Amplia Hits 7.8% Complete Response Rate in Pancreatic Cancer, 39x Standard Care
Amplia Therapeutics (ASX: ATX) has reported mature data from the Amplia ACCENT Trial Pancreatic Cancer study showing five confirmed complete responses and 11.1 months median overall survival. The results, derived from independent central analysis of 64 patients receiving 400mg narmafotinib combined with chemotherapy, include a 7.8% complete response rate and selection for presentation at the American Association of Cancer Research (AACR) conference in April 2026.
Amplia reports five complete responses and 11.1-month survival in ACCENT pancreatic cancer trial
The Phase 1b/2a Amplia ACCENT Trial Pancreatic Cancer data confirms five complete responses among 64 patients receiving 400mg narmafotinib, representing a 7.8% complete response rate. Independent central laboratory analysis, conducted as the trial approaches anticipated completion in Q3 2026, identified an additional four confirmed complete responses beyond the initial investigator-reported case, bringing the total to five confirmed CRs.
Median overall survival reached 11.1 months, representing an approximate two-month improvement compared to chemotherapy alone based on the MPACT study benchmark. The 35.9% objective response rate (23/64 patients) includes the five complete responses plus additional partial responses. As of 15 March 2026, four patients remain on study, with one patient approaching 24 months on trial.
The independent analysis represents a formal verification step planned from the trial’s inception. All previous clinical response data reported to the market was based on investigator assessment at individual trial sites. The expert central read laboratory applied the internationally recognised RECIST 1.1 criteria for measuring cancer treatment response, providing standardised verification of the efficacy signals.
Selection for presentation at the AACR annual meeting (17-22 April 2026, San Diego) validates the scientific significance of the data. AACR represents a premier oncology conference where pharmaceutical business development teams evaluate potential licensing opportunities and regulatory pathways.
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What is a complete response in cancer treatment?
A complete response in cancer treatment means CT scans have confirmed the disappearance of all measurable tumours and metastases for two months or more, with no new lesions appearing during that period. This represents the strongest possible efficacy signal in oncology trials, indicating the treatment has eliminated all detectable cancer that can be measured by imaging.
Complete responses are rare in advanced pancreatic cancer. The 7.8% complete response rate in the ACCENT trial significantly exceeds historical benchmarks for first-line pancreatic cancer treatment, where complete response rates typically fall below 1%. This rarity reflects the aggressive nature of pancreatic cancer and the difficulty of achieving complete tumour elimination in patients with metastatic disease.
The distinction between investigator-assessed and independently centrally-read data is critical for regulatory and partnership discussions. Investigator assessments, while valuable, can vary between sites based on individual clinical judgement. Independent central reading applies uniform RECIST 1.1 criteria across all patient scans, eliminating inter-observer variability and providing standardised, reproducible measurements accepted by regulatory authorities.
The five confirmed complete responses exclude the pathological complete response announced in June 2025, which represents a separate category of response where tissue analysis shows complete absence of viable cancer cells. The current five CRs are radiographic complete responses based on imaging assessment.
ACCENT trial results compared to standard of care
The 11.1 months median overall survival in the ACCENT trial matches the survival outcome achieved by NALIRIFOX in the NAPOLI 3 trial, a combination chemotherapy regimen that secured FDA approval based on its performance. The comparison positions narmafotinib favourably against established benchmarks, particularly given the dramatically superior complete response rate.
The MPACT trial established gemcitabine-Abraxane as the standard of care for advanced pancreatic cancer, demonstrating 8.5 months median overall survival and a 0.2% complete response rate. The ACCENT trial’s 11.1 months median overall survival represents an approximate two-month improvement over this benchmark, while the 7.8% complete response rate is approximately 39 times higher than the MPACT standard.
