AMPECT Study Shows Promising Safety With Nab-Sirolimus in PEComa Subgroups

Thomas J. Herzog, MD, Paul & Carolyn Flory professor, University of Cincinnati, deputy director, University of Cincinnati Cancer Center, Cincinnati, OH, discusses the safety findings of nab-Sirolimus (Fyarro; ABI-009) in a subgroup analysis of the phase 2 AMPECT study (NCT02494570) looking at patients with perivascular epithelioid sarcoma (PEComa).

Safety findings were presented at the 2024 Society of Gynecologic Oncology Annual Meeting and showed that 100% of patients experienced treatment-related adverse events (TRAEs) of any grade, while 63% of patients had a TRAE of grade 3. The most common any-grade TRAEs included stomatitis (81%), fatigue (63%), edema (56%), maculopapular rash (56%), diarrhea (50%), and nausea (50%).

For grade 3 TRAEs, stomatitis (25%), hyperglycemia (13%), hypokalemia (13%), increased amylase (6%), vomiting (6%), and diarrhea (6%) were observed. Additionally, there were no grade 4 or 5 TRAEs seen, TRAEs led to dose delay in 63% of patients, dose reduction in 31%, and treatment discontinuation in 6%.

Transcription:

0:09 | So all the patients in the gynecologic retroperitoneal subgroup analysis, all 16 of them experienced some treatment-related adverse events. Most of them were grade 1 or 2 with the most frequent in that category or overall being stomatitis, fatigue, edema, rash, and anemia.

0:33 | There were a number of patients that had grade 3 events, with almost two thirds experiencing that, and the most frequent there were stomatitis, anemia, dehydration, hyperglycemia, and hyperkalemia.

0:45 | The only thing that I would comment on is there were 4 patients that had interstitial lung disease or pneumonitis. Fortunately, in the subgroup only grade 1 and grade 2 was observed, and none of those patients had to come off treatment for this treatment-related adverse event.