Amplia Signs Lilly Trial Collaboration in Lung Cancer

Amplia (ASX:ATX) Therapeutics announced it has executed a Clinical Trial Collaboration and Supply Agreement with Eli Lilly and Company to evaluate the combination of Amplia's investigational FAK inhibitor narmafotinib with Lilly's investigational KRAS G12C inhibitor olomorasib. The Phase 1b/2b clinical trial will evaluate the safety and efficacy of the combination as a second line treatment in patients with advanced stage non-small cell lung cancer (NSCLC). Under the terms of the agreement, Amplia will conduct the study, which is planned to begin in late 2026, at sites in Australia and the USA. Amplia said Lilly and Amplia worked together to finalise an advanced draft clinical study protocol prior to signing and will now collaborate to finalise both the protocol and other associated clinical study documents, with Lilly providing olomorasib in kind.

Amplia said the collaboration extends narmafotinib's clinical development beyond pancreatic and ovarian cancer into NSCLC, broadening the company's clinical footprint and addressable opportunity. It cited a growing body of preclinical and translational research identifying Focal Adhesion Kinase as a central mediator of adaptive resistance to KRAS G12C inhibition, and said Lilly is currently advancing olomorasib in two separate global Phase 3 registrational trials in NSCLC. Referencing a third-party market estimate, the company said the NSCLC market is currently valued at approximately US$31 billion and estimated to grow to over US$60 billion by 2033, and that KRAS G12C mutations occur in 13 per cent of patients with NSCLC and 1 to 3 per cent of patients with other solid tumours. CEO and Managing Director Dr Chris Burns described the collaboration as an exciting new stage in the clinical progression of narmafotinib. The announcement was approved and authorised for release by the Board of Amplia Therapeutics and Lilly.