PharmaMar Announces That the ATLANTIS Study Has Reached the Goal of Patient Recruitment
MADRID, July 31, 2018 /PRNewswire/ --
ATLANTIS study, in small-cell lung cancer with lurbinectedin, recruited 600 patients in a total of 160 hospital centers in 20 countries
Top line data is expected to readout around the end of 2019
PharmaMar (MCE: PHM) has today announced that the pivotal phase III trial ATLANTIS in relapsed small-cell lung cancer has reached the targeted number of 600 patients recruited. This number will increase once those patients currently in screening evaluation are included into the study.
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The ATLANTIS trial compared 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 expected number of events, top line data analysis will be available once 510 events occurs, around the end of 2019. The trial is 90% powered to deliver a hazard ratio of 0.75. ATLANTIS recruited these 600 patients in 160 hospital centers in 20 countries being the largest recruiting countries Spain, Germany and the United States.
Anna Farago M.D., Ph.D., co-Principal Investigator of the ATLANTIS trial from Massachusetts General Hospital in Boston said, "The completion of enrollment to ATLANTIS marks an important moment for clinical trials in small cell lung cancer. New approaches for treating this aggressive cancer are sorely needed. We look forward to seeing the overall survival data from ATLANTIS soon, and we are hopeful that the combination lurbinectedin and doxorubicin will demonstrate a benefit compared to current standard of care therapy, and therefore provide a new option for patients with this terrible disease."
Luis Paz-Ares, M.D., Professor of Medicine, co-Principal Investigator of the ATLANTIS trial from Hospital Universitario 12 de Octubre, Madrid added, "The completion of the recruitment of the ATLANTIS clinical trial represents an important milestone. In a disease as relapsed small cell lung cancer, we are in need of new therapeutic opportunities for these patients and the results of this trial with lurbinectedin could help to change the therapeutic landscape in a setting in which, unfortunately, there have been no large advances in recent years. We are eagerly waiting for the trial data to mature and have the results available."
Luis Mora, Managing Director of PharmaMar´s Oncology Business Unit, said "we are pleased and excited that we have completed enrolment of this large trial. Between ATLANTIS and our monotherapy trial, we hope to deliver to regulators data sets that can lead to the approval of Lurbinectedin for this difficult to treat disease."
Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs. The company has a pipeline of drug candidates and a robust R&D oncology program. PharmaMar develops and commercializes YONDELIS® in Europe and has other clinical-stage programs under development for several types of solid and hematological cancers, Zepsyre® (lurbinectedin, PM1183), plitidepsin, PM184 and PM14. PharmaMar is a global biopharmaceutical company with subsidiaries in Germany, Italy, France, Switzerland, United Kingdom, Belgium, Austria and the United States. PharmaMar fully owns other companies: GENOMICA, a leading molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi); and two other chemical enterprises, Zelnova Zeltia and Xylazel. To learn more about PharmaMar, please visit us at http://www.pharmamar.com.
About Zepsyre[® ]
Zepsyre® (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.
About small-cell lung cancer
SCLC is a very aggressive cancer that usually presents with distant metastases and has already spread at the time of diagnosis, thus limiting the role of traditional approaches and posing a worse prognosis compared to other lung cancer types. The 5-year survival rate is about 5%[i]. About 18% of all the lung cancer cases diagnosed are SCLC, and only in the US more than 34,000 new cases are recorded every year. This tumor is strongly associated with tobacco smoking, posing an important public health problem[ii]. After failure to treatment with a platinum-based therapy in first line, the therapeutic alternatives are very limited, and the approval of the last drug for this disease took place 20 years ago.
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