Amplia Therapeutics Reports Four Additional Complete Responses and Improved
HIGHLIGHTS
- Formal centralised 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/C4)
- 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 202C in San Diego, CA, USA
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 tumours 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 Ǫ3 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…
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