LOS ANGELES - Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company, has announced the long-term results of its Phase 2 AMPECT study on nab-sirolimus, a treatment for malignant PEComa, a rare form of cancer. Published in the Journal of Clinical Oncology, the study shows a median duration of response of 39.7 months and a median survival time exceeding 53 months for patients with advanced malignant PEComa.
The AMPECT trial, the first prospective registrational study in this setting, showed a confirmed overall response rate of 38.7% with an additional patient achieving a complete response. This marks a significant improvement over historical median survival rates, which previously ranged from 16 to 29 months.
Senior Physician at Dana-Farber Cancer Institute and Associate Professor of Medicine at Harvard Medical School, Dr. Andrew J. Wagner, expressed optimism about the final outcomes of the trial, noting the durable responses and tolerable safety profile of nab-sirolimus.
Aadi's Chief Medical Officer, Dr. Loretta Itri, acknowledged the contributions of the principal investigators, study coordinators, and patients to sarcoma research and expressed hope for the continued advancement of nab-sirolimus.
No new or unexpected adverse events were reported during the trial, with the most common treatment-related adverse events being stomatitis, fatigue, and rash. No grade 4 or 5 treatment-related adverse events were reported.
These findings have supported the FDA approval of FYARRO® for the treatment of adult patients with locally advanced unresectable or metastatic malignant PEComa, regardless of mutational status.
Aadi Bioscience is also conducting clinical trials of nab-sirolimus as a single agent or in combination for the treatment of other mTOR-driven cancers.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.