Posted: 31 October 2024
Amplia Therapeutics has today released interim data from the Company’s Phase 2a clinical trial investigating narmafotinib in the treatment of advanced pancreatic cancer.
As previously reported, narmafotinib is generally well tolerated by patients with no dose reductions. In addition, six patients recorded confirmed partial responses (PRs), meaning in these patients there is at least a 30% decrease in the overall size of tumour lesions, with no new tumour lesions, sustained for two or more months.
Additional observations from the data analysis (up to 27 September 2024):
- 6 patients have recorded unconfirmed PRs, 4 of which are awaiting confirmation whilst 2 have subsequently recorded progressive disease (PD)
- 8 patients recorded sustained stable disease (SD), with 5 of these patients remaining on study
- 3 patients recorded PD as best response, while 3 other participants were considered ineligible or withdrew from the trial
- Of the 24 evaluable patients, 19 have recorded a decrease in tumour size as best response at any scan
- Median duration on trial at data cut-off is 136 days, which is longer than for comparative trials of chemotherapy alone
- Preliminary analysis indicates patients have a faster response to therapy in terms of tumour reduction, compared to historical data for chemotherapy alone
A total of 50 patients are planned for the Phase 2a ACCENT trial. Recruitment of the second cohort of patients has resumed and is expected to be completed by the end of Q1 2025.
Amplia CEO and MD Dr Chris Burns commented:
“We continue to be excited by the data coming from the clinical study of narmafotinib in this challenging disease. We thank the patients and their loved ones for their involvement in the study. Further trial updates will be provided to the market in due course.”
