nab-sirolimus (FYARRO) is a novel mTOR inhibitor that leverages albumin-bound nanoparticle technology and is approved for the treatment of locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
We are thrilled to share more information from our AMPECT and PRECISION 1 trials with the leading sarcoma specialists from around the globe at CTOS 2022,' said
Details of the poster presentations are below: Title: 'Phase 2, Multicenter, Open-Label Basket Trial of nab-Sirolimus for Patients with Malignant Solid Tumors Harboring Pathogenic Inactivating Alterations in TSC1 or TSC2 Genes (PRECISION 1)'
Date/Time:
Aadi and its collaborators present a trial-in-progress poster for PRECISION 1, a registrational-directed trial now recruiting for patients with solid tumors driven by TSC1/TSC2 alterations, an underserved patient population with no targeted therapeutic options.
Title: 'Study-end Analysis from AMPECT, an Open-Label, Phase 2 Registration Trial of Patients with Advanced Malignant PEComa Treated with nab-Sirolimus, Showing Durability of Responses and Long-Term Safety'
Date/Time:
Aadi and its collaborators present final 3-year follow up data from the AMPECT Phase 2 study. The AMPECT study met its primary endpoint, showing a median Duration of Response (DoR) of over 3 years. In addition, median Overall Survival (OS) was updated to 53.1 months. Overall Response Rate (ORR), Disease Control Rate (DCR), and Progression Free Survival (PFS) were consistent with prior analysis of nab-sirolimus in AMPECT.
Title: 'Management of Adverse Events in the AMPECT Trial of nab-Sirolimus for the Treatment of Advanced Malignant Perivascular Epithelioid Cell Neoplasm (PEComa)
Date/Time:
Aadi and its collaborators present data on the adverse event (AE) management in the AMPECT trial over three years after the primary analysis was presented. nab-Sirolimus was generally well-tolerated, and the majority of the AEs due to nab-sirolimus treatment in the AMPECT trial were manageable. Importantly, dose reductions for AE management did not appear to compromise efficacy in patients who responded to therapy.
More information can be found on the CTOS meeting website at 2022 CTOS Annual Meeting (eventscribe.net).
About
Aadi is a commercial-stage biopharmaceutical company focused on precision therapies for genetically defined cancers. Aadi's primary goal is to bring transformational therapies to cancer patients with mTOR pathway driver alterations where other mTOR inhibitors have not or cannot be effectively exploited due to problems of pharmacology, effective drug delivery, safety, or effective targeting to the disease site. In
Based on exploratory data from AMPECT, a registrational study supporting approval in advanced malignant PEComa, and following a pre-IND meeting with the FDA, Aadi has initiated PRECISION 1, a Phase 2 tumor-agnostic registration-intended trial in mTOR inhibitor-naive malignant solid tumors harboring TSC1 or TSC2 inactivating alterations. More information is available on the
Cautionary Note Regarding Forward-Looking Statements
This press release contains certain forward-looking statements regarding the business of Aadi Biosciences that are not a description of historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the Company's current beliefs and expectations; the Company's anticipated growth; plans and potential for success relating to commercializing FYARRO; expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of FYARRO; expectations regarding management's performance; plans related to further development and manufacturing of FYARRO; pricing and reimbursement of FYARRO; the rate and degree of market acceptance of FYARRO; anticipated reception of FYARRO in the physician community; the clinical results and timing of additional clinical trials, including the registration-directed trial in patients harboring TSC1 or TSC2 inactivating alterations; the timing and likelihood of regulatory filings and approvals of FYARRO, including in potential additional indications and potential filings in additional jurisdictions; plans regarding clinical trials, in collaboration with
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