Amplia Therapeutics has announced a promising development in its Phase 2a clinical trial (ACCENT) evaluating narmafotinib for advanced pancreatic cancer. The trial has reached the required response rate, with six patients showing confirmed partial responses (PRs) out of 16 assessed at the four-month mark. This positive outcome supports the continuation and expansion of the study.
The confirmed partial response is defined as at least a 30% decrease in the overall size of tumor lesions, with no new lesions, sustained over a two-month period.
Trial Expansion and Interim Analysis
The ACCENT trial aims to enroll a total of 50 patients. With six confirmed PRs, Amplia plans to recruit the remaining 24 patients at existing trial sites in Australia and South Korea. The company anticipates completing recruitment for this second cohort by the end of the first quarter of 2025.
Amplia Therapeutics plans to release a detailed interim analysis of the Phase 2a trial data in the coming weeks. This analysis will provide a more in-depth look at the efficacy and safety data collected thus far.
Safety and Tolerability
According to Amplia, narmafotinib has been generally well-tolerated by patients, with no significant safety trends identified or dose reductions recorded. In addition to the six confirmed PRs, seven patients have demonstrated stable disease for two or more months, including one patient whose condition improved from stable disease to a partial response at the four-month assessment.
Management Commentary
Dr. Chris Burns, CEO and MD of Amplia, stated, "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."
The combination therapy involves narmafotinib alongside the chemotherapies gemcitabine and Abraxane®.
