Amplia Therapeutics Reports Four Additional Complete Responses and Improved Overall Survival Data in Accent Pancreatic Cancer Trial
MWN-AI** Summary
Amplia Therapeutics Limited has recently reported promising updates from its ongoing ACCENT trial investigating the efficacy of narmafotinib, a potent inhibitor of focal adhesion kinase (FAK), combined with chemotherapy in patients with advanced pancreatic cancer. Notably, an independent analysis has confirmed five complete responses (CRs) among the 64 participants, achieving an unprecedented CR rate of 7.8%. This marks a significant advancement compared to traditional chemotherapy protocols, which have reported much lower CR rates.
In addition to the CRs, the trial has yielded a median overall survival (mOS) of 11.1 months, an approximate two-month improvement over the mOS associated with gemcitabine and Abraxane chemotherapy alone. This enhancement in survival rates is notable given that narmafotinib was administered without adding any significant toxicity compared to standard treatment regimens. The objective response rate (ORR) for all patients in the trial has been updated to 35.9%, highlighting the combination's potential effectiveness.
The data will be presented at the upcoming American Association of Cancer Research (AACR) annual meeting in April 2026, underscoring the significance of these findings within the oncology community. Dr. Chris Burns, CEO of Amplia, emphasized the importance of these results, noting that they provide new hope for patients facing this aggressive disease.
As the trial progresses, four patients remain active participants, with one nearing 24 months on the trial, further indicating the treatment's potential for prolonged efficacy. The ACCENT trial aims to contribute valuable insights into the treatment landscape for advanced pancreatic cancer, a challenging area with limited options.
MWN-AI** Analysis
Amplia Therapeutics Limited's recent updates from the ACCENT trial for its lead drug, narmafotinib, indicate a potentially promising opportunity for investors in the biotechnology sector. The trial reported a groundbreaking 7.8% complete response (CR) rate and a median overall survival (OS) of 11.1 months, demonstrating an improvement over standard treatments for advanced pancreatic cancer. This outcome is particularly noteworthy in a field where CR rates typically hover around 0.2% to 0.3%.
The confirmation of five complete responses following an independent analysis bolsters confidence in narmafotinib's efficacy, reinforcing its position as a viable alternative to existing chemotherapy regimens. Additionally, the updated objective response rate of 35.9% suggests that narmafotinib could redefine treatment paradigms in this aggressive cancer category, raising investor interest.
Given the two-month median OS improvement compared to historical data, investors should be cautious but optimistic. The comparable results to the NALIRIFOX combination therapy—recently granted FDA approval—could signal growing regulatory acceptance of narmafotinib. This, alongside the forthcoming presentation at the AACR meeting, provides an additional platform to enhance visibility and potentially attract new partnerships or funding opportunities.
However, potential investors should remain vigilant regarding the inherent risks in clinical-stage biotechnology investments, particularly in oncology. Factors such as market competition, the eventual regulatory pathway, and continued efficacy in larger trials are pivotal in determining Amplia's future valuation.
In summary, while Amplia Therapeutics presents a compelling investment thesis with its breakthrough findings, a careful analysis of its ongoing developments against the competitive landscape is crucial. Those considering involvement in ATX should closely monitor subsequent trial results and industry response, especially in the context of upcoming conferences and publications.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
HIGHLIGHTS
- Formal centralized and independent analysis of the clinical response data from the ACCENT trial has been undertaken and updated analysis provided to the Company
- The data confirm that five (5) patients have achieved a complete response (CR) in the Phase 1b/2a trial of narmafotinib combined with chemotherapy resulting in an unprecedented rate of CRs of 7.8% (5/64)
- A median Overall Survival of 11.1 months has also been determined which is a 2 month improvement compared to chemotherapy alone, with no additional toxicity burden
- The Company has been chosen to present trial data at the prestigious annual meeting of the American Association of Cancer Research (AACR) being held in April 2026 in San Diego, CA, USA
Melbourne, Australia, March 23, 2026 (GLOBE NEWSWIRE) -- Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), (“Amplia” or the “Company”), announces mature data from the ongoing ACCENT clinical trial in advanced pancreatic cancer in which the Company’s lead drug narmafotinib is combined with chemotherapy showing a median overall survival of 11.1 months, and five complete responses recorded to date.
Expert central reading of the clinical data by a contracted independent laboratory has reclassified some of the response data, identifying an additional four (4) confirmed complete responses (CRs). This brings the total CR’s for all patients in the ACCENT trial receiving a 400 mg dose of narmafotinib to five (5), resulting in a CR rate of 7.8% (5/64) which is unprecedented in this indication. Notably, this does not include the pathological complete response (pCR) recorded in the ACCENT trial, announced in June 2025. A confirmed CR means that CT scans have confirmed the disappearance of measurable tumors and metastases for two months or more, without the appearance of new lesions.
An additional confirmed partial response (PR) has also been identified, resulting in an updated Objective Response Rate (ORR) of 35.9% (23/64) for all patients in both stages of the 1b/2a ACCENT trial on a 400 mg dose of narmafotinib. As of 15 March 2026, four (4) patients remain on study, with one patient approaching 24 months on trial.
Up until the independent analysis, all clinical response data reported to the market has been based on analysis by the clinical investigator at each trial site. The Company has always planned for an independent data analysis to occur toward the conclusion of the trial, and with the anticipated completion in Q3 2026 this analysis was recently initiated. The expert and independent ‘central read’ laboratory has used the standardized and internationally recognized RECIST 1.1 criteria for measuring how a patient’s cancer responds to treatment.
