Amplia Therapeutics (ASX: ATX) has revealed that three patients enrolled in the company’s Phase 2a clinical trial investigating narmafotinib in the treatment of advanced pancreatic cancer have recorded a confirmed partial response.
The formal term ‘confirmed partial response’ means there is at least a 30% decrease in the overall size of tumour lesions, and no new tumour lesions, in these patients sustained over a two month period.
Of the six patients currently assessed at the four month time point, in addition to the three confirmed partial responses, two additional patients have recorded sustained stable disease.
“To be reporting that three confirmed partial responses have been observed so early in this stage of the trial is extremely encouraging,” CEO and MD, Dr Chris Burns, said.
“We are well on track to reach the efficacy threshold of six confirmed partial or complete responses by the end of this quarter, which will then allow us to restart the trial to recruit the full cohort of fifty patients.”
The company recently announced completion of enrolment of the first 26 patients in the trial as part of the industry-standard Simon’s Two-Stage Trial design. Once six confirmed partial or complete responses are obtained then an additional 24 patients will be enrolled, giving a total of 50 patients for the trial.
Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein over- expressed in pancreatic and other cancers, and a drug target gaining increasing attention for its role in solid tumours.
The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies. The drug has successfully completed a healthy volunteer study and is currently in an open-label Phase 2a trial in pancreatic cancer where a combination of narmafotinib and the chemotherapies gemcitabine and Abraxane is being assessed for safety, tolerability and efficacy.
