Posted: 23 September 2024
Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is pleased to announce that the Company’s Phase 2a clinical trial investigating narmafotinib in the treatment of advanced pancreatic cancer (the ACCENT trial) has achieved the required response rate to support continued enrolment in the study. Six (6) patients have now recorded confirmed partial responses (PRs) out of 16 assessed at the four-month timepoint, indicating that the combination of narmafotinib with the chemotherapies gemcitabine and Abraxane® is sufficiently active to support continuation 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.
A total of 50 patients are planned for the Phase 2a ACCENT trial. With the six (6) confirmed PRs now obtained, recruitment of the remaining 24 patients in the trial will begin at the existing open trial sites in Australia and South Korea. Recruitment of the second cohort of patients is expected to be completed by end of Q1 2025.
A detailed interim analysis of the Phase 2a trial data obtained to date will be reported in the coming weeks; however, key points are noted below:
- Narmafotinib continues to be generally well tolerated by patients with no safety trends identified or dose reductions recorded to date
- In addition to 6 confirmed PRs, there have been 7 patients who have recorded stable disease over 2 or more months, including one patient whose stable disease has improved to achieve a partial response at their 4-month assessment
Amplia CEO and MD Dr Chris Burns commented: “Having now confirmed our sixth PR, we will move forward with recruiting the remaining 24 patients for the trial. We are actively working with our clinical sites to ensure seamless reopening of enrolment with the goal of completing recruitment by the end of March 2025. As always, we thank the patients and their loved ones for being involved with this trial”
