Amplia Therapeutics reports first pathological complete response in ACCENT pancreatic cancer trial
Amplia Therapeutics (ASX: ATX) has recorded the first pathological complete response (pCR) from a patient participating in the company’s ongoing ACCENT clinical trial to treat metastatic pancreatic cancer.
The trial is investigating the company’s best-in-class FAK (focal adhesion kinase) inhibitor narmafotinib in combination with standard-of-care chemotherapies gemcitabine and Abraxane.
The patient recorded a pCR after routine assessment of their tumour burden, which noted a significant reduction in the size and number of hepatic metastases (secondary tumours in the liver) and in the primary pancreatic tumour.
Pathological examination
The patient underwent surgery to remove all tumours, with pathological examination determining that the tumours did not contain live cancer tissue.
Pancreatic cancer is the eighth most commonly diagnosed cancer in Australia, with an estimated one in 70 people diagnosed by the time they are 85 but pCR classification is an extremely rare observation in this population.
By comparison, around 5% of patients with locally advanced (or non-metastatic) pancreatic cancer record a pCR in response to treatment with neoadjuvant chemotherapy.
In these earlier-stage patients, a pCR can be associated with improvements in overall survival.
Encouraging outcome
Amplia chief executive officer Dr Chris Burns said the company was encouraged by the trial outcome.
“We are extremely excited to learn that a patient from our study has achieved a pathological complete response—it is wonderful news for the patient and for the clinical team involved,” he said.
“We firmly believe this demonstrates the promising activity that narmafotinib, on top of standard-of-care, is showing in the treatment of advanced pancreatic cancer.”
Fast-track designation
The US Food and Drug Administration granted fast-track designation to Narmafotinib in September after it delivered promising data in a range of pre-clinical cancer studies.
The designation is applicable to drugs that may provide an advantage over current therapies in the treatment of serious conditions.
It aims to speed the development of these drugs to enable patients to receive them sooner.