Safety And Efficacy Of Combination Lurbinectedin Plus Doxorubicin From A Phase 1b Trial In Patients With Advanced/Metastatic Soft Tissue Sarcoma.
In this study, patients with advanced/metastatic soft tissue sarcoma were treated with lurbinectedin (binds to DNA inhibiting transcription and causing double strand DNA breaks) and doxorubicin (inserts into the DNA also inhibiting transcription) to determine the recommended phase 2 dose of full-dose lurbinectedin with low-dose doxorubicin. The treatment was also found to be safe and tolerable. There were several subtypes enrolled with signals of activity in leiomyosarcoma (LMS), Dedifferentiated Liposarcoma (DDLPS), undifferentiated pleomorphic sarcoma (UPS), endometrial stromal sarcoma, and myxofibrosarcoma with an objective response rate (ORR) of 60% and estimated median PFS of 16.5 months. These data support the ongoing randomized phase 2 study in patients with LMS comparing lurbinectedin/doxorubicin with doxorubicin alone.