Posted: 22 August 2024
Amplia Therapeutics Limited is pleased to announce that a fifth patient enrolled in the Company’s Phase 2a clinical trial in pancreatic cancer has recorded a confirmed partial response, meaning a 30% or greater decrease in the overall size of tumour lesions maintained over a two-month period, and with no new tumor lesions.
In addition, six (6) patients have 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 timour lesions have reduced in size by less than 30% (i.e. not sufficient to be classified as a PR) or have shown either no growth or minimal growth (<20%), and no new lesions.
A total of 50 patients are planned for the Phase 2a ACCENT trial which is investigating the company’s lead asset narmafotinib in the treatment of advanced pancreatic cancer. Initially, a cohort of 26 patients have been recruited and response to the therapy is monitored every two months. A minimum of six (6) patients who recorded a confirmed partial or complete response are required before recruitment of the second cohort of 24 patients is initiated. We have previously reported that four (4) confirmed PRs have already 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. Importantly, the fifth PR has been observed from a total of 13 patients imaged at the four month time point, representing an initial response rate of 38%.
Amplia CEO and MD Dr Chris Burns commented: “The continued positive data from the trial is extremely gratifying and at this rate we remain confident we will reopen recruitment in early October.”
The Company will provide further updated on the trial as it proceeds.
