Posted: 8 August 2024
Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is pleased to announce 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.
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.
