Thursday, May 14, 2015

Study shows efficacy of YONDELIS (trabectedin) in patients with soft-tissue sarcoma


In continuation of my update on trabectedin

PharmaMar announced that the European Journal of Cancer published online data from a large retrospective study with soft-tissue sarcoma (STS) patients carried out at 25 French centers confirming that in routine practice YONDELIS® (trabectedin) shows comparable or better clinical outcomes than those observed in clinical trials . The results add to previous evidence from other studies with trabectedin , including the compassionate expanded access program of 1895 patients with incurable disease , demonstrating that response and disease control rates are higher than expected. The authors describe that long-term treatment of multiple types of STS patients without progressive disease delayed progression and improved survival compared to those who stopped it after six cycles, as recently suggested in the T-DIS studyiii. In this routine real-life scenario, the median progression-free survival (PFS) and overall survival (OS) were 4.4 and 12.2 months, respectively after a median follow-up of 22 month. Of the 304 patients who achieved non-progressive disease after six cycles, 227 continued receiving trabectedin and obtained significant superior PFS (11.7 versus 7.6 months) and OS (24.9 versus 16.9 months) than those who did not. The recent study reinforces an approach of early administration of YONDELIS® (trabectedin) to optimize its efficacy as second-line treatment in patients that will probably benefit from this drug. Despite the limitations of the study, the investigators emphasize that this clinical strategy may achieve longer disease control without compromising the safety profile of the treatment, given that a third of the patients received more 6 or more cycles of the drug and were able to tolerate longer treatments.

Study shows efficacy of YONDELIS (trabectedin) in patients with soft-tissue sarcoma

No comments: