YONDELIS Data Presented at ASCO Interim Data From Three Phase II Studies Confirm Activity in Soft Tissue Sarcoma, Ovarian and Endometrial Cancer Interim results from three Phase II trials on YONDELIS (TM) were presented at the 40th Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in New Orleans from 5-8 June 2004. The three trials were led by Johnson & Johnson Pharmaceutical Research & Development. YONDELIS (TM) is a novel marine-derived anti-tumour agent isolated from the colonial tunicate Ecteinascidia turbinata. It is being co-developed by PharmaMar and Johnson & Johnson Pharmaceutical Research & Development, and is in Phase II clinical trials for, soft tissue sarcoma (STS), ovarian, breast, endometrial, prostate and non-small cell lung cancers. At the meeting, Dr Brian Samuels, from the Lutheran General Hospital in Chicago gave an oral presentation of interim results from: A randomised Phase II study of trabectedin (ET-743) given by two different dosing schedules in patients with leiomyosarcomas (LMS) or liposarcomas (LPS) refractory to conventional doxorubicin and ifosfamide chemotherapy." YONDELIS has previously shown anti-tumour activity in US and European studies as a therapy for advanced STS in patients failing to respond to conventional chemotherapies. The study evaluated the efficacy and tolerability of YONDELIS either as a three-hour intravenous infusion given weekly for three consecutive weeks in a four week cycle (arm A, 0.58 mg/msquared), or as a 24-hour intravenous infusion every three weeks (arm B, 1.5 mg/msquared). This multi-centre trial has recruited 130 patients of a total target of 90 evaluable patients, at 30 sites in the US and Europe. In order to evaluate the activity of YONDELIS in this patient population, the investigator assessed the response rate and disease stabilisation at week 16. In Arm A there was one partial response in 45 evaluable patients (2% response rate), compared to 4 partial responses in 35 evaluable patients (12% response rate) in Arm B. Overall tolerability was acceptable and consistent with prior experience with YONDELIS. Disease control as expressed by time to progression and overall survival are consistently in favour of Arm B. The median time to disease progression is about 2 months in Arm A while it has not yet been reached in Arm B. The median follow up for the study is 4.1 months. These results indicate that YONDELIS has activity in this heavily pre-treated group of patients with sarcomas. Dr Carolyn N. Krasner, from Massachusetts General Hospital, Boston, MA, presented a poster on interim results from: "A Phase II study of weekly trabectedin (ET-743) in second/third line ovarian carcinoma." This ongoing multi-centre (US and European) Phase II study was designed to evaluate activity and tolerance of YONDELIS administered weekly for three weeks with a one-week break. Patients included in the trial are ovarian cancer patients, either resistant or sensitive to previous platinum-based therapies, treated with no more than two prior platinum containing regimens. The trial is designed to include more than 100 patients with response rate as the primary endpoint. The results of the 78 patients evaluated, out of a total of 115 patients treated to date, demonstrate that YONDELIS administered weekly as a single agent is well tolerated. Grade 3-4 toxicity rates in pooled cycles are SGPT (ALT) (1) increase (10%) and granulocytopenia (8%). Five per cent (5%) of patients experienced severe nausea. No other severe toxicity was observed, in particular no alopecia or mucositis. Activity was observed in both groups. In the platinum-resistant group 2 out of 41 evaluable patients had an objective response (5% response rate) and in the platinum-sensitive group 8 out of 37 evaluable patients had a complete or partial response to therapy (21% response rate). Preliminary results of this ongoing study show YONDELIS activity in pre-treated ovarian cancer. A poster presented by Dr Scott McMeekin, from the University of Oklahoma Health Science Centre, detailed interim results from: "A Phase II study of trabectedin (ET-743) YONDELIS as a second line therapy in patients with persistent or recurrent endometrial carcinoma." Forty-four (44) patients have been dosed in this multi-centre trial (US, Canada and Europe). The primary objective is to determine response rate, secondary endpoints are safety profile, time to progression, progression free survival and the overall survival. To date, one complete response (3%) has been observed out of the 40 evaluable patients. The most frequent grade 3-4 adverse events were transient elevation of alanine aminotransferase (ALT) (36%), neutropenia (14%) and asthenia (11%). YONDELIS administered as a single agent in 3 hours infusion every 3 weeks is a reasonably well-tolerated drug with activity in endometrial carcinoma, a tumour for which no standard therapy has been approved to date. Dr Miguel Angel Izquierdo, Director of Clinical Development at PharmaMar, said: "The interim results of these Phase II YONDELIS trials demonstrate evidence of clinical activity in our lead compound which is consistent with earlier findings. Recruitment for the trials continues to progress on schedule as further development is warranted." If approved, YONDELIS will be commercialised by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., in the US, and by PharmaMar within Europe. (1) SGPT: serum glutamate pyruvate transferase; ALT: alanine aminotransferase Source: Zeltia Group Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.