Amplia Secures US Approval to Test Narmafotinib with FOLFIRINOX in Phase 2

Ethics Approval Unlocks New Clinical Trial

Amplia Therapeutics Limited (ASX – ATX) has reached a significant milestone by obtaining ethics clearance from a central US Institutional Review Board to initiate a Phase 2 clinical trial investigating narmafotinib in combination with the chemotherapy regimen FOLFIRINOX for advanced pancreatic cancer patients. This approval is a crucial regulatory step that allows Amplia to proceed with patient recruitment and site activations in the US, with parallel efforts underway to secure ethics approval for Australian sites.

Exploring a New Combination Strategy

The upcoming trial will explore the safety, tolerability, and efficacy of combining Amplia’s FAK inhibitor narmafotinib with FOLFIRINOX, a four-drug chemotherapy cocktail considered the preferred first-line treatment for newly diagnosed advanced pancreatic cancer in the US. This approach differs from Amplia’s ongoing ACCENT trial, which pairs narmafotinib with gemcitabine and Abraxane. By testing narmafotinib alongside FOLFIRINOX, Amplia aims to identify the optimal oral dose of narmafotinib that can be safely combined with the biweekly intravenous chemotherapy regimen.

Trial Design and Expectations

The open-label Phase 2a study is designed as a single-arm, multicenter trial enrolling approximately 60 to 70 patients. It will proceed in two parts – Part A will assess a range of narmafotinib doses for safety and pharmacokinetics, while Part B will compare two selected doses to determine the optimal dosing for future studies. The trial is conducted under an open Investigational New Drug (IND) application with the US Food and Drug Administration, incorporating the FDA’s Project Optimus guidance aimed at optimizing oncology drug development.

Building on Promising Preclinical and Clinical Data

Preclinical studies have shown that adding narmafotinib to FOLFIRINOX improves survival in animal models compared to chemotherapy alone. Meanwhile, the ACCENT trial has already demonstrated encouraging results, including two complete responses, when narmafotinib was combined with gemcitabine and Abraxane. Amplia’s CEO Dr Chris Burns highlighted that the new trial will complement these findings and help establish narmafotinib as a potent combination partner in pancreatic cancer treatment.

Next Steps and Market Implications

With ethics approval secured, Amplia is now focused on finalising site activations and commencing patient recruitment in both the US and Australia. Success in this trial could significantly enhance narmafotinib’s clinical profile and commercial potential in a disease area with high unmet need. Investors and analysts will be watching closely for emerging data and regulatory progress as Amplia advances its pipeline.