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. 

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData

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. 

GlobalData is the parent company of Clinical Trials Arena.