- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
PharmaMar initiates a phase III ATLANTIS study for small cell lung cancer
2 August 2016 • Author: PharmaMar
PharmaMar announced the start of a pivotal Phase III ATLANTIS study evaluating efficacy and safety of PM1183 (lurbinectedin) in combination with doxorubicin versus topotecan or the combination VCR (cyclophosphamide, adriamicine (doxorubicin) and vincristine) in patients with small cell lung cancer (SCLC) after the failure of one prior platinum-containing line. Topotecan is the only drug approved both in USA and Europe for this indication.
ATLANTIS is a multicenter, open-label, randomised, and controlled Phase III clinical trial that is to include 600 patients at clinical sites across 21 countries. The primary endpoint of this study is to improve the progression free-survival (PFS) of those patients that will be evaluated by an Independent Review Committee following Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Secondary objectives include overall survival (OS); duration of the response (DR); along with quality of life indicators; response rate (RR) according to the RECIST 1.1 criteria; and also the correlation between pharmacokinetics and pharmacodynamics.
“We are pleased to start this pivotal Phase III clinical trial after PM1183 demonstrated encouraging results of the Phase IB study, where 67% of the patients responded to the treatment of lurbinectedin in combination with doxorubicin. In the Phase IB study we have seen a complete response, with total remission of the symptoms of the illness in 10% of the patients”, explains Dr Arturo Soto, director of Clinical Development of PharmaMar´s Oncology Business Unit, who also adds “that the novel mechanism of action of PM1183, along with the synergy observed in the combination with doxorubicin, could provide a new treatment option for patients with small cell lung cancer, an indication that has such a poor prognosis”.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited CAPSUGEL NV Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) Eurofins BioPharma Product Testing EUROGENTEC F.P.S. Food and Pharma Systems Srl GE Analytical Instruments IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics