MADRID, September 24, 2018 /PRNewswire/ --
- The results are from Cohort B of the Phase I/II Study in patients with relapsed Small
Cell Lung Cancer (SCLC). This study preceded the Phase III
ATLANTIS study with the same doses and a similar population
- The poster has been presented at the World Congress of the International Association for the Study of Lung Cancer
(IASLC 2018), in Toronto
- The data reveal an Overall Survival of 10.2 months in patients with SCLC and a chemotherapy free
interval (CTFI) of 30 days or longer, reaching 11.5 months in platinum-sensitive patients
- Safety data, Overall Survival and also Progression Free Survival can be observed on the
poster
PharmaMar (MCE: PHM) 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.
(Logo: http://mma.prnewswire.com/media/624563/PharmaMar_Logo.jpg )
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/m[2] of lurbinectedin +
40mg/m[2] 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 Madrid Norte 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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About PharmaMar
Headquartered in Madrid, PharmaMar is a biopharmaceutical company, focused on oncology and
committed to research and development which takes its inspiration from the sea to discover molecules with antitumor activity. It
is a company that seeks innovative products to provide healthcare professionals with new tools to treat cancer. Its commitment to
patients and to research has made it one of the world leaders in the discovery of antitumor drugs of marine origin.
PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes
Yondelis® in Europe and has other clinical-stage programs under development for
several ty-pes of solid cancers: lurbinectedin (PM1183), PM184 and PM14. With subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and
the United States. PharmaMar wholly owns other companies: GENOMICA, a molecular diagnostics
company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi); and a chemical enterprise, Zelnova
Zeltia.
To learn more about PharmaMar, please visit us at http://www.pharmamar.com.
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.
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SOURCE PharmaMar