ACCENT mature data presented at AACR Annual Meeting

The following press release was reproduced from here.

Amplia Therapeutics (ASX:ATX; OTCQB:INNMF) is presenting mature data from its ACCENT Phase 2a trial in metastatic pancreatic cancer at the AACR Annual Meeting as part of a mini-symposium entitled Advances in Precision Oncology being held in San Diego, USA today. 

The oral presentation, delivered by Amplia’s Director of Translational Biology, Dr Terrie-Anne Cock, provides further analysis of the promising efficacy and survival data recently reported for our best-in-class FAK inhibitor, narmafotinib, in combination with standard-of-care chemotherapy. 

Key highlights from the presentation include: 

• Narmafotinib shows a manageable toxicity profile with no added burden versus chemotherapy
• Independent central review confirmed 5 complete responses in 64 patients (8%) versus 0.2% with chemotherapy
• Overall response rate: 36% (42% including unconfirmed responses)
• Disease control rate: 70% versus 50% with chemotherapy
• Median overall survival: 11.1 months; median progression-free survival: 7.7 months—both more than two months longer than chemotherapy
• Trend toward improved overall survival across Stable Disease, Partial Response and Complete Response patients
• Efficacy exceeds chemotherapy across all endpoints despite intermittent dosing (12 days in each 28-day cycle)
• Future trials will employ daily dosing, which may further improve responses given observed tolerability 

Amplia CEO and Managing Director, Dr Chris Burns, commented:  

“These extremely promising clinical responses demonstrate the potential narmafotinib has in the treatment of this terrible disease. We are now focused on building on this promising data with additional clinical studies, including a pivotal study based on the ACCENT trial, as well as combination studies with the exciting new class of drugs called kRAS inhibitors.” 

Amplia Therapeutics Limited is an Australian pharmaceutical company advancing a pipeline of Focal
Adhesion Kinase (FAK) inhibitors for cancer and fibrosis. FAK is an increasingly important target in the field of cancer and Amplia has a particular development focus in fibrotic cancers such as pancreatic and ovarian cancer. FAK also plays a significant role in a number of chronic diseases, such as idiopathic pulmonary fibrosis (IPF). For more information visit www.ampliatx.com and follow Amplia on X (@ampliatx) and LinkedIn.

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.

Investor Contact:
Dr Chris Burns
Chief Executive Officer
[email protected]

U.S. Contact:
Robert Giordano
[email protected]
+1 917 327 3938

Amplia Media Contact:
Tom Trezona, H^CK Acting MD
[email protected]
+61 411 235 692

U.S. Media:
[email protected]