PharmaMar has announced the completion of patient recruitment for the randomised and key Phase III of CORAIL study with lurbinectedin (PM1183) for the treatment of platinum-resistant ovarian cancer.
A total of 443 patients from more than 100 hospitals within Europe and the US participated in the study.
The CORAIL trial analyses the efficacy of PM1183 in comparison with topotecan or pegilated lyposomal doxorrubicin, standard of care for this pathology.
PharmaMar oncology business unit's clinical department director Dr Arturo Soto said: “The study has been completed three months ahead of schedule, which reflects the interest in the drug and in the study and is also a necessity by the investigators for a new therapeutic alternative for these patients.”
Lurbinectedin (PM1183) PM1183 is a compound under clinical probe.
An inhibitor of RNA polymerase II, this enzyme is key for the transcription process that is over-activated in tumours with transcription addiction.
The anti-tumour efficacy of lurbinectedin is being investigated in several kinds of solid tumours, including the Phase III study for platinum-resistant ovarian cancer, a Phase II study for BRCA 1 and BRCA 2- associated metastatic breast cancer and a key Phase III study for small-cell lung cancer.
It is estimated that about 240,000 cases of ovarian cancer will be diagnosed worldwide and approximately 150,000 women will die of the disease. Among gynaecological malignancies, it is the second most common cancer.