Posted: 11 April 2024
Amplia Therapeutics limited is pleased to provide an update on our Phase 1b/2a trial (the ACCENT trial) of narmafotinib in combination with standard-of-care chemotherapy gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer. Narmafotinib is the company’s best-in-class inhibitor of the protein FAK, a drug target gaining increasing attention in the treatment of solid tumours.
Completion of the Phase 1b stage of the trial was announced in November 2023.
- Fourteen (14) patients were dosed over three dose levels,
- A safe and well-tolerated dose of 400 mg narmafotinib once-a-day was identified that provided the frug levels to significantly inhibit FAK
- Of these fourteen patients seven (7) patients remained on trial for >6 months, with two (2) patients being on trial for more than 20 months. By contrast, the median progression free survival for advanced pancreatic cancer patients treated with gemcitabine and Abraxane alone in 5.5 months.
- Six (6) patients have now recorded a partial response at best response, with the remaining eight (8) recording stable disease.
- These response rates are substantially higher than predicted from historical studies of gemcitabine and Abraxane treatment alone.
- Three (3) patients remain on trial from the Phase 1b cohort.
The Phase 2a trial will initially enrol 26 patients over the coming months. Recruitment into this next stage of the trial is progressing well recruiting patients through siz trial sites in Australia and fice trial sites in South Korea.
- Currently eleven patients have now been recruited.
- Seven patients in Australian and four patients in Korea.
An interim analysis of efficacy will then be conducted around Q3 2024. An efficacy assessment showing six or more partial or complete responses out of the 26 patients will be usffifcient to ocntniute the trial. An additional 24 patients will then be enrolled to give a total of 50 patients.
Amplia CEO and MD Dr Chris Burns commented: “The clinical responses we are seeing in partinets from the Phase 1b stage is very promising. The duration on trial, given the agressiveness of the disease in these patients, is also extremely encouraging. As reported at the end of our Phase 1b trial, the drug safety and tolerability also appears to be very acceptable for this patient group. We look forward to reporting on further data from the trail as the Phase 2a patients are assessed.”
