On September 24, 2018 PharmaMar (MSE:PHM) reported that it has presented data during the International Association for the Study of Lung Cancer (IASLC 2018), that is taking place from the 23rd to the 26th of September in Toronto (Canada), on Overall Survival (OS) from the Phase I/II Study of lurbinectedin in combination with doxorubicin for relapsed small cell lung cancer (Press release, PharmaMar, SEP 24, 2018, View Source [SID1234529550]).
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An OS of 10.2 months has been observed in the study for patients treated with lurbinectedin in combination with doxorubicin in patients with a CTFI of 30 days or longer, reaching 11.5 months in platinum-sensitive patients (CTFI- equal or better than 90 days).
We believe that the OS periods observed in this trial are more favorable than those seen in historical trials of the primary treatments used for second line in SCLC, such as topotecan or the CAV combination (cyclophosphamide, adriamycin, vincristine).
This Phase I/II multicenter, clinical study has analyzed the second line treatment of patients with SCLC, corresponding to cohort B (n=27), of the study, involving a doses of 2mg/m2 of lurbinectedin + 40mg/m2 of doxorubicin, the same doses and similar population to that being evaluated in the randomized Phase III ATLANTIS Study. In July 2018 this study reached its recruitment objective of 600 patients from 160 centers in 20 countries, and the results are expected at the end of 2019. Dr. Martin Forster, MD, PhD, of the University College London Hospitals and UCL Cancer Institute, UK, has commented, "I have been involved in a wide number of trials with lurbinectedin for more than five years, both in studies as a single agent and in combination, and I think that it is a molecule with a novel mechanism of action and promising anti-cancer activity, which has exhibited acceptable safety profile both as a single agent and in combination. I consider lurbinectedin as an innovative molecule, which I think may have an important role to play in the treatment of patients with this particularly aggressive type of lung cancer, if approved."
Dr. Emiliano Calvo, MD, from the START Madrid-CIOCC Early Phase Clinical Drug Development program, at Hospital Universitario HM Sanchinarro, Madrid, Spain, has affirmed that "it is very necessary to have new alternatives for the treatment of this type of aggressive cancer. As we have been able to observe in the Overall Survival data, the combination of lurbinectedin plus doxorubicin appears to show a greater benefit than the current standard treatments, therefore, possibly providing a new therapeutic alternative for the patients that suffer this terrible illness." He adds, "patients with small cell lung cancer need new therapeutic alternatives, and the results of this lurbinectedin study could help change the landscape of treatment in an environment where, unfortunately, important progress has not been made within the last 15-20 years."
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