PharmaMar, a leading biopharmaceutical company in advancing cancer care, has begun 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 randomised, 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.
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. By targeting transcription, the drug inhibits the expression of factors important for tumour progression, and impairs the DNA repair system called NER, thereby enhancing tumour cell killing. PM1183 (lurbinectedin) is currently being investigated in different tumour 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.
It is estimated that about 240,000 cases are diagnosed worldwide and about 150,000 women die of ovarian cancer. Among gynaecological malignancies, it is the second most common cancer and the one causing more deaths . Most patients with ovarian cancer have late-stage disease, in which the cancer has spread, at the moment of diagnosis. Debulking surgery to remove most of the tumour is usually followed by chemotherapy; however, about 80 per cent of women will relapse after treatment with platinum or a taxane and they may benefit from other therapeutic alternatives.