 its recruitment objective of 600 patients. The trial recruited patients at 160 centers in 20 countries, and results are expected at the end of 2019.
The abstract with all this data is available on the Congress web page: View Source
Overall survival with lurbinectedin plus doxorubicin in relapsed SCLC. Results from an expansion cohort of a phase Ib trial.
Poster: P1.12-20. Monday, September 24th, 2018, from 16:45 to 18:00. Exhibit Hall.
Lead author: Martin Forster, MD. University College of London Hospital and UCL Cancer Institute, London, UK
About lurbinectedin
Lurbinectedin (PM1183) is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction.