PM01183 Phase III - Corail Trial .(Abstract TPS5597):
Randomized Phase III Study of Lurbinectedin (PM01183) versus Pegylated Liposomal Doxorubicin (PLD) or Topotecan (T) in Patients with Platinum-resistant Ovarian Cancer. Poster Session :
Gynecologic Cancer. Monday, June 6th from 1:00 pm to 4:30 pm.
Lead author:
S. Gaillard et al. MD, Duke Cancer Institute, Durham, USA.
****************************************+
*.- PM1183 Development Programme on Track.
*.- A Phase III trial in platinum-resistant ovarian cancer is expected to report interim futility data in the current quarter, and to complete recruitment around the end of the year.
*.- A Phase III in small cell lung cancer (SCLC) is expected to commence in June or July following an impressive 67% response rate in a Phase Ib/II study.
*.- Initial data from a Phase II trial in breast cancer are also expected this year.
******************************************+
*.- Results Phase IIb :
420-pt monotherapy CORAIL trial in platinum-resistant ovarian cancer commenced recruitment in June 2015. The trial will compare PM1183 vs investigators’ choice of topotecan or pegylated liposomal doxorubicin (PLD). Recruitment is expected to take 18 months. In a Phase IIb trial PFS 5.7 months for PM1183 vs 1.7 months for topotecan (p=0.0005).
*******************************************+
*.- Recomendation IDMC ( Independent Data Monitoring Committee ) :
Madrid, Spain , February 09, 2016 .
PharmaMar, a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs, announced 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.
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.
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 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 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.