Breakthrough Response Observed in Amplia's Pancreatic Cancer Trial

June 16, 2025 12:56 PM AEST | By Team Kalkine Media
 Breakthrough Response Observed in Amplia's Pancreatic Cancer Trial
Image source: Shutterstock

Highlights

  • Amplia Therapeutics reports rare complete response in metastatic pancreatic cancer trial
  • Narmafotinib shows potential in combination with standard chemotherapy
  • Fast-track status granted by FDA supports accelerated development

Amplia Therapeutics (ASX:ATX) has shared a promising update from its ongoing ACCENT clinical trial focused on treating metastatic pancreatic cancer. A patient participating in the trial has achieved a pathological complete response (pCR), marking a rare and highly encouraging milestone in the treatment of this aggressive cancer type.

Trial Progress and Medical Impact

The ACCENT study is evaluating Amplia’s novel FAK (focal adhesion kinase) inhibitor, narmafotinib, when used alongside the established chemotherapy combination of gemcitabine and Abraxane. The therapy aims to tackle both primary pancreatic tumors and secondary liver metastases, a common challenge in late-stage patients.

In this instance, the patient exhibited significant shrinkage of both liver metastases and the original pancreatic tumor. Following surgical removal of the tumors, pathological examination confirmed the absence of live cancer cells, officially qualifying the outcome as a pCR.

This level of response is extremely rare, especially in cases of metastatic pancreatic cancer. While around 5% of patients with locally advanced forms of the disease can reach a pCR with neoadjuvant chemotherapy, such outcomes are almost unheard of in metastatic cases. A pCR is often associated with extended survival outcomes, making this result noteworthy for clinicians and researchers alike.

Clinical Significance and Future Outlook

Amplia’s management expressed optimism about the clinical potential of narmafotinib, describing the pCR as a significant outcome for the patient and a strong signal of the therapy’s promise. The development supports ongoing research into narmafotinib's effectiveness and may inform future treatment strategies for advanced pancreatic cancer.

Adding to the momentum, the US Food and Drug Administration granted fast-track designation to narmafotinib in recognition of its potential to outperform current treatment options for serious conditions. This designation enables a faster path to clinical review and potential availability, accelerating access for patients in need.

The results from this trial represent a meaningful advancement in the fight against one of the most challenging cancers, highlighting the potential of next-generation targeted therapies like narmafotinib. As the ACCENT trial progresses, further data will shed light on its broader impact and suitability in wider patient populations.


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