Amplia Therapeutics Partners with Eli Lilly in FAK-KRAS Combination Lung Cancer Trial

Amplia Therapeutics (ASX: ATX) will partner with US drug maker Eli Lilly & Company on a Phase 1b/2b clinical trial to assess the combination of Amplia’s investigational focal adhesion kinase (FAK) inhibitor narmafotinib with Eli Lilly’s investigational KRAS G12C inhibitor olomorasib.

The companies have entered an agreement that will see Eli Lilly’s in-kind supply of olomorasib for the trial evaluate the safety and efficacy of the novel targeted therapy combination as a second-line treatment in patients with advanced stage non-small cell lung cancer (NSCLC).

In studies to date, olomorasib has demonstrated an efficacy and safety profile to support late-stage clinical development and Lilly is now advancing the drug in two separate, global Phase 3 registrational trials into NSCLC.

Amplia will commence work in late 2026 at sites in Australia and the US, with both companies moving towards finalising the clinical study protocol and associated documents.

Important Cell Protein

FAK is an increasingly important cell protein in the field of cancer and plays a significant role in chronic diseases such as idiopathic pulmonary fibrosis.

A growing body of preclinical and translational research has identified FAK as a central mediator of adaptive resistance to KRAS G12C inhibition.

Adaptive FAK activation supports tumour cell survival and proliferation, driving resistance through several interconnected mechanisms including FAK-YAP signalling, along with FAK-driven fibrogenesis and remodelling of the tumour microenvironment.

The new trial will build on promising clinical data from Amplia’s ACCENT study showing that narmafotinib had no significant tolerability burden over chemotherapy alone, at the same time extending its clinical development from pancreatic cancer into NSCLC and materially broadening Amplia’s addressable market.

Oncology Combination Agent

Amplia chief executive officer Dr Chris Burns said the collaboration with Lilly would position narmafotinib as a versatile oncology combination agent with potential to enhance therapies across several high-value indications.

“This collaboration is an exciting new stage in the clinical progression of narmafotinib,” he said.

“Amplia and other companies have shown that FAK and KRAS inhibition can lead to improved outcomes, and we are excited to advance this clinical study to explore the combination potential with olomorasib.”

The global NSCLC market is currently valued at approximately US$31 billion and forecast to grow to over US$60 billion by 2033 at a compound annual growth rate of 9.8%.

KRAS G12C mutations occur in 13% of patients with NSCLC and up to 3% of patients with other solid tumours.