Data from the phase IV NIMES-ROC clinical trial of trabectedin (Yondelis®; Pharmamar), presented at the European Congress of Oncological Gynecology (ESGO) being held from 2-5 November in Athens, Greece, show favorable results in the treatment of adult women with platinum-sensitive recurrent ovarian cancer (PSROC).
Trabectedin is a marine-derived tetrahydroisoquinoline alkaloid that was initially isolated from the marine ascidian Ecteinascidia turbinata and is currently prepared synthetically.
The study, a non-interventional, multicenter, prospective, European study designed to evaluate the use of trabectedin, previously known as Ecteinascidin-743 or ET-743, with pegylated liposomal doxorubicin (PLD) in routine real-life clinical practice, demonstrated Progression Free Survival (PFS) of 11.4 months compared to 9.2 months in the pivotal OVA-301 trial.
Given in accordance with marketing authorization and standard local clinical practice, regardless of prior use of antiangiogenics, the results of the study, even with a larger population of pre-treated patients (39.9% with more than 2 previous chemotherapy lines) further show that the Overall Response Rate (ORR) and safety profile are also in line with the results of the pivotal study OVA-301 trial.
“These studies allow us to observe how drugs behaves in real life clinical practice. Although this is an interim analysis we can see that trabectedin obtains similar results, even better in some cases, than those observed when it was approved in 2009 with the OVA-301 study,” noted María Ángeles Forés, MD, Director of Medical Affairs at PharmaMar.
Non-interventional European Study of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients (NIMES-ROC) – NCT02825420
European, non-interventional, phase IV NIMES-ROC trial of trabectedin plus pegylated liposomal doxorubicin in patients with platinum-sensitive recurrent ovarian cancer: an interim analysis.