Importantly, analysis of overall survival data (with a data cut-off of mid-March), indicates a median Overall Survival (mOS) of 11.1 months. This is an approximate two-month improvement when compared to clinical studies of the gemcitabine-Abraxane® chemotherapy alone, including the MPACT study1, which established this standard-of-care for advanced pancreatic cancer and against which ACCENT is benchmarked.
Combined, these data compare very favorably to published data for the gemcitabine-Abraxane chemotherapy alone from both the historical MPACT trial1 and the recent NAPOLI 3 trial2 (see table). Particularly noteworthy is that the mOS data from the ACCENT trial is identical to that obtained for the combination chemotherapy regimen NALIRIFOX in NAPOLI 3, and which resulted in its subsequent approval by the US FDA.
| ACCENT Trial (P1b/2a) (Narmafotinib + Gemcitabine/Abraxane) (n = 64) | MPACT Trial (Gemcitabine/ Abraxane) (n = 431)1 | NAPOLI 3 (Gemcitabine/ Abraxane) (n = 387)2 | |
| Complete Response (CR) | 7.8% | 0.2% | 0.3% |
| Objective Response Rate (ORR) | 35.9% | 23% | 36.2% |
| Median Overall Survival (mOS) | 11.1 | 8.5 | 9.2 |
Narmafotinib continues to be well tolerated by patients with the adverse effect profile of the narmafotinib-chemotherapy combination similar to chemotherapy alone.
The Company has been selected to present its trial data, along with additional ACCENT data derived from further analysis of the independently read data, at the annual meeting of the American Association of Cancer Research (AACR) meeting to be held April 17-22 in San Diego, California.
Dr Chris Burns, CEO and Managing Director of Amplia, commented on the latest results, “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.”
WEBINAR
A webinar discussing these results will be held on Tuesday 22 March 2026, 9:30am AEDT (Monday 23 March, 6:30pm EST). The webinar can be accessed by this link: https://ampliatx.com/webinars/pegkve-amplia-therapeutics-shareholder-webinar.
This ASX announcement was approved and authorized for release by the Board of Amplia Therapeutics.
| Investor Contact: Dr Chris Burns Chief Executive Officer chris@ampliatx.com U.S. Contact: Robert Giordano rjgiordano@ggrouplifesciences.com +1 917 327 3938 | Media Contact: Tom Trezona, H^CK Acting MD tom@hck.digital +61 411 235 692 U.S. Media: media@ampliatx.com |
About Amplia Therapeutics Limited
Amplia Therapeutics Limited is an Australian pharmaceutical company advancing a pipeline of Focal Adhesion Kinase (FAK) inhibitors for cancer and fibrosis. FAK is an increasingly important target in the field of cancer and Amplia has a particular development focus in fibrotic cancers such as pancreatic and ovarian cancer. FAK also plays a significant role in a number of chronic diseases, such as idiopathic pulmonary fibrosis (IPF). For more information visit www.ampliatx.com and follow Amplia on X (@ampliatx) and LinkedIn.
About Narmafotinib
Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein over-expressed in pancreatic cancer and a drug target gaining increasing attention for its role in solid tumors. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies. Narmafotinib is currently undergoing a clinical trial (the ACCENT trial) where it is dosed in combination with the chemotherapies gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer. The trial has already achieved its desired outcome in achieving a response rate of 31%, superior to chemotherapy alone and an interim PFS of 7.6 months has been reported. A second trial – AMPLICITY – has recently opened and is being run under an IND at sites in Australia and the US, investigating the combination of narmafotinib with the chemotherapy FOLFIRINOX in advanced pancreatic cancer patients.
About the ACCENT Trial
The ACCENT trial is entitled ‘A Phase 1b/2a, Multicenter, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients’.
The trial is a single-arm open label study conducted in two stages. The first stage (Phase 1b), completed in November 2023, determined an optimal dose of narmafotinib (AMP945) by assessing the safety, tolerability, pharmacokinetics and preliminary efficacy when dosed in combination with gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer.
The second stage (Phase 2a) of the trial is designed to assess efficacy in combination with gemcitabine and Abraxane. The primary endpoints are Objective Response Rate (ORR) and safety and tolerability, with secondary endpoints including Progression Free Survival (PFS), Overall Survival (OS) and Duration on Trial (DOT).
The trial is being conducted at seven sites in Australia and five sites in South Korea.
More information about the ACCENT trial can be found via the ACCENT trial site, the Amplia Therapeutics website and at ClinicalTrials.gov under the identifier NCT05355298.
1 New England Journal of Medicine 2011, 364, 1817-1825
2 The Lancet 2023, 402(10409), 1272-1281
FAQ**
How does the unprecedented 7.8% complete response rate for narmafotinib, as reported by Amplia Therapeutics Ltd INNMF, compare to historical rates for other treatments in advanced pancreatic cancer?
With a median overall survival improvement of two months over chemotherapy alone, what implications does this have for the future development strategy of Amplia Therapeutics Ltd INNMF?
What specific measures is Amplia Therapeutics Ltd INNMF taking to ensure the ongoing safety and tolerability of narmafotinib in combination with chemotherapy throughout the ACCENT trial?
How might the findings presented by Amplia Therapeutics Ltd INNMF at the AACR annual meeting influence investor confidence and future funding opportunities for the company?
**MWN-AI FAQ is based on asking OpenAI questions about Amplia Therapeutics Limited (OTC: INNMF).
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