Posted: 11 December 2024
Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is pleased to report updated data from Company’s ongoing Phase 2a clinical trial. This trial is investigating the Company’s FAK inhibitor narmafotinib in combination with standard-of-care chemotherapy of gemcitabine and Abraxane® in the treatment of advanced pancreatic cancer (the ACCENT trial). This latest data analysis was conducted up to 6 December 2024 and expands on the previous interim data release1 which covered data up to 27 September 2024.
Nine (9) confirmed partial responses (PRs) have now been recorded from the initial 26 patient cohort of the Phase 2a trial. This represents an objective response rate of ~35%, significantly better than the 23% reported for the historical trial2 being used as the benchmark for this study. A confirmed PR is recorded when there is at least a 30% decrease in the overall size of tumour lesions sustained for two or more months, with no new tumour lesions apparent.
Importantly, the median duration on trial for the 26 patients is currently 172 days which is a 47% improvement over the historical data of 117 days. The duration on trial is a measure of how effective the treatment is in inhibiting disease progression, as patients with progressive disease must leave the trial. Currently 11 patients from the initial 26 enrolled remain on trial.
Narmafotinib continues to be generally well tolerated by patients and no patients have withdrawn from study due to issues from narmafotinib.
The Company is now recruiting the second cohort of patients for the Phase 2a study to bring the total number of evaluable patients for the trial to 50. At this time 12 new patients have enrolled on the trial since reopening recruitment in October.
Amplia CEO and MD Dr Chris Burns commented: “Adding narmafotinib to the standard-of-care treatment continues to show promise in comparison to the historical data for standard-of-care alone. We’ve recruited over 75% of the trial at this time, and with ongoing positive support from clinicians involved in the study, we are well on track to fully recruit the trial by end of Q1 2025. In addition, we have been reassured by our clinical team in Korea that the recent political situation in the country is not impacting the trial sites located there in terms of recruitment and ongoing support of patients.”
This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.
