Amplia Therapeutics has completed enrolment for its ACCENT Phase 2a trial in advanced pancreatic cancer two months early, reporting encouraging partial response rates and improved patient outcomes.
- ACCENT Phase 2a trial recruitment completed ahead of schedule
- 10 confirmed partial responses recorded among 53 patients
- Median duration on trial improved by 68% over historical data
- Top-line data expected mid-Q3 2025
- Narmafotinib combined with standard chemotherapy shows promising efficacy and safety
Accelerated Recruitment Milestone
Amplia Therapeutics Limited (ASX: ATX) has announced the successful completion of patient enrolment for its ACCENT Phase 2a clinical trial, targeting advanced pancreatic cancer. The company achieved this milestone two months ahead of schedule, enrolling 53 patients in total, including replacements for non-evaluable participants. This rapid recruitment underscores both the operational efficiency of Amplia and the strong clinical interest in narmafotinib, its lead FAK inhibitor candidate.
Promising Early Efficacy Signals
The ACCENT trial evaluates narmafotinib in combination with standard-of-care chemotherapy (gemcitabine and nab-paclitaxel) in first-line advanced pancreatic cancer patients. Preliminary data from the initial 26 patients revealed 10 confirmed partial responses (PRs), representing an objective response rate (ORR) of 38.5%. This notably exceeds the 23% ORR benchmark from historical controls, suggesting a meaningful therapeutic benefit. What's more, the median duration on trial for these patients is 197 days, a 68% improvement over the 117 days observed in prior studies.
Safety and Tolerability Profile
Safety remains a critical consideration in oncology drug development, and Amplia reports that narmafotinib continues to be well tolerated. The Phase 1b portion of the ACCENT trial, completed in late 2023, established a safe and tolerable oral dose. Ongoing monitoring in Phase 2a supports this profile, reinforcing confidence in narmafotinib’s potential as a viable adjunct to chemotherapy.
Strategic Implications and Next Steps
With recruitment complete, Amplia now shifts focus to data maturation and analysis, with top-line results anticipated by mid-Q3 2025. These results will be pivotal in determining narmafotinib’s clinical value proposition and potential regulatory pathways. Amplia’s CEO, Dr Chris Burns, highlighted the team’s dedication and the importance of patient participation, signaling continued commitment to advancing treatment options in a notoriously challenging cancer indication.
Broader Context in Oncology Innovation
FAK inhibitors like narmafotinib represent an emerging class of targeted therapies addressing tumor microenvironment and fibrosis, areas of growing interest in oncology research. Amplia’s progress with ACCENT positions the company at the forefront of this niche, potentially unlocking new avenues for treating fibrotic cancers beyond pancreatic cancer. The trial’s multicenter design, spanning Australia and South Korea, also reflects a strategic approach to diverse patient recruitment and data robustness.
Bottom Line?
Amplia’s ahead-of-schedule recruitment and encouraging early responses set the stage for a critical data readout that could reshape pancreatic cancer treatment.
Questions in the middle?
- Will the final efficacy data confirm the early partial response rates and duration improvements?
- How might Amplia position narmafotinib in the competitive pancreatic cancer treatment landscape post-trial?
- What are the implications of the safety profile for potential regulatory approval and broader patient use?