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Aadi Bioscience Announces Exploratory Biomarker Data from Patients in Its AMPECT Trial and Expanded Access Program to be Presented at 2022 ASCO Annual Meeting
Target tumor reductions observed in advanced malignant PEComa patients harboring TSC1 or TSC2 inactivating alterations regardless of prior mTOR inhibitor
About this update from Whitehawk Therapeutics, Inc.
[{"type":"text","content":"Target tumor reductions observed in advanced malignant PEComa patients harboring TSC1 or TSC2 inactivating alterations regardless of prior mTOR inhibitor exposure\nLOS ANGELES, May 26, 2022 (GLOBE NEWSWIRE) -- Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes, today announced presentation of a poster entitled, “nab-Sirolimus for patients with advanced malignant PEComa with or without prior mTOR inhibitors: Biomarker results from AMPECT and an expanded access program” at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, being held online and in person from June 3-7 in Chicago, IL. The data represent exploratory biomarker results reported from the final analysis of mTOR inhibitor-naïve advanced malignant PEComa patients treated with nab-sirolimus in Aadi’s Advanced Malignant PEComa Trial (AMPECT) trial as well as an analysis of prior mTOR inhibitor exposed advanced malignant PEComa patients treated with nab-sirolimus in the Expanded Access Program (EAP) through June 2021. While the AMPECT and EAP studies cannot be directly compared, the findings of each show a greater clinical benefit in the patients harboring TSC1 or TSC2 alterations who received nab-sirolimus compared to all evaluable patients, regardless of prior mTOR inhibitor exposure. “Given that inactivating alterations in TSC1 or TSC2 are potentially targetable biomarkers for mTOR inhibition, the exploratory biomarker results from these studies are encouraging as they support the rationale for our ongoing PRECISION 1 Phase 2 registrational trial,” said Neil Desai, Ph.D., Founder, President and Chief Executive Officer of Aadi. “The response rates to nab-sirolimus in both AMPECT and the EAP showed similar positive trends in patients with TSC1 or TSC2 alterations, regardless of prior mTOR inhibitor exposure.” Nab-sirolimus is an albumin-bound mTOR inhibitor approved by the U.S. Food and Drug Administration (FDA) as FYARRO™ for the treatment of adult patients with locally advanced unresectable or metastatic malignant PEComa. The data to be presented include 31 mTOR inhibitor naïve patients from the AMPECT trial and 16 patients with prior mTOR inhibitor treatment from the EAP, all of which were treated with nab-...