Amplia Therapeutics reports a significant milestone in its ACCENT trial, with 15 confirmed partial responses indicating that narmafotinib combined with chemotherapy outperforms chemotherapy alone in advanced pancreatic cancer.
- 15 confirmed partial responses achieved in ACCENT Phase 1b/2a trial
- Narmafotinib combined with gemcitabine and Abraxane shows superiority over chemotherapy alone
- Trial fully recruited with 55 patients enrolled, 21 still ongoing
- Drug well tolerated with adverse events comparable to chemotherapy alone
- Top-line data expected mid Q3 2025
A Promising Step Forward in Pancreatic Cancer Treatment
Amplia Therapeutics Limited (ASX: ATX) has announced encouraging interim results from its ongoing ACCENT Phase 1b/2a clinical trial, investigating the efficacy of its novel FAK inhibitor, narmafotinib, in combination with standard chemotherapy for advanced pancreatic cancer. The trial has now recorded 15 confirmed partial responses, a key milestone that statistically demonstrates the combination therapy’s superiority over chemotherapy alone.
Understanding the Trial and Its Significance
The ACCENT trial is a single-arm, open-label study evaluating narmafotinib alongside gemcitabine and Abraxane, two well-established chemotherapies. Unlike randomized controlled trials, this study compares its results to historical data, particularly from the landmark MPACT study, which has set the benchmark for chemotherapy efficacy in pancreatic cancer. Achieving 15 or more confirmed responses among the 50-patient cohort was the pre-specified threshold to confidently assert improved efficacy, and with 55 patients enrolled, Amplia has surpassed this target.
A confirmed partial response means a sustained tumour shrinkage of over 30% lasting at least two months without new lesions, a notable achievement given the aggressive nature of pancreatic cancer where complete responses are exceedingly rare. This outcome suggests that narmafotinib’s targeted inhibition of FAK, a protein implicated in tumour progression, may enhance chemotherapy’s effectiveness.
Safety Profile and Ongoing Data Collection
Importantly, Amplia reports that narmafotinib’s addition does not increase adverse events beyond what is typically observed with chemotherapy alone, indicating a manageable safety profile. With 21 patients still on study, there is potential for further responses, which could strengthen the case for narmafotinib as a valuable adjunct therapy.
Looking Ahead: What to Expect Next
The trial is fully recruited and conducted across multiple sites in Australia and South Korea, reflecting a robust and diverse patient population. Amplia anticipates releasing top-line data by mid Q3 2025, which will provide deeper insights into progression-free survival and overall survival metrics, critical factors for regulatory approval and clinical adoption.
Amplia’s CEO, Dr Chris Burns, expressed optimism about these early results, highlighting the potential for narmafotinib to improve outcomes in a cancer type that has seen limited therapeutic advances. The company’s focus on FAK inhibition aligns with growing scientific interest in targeting tumour microenvironments and fibrosis, areas that could redefine cancer treatment paradigms.
Bottom Line?
Amplia’s ACCENT trial data marks a hopeful advance in pancreatic cancer therapy, with the next data release poised to further clarify narmafotinib’s clinical impact.
Questions in the middle?
- Will the upcoming top-line data confirm improvements in overall survival?
- How will narmafotinib’s safety profile hold up in larger, more diverse populations?
- Could narmafotinib’s mechanism open doors to treating other fibrotic or solid tumours?