Announcement • May 21
Amplia Therapeutics Limited Initiates Phase 2B Study of Narmafotinib in Pancreatic Cancer Amplia Therapeutics Limited announced that it is initiating a Phase 2b study of narmafotinib in pancreatic cancer exploring a new dosing regimen. Designed in alignment with FDA feedback, the study will form the basis – and first stage – of a registrational study in this indication given the high existing unmet need for innovative treatments. Narmafotinib is a best-in-class FAK inhibitor that has received orphan drug designation and fast track designation from the U.S. FDA as a potential treatment in pancreatic cancer. The study will investigate, for the first time, a daily dosing schedule for narmafotinib, at two dosing levels, with the chemotherapies gemcitabine and Abraxane in newly diagnosed advanced pancreatic cancer patients. In this first stage, each dosing cohort will have 6 patients (12 patients in total), which will be combined with gemcitabine and Abraxane given on their conventional schedule. In addition to safety and tolerability, pharmacokinetics (PK) and efficacy will be assessed. Exploratory endpoints will include effects on disease biomarkers as well as effects on fibrosis, a key indicator of FAK activity. The study will enroll patients across 3-4 sites in Australia. The Company anticipates patient enrolment will begin by the fourth quarter of this year with the safety, tolerability and PK assessment for the 12 patients completed in the second quarter of 2027. Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein over-expressed in pancreatic cancer and a drug target gaining increasing attention for its role in solid tumors. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies. Narmafotinib is currently undergoing a clinical trial (the ACCENT trial) where it is dosed in combination with the chemotherapies gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer. The trial has achieved its desired outcome in achieving a response rate of 36%, superior to chemotherapy alone, and a mOS of 11.1 months has been reported. A second trial – AMPLICITY – is being run at sites in Australia investigating the combination of narmafotinib with the chemotherapy FOLFIRINOX in advanced pancreatic cancer patients. Announcement • May 11
Amplia Therapeutics Limited And Australia New Zealand Gynaecological Oncology Group Announce Clinical Study Of Narmafotinib In Ovarian Cancer Amplia Therapeutics Limited and the Australia New Zealand Gynaecological Oncology Group announced that they have entered into an agreement to conduct a new clinical study investigating the Company’s lead drug narmafotinib in ovarian cancer. Narmafotinib is a best-in-class FAK inhibitor currently undergoing clinical development in pancreatic cancer where it is showing promising efficacy combined with good tolerability. The study is an investigator-initiated clinical trial led by Dr Gwo Yaw Ho of Monash Health and Monash University, and sponsored and coordinated through ANZGOG, an international cooperative clinical trials network spanning major hospitals across Australia and New Zealand. The study is expected to enroll approximately 15–20 patients with high-grade serous ovarian cancer (HGSOC) who demonstrate poor response to up-front standard-of-care platinum-based chemotherapy prior to planned interval debulking surgery. The trial, to be called the PRROSE trial, will evaluate the safety of narmafotinib in combination with standard-of-care chemotherapy (carboplatin and paclitaxel) in this patient population. Approximately one in five ovarian cancer patients do not respond adequately to initial chemotherapy, limiting their ability to undergo surgery and contributing to poor clinical outcomes. This study is designed to address this significant unmet medical need. The study will therefore also explore whether the addition of narmafotinib can increase the proportion of patients eligible for successful surgical resection. Extensive tissue and blood biomarkers will be examined for insight into narmafotinib’s mechanism of action to further enrich data provided from the study. Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein over-expressed in pancreatic cancer and a drug target gaining increasing attention for its role in solid tumors. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies. Narmafotinib is currently undergoing a clinical trial (the ACCENT trial) where it is dosed in combination with the chemotherapies gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer. The trial has achieved its desired outcome in achieving a response rate of 36%, superior to chemotherapy alone, and a mOS of 11.1 months has been reported. A second trial – AMPLICITY – is being run at sites in Australia investigating the combination of narmafotinib with the chemotherapy FOLFIRINOX in advanced pancreatic cancer patients. Announcement • Apr 24
Amplia Therapeutics Limited Presents Mature Data from Accent Trial in Pancreatic Cancer Amplia Therapeutics Limited announced that an oral presentation highlighting mature data from the Company’s ACCENT trial in metastatic pancreatic cancer is being delivered at the annual meeting of the AACR. The presentation includes more detailed analysis of the recently reported data from the ACCENT study, which is investigating the Company’s best-in-class FAK inhibitor narmafotinib in combination with standard-of-care chemotherapy. The key points from the presentation are: Narmafotinib displays a manageable toxicity profile, with no significant tolerability burden over chemotherapy alone. Independent (central) reading of data identified 5 confirmed Complete Responses (CR’s) from 64 patients, an 8% CR rate compared to a 0.2% rate for chemotherapy alone. A response rate of 36% is observed (23 of 64 patients); 42% if unconfirmed responses included. A Disease Control Rate (DCR) of 70% was determined, compared to 50% for chemotherapy alone. Median overall survival (mOS) was found to be 11.1 months, while median progression-free survival (mPFS) was 7.7 months, both showing improvements of over two months compared to chemotherapy alone. A trend to improved Overall Survival is observed when comparing Stable Disease, Partial Response and Complete Response patients. The combined efficacy data is superior to chemotherapy alone across all measures despite the intermittent narmafotinib dosing schedule employed (12 days of each 28 day treatment cycle). Subsequent trials will employ a daily dosing regimen of narmafotinib given the tolerability observed to date, which may lead to improved responses. Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein over-expressed in pancreatic cancer and a drug target gaining increasing attention for its role in solid tumors. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies. Narmafotinib is currently undergoing a clinical trial (the ACCENT trial) where it is dosed in combination with the chemotherapies gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer. The trial has already achieved its desired outcome in achieving a response rate of 31%, superior to chemotherapy alone and an interim PFS of 7.6 months has been reported. A second trial – AMPLICITY – has recently opened and is being run under an IND at two sites in Australia, investigating the combination of narmafotinib with the chemotherapy FOLFIRINOX in advanced pancreatic cancer patients. The ACCENT trial is entitled ‘A Phase 1b/2a, Multicenter, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients’. The trial is a single-arm open label study conducted in two stages. The first stage (Phase 1b), completed in November 2023, determined an optimal dose of narmafotinib (AMP945) by assessing the safety, tolerability, pharmacokinetics and preliminary efficacy when dosed in combination with gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer. The second stage (Phase 2a) of the trial is designed to assess efficacy in combination with gemcitabine and Abraxane. The primary endpoints are Objective Response Rate (ORR) and safety and tolerability, with secondary endpoints including Progression Free Survival (PFS) and Overall Survival (OS). The trial is being conducted at seven sites in Australia and five sites in South Korea. 
