• Recruitment halted in AMPLICITY trial due to Dose Limiting Toxicities (DLTs) related to chemotherapy regimen mFOLFIRINOX
• No toxicity concerns identified regarding narmafotinib
• Patients already on trial will remain on study and continue treatment

Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF) has announced that it is halting further recruitment in the AMPLICITY clinical trial in advanced pancreatic cancer investigating the Company's lead drug narmafotinib in combination with the chemotherapy regimen modified FOLFIRINOX (mFOLFIRINOX). Eight patients have been dosed with daily narmafotinib in combination with the mFOLFIRINOX regimen, and three events of protocol-defined dose-limiting toxicity (DLT) have been observed, though none have been attributed to narmafotinib and instead relate to the chemotherapy regimen. Five of the 8 patients remain on study and will continue to receive the narmafotinib - mFOLFIRINOX combination with continuing safety monitoring. FOLFIRINOX has been one of the main chemotherapy regimens used in the treatment of pancreatic cancer patients who are generally fitter and have a higher performance status, but it is recognized as being more aggressive and less well tolerated by patients compared to other chemotherapies. Amplia anticipates an increasing preference for less toxic chemotherapeutic regimens in clinical practice and will therefore halt recruitment in AMPLICITY and focus its resources on exploring combinations other than with FOLFIRINOX. While efficacy data from AMPLICITY is early, four of the eight patients in the trial have recorded stable disease at their first (2-month) scan, with one of these patients subsequently recording a partial response at their 4-month scan.

Amplia will continue to build on the promising ACCENT trial data, as well as plan for additional studies with new, targeted agents being developed for pancreatic cancer.