Posted: 19 January 2024
Amplia Therapeutics Limited is pleased to announce that the first patient in the Phase 2a portion of the ACCENT trial has begun dosing. The ACCENT trial is examining the combination of Amplia’s best-in-class FAK inhibitor narmafotinib in combination with standard-of-care chemotherapy in first-line patients with advanced pancreatic cancer.
In November 2023, the company announced completion of the Phase 1b stage of the ACCENT trial where ascending doses of narmafotinib, in combination with the standard-of-care chemotherapy regime of gemcitabine and Abraxane, were dosed to first-line patients wth advanced pancreatic cancer. This dose-escalation stage identified a safe and well-tolerated dose of narmafotinib that provides sufficient circulating drug levels to significantly block the activity of the FAK enzyme.
Importantly, there were promising preliminary signs of efficiency from the collected Phase 1b data. The identified dose of narmafotinib is now being tested in patients, in combination with gemcitabine and Abraxane, in a Phase 2a trial.
The Phase 2a trial is being conducted at six trial sites open in Melbourne, Sydney and Brisbane and the five additional sites which have been opened in Korea. The Trial will initially enrol 26 patients over the combing months and an interim analysis of efficacy will then be conducted in mid-2024. An efficacy assessment showing six or more partial or complete responses out of the 26 patients will be considered statistically significant to continue the trial. An additional 24 patients will then be enrolled to give a total of 50 patients for this trial.
Amplia CEO and MD Dr Chris Burns commented: ‘Initiation of the Phase 2a sage of the trial is a significant milestone for Amplia. We are excited to be moving ahead with the next stage of the ACCENT trial with a safe and well-tolerated dose of narmafotinib. The trial in advanced pancreatic patients will determine whether narmafotinib, in combination with gemcitabine and Abraxane, provides for improved treatment options given the current five-year survival for newly diagnosed patients is only 12%.”
