On October 31, 2023 PharmaMar (MSE:PHM) reported the initiation of a Phase IIb/III clinical trial (SaLuDo, Sarcoma patients treated with Lurbinectedin and Doxorubicin)) with lurbinectedin in combination with doxorubicin for the first-line treatment of patients with metastatic Leiomyosarcoma (LMS) (Press release, PharmaMar, OCT 31, 2023, View Source [SID1234636551]). The trial will evaluate Progression-Free Survival (PFS) as the primary endpoint and Overall Survival (OS) as one of the secondary endpoints of treatment with the combination of lurbinectedin and doxorubicin compared to the current standard of care in Leiomyosarcoma, which is doxorubicin.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This clinical trial consists of 2 phases. Phase IIb includes three treatment arms: two arms will evaluate the combination of lurbinectedin plus doxorubicin at different doses, and the control arm will evaluate single-agent doxorubicin. At the end of this phase, the best combination scheme of the lurbinectedin plus doxorubicin combination will be chosen to continue with phase III in which the chosen combination scheme will be compared with doxorubicin administered as a single agent.

The trial will be conducted in patients with metastatic LMS as a first line of treatment. Leiomyosarcoma is a subtype of Soft Tissue Sarcoma (STS) that accounts for 10-20% of all cases. Due to the low frequency of STS (1% of all cancers seen in adult population), Leiomyosarcoma is categorized as a "rare tumor". Leiomyosarcoma originates in smooth muscles. The body contains smooth muscle tissue in hollow organs (intestines, stomach or bladder), as well as in blood vessels (including the extremities) and in women, there are also smooth muscles in the uterus.

The SaLuDo trial involves 76 centers in the United States and several European countries, including Spain.

"We are initiating this trial for the treatment of a pathology that today has few therapeutic alternatives for patients despite representing one of the most common sarcoma subtypes. With the promising results presented recently at ASCO (Free ASCO Whitepaper) this year from a phase Ib presented by Dr Gregory Cote, lurbinectedin in combination with doxorubicin would be a better option for patients with this pathology in first line treatment if the trial confirms the endpoint," commented Dr. Ali Zeaiter, VP and Head of Clinical Development at PharmarMar.