Aadi Bioscience’s nab-sirolimus shows anti-tumor activity in interim trial

Aadi Bioscience reported results from a planned interim analysis on the first third of participants in the ongoing tumor-agnostic PRECISION1 trial evaluating nab-sirolimus in patients with TSC1 or TSC2 inactivating alterations. Full enrollment in the trial is expected by the spring of 2024. Interim analysis includes data from the first third of trial participants with a minimum of 4.5 months of follow-up. Nine different tumor types were enrolled in the TSC1 arm and 13 tumor types were enrolled in the TSC2 arm. Observations included a 26% Overall Response Rate – ORR – including 5 partial responses with 4 confirmed responses and 1 unconfirmed response. All responses were ongoing at the time of data cutoff. 9 patients had stable disease, 3 of which were greater than or equal to six months in duration, resulting in a clinical benefit rate of 42%. Median time to response was 1.4 months. Responses were seen across four different epithelial carcinomas. 60% of responders experienced greater than 50% tumor reduction. In patients with tumors harboring pathogenic inactivating alteration in TSC2, observations included an 11% ORR including 2 PRs with 1 confirmed and 1 uPR; 12 patients had SD, 3 of which were greater than or equal to six months resulting in a clinical benefit rate of 28%; responses were seen in one epithelial carcinoma and one sarcoma. No new safety signals were observed, and no grade four treatment-related events or deaths occurred. 80 patients are currently enrolled in the PRECISION1 trial, supporting the two-thirds interim analysis expected in Q3 2024. The trial is expected to be completed by the end of 2024 with results anticipated in early 2025.