On October 30, 2024 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), reported the interim data analysis from the Company’s Phase 2a clinical trial investigating narmafotinib in the treatment of advanced pancreatic cancer (the ACCENT trial) (Press release, Amplia Therapeutics, OCT 30, 2024, View Source [SID1234647494]). The trial is investigating the combination of the Company’s best-in-class FAK inhibitor narmafotinib with the standard-of-care chemotherapy regimen of gemcitabine and Abraxane. Data cut-off for the interim analysis is 27 September 2024.
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As previously reported by the Company, narmafotinib continues to be generally well tolerated by patients with no dose reductions. In addition, six (6) 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.
Further details regarding the responses observed by trial participants are summarised below and presented in the attached slides:
• 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 compares favourably with historical data for chemotherapy alone of 117 days
• 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. With the six (6) confirmed PRs obtained, recruitment of the remaining 24 patients has begun. Recruitment of the second cohort of patients is expected to be completed by end of Q1 2025 and three patients have already been enrolled as of 24 October 2024.
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. "
About Narmafotinib
Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein overexpressed in pancreatic and other cancers, and a drug target gaining increasing attention for its role in solid tumours. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies. The drug has successfully completed a healthy volunteer study, and is currently in an open-label Phase 2a trial in pancreatic cancer where a combination of narmafotinib and the chemotherapies gemcitabine and Abraxane is being assessed for safety, tolerability and efficacy
About the ACCENT Trial
The ACCENT trial is entitled ‘A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients’.
The ACCENT trial explores the use of narmafotinib in combination with standard-of-care chemotherapy of gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer. The trial is a single-arm open label study conducted in two stages. The firststage (Phase 1b), completed in November 2023, identified a 400 mg oral daily dose of narmafotinib, given in the days preceding regular chemotherapy infusion, as safe and well tolerated.
This second stage (Phase 2a), of the trial is designed to assess drug efficacy in combination with gemcitabine and Abraxane. The primary endpoints are Objective Response Rate (ORR) and Duration on Trial (DOT) with secondary endpoints being Progression Free Survival (PFS) and Overall Survival (OS). Safety and tolerability will continue to be assessed.
More information about the ACCENT trial, including a list of participating sites, can be found via the Amplia Therapeutics website and at ClinicalTrials.gov under the identifier NCT05355298.