Aadi Bioscience publishes long-term efficacy, safety results from AMPECT study

Aadi Bioscience announced that long-term efficacy and safety results from its completed Phase 2 registrational AMPECT study of nab-sirolimus in malignant PEComa were published in the Journal of Clinical Oncology, or JCO. The AMPECT trial evaluated the efficacy and safety of nab-sirolimus in patients with advanced malignant PEComa and was the first prospective registrational study in this setting. Data from this Phase 2, open-label, single-arm, multi-center study served as the basis for the FDA approval of Fyarro in advanced malignant PEComa regardless of mutational status. At study completion, the confirmed ORR on the basis of independent radiographic review using RECIST v1.1 remained at 38.7%, with an additional converted confirmed complete response, or CR, since the previously published analysis. The disease control rate, or DCR, remained at 71%. At the time of the primary analysis, the median duration of response, or mDOR, had not been reached. At study completion, the mDOR was reached at 39.7 months, median PFS remained the same at 10.6 months and median OS was 53.1 months.