New study arm in rEECur trial with Trabectedin for relapsed Ewing sarcoma

Ewing sarcoma, a rare bone and soft tissue cancer in children and young adults has poor outcomes at relapse. The drug trabectedin offers a hopeful new option for treatment.
Patient advocates have collaborated with investigators and the manufacturer of trabectedin, to open a new treatment arm containing trabectedin within rEECur, the largest international randomised trial in relapsed Ewing sarcoma. This development will offer additional options for patients with limited treatment alternatives. The treatment arm is planned to open in the UK and internationally later this year.

rEECur is an international academic trial developed by the Euro Ewing Consortium (EEC) and coordinated by Cancer Research Clinical Trials Unit (CRCTU) van , University of Birmingham. Its flexible, multi-arm design allows multiple treatments to be studied within the same trial, helping to make the most of the limited patient population available for this rare cancer.

The inclusion of trabectedin is underpinned by promising data presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) 2024, which demonstrated clinical benefit in Ewing sarcomai. This provides strong scientific rationale for evaluating the drug in rEECur. For the predominantly young patient population affected by Ewing sarcoma, the supply of trabectedin represents time, hope and opportunity. The timing of the trial arm is crucial to avoid overlap with other studies that might need access to the same, small patient pool. The drug offers hope to patients in relapse who would have access to a potentially more effective and less toxic drug combination, providing better quality of life. For the company providing the drug, PharmaMar, the trial is an opportunity to refresh one of their key products with a new clinical application.

Chief investigator for the study, Professor Martin McCabe of The University of Manchester, has said:
"Deze samenwerking tussen het klinische onderzoeksteam, patiëntenvertegenwoordigers, financiers van de studie en PharmaMar is een geweldig voorbeeld van wat er bereikt kan worden wanneer partners met verschillende doelstellingen eerlijk en respectvol met elkaar communiceren. Ik ben verheugd dat onze gesprekken hebben geleid tot een wederzijds voordelig resultaat voor iedereen, maar met name voor patiënten met terugkerend Ewing-sarcoom."

"Deze beslissing schept een belangrijk precedent voor een positieve samenwerking tussen patiënten, artsen en de industrie", aldus Natalia Fernandez, patiëntenbelangbehartiger. "Het laat zien dat wanneer alle belanghebbenden samenwerken, de vooruitgang kan worden versneld voor de mensen die het het hardst nodig hebben."

Background

Ewing sarcoma is a rare paediatric cancer with an incidence in the UK of only about 250 individuals per year. Survival rates for metastatic patients and those at relapse are poor. The rEECur trial has been running for ten years and, over this period, has opened six arms comparing different chemotherapy treatments. Trabectedin is the first agent the trial has utilised that acts directly on the function of the fusion gene which drives Ewing sarcoma, EWSR1::FLI1. It also has the benefit of being delivered in an outpatient setting and appears to have lower toxicity compared to other treatments.

The rEECur trial is currently recruiting in the United Kingdom, Spain, Italy, Australia, New Zealand, Switzerland, Denmark and Austria and will re-open soon in Finland, Norway, France, Belgium and Netherlands.

Source: https://www.sarcoma-patients.org/blog/new-study-arm-in-reecur-trial-with-trabectedin-for-relapsed-ewing-sarcoma/

i Grohar PJ, Ballman KV, Heise R, et al. SARC037: Fase II-resultaten van trabectedine toegediend als een infusie van 1 uur in combinatie met een lage dosis irinotecan bij patiënten met recidiverend/refractair Ewing-sarcoom. J Clin Oncol. 2024;42(16_suppl):11508. doi:10.1200/JCO.2024.42.16_suppl.11508.