Trial results for the Phase 2 study (NCT03899805) investigating a combination of pembrolizumab and eribulin in soft tissue sarcomas were posted on ClinicalTrials.gov on 2025-08-28. The study reported a 12-week progression-free survival (PFS) rate of 69.6% for participants with liposarcomas, with varying rates observed across other sarcoma subtypes.
Background
This research study investigated the combination of eribulin (chemotherapy) and pembrolizumab (immunotherapy) as a potential treatment for advanced liposarcoma, leiomyosarcoma, or undifferentiated pleomorphic sarcoma that had spread and not responded to standard treatment.
Trial design
The study (NCT03899805) was a Phase 2 trial with an overall status of COMPLETED. It enrolled 57 participants diagnosed with advanced soft tissue sarcomas, specifically liposarcoma, leiomyosarcoma, or undifferentiated pleomorphic sarcoma. The trial evaluated the efficacy of combining eribulin and pembrolizumab.
Key results
The trial results provided data on 12-week Progression Free Survival (PFS), Median Overall Survival (OS), Objective Response Rate (ORR), and Clinical Benefit Response Rate (CBR) across different sarcoma subtypes:
- 12-week Progression Free Survival (PFS):
- For Liposarcomas: 69.6% of participants
- For Leiomyosarcomas: 36.8% of participants
- For Undifferentiated Pleomorphic Sarcomas: 52.6% of participants
- Median Overall Survival (OS):
- For Liposarcomas: 97.6 Weeks
- For Leiomyosarcomas: 59.1 Weeks
- For Undifferentiated Pleomorphic Sarcomas: Data not available
- Objective Response Rate (ORR):
- For Liposarcomas: 0.25 proportion of participants
- For Leiomyosarcomas: 0.47 proportion of participants
- For Undifferentiated Pleomorphic Sarcomas: 0.56 proportion of participants
- Clinical Benefit Response Rate (CBR):
- For Liposarcomas: 0.75 proportion of participants
- For Leiomyosarcomas: 0.53 proportion of participants
- For Undifferentiated Pleomorphic Sarcomas: 0.44 proportion of participants
What this means
The results from this Phase 2 trial suggest that the combination of pembrolizumab and eribulin may offer varying degrees of benefit across different soft tissue sarcoma subtypes. The observed 12-week PFS rate of 69.6% for liposarcomas indicates a potentially favorable outcome in this specific group. While other subtypes like leiomyosarcomas and undifferentiated pleomorphic sarcomas showed lower PFS rates, the Objective Response Rates and Clinical Benefit Response Rates provide further insights into the activity of this combination therapy. These findings contribute to the understanding of potential treatment strategies for advanced soft tissue sarcomas that have progressed after standard therapies, highlighting the importance of subtype-specific considerations.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03899805, titled "A Phase II Study of Eribulin and Pembrolizumab in Soft Tissue Sarcomas," were posted on 2025-08-28 on clinicaltrials.gov.