Lilly, Amplia to Evaluate Combined Investigational Treatments for Advanced NSCLC

Editor’s Take: Having a new oncology combination agent carries potential to enhance existing or investigational therapies in high value indications.

Amplia Therapeutics and Eli Lilly & Company have a new clinical trial collaboration and supply agreement. Namely, Amplia will leverage narmafotinib, its investigational best-in-class focal adhesion kinase (FAK) inhibitor.

Narmafotinib will combine with Lilly’s olomorasib, an investigational inhibitor of the KRAS G12C protein. KRAS G12C inhibitors have moved treatment forward. As single agents, however, they can be frequently short-lived. A need exists for a strategy that extends the benefits of the treatment.

NSCLC Trial Upcoming

A Phase Ib/IIb clinical trial is planned in patients with advanced stage non-small cell lung cancer (NSCLC). This will evaluate the novel targeted therapy combination’s safety and efficacy as a second line treatment for these patients.

“This collaboration is an exciting new stage in [narmafotinib’s] clinical progression,” Amplia CEO and Managing Director Chris Burns, PhD, said. “We and others have shown that the combination of FAK and KRAS inhibition can lead to improved outcomes. We are excited to advance with this clinical study to explore the combination potential with olomorasib.”

Amplia and Lilly Drugs Effective Separately

Burns added that olomorasib is already in two current global Phase III studies in NSCLC.

Narmafotinib, meanwhile, may be progressing to NSCLC from its previous clinical development in pancreatic and ovarian cancers. Amplia says current NSCLC market value is approximately $31 billion, and could grow to more than $60 billion by 2033.

Lilly’s supply of olomorasib, under the agreement terms, affords Amplia to pursue narmafotinib’s expansion into a high-value indication. Amplia wants  to position the treatment as a versatile oncology combination agent that can enhance existing or investigational therapies.

The agreement stipulates that Amplia will conduct the study, to begin at sites in Australia and the United States in late 2026.