Amplia Therapeutics Ltd (ASX: ATX) (OTCMKTS: INNMF) has signed a clinical collaboration agreement with Eli Lilly and Company (NYSE: LLY) to test its lead drug narmafotinib alongside Lilly’s next-generation KRAS G12C inhibitor olomorasib in patients with advanced non-small cell lung cancer.
Announced on Monday, the companies plan to launch a Phase 1b/2b clinical trial in late 2026 that will evaluate the combination as a second-line treatment for patients with KRAS G12C-mutated disease.
Amplia will conduct the study at clinical sites across Australia and the United States. Additionally, Lilly will supply olomorasib under the clinical trial collaboration and supply agreement, allowing Amplia to advance the program without bearing the full cost of providing both medicines.
The companies have already prepared an advanced draft of the trial protocol. They will now finalize the protocol and complete the remaining study documents before patient enrolment begins.
The agreement expands narmafotinib’s development beyond Amplia’s pancreatic and ovarian cancer programs. It also gives the company an opportunity to evaluate the drug in one of the largest cancer treatment markets.
Chief executive officer and managing director Dr. Chris Burns described the partnership as an important step for narmafotinib. He said previous research has suggested that combining focal adhesion kinase, or FAK, inhibitors with KRAS inhibitors may improve patient outcomes. Furthermore, he said the trial will examine that potential using olomorasib, which Lilly is currently evaluating in two global Phase 3 studies for non-small cell lung cancer.
Researchers believe FAK plays an important role in helping cancer cells resist KRAS G12C inhibitors. However, many patients who initially respond to KRAS-targeted drugs eventually see their disease progress after several months because tumours develop resistance.
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Collaboration provides a large commercial opportunity
Narmafotinib aims to block FAK, a protein involved in tumour growth and survival. Scientists believe the approach may prevent or delay resistance mechanisms that allow cancer cells to continue growing after KRAS inhibition.
The combination therapy targets both the KRAS mutation and the biological pathways linked to treatment resistance. Consequently, Amplia hopes the dual approach will produce deeper and longer-lasting responses than KRAS inhibition alone.
Olomorasib is Lilly’s next-generation KRAS G12C inhibitor. The drug is currently progressing through two global Phase 3 registration studies for patients with non-small cell lung cancer.
The collaboration also gives Amplia access to a large commercial opportunity. The company estimates the non-small cell lung cancer treatment market is worth about USD$31 billion today and could exceed USD$60 billion by 2033.
KRAS G12C mutations appear in about 13 per cent of patients with non-small cell lung cancer. They also occur in between 1 per cent and 3 per cent of patients with several other solid tumours.
Amplia believes narmafotinib could become a combination therapy across multiple cancers. Additionally, the company intends to evaluate the drug alongside both approved and investigational cancer treatments.
The lung cancer program builds on clinical work already underway in pancreatic cancer. Amplia previously tested narmafotinib with the chemotherapy drugs gemcitabine and nab-paclitaxel in its ACCENT trial for advanced pancreatic cancer.
The company reported a response rate of 36 per cent in that study. It also reported median overall survival of 11.1 months and a complete response rate of 7.8 per cent.
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Amplia develops medicines that target a protein found in solid tumours
Meanwhile, Amplia continues to evaluate narmafotinib with mFOLFIRINOX chemotherapy in its AMPLICITY pancreatic cancer trial. The company also plans to begin recruiting patients later in 2026 for PRROSE, a separate ovarian cancer study.
Amplia develops medicines that target FAK, a protein that is overexpressed in several solid tumours. Furthermore, the company believes FAK inhibitors may eventually have applications beyond oncology, including chronic fibrotic diseases such as idiopathic pulmonary fibrosis.
joseph@mugglehead.com
