Phase IB/II Trial with Correlative Analyses of Doxorubicin plus Durvalumab Combination in Patients with Advanced Soft Tissue Sarcoma
Researchers conducted an open-label, phase IB/II study in patients with advanced soft tissue sarcoma (STS) who have not been previously treated with a class of chemotherapies called anthracyclines, or PD-1/PD-L1 inhibitors (these work to “release the brakes” that the tumors place on a patient’s immune system), which then may allow the immune system to fight the tumor.
The purpose of the clinical trial was to determine the efficacy and safety of doxorubicin (an anthracycline) combined with durvalumab, a PD-L1 inhibitor. Additionally, the trial looked to identify patients who would most likely benefit from this treatment combination. In total, 41 patients that were evaluated, 1 (2.4%) achieved a complete response and 12 (29.3%) achieved a confirmed partial response. Median progression-free survival (PFS) was 7.6 months, and median overall survival was 23.8 months.
Analysis indicated that the absence genetic alterations in a cell signaling pathway called RTKRAS and high levels the PD-1 protein were predictors of longer PFS. Additional studies need to be carried out, but the combination of doxorubicin plus durvalumab may prove to be an effective treatment for a subset of patients with advanced STS.