Amplia Therapeutics (ASX:ATX) has progressed its ACCENT trial to evaluate narmafotinib, a drug that treats solid tumours in advanced pancreatic cancer patients.
The ACCENT trial, conducted in two stages, assesses the safety and efficacy of narmafotinib in combination with chemotherapy treatment.
The Phase 1b stage of the trial, completed in November 2023, produced encouraging results. Amongst the 14 patients treated, a daily dose of 400 mg narmafotinib was found to be safe and significantly well-tolerated, inhibiting the targeted protein FAK. Seven patients were on trial for over six months, with two extending beyond ten months. This duration exceeded the median progression-free survival of 5.5 months observed in patients receiving chemotherapy alone. Six patients achieved a partial response, indicating a positive outcome compared to historical data.
The trial is now progressing to Phase 2a, which aims to enroll 26 patients across trial sites in Australia and South Korea. 11 patients have been recruited as of now, with more recruitment underway.
An interim efficacy analysis is scheduled for Q3 2024, where a sufficient number of partial or complete responses will determine the trial’s continuation, followed by the enrollment of an additional 24 patients.
“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 trial as the Phase 2a patients are assessed,” Amplia CEO and Managing Director Dr Chris Burn said.
Cancer has been at the forefront of the news, with the Princess of Wales Kate Middleton recently opening up about her diagnosis and after King Charles started treatment for the same disease. Middleton, in particular, was praised for her transparency, which medical authorities said he encouraged many members of the public to go for tests in the United Kingdom.
Amplia Therapeutics remains committed to continue developing novel treatments for pancreatic cancer, offering hope for improved outcomes and better quality of life for patients battling this deadly disease.
ATX has been trading at 7.7 cents.