Amplia Therapeutics has announced a second confirmed complete response in its ACCENT trial for advanced pancreatic cancer, a notably rare achievement in this challenging disease.
- Second confirmed complete response in ACCENT trial
- Narmafotinib combined with chemotherapy shows promising activity
- Complete responses are exceptionally rare in advanced pancreatic cancer
- Trial conducted across Australia and South Korea
- Ongoing Phase 2a study assessing efficacy and safety
Rare Clinical Milestone in Pancreatic Cancer
Amplia Therapeutics Limited (ASX – ATX) has reported a significant development in its ongoing ACCENT clinical trial, revealing a second confirmed complete response (CR) in patients with advanced pancreatic cancer. This outcome is particularly striking given the rarity of complete responses in this notoriously aggressive and difficult-to-treat cancer type.
In the context of pancreatic cancer that has metastasized, achieving a complete disappearance of all tumor lesions sustained for over two months is an exceptional event. To illustrate, landmark chemotherapy studies such as those involving gemcitabine and Abraxane documented only a single complete response among hundreds of patients, underscoring the potential impact of Amplia's investigational drug.
Narmafotinib’s Role and Trial Design
The ACCENT trial is evaluating narmafotinib (AMP945), Amplia’s best-in-class inhibitor of focal adhesion kinase (FAK), a protein implicated in pancreatic cancer progression. Narmafotinib is administered in combination with standard chemotherapy agents gemcitabine and nab-paclitaxel (Abraxane). The trial is structured in two stages – Phase 1b, which established the optimal dosing and safety profile, and the ongoing Phase 2a, focused on assessing efficacy endpoints such as objective response rate and duration on trial.
Conducted across multiple sites in Australia and South Korea, the study’s open-label, single-arm design allows for close monitoring of narmafotinib’s effects alongside chemotherapy. The recent announcement follows an earlier report of a pathological complete response in a separate patient, further highlighting the drug’s promising activity.
Implications and Future Outlook
Amplia’s CEO, Dr Chris Burns, expressed optimism about these developments, emphasizing the rarity and significance of multiple complete responses in this patient population. While these results are encouraging, the trial remains ongoing, and longer-term data on progression-free and overall survival will be critical to fully understand narmafotinib’s therapeutic potential.
As the ACCENT trial progresses, Amplia is positioned to contribute meaningful advances in pancreatic cancer treatment, a field with few effective options. The company’s focus on FAK inhibition also aligns with broader research trends targeting the tumor microenvironment and fibrosis, which may open additional avenues for clinical application.
Bottom Line?
Amplia’s rare clinical successes in pancreatic cancer hint at a potential breakthrough, but sustained efficacy and safety data will be key to unlocking its full promise.
Questions in the middle?
- Will the complete responses translate into longer overall survival benefits?
- How will narmafotinib’s safety profile hold up in larger patient cohorts?
- Could FAK inhibition become a new standard component in pancreatic cancer therapy?