Spanish biopharmaceutical company PharmaMar has initiated the pivotal Phase III ATLANTIS study of PM1183 combined with doxorubicin versus topotecan or the combination VCR (cyclophosphamide, adriamicine (doxorubicin) and vincristine) to treat small-cell-lung cancer (SCLC).
PM1183 (lurbinectedin) is a compound of marine origin, which acts as an inhibitor of RNA polymerase II.
This enzyme is considered important for the transcription process that is largely expressive in tumours with transcription addiction.
Around 600 patients at clinical sites across 21 countries are expected to be enrolled in the multicentre, open-label, randomised and controlled Phase III ATLANTIS trial, which has been designed to evaluate the safety and efficacy of PM1183.
The trial is primarily focused to determine the improvement in progression free-survival (PFS) within the patients, which will be examined by an Independent Review Committee after response evaluation criteria in solid tumours.
The secondary goals of the trial are the evaluation of overall survival (OS), duration of the response (DR), along with quality of life indicators, response rate (RR), as well as determining the pharmacokinetics and pharmacodynamics profile of PM1183.
PharmaMar oncology business unit clinical development director Dr Arturo Soto said: “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.”
PM1183 is also being investigated for its anti-tumour efficacy in addressing platinum-resistant ovarian cancer within a Phase III trial and in treating BRCA 1 and BRCA 2-associated metastatic breast cancer in a Phase II trial.