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Highlights

  • Amplia's ACCENT trial hits key efficacy threshold with 15 confirmed partial responses

  • Trial shows narmafotinib + chemotherapy outperforms chemotherapy alone

  • Top-line data expected Q3 2025; ATX shares jump 58% to 8.7 cents

Amplia Therapeutics (ASX:ATX) soared 58% on Thursday after announcing a major milestone in its Phase 1b/2a ACCENT clinical trial for pancreatic cancer. The trial, evaluating its FAK inhibitor narmafotinib combined with chemotherapy, has now recorded 15 confirmed partial responses (PRs).

The result provides early evidence that the combination therapy is superior to chemotherapy alone, a significant outcome in the treatment of one of the most aggressive and difficult-to-treat cancers.

What the Results Mean

The trial, which enrolled 55 advanced pancreatic cancer patients since January 2024, uses an open-label design. All patients receive narmafotinib alongside the standard-of-care drugs gemcitabine and Abraxane®. Efficacy is benchmarked against historical outcomes from the MPACT study, which serves as a comparator.

A confirmed partial response requires tumor shrinkage of more than 30% for over two months without new lesions—considered meaningful given the aggressive nature of pancreatic cancer, where complete responses are exceedingly rare.

Importantly, Amplia’s statistical plan had pre-specified that 15 or more PRs or CRs out of 50 patients would be enough to indicate a positive efficacy signal. The current tally meets that threshold, with 21 patients still undergoing treatment, leaving room for further upside.

Drug Tolerance and Safety

Amplia also reported that narmafotinib is well tolerated, with side effects comparable to chemotherapy alone. That tolerability strengthens the drug’s case as a viable future option for combination therapy.

Looking Ahead

With the ACCENT trial fully recruited, top-line data is expected by mid-Q3 2025. Amplia’s narmafotinib, discovered through the Melbourne-based Cooperative Research Centre for Cancer Therapeutics, continues to show promise as a highly selective FAK inhibitor—a class of drugs believed to reduce cancer cell survival and resistance.

Following the update, ATX shares surged to 8.7 cents.