By Trend News Line 2024-03-20 12:00:00.
Patients with perivascular epithelioid sarcoma (PEComa) have shown promising responses to treatment with Nab-Sirolimus (Fyarro; ABI-009), as revealed in a recent subgroup analysis from the phase 2 AMPECT study presented at the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer.
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### Responses to Nab-Sirolimus Treatment
The analysis focused on 16 female patients with malignant PEComa in various gynecologic sites, irrespective of their TSC1/TSC2 mutation status. Among these patients, an overall response rate (ORR) of 37.5% was observed, with all responses being confirmed partial responses (PRs). Additionally, the disease control rate (DCR) in this subgroup was 62.5%, with 25% of patients experiencing stable disease for at least 12 weeks.
### Subgroup vs. Overall Population Results
This subgroup constituted more than half of the study population and showed ORR results similar to the overall population evaluation. The overall DCR in the study was 71%, with a median duration of response (DOR) of 39.7 months and a median overall survival (OS) of 53.1 months for all patients with malignant PEComa.
### Safety Profile of Nab-Sirolimus
While all patients experienced treatment-related adverse events (TRAEs) of any grade, 63% of patients reported a grade 3 TRAE. The most common TRAEs included stomatitis, fatigue, edema, rash, diarrhea, and nausea. No grade 4 or 5 TRAEs were observed, and TRAEs led to dose adjustment in some cases.
### Overview of the Phase 2 AMPECT Study
The AMPECT study aimed to evaluate the ORR, DOR, DCR, and safety of Nab-Sirolimus in patients with malignant PEComa. Patients had locally advanced or metastatic disease and had not received prior mTOR inhibitor treatment. A total of 16 female patients were included in the subgroup analysis, with a median age of 61.5 years.
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### Importance of Nab-Sirolimus in PEComa Treatment
Nab-Sirolimus is the first FDA-approved treatment for locally advanced or metastatic malignant unresectable PEComa. Its approval in this population in November 2021 marked a significant advancement in the treatment landscape for this rare cancer. Patients with advanced malignant PEComas face poor prognoses, making Nab-Sirolimus a crucial therapeutic option.
### Ongoing Research on Nab-Sirolimus
Dr. Thomas Herzog from the University of Cincinnati Cancer Center highlighted that more studies are underway to explore the use of Nab-Sirolimus in treating mTOR-driven cancers of gynecologic origin, including malignant PEComa. This ongoing research aims to further enhance treatment options for patients with these challenging cancers.
In conclusion, the findings from the AMPECT study underscore the efficacy and safety of Nab-Sirolimus in treating malignant PEComa, offering hope to patients with this rare and aggressive cancer. Ongoing research efforts will continue to expand our understanding of this treatment approach and its potential benefits for individuals facing this challenging diagnosis..
– nab-sirolimus gynecologic sarcomas
– sustained responses gynecologic sarcomas.
