The interim analysis includes data from the first third of trial participants (n=40) with a minimum of 4.5 months of follow-up, including investigator-assessed response and safety analyzed separately in each TSC1 and TSC2 arms. 

Efficacy of nab-sirolimus in patients with tumors harboring pathogenic inactivating alteration in TSC1

Efficacy of nab-sirolimus in patients with tumors harboring pathogenic inactivating alteration in TSC2

• An 11% ORR, including 2 PRs with one confirmed and one uPR.
• Twelve 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.

Eighty patients are enrolled in the PRECISION1 trial, supporting the two-thirds interim analysis expected in Q3 of 2024. The ORR analysis in this cohort will be based on an independent radiological review with at least six months of follow-up for all patients. 

The trial is expected to be completed by the end of 2024, with results anticipated in early 2025.

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