Amplia Therapeutics has announced positive updated data from its Phase 2a clinical trial (ACCENT) evaluating narmafotinib, a FAK inhibitor, in combination with gemcitabine and Abraxane for advanced pancreatic cancer. The data, analyzed up to December 6, 2024, reveal a promising objective response rate and improved duration on trial compared to historical data for standard-of-care treatment alone.
The trial has recorded nine confirmed partial responses (PRs) out of the initial 26 patients, resulting in an objective response rate of approximately 35%. This is a notable improvement over the 23% objective response rate reported in the historical trial used as a benchmark. A confirmed PR is defined as a sustained reduction of at least 30% in the overall size of tumor lesions for two or more months, with no new lesions observed.
Improved Duration on Trial
An important indicator of treatment effectiveness, the median duration on trial for the 26 patients is currently 172 days. This represents a 47% increase compared to the historical data of 117 days. Duration on trial reflects the treatment's ability to inhibit disease progression, as patients with progressive disease are discontinued from the trial. As of the data cutoff, 11 patients from the initial cohort of 26 remain on the trial.
Tolerability and Recruitment
Narmafotinib continues to demonstrate good tolerability among patients, with no withdrawals from the study attributed to the drug. Amplia is actively recruiting the second cohort of patients for the Phase 2a study, aiming for a total of 50 evaluable patients. Since reopening recruitment in October, 12 new patients have been enrolled.
Management Commentary
Dr. Chris Burns, CEO and MD of Amplia, 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."
