PM 1183 (lurbinectedin) enters pivotal Phase III trial for small cell lung cancer

PharmaMar has announced the start of a pivotal Phase III ATLANTIS study evaluating efficacy and safety of PM 1183 (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, randomized, 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.

PM1183 is a compound of marine origin 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. The antitumor efficacy of lurbinectedin is being investigated in various types of solid tumors, including a Phase III study for platinum-resistant ovarian cancer, a Phase II study for BRCA 1 and BRCA 2-associated metastatic breast cancer and a Phase III study for small cell lung cancer.