PharmaMar reports progress for Yondelis in soft tissue sarcoma

Spain's PharmaMar says that the independent data monitoring committee for the pivotal trial of Yondelis (trabectedin) in soft tissue sarcoma has reviewed data from a pre-planned interim analysis of the primary end-point, time-to-progression, which indicate that there is a positive trend in TTP in favor of patients receiving the 24-hour dosing regime.

The trial, known as STS-201, compares the efficacy of two dosing schedules of Yondelis (24 hours and weekly) in patients who have failed to respond to prior available therapies. Enrolment of 270 subjects was completed during the second quarter of 2005, making this the largest randomized trial ever conducted in this patient setting. Following the review, the IDMC has concluded that the 24-hour regime provides an added advantage to patients. In addition, no unexpected toxicities were identified in this trial. In light of the IDMC's findings, PharmaMar and its partner for the development of Yondelis, Johnson & Johnson Pharmaceutical R&D, have offered all patients who are still in treatment the option of switching to the 24-hour regime. Analysis of the resulting data is likely to take some additional time to compile and review.

Both PharmaMar and J&JPRD are continuing to work with the regulatory authorities towards submission of Yondelis in STS for marketing authorization in the shortest possible timeframe. PharmaMar also said that it has held a pre-submission meeting with the European Medicines Agency to confirm plans for submission of the Market Authorization Application and that it has presented a formal letter of intent to file. No further studies will be conducted prior to the submission.