On August 20, 2024 Aadi Bioscience, Inc. (NASDAQ: AADI) reported it will halt the registration-intended PRECISION1 trial of nab-sirolimus in patients with solid tumors harboring TSC1 or TSC2 inactivating alterations. An analysis by the Independent Data Monitoring Committee demonstrated that the study was unlikely to exceed an efficacy threshold necessary to support an accelerated approval, the key goal of this Phase 2 study (Press release, Aadi Bioscience, AUG 20, 2024, View Source [SID1234646015]). The approximately 25 patients in PRECISION1 who are still benefiting from nab-sirolimus will be eligible for transition to a planned expanded access protocol, and a complete analysis of the PRECISION1 trial will be provided at a later date.
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Aadi will now focus on preserving cash while maximizing its commercial business. Aadi’s marketed product, FYARRO, is the only preferred treatment for patients with advanced malignant PEComa, a rare and aggressive cancer. In the second quarter of this year, FYARRO delivered sales of $6.2M.
To further preserve cash runway, Aadi will pause new enrollment, but continue dosing previously enrolled patients, in two, ongoing Phase 2 trials of nab-sirolimus for advanced or recurrent endometrioid-type endometrial cancer (EEC) and neuroendocrine tumors (NETs). Both studies have enrolled sufficient patients (n=20 and n=10 for EEC and NETs, respectively) to assess initial efficacy signals later this year. Aligned to these pipeline adjustments, the Company is reducing its Research & Development workforce by 80%. Together these actions extend cash runway into at least 2H 2026.
"We are humbled by the effort of the investigators, support staff, and most importantly, the patients and their families who took part in PRECISION1. While nab-sirolimus showed monotherapy activity in the study population, the trial fell short of delivering what we believe would be required to support an accelerated approval in the broad TSC1/TSC2 inactivating mutations indication. We look forward to providing the full trial analysis at a later date," said David Lennon, President and CEO of Aadi Bioscience. "I want to thank the dedicated Aadi employees who worked tirelessly on this trial and are negatively impacted by this outcome. Given the change in the development pipeline, we have taken the necessary steps to immediately preserve cash runway, and have hired an advisory firm to explore all options to maximize value for shareholders."