Amplia and Lilly Collaborate on Lung Cancer Trial Combining Narmafotinib and Olomorasib

Amplia and Lilly Join Forces to Target Lung Cancer Resistance

Amplia Therapeutics (ASX:ATX) has inked a Clinical Trial Collaboration and Supply Agreement with Eli Lilly, aiming to combine Amplia’s investigational FAK inhibitor narmafotinib with Lilly’s next-generation KRAS G12C inhibitor olomorasib. This partnership targets advanced non-small cell lung cancer (NSCLC) patients who have progressed beyond first-line therapy, addressing a critical need to overcome resistance to KRAS blockade.

The planned Phase 1b/2b trial will evaluate the safety and efficacy of this combination starting in late 2026 across Australian and US sites. Amplia will lead the study execution, while Lilly provides olomorasib in-kind, enabling a capital-efficient expansion of Amplia’s clinical footprint.

Strategic Leap Beyond Pancreatic and Ovarian Cancer

This collaboration marks a significant broadening of Amplia’s clinical development beyond its established pancreatic and ovarian cancer programs. Amplia’s CEO Dr Chris Burns highlighted the potential synergy, noting that FAK activation is a known driver of resistance to KRAS G12C inhibitors, and combining these agents could improve patient outcomes.

The NSCLC market currently sits at an estimated US$31 billion and is expected to nearly double by 2033. KRAS G12C mutations, the target of olomorasib, occur in roughly 13% of NSCLC cases, representing a sizeable addressable population. This move positions Amplia to tap into one of oncology’s most commercially significant segments.

Scientific Rationale Anchored in Resistance Mechanisms

KRAS G12C inhibitors like sotorasib and adagrasib have transformed treatment paradigms but suffer from modest response rates and short median progression-free survival, often only a few months. Preclinical and translational research implicates Focal Adhesion Kinase (FAK) as a central mediator of adaptive resistance, promoting tumour survival through pathways such as FAK-YAP signalling and tumour microenvironment remodelling.

Amplia’s narmafotinib is a potent and selective FAK inhibitor that has demonstrated promising efficacy signals and tolerability in its ACCENT pancreatic cancer trial, including a median overall survival of 11.1 months and a complete response rate of 7.8%. This trial builds on that foundation by exploring whether combining FAK inhibition with Lilly’s olomorasib can deepen and prolong the anti-tumour effects in NSCLC.

Leveraging Established Clinical Momentum and Resources

Amplia’s ACCENT trial has provided encouraging mature data, supporting the rationale for combination strategies and highlighting narmafotinib’s manageable safety profile and efficacy signals. This collaboration leverages that momentum while benefiting from Lilly’s ongoing global Phase 3 trials of olomorasib, which have established its safety and efficacy profile.

By partnering with Lilly, Amplia gains access to a cutting-edge KRAS inhibitor without the upfront costs of drug supply, enabling a more capital-efficient clinical expansion. This strategic approach aligns with Amplia’s broader ambition to position narmafotinib as a versatile oncology combination agent across multiple high-value indications.