Amplia signs Lilly deal to test FAK inhibitor in KRAS G12C lung cancer
Amplia Therapeutics has signed a Clinical Trial Collaboration and Supply Agreement with Eli Lilly, under which the two companies will evaluate whether adding Amplia's FAK inhibitor narmafotinib to Lilly's next-generation KRAS G12C inhibitor olomorasib can overcome resistance in patients with advanced non-small cell lung cancer. The Phase 1b/2b study is planned to start in late 2026 at sites in Australia and the United States, with Amplia conducting the trial and Lilly supplying olomorasib in kind.
The scientific premise rests on a well-documented vulnerability of approved KRAS G12C inhibitors: durable responses remain rare. Sotorasib and adagrasib, the two marketed KRAS G12C agents, show modest objective response rates in NSCLC of around 35–45% and median progression-free survival of only several months before resistance emerges. A growing body of preclinical work has implicated Focal Adhesion Kinase activation as a key adaptive mechanism that allows tumour cells to survive KRAS blockade, operating partly through FAK-YAP signalling and remodelling of the tumour microenvironment. Narmafotinib's role in this combination is to suppress that escape route.
The deal and pipeline context
Under the terms of the agreement, Amplia retains operational responsibility for the study. Lilly's contribution is the in-kind supply of olomorasib, which is currently being evaluated in two global Phase 3 registrational trials in NSCLC. No financial payments between the parties were disclosed. The arrangement gives Amplia access to a high-profile late-stage asset without the capital outlay of acquiring drug supply commercially, a model increasingly used by smaller biotechs seeking to test rational combinations alongside well-resourced partners.
For Amplia, the deal extends narmafotinib's clinical reach beyond pancreatic and ovarian cancer, its current focus areas. The company's ACCENT study in first-line pancreatic cancer has reported a response rate of 36% with narmafotinib added to gemcitabine and nab-paclitaxel, a median overall survival of 11.1 months, and a complete response rate of 7.8%. A second pancreatic study, AMPLICITY, and an ovarian cancer trial, PRROSE, are also in progress or imminent. Chief executive Chris Burns said the company and others had shown that combining FAK and KRAS inhibition "can lead to improved outcomes" and that he was keen to explore the pairing with olomorasib specifically.
Market and competitive landscape
NSCLC is among the most commercially valuable oncology segments. The source cites third-party estimates placing the current market at around US$31 billion, with projections above US$60 billion by 2033, though such forward-looking figures warrant caution given the pace of competitive change. KRAS G12C mutations are found in roughly 13% of NSCLC patients, a substantial addressable population given the overall incidence of the disease globally.
Beyond the approved sotorasib and adagrasib, a number of other KRAS G12C programmes are in development, and combination strategies pairing KRAS inhibition with SHP2 inhibitors, SOS1 inhibitors, and MEK pathway blockers are all under active clinical investigation. FAK inhibition as a resistance-reversal strategy is comparatively less explored in NSCLC specifically, which, if the clinical hypothesis holds, could differentiate narmafotinib in a crowded field. The strength of the Lilly partnership lends credibility to the scientific rationale, even though the study is early stage and efficacy data remain some way off. Investors will be watching for a confirmed trial start date, site activation in the US, and any interim safety readout as early signals of programme progress.