Aadi Bioscience presents new subgroup analysis in advanced malignant PEComa

Aadi Bioscience announced patients in the AMPECT trial whose malignant perivascular epithelioid cell tumor, or PEComa, had gynecologic origins experienced efficacy and safety consistent with the overall study population. The AMPECT trial formed the basis for the FDA approval of the company’s nab-sirolimus, FYARRO, for advanced malignant PEComa regardless of mutational status. Of the 31 patients enrolled in AMPECT, 16 had malignant PEComas originating from uterine, ovarian, pelvic or retroperitoneal sites. Overall response rate to nab-sirolimus for the subgroup was 37.5% (6/16), consistent with the overall AMPECT population Subgroup responses were rapid and durable, with 1.4 months median time to response and 36.2 months median duration of response. Safety profile of the subgroup was manageable and consistent with the overall AMPECT population. Additional data presented at SGO further highlight nab-sirolimus as a potential approach for mTOR-driven gynecologic cancers. These presentations include a real-world study characterizing TSC1 and TSC2 inactivating alterations in patients with advanced gynecologic cancers; trial-in-progress updates for the ongoing, tumor agnostic, registration-intended PRECISION1 trial; and a Phase 2 study of nab-sirolimus in combination with letrozole for advanced or recurrent endometrioid-type endometrial cancer. Registration-directed PRECISION1 study is enrolling patients with solid tumors harboring TSC1 and/or TSC2 inactivating alterations. In a large real-world database of patients with advanced cancer, 1,342 of the 54,911 patients with gynecological cancers harbored at least one inactivating alteration in TSC1 or TSC2. TSC1 and/or TSC2 inactivating alterations were present in 3.6% of endometrial cancers, 2.0% of ovarian cancers and 1.5% of cervical cancers.