On Febraury 8, 2016 PharmaMar (MSE:PHM) reported that the Independent Data Monitoring Committee (IDMC) has notified the Company of its recommendation that the Phase III (CORAIL) trial currently under way with PM1183 in platinum-resistant ovarian cancer patients should continue without any changes (Press release, PharmaMar, FEB 8, 2016, View Source [SID:1234508992]). Schedule your 30 min Free 1stOncology Demo! The IDMC’s recommendation came after an analysis of the safety data obtained with the first 80 patients treated in the trial. This pivotal randomised Phase III trial assesses the efficacy of PM1183 compared with the standard treatment for this indication—topotecan or pegylated liposomal doxorubicin—in a total of 420 patients.
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About PM1183 (lurbinectedin)
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 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.
About ovarian cancer
It is estimated that about 240,000 cases will be diagnosed worldwide and about 150,000 women will die of ovarian cancer. Among gynaecological malignancies, it is the second most common cancer and the one causing more deathsi . Most patients with ovarian cancer have late-stage disease, in which the cancer has spread, at the moment of diagnosisii. Debulking surgery to remove most of the tumor is usually followed by chemotherapy; however, about 80% of women will relapse after treatment with platinum or a taxane and they may benefit from other therapeutic alternativesiii .