Positive ACCENT Trial Topline Data Released

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Stock Amplia Therapeutics Ltd (ATX.ASX)
Release Time 6 Aug 2025, 8:29 a.m.
Price Sensitive Yes
 Positive ACCENT Trial Topline Data Released
Key Points
  • Progression Free Survival (PFS) of 7.6 months, a 2-month improvement over chemotherapy alone
  • Days on Trial (DOT) of 202 days, a material improvement on chemotherapy alone (117 days)
  • Objective Response Rate (ORR) of 31%, significantly better compared to chemotherapy alone (23%)
Full Summary

Amplia Therapeutics has released positive topline data from the ongoing ACCENT clinical trial of its FAK inhibitor narmafotinib in combination with standard-of-care chemotherapies gemcitabine and Abraxane for advanced pancreatic cancer. The interim analysis found a median Progression Free Survival (PFS) of 7.6 months, a 2-month improvement over chemotherapy alone. The mean Days on Trial (DOT) was 202 days, substantially better than the 117 days reported for chemotherapy alone. The Objective Response Rate (ORR) was 31%, significantly higher than the 23% observed with chemotherapy alone, including a confirmed Complete Response and a pathological Complete Response. The adverse event profile of the narmafotinib combination was very similar to that of chemotherapy alone, with narmafotinib treatment resulting in negligible additional patient burden. Seven patients have stayed on trial for over 12 months, indicating excellent durability of response. The Company will provide further updates as the ACCENT trial matures, and is accelerating towards a potential pivotal phase 2b/3 trial in the second half of 2026.

Outlook

The Company will provide further updates on the ACCENT trial as data is accrued, and is accelerating towards potential initiation of a pivotal phase 2b/3 trial in the second half of 2026.