Olomorasib - (LOXO-RAS-20001)

Aug. 3, 2026: Eli Lilly and Company (NYSE: LLY) said the FDA granted Breakthrough Therapy designation to olomorasib (LY3537982) monotherapy for adults with advanced pancreatic cancer harboring a KRAS G12C mutation who have received at least one prior systemic therapy. The designation was based on preliminary results from the open-label, multicenter Phase 1/2 LOXO-RAS-20001 study (NCT04956640) in KRAS G12C-mutant advanced solid tumors, including pancreatic cancer, though no efficacy numbers were disclosed.

Lilly said there are currently no approved therapies specifically targeting KRAS G12C-mutant pancreatic cancer. Olomorasib is an investigational oral KRAS G12C inhibitor.

The company also noted this is olomorasib’s second Breakthrough Therapy designation. The first was granted in September 2025 for olomorasib plus pembrolizumab as first-line treatment for locally advanced or metastatic KRAS G12C-mutant NSCLC with PD-L1 expression ≥50%.

Ongoing programs mentioned:

• LOXO-RAS-20001 (NCT04956640): Phase 1/2 monotherapy and combination study in KRAS G12C-mutant advanced solid tumors.
• SUNRAY-01 (NCT06119581): pivotal registrational global study of olomorasib plus pembrolizumab with or without chemotherapy in first-line advanced KRAS G12C-mutant NSCLC.
• SUNRAY-02 (NCT06890598): global study of olomorasib with standard-of-care immunotherapy in resected or unresectable KRAS G12C-mutant NSCLC.