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- A formal centralized and independent analysis of the clinical response data from the ACCENT trial has been conducted and updated analysis has been provided to the Company
- Data confirms that five (5) patients have achieved complete response (CR) in the Phase 1b/2a trial of normafotinib with chemotherapy resulting in an unprecedented CR rate of 7.8% (5/C4).
- A median overall survival of 11.1 months was also determined, which is an improvement of 2 months compared to chemotherapy alone, with no additional toxicity burden.
- The company has been selected to present the trial data at the prestigious annual meeting of the American Association for Cancer Research (AACR) to be held in San Diego, CA, USA in April 202C.
Expert central reading of the clinical data by a contracted independent laboratory has reclassified some response data, identifying an additional four (4) confirmed complete responses (CRs). This brings the total CR for all patients receiving the 400 mg dose of nermofotinib in the ACCENT trial to five (5), resulting in a CR rate of 7.8% (5/64) which is unprecedented in this indication. Notably, it does not include pathological complete responses (pCR) recorded in the ACCENT trial announced in June 2025. A confirmed CR means that CT scans have confirmed the disappearance of measurable tumor and metastases for two months or longer, without the appearance of new lesions.
One additional confirmed partial response (PR) was also identified, resulting in an updated objective response rate (ORR) of 35.9% (23/64) for all patients in both Phase 1b/2a ACCENT trials at the 400 mg dose of normafotinib. As of March 15, 2026, four (4) patients remain on the study, with one patient approaching the 24-month trial.
Until the independent analysis, all clinical response data reported in the market were based on analysis by the clinical investigator at each trial site. The company has always planned an independent data analysis prior to the conclusion of the trial, and this analysis was recently initiated with an anticipated completion in 2026. The specialist and independent ‘Central Read’ laboratory uses standardized and internationally recognized RECIST 1.1 criteria to measure 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 improvement of approximately two months compared to clinical studies of gemcitabine-Abraxane® chemotherapy alone, including the MPACT study.1which 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 gemcitabine–abraxane chemotherapy alone from both the landmark MPACT trial1 and the recent NAPOLI 3 trial.2 (See table). Particularly noteworthy is that the mOS data obtained from the ACCENT trial is similar to the data obtained for the combination chemotherapy regimen NALIRIFOX in NAPOLI 3, and which resulted in its subsequent approval by the US FDA.
Nermafotinib continues to be well tolerated by patients with the adverse effect profile of the nermafotinib-chemotherapy combination similar to that of chemotherapy alone.
The company has been selected to present its trial data, along with additional ACCENT data derived from further analysis of independently studied data, at the American Association for Cancer Research (AACR) annual meeting, taking place April 17-22 in San Diego, California.
Dr. Chris Burns, CEO and Managing Director of AmpliaCommented 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 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 upcoming AACR conference.”
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