Amplia Therapeutics Ltd (ASX:ATX, OTCQB:INNMF) has signed a clinical collaboration agreement with Eli Lilly and Company to evaluate its lead drug narmafotinib alongside Lilly’s next-generation KRAS G12C inhibitor olomorasib in patients with advanced non-small cell lung cancer (NSCLC).
The planned Phase 1b/2b trial will assess the safety and efficacy of the targeted combination as a second-line treatment for patients with KRAS G12C-mutated NSCLC.
Amplia will conduct the study at clinical sites in Australia and the United States, with enrolment planned to begin in late 2026.
Collaboration expands narmafotinib into lung cancer
The agreement broadens the clinical development of narmafotinib beyond Amplia’s existing pancreatic and ovarian cancer programs and positions the drug as a potential combination treatment across multiple high-value cancer indications.
Under the Clinical Trial Collaboration and Supply Agreement, Lilly will provide olomorasib for the study, allowing Amplia to advance the program in a capital-efficient manner.
The companies have already prepared an advanced draft of the clinical trial protocol and will now work together to finalise the protocol and associated study documentation.
Amplia chief executive officer and managing director Dr Chris Burns said the collaboration represented an important new stage in the development of narmafotinib.
“This collaboration is an exciting new stage in the clinical progression of narmafotinib,” Burns said.
“We and others have shown that the combination of FAK and KRAS inhibition can lead to improved outcomes, and we are excited to advance with this clinical study to explore the combination potential with olomorasib, Lilly’s leading KRAS G12C inhibitor currently undergoing two global Phase 3 studies in NSCLC.”
Targeting resistance to KRAS inhibitors
The study is supported by research indicating that focal adhesion kinase, or FAK, plays a central role in the development of resistance to KRAS G12C inhibitors.
While approved KRAS G12C inhibitors have improved treatment options for patients with advanced NSCLC, Amplia said the benefits are often short-lived, with many patients developing resistance after several months.
Narmafotinib is designed to inhibit FAK and suppress mechanisms that allow tumour cells to survive and continue growing following KRAS G12C treatment.
The combination with olomorasib is intended to deepen and prolong the therapeutic response by simultaneously targeting the KRAS mutation and the pathways associated with treatment resistance.
Olomorasib is a potent and selective next-generation KRAS G12C inhibitor being advanced by Lilly in two global Phase 3 registration studies in NSCLC.
Large addressable market
The collaboration gives Amplia exposure to the growing NSCLC treatment market, which the company said is currently valued at about US$31 billion and is forecast to exceed US$60 billion by 2033.
KRAS G12C mutations occur in about 13% of NSCLC patients and in between 1% and 3% of patients with other solid tumours.
Amplia said the agreement strengthens its strategy of developing narmafotinib as a versatile oncology combination agent capable of improving the effectiveness of existing and investigational cancer treatments.
Growing clinical evidence
The lung cancer study builds on results from Amplia’s ACCENT trial in advanced pancreatic cancer.
In that trial, narmafotinib was administered alongside the chemotherapy drugs gemcitabine and nab-paclitaxel.
Amplia has reported a response rate of 36%, median overall survival of 11.1 months and a complete response rate of 7.8%.
The company is also evaluating narmafotinib with mFOLFIRINOX chemotherapy in the AMPLICITY pancreatic cancer trial, while a separate ovarian cancer study, known as PRROSE, is scheduled to begin recruitment later in 2026.
About Amplia Therapeutics
Amplia Therapeutics is an Australian pharmaceutical company developing FAK inhibitors for cancer and fibrotic diseases.
Its lead candidate, narmafotinib, is a potent and selective FAK inhibitor targeting a protein that is overexpressed in several solid tumours.
The company’s development programs are focused primarily on fibrotic cancers, including pancreatic and ovarian cancer, while FAK may also have therapeutic potential in chronic fibrotic conditions such as idiopathic pulmonary fibrosis.