Amplia Therapeutics (ASX:ATX) has announced that a fifth patient enrolled in its Phase 2a ACCENT clinical trial in pancreatic cancer has recorded a confirmed partial response, meaning a 30 per cent or greater decrease in the overall size of tumour lesions maintained over two months, and with no new tumour lesions.
The company said six patients had shown stable disease (SD) at their 2-month and 4-month assessment time points.
By the standard RECIST 1.1 criteria, SD is reported when tumour lesions have reduced in size by less than 30 per cent or have shown either no growth or minimal growth (less than 20 per cent) and no new lesions.
The company said 50 patients are planned for the Phase 2a ACCENT trial investigating the company’s lead asset, narmafotinib, in the treatment of advanced pancreatic cancer. Initially, a cohort of 26 patients has been recruited, and response to the therapy is monitored every two months. A minimum of six patients who record a confirmed partial or complete response are required before recruitment of the second cohort of 24 patients is initiated.
Amplia has previously reported that four confirmed PRs have been observed and this latest patient response means that only one more confirmed response (partial or complete) is required before recruitment of the additional 24 patients can begin.
Amplia CEO and managing director Dr Chris Burns said, “The continued positive data from the trial is extremely gratifying and at this rate we remain confident we will reopen recruitment in early October.”
