Amplia Therapeutics has secured a significant validation of its lead drug candidate, signing a clinical collaboration agreement with global pharmaceutical giant Eli Lilly to evaluate narmafotinib alongside Lilly’s next-generation KRAS inhibitor, olomorasib.
The agreement expands Amplia beyond pancreatic and ovarian cancer into non-small cell lung cancer (NSCLC), opening the door to one of the world’s largest oncology markets.
A new indication with major upside
The Phase 1b/2 study will assess the safety and efficacy of combining narmafotinib with olomorasib as a second-line treatment for advanced NSCLC patients. The trial is expected to begin in late 2026 across Australia and the United States.
Importantly, Lilly will supply olomorasib for the study, allowing Amplia to pursue the program in a capital-efficient way while leveraging an established global pharmaceutical partner.
Tackling drug resistance
The collaboration is built around growing evidence that FAK activation is a key driver of resistance to KRAS G12C inhibitors.
Narmafotinib is designed to suppress those resistance pathways, potentially improving both the depth and duration of patient responses when combined with KRAS-targeted therapies.
The program also builds on encouraging data from Amplia’s ACCENT study, which has demonstrated promising efficacy signals without adding significant tolerability concerns over chemotherapy alone.
A much bigger market
The move materially broadens Amplia’s clinical footprint.
The global NSCLC market is estimated to be worth around US$31B today, with forecasts exceeding US$60B by 2033, while KRAS G12C mutations occur in around 13% of NSCLC patients.
Management said the collaboration represents an important step in positioning narmafotinib as a combination therapy across multiple high-value cancer indications.
What’s next?
Amplia will now work alongside Lilly to finalise the study protocol ahead of launching the Phase 1b/2 trial in late 2026, with investors set to watch for regulatory progress and the commencement of patient recruitment.