NAPOLI 3 evaluated the NALIRIFOX regimen (nanoliposomal irinotecan, oxaliplatin, leucovorin, fluorouracil) against gemcitabine-Abraxane, demonstrating 9.2 months median overall survival and 0.3% complete response rate. While NALIRIFOX achieved regulatory approval, its complete response rate remained below 1%. The ACCENT trial matched NALIRIFOX’s survival outcome while achieving a 7.8% complete response rate, representing a 26-fold improvement in this metric.
| Metric | ACCENT Trial (Narmafotinib + Gemcitabine/Abraxane) n=64 | MPACT Trial (Gemcitabine/Abraxane) n=431 | NAPOLI 3 (Gemcitabine/Abraxane) n=387 |
|---|---|---|---|
| Complete Response Rate | 7.8% | 0.2% | 0.3% |
| Objective Response Rate | 35.9% | 23% | 36.2% |
| Median Overall Survival | 11.1 months | 8.5 months | 9.2 months |
Narmafotinib continues to be well tolerated, with the adverse effect profile of the narmafotinib-chemotherapy combination similar to chemotherapy alone. This safety profile indicates narmafotinib adds no additional toxicity burden to the standard chemotherapy regimen, an important consideration for regulatory review and clinical adoption.
Matching survival outcomes of an FDA-approved regimen while demonstrating dramatically superior complete response rates positions narmafotinib competitively for partnership discussions and potential regulatory pathways. The data suggests narmafotinib may offer patients an improved efficacy profile without compromising safety or tolerability.
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AACR presentation and trial completion timeline
The AACR annual meeting presentation is scheduled for 17-22 April 2026 in San Diego, California. The company will present additional ACCENT data derived from further analysis of the independently read data, providing more detailed insights into the trial outcomes beyond the headline complete response and survival metrics.
AACR is a premier oncology conference where pharmaceutical business development teams, regulatory experts, and academic researchers evaluate emerging drug candidates and clinical data. Presentation selection by AACR’s scientific committee indicates peer recognition of the data’s scientific merit and potential clinical significance.
Trial completion is anticipated in Q3 2026, with the independent central analysis conducted as the study approaches this milestone. The timing positions the company for potential partnership discussions and regulatory pathway decisions in the second half of 2026, following presentation of the complete dataset at AACR and final data maturation.
Dr Chris Burns, CEO and Managing Director
“These latest data from the ACCENT trial clearly demonstrate the significant clinical benefit of narmafotinib. The unprecedented 7.8% rate of CR’s in the first line setting provides new hope for patients with this very aggressive cancer and provides further strong support for the benefit that narmafotinib can bring when combined with other treatment modalities. We look forward to presenting a detailed analysis of the ACCENT trial at the forthcoming AACR conference.”
A webinar discussing these results was scheduled for Tuesday 24 March 2026 at 9:30am AEDT (Monday 23 March, 6:30pm EST), providing investors with direct access to management commentary on the data and strategic implications.
Amplia’s pipeline and next steps
The AMPLICITY trial, investigating narmafotinib combined with FOLFIRINOX chemotherapy in advanced pancreatic cancer patients, is now recruiting at sites in Australia and the United States under an Investigational New Drug (IND) application. This second trial expands the clinical programme beyond the ACCENT study’s gemcitabine-Abraxane combination.
Amplia’s broader Focal Adhesion Kinase (FAK) inhibitor pipeline includes applications in fibrotic cancers such as ovarian cancer and chronic diseases including idiopathic pulmonary fibrosis. FAK is increasingly recognised as an important target in cancer and fibrosis, with Amplia’s development focus on leveraging narmafotinib’s best-in-class FAK inhibition across multiple indications.
Near-term catalysts within the next six months include:
- ACCENT trial completion anticipated Q3 2026
- AACR data presentation April 2026
- AMPLICITY trial recruiting in Australia and US
Multiple catalysts within a six-month timeframe provide near-term newsflow opportunities and de-risking events for the narmafotinib asset. The progression of both ACCENT towards completion and AMPLICITY through patient recruitment demonstrates execution momentum across the clinical development programme.
Independent verification of response data through central laboratory analysis strengthens credibility ahead of potential partnering discussions and regulatory pathway decisions. The complete response rate differential compared to standard of care provides a differentiated efficacy profile that may support premium valuation in partnership negotiations or inform regulatory strategy for potential approval pathways.
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