Amplia Therapeutics Ltd Signs Eli Lilly Trial Supply Deal for Lung Cancer

Amplia signs Clinical Trial Collaboration & Supply Agreement with Eli Lilly for narmafotinib in lung cancer

Amplia Therapeutics (ASX:ATX) has executed a Clinical Trial Collaboration and Supply Agreement (CTCSA) with global pharmaceutical major Eli Lilly & Company, marking a significant external validation for the ASX biotech. The deal will evaluate Amplia’s investigational FAK inhibitor narmafotinib in combination with Lilly’s late-stage investigational KRAS G12C inhibitor olomorasib.

The collaboration centres on a Phase 1b/2b clinical trial assessing the safety and efficacy of this combination as a second-line treatment in patients with advanced-stage non-small cell lung cancer (NSCLC). The study is planned to begin in late 2026, at sites in Australia and the USA.

Financial terms of the agreement have not been disclosed. The agreement includes Lilly’s in-kind supply of olomorasib, meaning Amplia will conduct the study while Lilly provides its investigational drug. Neither drug is approved for commercial use.

The three headline points of the announcement are:

• A new CTCSA has been executed with Eli Lilly & Company.

• The collaboration is underpinned by narmafotinib’s growing base of clinical evidence and the scientific rationale that FAK activation is a key driver of resistance to KRAS G12C inhibitors.

• The deal extends narmafotinib beyond pancreatic and ovarian cancer into NSCLC, broadening Amplia’s clinical footprint and addressable opportunity.

Why the Lilly deal matters for Amplia investors

For an ASX developer, a collaboration with a global pharma major carries strategic weight beyond the science itself. The agreement rests on three pillars: leveraging narmafotinib’s growing clinical evidence base, an expanded addressable market, and capital-efficient execution.

The capital efficiency point is material. Lilly’s in-kind supply of olomorasib gives Amplia the ability to pursue a high-value indication without funding the partner drug, reducing the financial burden of entering a new and competitive therapeutic area.

The commercial opportunity is substantial. The NSCLC market is currently valued at approximately US$31 billion and is estimated to grow to over US$60 billion by 2033. KRAS G12C mutations occur in 13% of patients with NSCLC and in 1–3% of patients with other solid tumours, defining a clear target population within that market.

The science: how FAK inhibition tackles KRAS resistance

KRAS G12C inhibitors are drugs designed to block a specific mutation that drives certain cancers. Approved therapies such as sotorasib and adagrasib have advanced the treatment of KRAS G12C-mutant NSCLC and are approved for use after prior therapy. However, their clinical benefit as single agents is frequently short-lived.

Response rates are modest, the majority of patients develop resistance, and reported median progression-free survival is only several months. This creates a clear and urgent need for strategies that deepen and prolong the benefit of KRAS G12C blockade.

This is where Focal Adhesion Kinase (FAK) comes in. A growing body of preclinical and translational research has identified FAK as a central mediator of adaptive resistance to KRAS G12C inhibition. When cancer cells are treated, adaptive FAK activation supports tumour cell survival and proliferation, driving resistance through several interconnected mechanisms:

1. FAK–YAP signalling

2. FAK-driven fibrogenesis

3. Remodelling of the tumour microenvironment

Narmafotinib’s role is to suppress these resistance mechanisms via inhibition of FAK, potentially deepening and prolonging the benefit of KRAS blockade when used alongside olomorasib.

Preclinical data presented at the AACR Special Conference in March 2026 provided early mechanistic support for this approach, with narmafotinib restoring tumour responsiveness in a KRAS inhibitor-insensitive lung cancer model when combined with adagrasib.

Olomorasib is described by Lilly as a potent and highly selective next-generation KRAS G12C inhibitor. In studies to date, it has demonstrated an efficacy and safety profile that has supported later-stage clinical development, with Lilly now advancing the drug in two separate, global Phase 3 registrational trials in NSCLC.

Building on narmafotinib’s clinical momentum

The Lilly collaboration extends an already active development story rather than marking narmafotinib’s first clinical progress. The agreement is underpinned by data from Amplia’s ACCENT study in advanced pancreatic cancer, where narmafotinib is dosed in combination with the chemotherapies gemcitabine and nab-paclitaxel in first-line patients.

The ACCENT trial has reported a response rate of 36%, described as superior to chemotherapy alone as reported for the benchmark MPACT study. A median Overall Survival of 11.1 months has been reported, along with an unprecedented complete response rate of 7.8%. Importantly, narmafotinib showed no significant tolerability burden over chemotherapy alone.

These efficacy signals across responses and survival form the clinical evidence base that supports the rationale for combining FAK and KRAS inhibition.

Dr Chris Burns, CEO and Managing Director, Amplia Therapeutics

“This collaboration is an exciting new stage in the clinical progression of narmafotinib. 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.”

What comes next for Amplia

The immediate next step is procedural. Amplia and Lilly will collaborate to finalise the clinical study protocol and other associated clinical study documents, having already worked together to complete an advanced draft. The trial is planned to begin in late 2026 at Australian and US sites.

The deal also reinforces narmafotinib’s positioning as a versatile oncology combination agent across a broadening pipeline:

• ACCENT — advanced pancreatic cancer (first-line)

• AMPLICITY — advanced pancreatic cancer with mFOLFIRINOX, at Australian sites

• PRROSE — ovarian cancer, scheduled to begin recruiting later this year

• NSCLC — new combination with Lilly’s olomorasib

For investors, the collaboration broadens Amplia’s addressable opportunity and provides external validation of its FAK-inhibitor platform strategy. With multiple trials progressing across several high-value indications, the company now has multiple potential readouts ahead, spanning pancreatic, ovarian, and lung cancer programmes.

For investors wanting to understand the regulatory pathway for narmafotinib’s pancreatic cancer programme in greater depth, our dedicated guide to narmafotinib’s FDA-aligned pivotal trial covers the Phase 2b design, the orphan drug and fast track designations, and the expected data readout timeline through to Q2 2027.

Ready to Explore Amplia’s Expanding Narmafotinib Pipeline?

Amplia’s newly executed collaboration with Eli Lilly positions narmafotinib as a potential best-in-class FAK inhibitor across a broadening set of high-value oncology indications, from pancreatic and ovarian cancer to a NSCLC market forecast to exceed US$60 billion by 2033. The in-kind supply of olomorasib by Lilly underscores the capital-efficient nature of the deal, offering external validation of Amplia’s FAK-inhibitor platform strategy.

Investors seeking a deeper understanding of narmafotinib’s clinical programmes, pipeline, and development strategy can explore the full details at the Amplia Therapeutics investor centre, where the company’s broader vision across ACCENT, AMPLICITY, PRROSE, and the new NSCLC collaboration is outlined.