A significant development has emerged from the ACCENT pancreatic cancer clinical trial sponsored by Amplia Therapeutics in collaboration with Professor Paul Timpson and his team at the Garvan Institute of Medical Research, two patients have achieved a pathological complete response (pCR) following treatment with the drug narmafotinib (AMP945) in combination with standard chemotherapy treatment.
The foundation for the ACCENT trial was developed from preclinical research models spearheaded by Professor Paul Timpson, Head of the Invasion and Metastasis Lab. These studies revealed that FAK inhibitors reduce the stiffness and density of the fibrous tissue surrounding pancreatic cancer cells. This ‘priming’ effect sensitizes the tumour to chemotherapy, thereby reducing cancer growth and spread, opening up the possibility of surgical intervention.
The ongoing clinical trial is investigating Amplia’s FAK inhibitor narmafotinib (AMP945), administered in combination with standard of care chemotherapy gemcitabine and Abraxane in patients diagnosed with metastatic pancreatic cancer.
During routine assessment of the tumour burden, it was noted that two patients experienced significant reduction in the size and number of the tumour metastasis in the liver and in the primary tumour in the pancreas. This response allowed for surgical removal of both the liver and the pancreatic lesions. On pathological examination, the tumours were determined to contain no live cancer tissue. This is classified as a pathological compete response (pCR).
Pathological Complete Response is rare in patients presenting with advanced pancreatic cancer, where the tumour has metastasised beyond the pancreas. It has been shown in only 5% of locally advanced (non-metastatic cancer) pancreatic cancer in response to neoadjuvant treatment and can be associated with improved survival outcomes.
On the announcement of the pCR, Amplia CEO and MD Dr Chris Burns commented “This is wonderful news for the patient and the clinical team involved. We firmly believe this outcome further demonstrates the promising activity narmafotinib, on top of standard-of-care, is showing in the treatment of advanced pancreatic cancer”
Currently, results from the trail have show that of the participants recruited to the early Phase 2 trial, 2 patients have shown a complete response, with a further 16 showing some degree of tumour shrinkage.
The ACCENT trial is entitled ‘ACCENT: AMP945 in Combination with Nab-paclitaxel and Gemcitabine for Treatment of Pancreatic Cancer’. The Trail is running at 7 sites in Australia and 5 sites in South Korea.
More information on the trial can be found on the trial website, accenttrail.com and in ClinicalTrials.gov, identifier NCT05355298.
An article on Peter Moulding who had stage 4 pancreatic cancer when he joined the ACCENT trial and is now in remission, was published in The Australian on July 24th.