US-based Aadi Bioscience has announced interim data from the Phase II trial investigating nab-sirolimus to treat patients with malignant solid tumours exhibiting pathogenic alterations in TSC1/TSC2 genes.
The preliminary data from the TSC1 arm of 22 patients showed a 26% overall response rate (ORR) with ongoing responses, whilst the TSC2 arm of 18 patients exhibited an 11% ORR. Clinical benefit rates were 42% and 28%, respectively, with no new safety concerns. All 40 patients were previously heavily treated with at least three forms of therapy.
The randomised, open-label, multicentred PRECISION-1 trial (NCT05103358) is evaluating the safety and efficacy of nab-sirolimus in 80 patients with various TSC1/TSC2 altered tumours.
The primary outcome of the study is ORR, as determined by independent radiographic review (IRR) using Response Evaluation Criteria in Solid Tumours (RECIST) v 1.1. The study concludes by the end of 2024, with results anticipated in early 2025.
In the announcement accompanying the data, Aadi Bioscience’s CMO Loretta Itri said: “Full enrolment in the trial is expected by the spring of 2024 and we believe we are on track to generate compelling clinical evidence for advancing nab-sirolimus toward potential expansion of the current registration, bringing this innovative therapeutic agent to more cancer patients.”
Nab-sirolimus is an mTOR inhibitor bound to human albumin. In May 2021, Aadi completed a rolling new drug application (NDA) for the candidate’s use as a treatment for advanced malignant PEComa.
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Nab-sirolimus received a fast track designation from the US Food and Drug Administration for the treatment of adults and adolescents with solid tumours that have a pathogenic inactivating alteration of the TSC1 or TSC2 in September 2021.
Aadi joined forces with Mirati last year to assess its adagrasib and nab-sirolimus in a combination treatment for KRAS G12C -mutated, non-small cell lung cancer (NSCLC) and other solid tumours in Phase I/II trial (NCT05840510). The study, which plans to enrol 79 patients, began in August 2023 and will conclude at the end of 2025.
According to GlobalData’s Pharma Intelligence Center, nab-sirolimus is forecasted to generate $481m in 2029.
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