Amplia positions narmafotinib as a potential step change in pancreatic cancer

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Amplia Therapeutics (ASX:ATX) has used one of the world’s largest oncology stages to sharpen its case for narmafotinib, presenting mature data from its ACCENT trial that suggest the drug could meaningfully shift outcomes in one of the most difficult to treat cancers.

The company’s oral presentation at the American Association for Cancer Research annual meeting in San Diego builds on earlier disclosures, offering a more detailed look at efficacy and survival signals in patients with metastatic pancreatic cancer treated with narmafotinib in combination with standard chemotherapy.

At the centre of the update is a set of response and survival outcomes that compare favourably with historical benchmarks. Independent central review identified five confirmed complete responses among 64 patients, translating to an eight per cent complete response rate, a striking contrast to the approximately 0.2 per cent typically observed with chemotherapy alone.

Overall response rates reached 36 per cent, rising to 42 per cent when unconfirmed responses were included, while disease control was achieved in 70 per cent of patients. Median progression-free survival was 7.7 months, and median overall survival was 11.1 months, both representing improvements of more than 2 months compared with standard chemotherapy regimens.

The depth and durability of responses also stood out, with some patients remaining on study beyond 12 months and tumour reductions averaging close to 70 per cent among responders, according to the data presented in the conference materials. These findings reinforce a broader signal that targeting focal adhesion kinase may enhance the effectiveness of chemotherapy by disrupting tumour survival mechanisms and the surrounding microenvironment.

The addition of narmafotinib did not introduce a significant tolerability burden beyond chemotherapy alone, with most treatment-related adverse events described as mild to moderate and predominantly gastrointestinal in nature.

The trial design itself reflects a conventional early-stage pathway, beginning with dose escalation before moving into a single-arm efficacy phase across sites in Australia and South Korea. Patients received narmafotinib alongside gemcitabine and nab-paclitaxel, with endpoints including response rates, survival outcomes, and safety.

Chief Executive Dr Chris Burns said, “We are excited to present this mature ACCENT data at the AACR annual meeting. Being able to present the extremely promising clinical responses to colleagues and peers at one of the world’s most prestigious oncology conferences allows us to demonstrate the potential narmafotinib has in the treatment of this terrible disease. We are now focused on building on this promising data with additional clinical studies, including a pivotal study based on the ACCENT trial, as well as combination studies with the exciting new class of drugs called kRAS inhibitors.”

The company said the next phase of development will test whether these signals can be translated into a definitive clinical benefit in larger and more rigorous trials.