On August 5, 2024 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), reported that a fourth patient enrolled in the Company’s Phase 2a clinical trial investigating narmafotinib in the treatment of advanced pancreatic cancer (the ACCENT trial) has recorded a confirmed partial response (Press release, Amplia Therapeutics, AUG 5, 2024, View Source [SID1234645349]).
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A total of 50 patients are planned for the Phase 2a ACCENT trial, recruited in two cohorts. In the first cohort of 26 patients, 6 or more patients with confirmed partial or complete responses are required to initiate recruitment of the second cohort of 24 patients. We have previously reported that three (3) confirmed partial responses have already been observed in the first patient cohort. This latest confirmed partial response means that only a further two (2) confirmed responses (partial or complete) are required for the trial’s interim analysis to support recruitment of the additional 24 patients in the second cohort of the trial.
The formal term ‘confirmed partial response’ means in these patients there is at least a 30% decrease in the overall size of tumour lesions, with no new tumour lesions, sustained over a two-month period, while a confirmed complete response refers to a total absence of tumour lesions over a two-month period.
Amplia CEO and MD Dr Chris Burns commented: "The activity of narmafotinib in the ACCENT trial continues to be very positive, consistent with our previous clinical and preclinical data. We remain on track to complete the interim analysis by the end of this quarter."
The Company will provide further updates on the trial as recruitment proceeds.
This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.
About Narmafotinib
Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein overexpressed in pancreatic and other cancers, and a drug target gaining increasing attention for its role in solid tumours. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies. The drug has successfully completed a healthy volunteer study, and is currently in an open-label Phase 2a trial in pancreatic cancer where a combination of narmafotinib and the chemotherapies gemcitabine and Abraxane is being assessed for safety, tolerability and efficacy.
About the ACCENT Trial
The ACCENT trial is entitled ‘A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients’.
The ACCENT trial explores the use of narmafotinib in combination with standard-of-care chemotherapy of gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer. The trial is a single-arm open label study conducted in two stages. The firststage (Phase 1b), completed in November 2023, identified a 400 mg oral daily dose of narmafotinib, given in the days preceding regular chemotherapy infusion, as safe and well tolerated. This second stage (Phase 2a), of the trial is designed to assess drug efficacy in combination with gemcitabine and Abraxane. The primary endpoints are Objective Response Rate (ORR) and Duration on Trial (DOT) with secondary endpoints being Progression Free Survival (PFS) and Overall Survival (OS). Safety and tolerability will continue to be assessed.
More information about the ACCENT trial, including a list of participating sites, can be found via the Amplia Therapeutics website and at ClinicalTrials.gov under the identifier NCT05355298.