Amplia Therapeutics Achieves Rare Complete Response in Advanced Pancreatic Cancer Trial

A Breakthrough in a Challenging Cancer

Amplia Therapeutics Limited (ASX – ATX) has announced a significant milestone in its ongoing ACCENT clinical trial for advanced pancreatic cancer. A patient treated with the company’s novel FAK inhibitor, narmafotinib, in combination with standard chemotherapy, has achieved a pathological complete response (pCR). This outcome, where no viable cancer cells are detected in tissue samples following surgery, is exceptionally rare in patients with metastatic pancreatic cancer.

Pancreatic cancer remains one of the most difficult cancers to treat, particularly once it has spread beyond the pancreas. The ACCENT trial evaluates narmafotinib alongside gemcitabine and Abraxane®, aiming to improve outcomes in this aggressive disease. The recent pCR finding suggests that narmafotinib may enhance the effectiveness of chemotherapy in shrinking tumors to the point where surgery can remove all detectable cancer.

Details of the Clinical Response

During routine monitoring, the patient showed a marked reduction in both the primary pancreatic tumor and secondary liver metastases. This improvement allowed the clinical team to proceed with surgical resection of the tumors. Subsequent pathological examination revealed no live tumor cells, confirming the pCR. Such responses are typically seen in only about 5% of patients with locally advanced, non-metastatic pancreatic cancer undergoing neoadjuvant chemotherapy, making this result in a metastatic case particularly noteworthy.

Amplia’s CEO, Dr Chris Burns, expressed optimism about the result, emphasizing that it underscores the potential of narmafotinib to make a meaningful difference in advanced pancreatic cancer treatment. While this is a single patient outcome, it provides a compelling signal of efficacy that warrants further investigation as the trial progresses.

The ACCENT Trial and Future Prospects

The ACCENT trial is a two-stage, open-label study conducted across multiple sites in Australia and South Korea. The first phase established the optimal dose of narmafotinib combined with chemotherapy, while the ongoing second phase focuses on measuring objective response rates and survival outcomes. The trial’s design aims to build a comprehensive understanding of the drug’s safety and efficacy profile.

Amplia’s focus on FAK inhibition taps into a growing area of cancer research, as this protein plays a key role in tumor progression and metastasis. Narmafotinib’s selective targeting of FAK could represent a new therapeutic avenue not only for pancreatic cancer but potentially other solid tumors as well.

Investors and the medical community will be watching closely for further data releases from the ACCENT trial, which could validate these early promising results and support regulatory advancement.