PharmaMar completes patient recruitment for its Phase III leiomyosarcoma study

On May 11, 2026 PharmaMar (MSE:PHM) reported that it has completed patient recruitment objective for the Phase III SaLuDo clinical trial (Sarcoma Patients treated with Lurbinectedin and Doxorubicin), which is evaluating lurbinectedin in combination with doxorubicin as a first-line treatment for patients with metastatic leiomyosarcoma (LMS).

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SaLuDo is a global, open-label, multicenter, randomized Phase III clinical trial in metastatic leiomyosarcoma (LMS). The primary endpoint of the study is progression-free survival (PFS), with overall survival (OS) as the key secondary endpoint. The trial includes three treatment arms: two arms evaluating different dose combinations of lurbinectedin and doxorubicin, and a control arm evaluating doxorubicin as a single agent. A total of 450 patients have been enrolled across more than 90 centers in the United States and several European countries.

Leiomyosarcoma is a subtype of soft tissue sarcoma that accounts for approximately 10–20% of all cases within this group of tumors. Soft tissue sarcoma represents around 1% of all cancers in the adult population, so leiomyosarcoma is considered a rare tumor. This type of cancer originates in smooth muscle tissue, which is found in organs such as the retroperitoneum, the gastrointestinal tract, blood vessels, and, in women, the uterus[1].

PharmaMar expects the results of the trial to be available during the first half of 2027, following completion of patient follow-up and data analysis.

(Press release, PharmaMar, MAY 11, 2026, View Source [SID1234665441])