226TiP Randomized, open-label, phase III study of lurbinectedin in combination with doxorubicin versus doxorubicin alone as first-line treatment in patients with metastatic leiomyosarcoma (SaLuDo)

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Authors: Gregory Michael Cote, A. Napolitano, Jean‐Yves Blay, Maud Toulmonde, Antonella Brunello, Vasilios Karavasilis, Jenny Sherriff, Salvatore Tafuto, L. D'Ambrosio, Javier Martin-Broto, B. Kasper, R.L. Jones
+7 more George D. Demetri, Gastón Boggio, S. Martínez, A. Nieto, Carmen Maria Kahatt, J. Jiménez Jiménez, Axel Le Cesne
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Abstract

Lurbinectedin (LUR) is a synthetic chemical entity structurally related to trabectedin that inhibits oncogenic transcription. Two trials showed activity for LUR/doxorubicin (DOX) in anthracycline-naïve advanced leiomyosarcoma (LMS) patients (pts). In a phase II trial, DOX 50 mg/m2 + LUR 2 mg/m2 Day (D)1 every three weeks (q3wk) resulted in a response rate (RR) of 33% in LMS pts. A phase Ib/II trial found a RR of 60% (3/5 LMS with partial response) with DOX 25 mg/m2 D1 or D1,D8 + LUR 3.2 mg/m2 D1 q3wk.

Fields of Study & Subjects

Sarcoma Diagnosis and Treatment Acute Myeloid Leukemia Research Cancer therapeutics and mechanisms

Publication details

Journal / source
ESMO rare cancers.
Volume
5
Pages
100432–100432
Publication date
1 March 2026
Language
EN