FDA’s Feedback Poses Minimal Delay Risk for Amplia’s Cancer Drug Trial
Amplia Therapeutics has secured positive feedback from the US FDA on its Phase 2b/3 trial design for narmafotinib in pancreatic cancer, paving the way for a late 2026 trial start.
- FDA supports two-dose comparison design in Phase 2b trial
- Minor protocol changes expected with minimal timeline impact
- Full trial protocol submission planned for first half of 2026
- Trial combines narmafotinib with gemcitabine and Abraxane
- Registration-enabling study targeted to commence late 2026
FDA Endorsement Marks Key Regulatory Milestone
Amplia Therapeutics Limited (ASX, ATX) has received encouraging feedback from the US Food and Drug Administration (FDA) following a Type D meeting focused on its upcoming Phase 2b/3 clinical trial. The trial will evaluate the efficacy of Amplia's lead drug candidate, narmafotinib, in combination with established chemotherapies gemcitabine and Abraxane for treating pancreatic cancer.
The FDA's positive response specifically endorses the trial's two-dose comparison strategy in the Phase 2b portion, which precedes the pivotal Phase 3 stage. This regulatory nod is significant as it confirms the company’s approach to dose optimisation and trial design, while only requesting minor adjustments that are not expected to delay the overall timeline.
Advancing Towards Late 2026 Trial Commencement
Amplia plans to prepare and submit the full trial protocol for FDA review in the first half of 2026. This step is critical to securing final regulatory approval and aligns with the company’s goal to initiate the registration-enabling Phase 2b/3 study by late 2026. The trial aims to build on promising earlier data from the ACCENT trial, where narmafotinib demonstrated a confirmed response rate of 33%, outperforming historical benchmarks for the chemotherapy combination alone.
Dr Chris Burns, Amplia’s CEO, highlighted the importance of the FDA’s feedback, noting that the agency’s support for the dose comparison design allows the company to proceed confidently with trial planning. He emphasised that the minor changes requested will have minimal impact on the timeline, reinforcing the company’s strategic roadmap.
Broader Implications for Pancreatic Cancer Treatment
Pancreatic cancer remains one of the most challenging cancers to treat, with limited effective therapies and poor survival rates. Amplia’s focus on Focal Adhesion Kinase (FAK) inhibition, through narmafotinib, represents a novel approach targeting the tumor microenvironment and fibrotic processes that contribute to disease progression.
The company’s ongoing clinical programs, including the ACCENT and AMPLICITY trials, position Amplia at the forefront of developing next-generation treatments for this aggressive cancer. The FDA’s supportive stance on the upcoming Phase 2b/3 trial could accelerate the pathway to potential approval and broaden therapeutic options for patients.
Investors and industry watchers will be closely monitoring the protocol submission and subsequent FDA review, which will provide further clarity on the trial’s design and regulatory expectations.
Bottom Line?
Amplia’s FDA endorsement sets the stage for a critical trial launch that could reshape pancreatic cancer therapy.
Questions in the middle?
- What specific minor changes did the FDA request for the trial protocol?
- How will narmafotinib’s efficacy compare to existing treatments in the Phase 3 stage?
- What are the potential market implications if the trial meets its endpoints?
