MADRID, June 29, 2015 /PRNewswire/ --
PharmaMar announced today the start of a phase III study for the anticancer agent PM1183 in patients with platinum-resistant ovarian cancer (PROC). Once study objectives are met, the CORAIL trial (NCT02421588) will be used to support the regulatory filing of PM1183 as treatment for this indication.
The pivotal study is a randomized, open-label, and international multicenter trial designed to evaluate the activity and safety of PM1183 compared with investigator´s choice of topotecan or pegylated liposomal doxorubicin (PLD) in patients with PROC. Enrolling a total of 420 women with unresectable disease across more than 100 medical centers in the US and Europe, the CORAIL trial will assess whether PM1183 can improve progression-free survival, as primary endpoint, compared to topotecan and PLD, which are currently approved for ovarian cancer in second-line treatment. Secondary outcome measures include assessing overall survival, overall response rate and patient-reported quality of life.
Data from the preceding phase II trial in these patients showed a progression-free survival of 5.7 months, which was significantly better compared to the 1.7 months achieved by patients treated with topotecan[i].
Arturo Soto, Director of Clinical Development at PharmaMar said, "Women with platinum-resistant ovarian cancer have poor prognosis and do not respond well to current therapies. PM1183 is a novel drug that works differently compared to other drugs used to treat this type of cancer."
PM1183 is an investigational drug from the class of inhibitors of the enzyme RNA polymerase II, which is crucially involved in transcription[ii]. By targeting transcription, the drug inhibits the expression of factors important for tumor progression, and impairs the DNA repair system called NER, thereby enhancing tumor cell killing. PM1183 (lurbinectedin) is currently being investigated in different tumor types, including a Phase 3 study for platinum-resistant ovarian cancer, a Phase 2 study for BRCA1/2-associated metastatic breast cancer and a Phase 1b study for small cell lung cancer.
Carolina Pola - Communications Director
Sara García - Media Relations
SOURCE PharmaMar, SA